WHO has established several guidelines for quality control and standardization of herbal medicines. This includes guidelines for crude plant materials, processed plant materials, and analytical procedures. Key aspects that must be standardized include authentication of plant identity and source, absence of contaminants, determination of marker compounds, and ensuring safety through tests for heavy metals, pesticides, and microbiological limits. Proper application of WHO guidelines can help ensure the quality, safety and efficacy of herbal medicines.
The document provides an analysis of various Ayurvedic formulations including Brahmi hills, Diabohills juice, and Ashwagandha capsules. It discusses the preparation, composition, benefits, and HPTLC analysis of Brahmi Ghrita and Brahmi hills capsules to identify compounds like Bacoside A. The physicochemical properties of formulations like acid value, saponification value, and refractive index are also analyzed.
Standardization of herbal drugs ppt for webinar BhanuSagar3
This document discusses standardization and quality control of herbal drugs and multi-herbal formulations. It states that herbal drugs can be single herbs or combinations of plants in crude or processed forms. Quality evaluation through parameters like authenticity, purity and safety is required. Standardization of herbal drugs and formulations includes pharmacognostical, physicochemical and phytochemical analysis. Marker compounds are used for quality control but may transform or decompose in multi-herbal formulations, requiring isolation of new formulation-specific markers. A six-point protocol is recommended for efficient standardization and quality control of multi-herbal formulations.
In this power points viewer will be able to know the meaning of Pharmacopoeia and its coposition. History behind the different pharmacopoeia and popular pharmacopoeia existing world wide in herbal medicines. List of different pharmacopoeias also has been included.
This document provides an overview of the Ayurvedic Pharmacopoeia of India (API) and Ayurvedic Formulary of India (AFI). It discusses that the API is published by the Ministry of Ayush and contains 645 monographs in Part 1 and 202 in Part 2 describing single drugs and their formulations. The AFI contains compound Ayurvedic formulations and has published 444 formulations in Part 1 and 350 in Part 3. The Ayurvedic Pharmacopoeia Committee was established in 1962 to develop standards and monographs for drugs and formulations in the API and AFI.
Process of implementing and developing technical standards based on the consensus of different parties that include firms, users, interest groups, standards organizations and governments
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers.
The importance of medicinal plants in the treatment of a variety of human ailments man has been dependent on the higher plants as a source of food and medicine.
This document discusses the standardization of Ayurvedic formulations. It explains that standardization involves quantifying the purity, quality, identity and constituents of drugs and formulations. For churnas (powders), both Ayurvedic and modern parameters are used for standardization, including organoleptic evaluation, microscopy, physical analysis, phytochemical analysis, and testing for contaminants. Similar parameters are discussed for standardizing other formulations like asavas, arishtas, avalehas, vatis, gutikas, tailas, ghritas and arka. Shelf life testing is also important for ensuring formulations remain within approved specifications when stored properly.
The document provides an analysis of various Ayurvedic formulations including Brahmi hills, Diabohills juice, and Ashwagandha capsules. It discusses the preparation, composition, benefits, and HPTLC analysis of Brahmi Ghrita and Brahmi hills capsules to identify compounds like Bacoside A. The physicochemical properties of formulations like acid value, saponification value, and refractive index are also analyzed.
Standardization of herbal drugs ppt for webinar BhanuSagar3
This document discusses standardization and quality control of herbal drugs and multi-herbal formulations. It states that herbal drugs can be single herbs or combinations of plants in crude or processed forms. Quality evaluation through parameters like authenticity, purity and safety is required. Standardization of herbal drugs and formulations includes pharmacognostical, physicochemical and phytochemical analysis. Marker compounds are used for quality control but may transform or decompose in multi-herbal formulations, requiring isolation of new formulation-specific markers. A six-point protocol is recommended for efficient standardization and quality control of multi-herbal formulations.
In this power points viewer will be able to know the meaning of Pharmacopoeia and its coposition. History behind the different pharmacopoeia and popular pharmacopoeia existing world wide in herbal medicines. List of different pharmacopoeias also has been included.
This document provides an overview of the Ayurvedic Pharmacopoeia of India (API) and Ayurvedic Formulary of India (AFI). It discusses that the API is published by the Ministry of Ayush and contains 645 monographs in Part 1 and 202 in Part 2 describing single drugs and their formulations. The AFI contains compound Ayurvedic formulations and has published 444 formulations in Part 1 and 350 in Part 3. The Ayurvedic Pharmacopoeia Committee was established in 1962 to develop standards and monographs for drugs and formulations in the API and AFI.
Process of implementing and developing technical standards based on the consensus of different parties that include firms, users, interest groups, standards organizations and governments
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers.
The importance of medicinal plants in the treatment of a variety of human ailments man has been dependent on the higher plants as a source of food and medicine.
This document discusses the standardization of Ayurvedic formulations. It explains that standardization involves quantifying the purity, quality, identity and constituents of drugs and formulations. For churnas (powders), both Ayurvedic and modern parameters are used for standardization, including organoleptic evaluation, microscopy, physical analysis, phytochemical analysis, and testing for contaminants. Similar parameters are discussed for standardizing other formulations like asavas, arishtas, avalehas, vatis, gutikas, tailas, ghritas and arka. Shelf life testing is also important for ensuring formulations remain within approved specifications when stored properly.
Dr.Lavanya.S.A - standardization of herbal drugsDr.Lavanya .S.A
The document discusses the standardization of herbal drugs. It begins by introducing the growth of herbal medicine and the need for standardization. It then defines herbs, herbal drugs, and what standardization of herbal drugs refers to. The document outlines some of the key procedures for standardizing herbal drugs, including authentication, physical and chemical analysis, and microbiological and residue testing. It also discusses identifying crude drugs through systematic study, microscopic identification of features like stomata and veins, and various quantitative studies that can be done on crude drugs. Overall, the document provides an overview of the importance and processes involved in standardizing herbal medicines.
Formulation development of ayurvedic medicinesSwati Wadhawan
The document discusses Ayurvedic formulations including Arishtas, Avalehas, Churnas, and Gutikas. It provides examples of common Ayurvedic medicines like Jirakadyarishta and Amritadi churna. It outlines the ingredients, manufacturing process, quality parameters for testing, therapeutic uses and dosages of these Ayurvedic formulations. Classical Ayurvedic formulations are prepared according to texts like Charaka Samhita while proprietary medicines are developed by companies. The quality of finished products is evaluated using organoleptic, physical, chemical and microbiological parameters.
Research Guidline safety & efficacy of herbal drug.pptxEasy Concept
The Research guidelines for evaluating the safety and efficacy of herbal medicines are intended to facilitate the work of research scientists and clinicians in this field and to furnish some reference points for the governmental, industrial and non-profit organizations that provide financial support for their work.
It must be emphasized that these guidelines are offered as a summary of scientific standards governing various aspects of the study of herbal medicines.
This document describes various types of herbal and Ayurvedic formulations used in traditional Indian medicine. Some key formulations mentioned include decoctions (kvatha), powders (churna), pastes (kalka), oils (taila), medicated ghee (ghrita), pills/tablets (vatika, gutika), bhasmas (calcined metals), and rasa formulations (containing minerals). The document provides examples of common formulations for each type.
Standardization of herbal drugs refers to “confirmation of its identity and determination of its quality, purity and detection of nature of adulterant by various parameters”.
03 b. Preparation and Standardization of Ayurvedic Formulationphcognosy
This document discusses various Ayurvedic dosage forms and how they are standardized. It begins by categorizing Ayurvedic dosage forms into solid, semi-solid, liquid and powder forms. Examples of specific forms are provided like Asavas, Aristas, Vati, Gutika, Churna, Avaleha and Bhasmas. The document then describes the methods of preparation, characteristics and preservation of these various forms. It emphasizes the importance of standardizing both raw materials and manufacturing processes for Ayurvedic medicines. Parameters for standardizing extraction methods, solid dosages, semi-solids and finished products are outlined. The goal of standardization is to ensure safety, quality, and efficacy of Ayur
The Ayurvedic Pharmacopoeia of India is the official book of standards for single drugs and formulations in Ayurveda. It was established in 1962 and provides standards for identity, purity, strength and quality to ensure uniformity of finished formulations. It has published 8 volumes describing over 500 single drugs and 635 compound formulations. The Pharmacopoeia Laboratory for Indian Medicines was established in 2010 to analyze samples and provide reference standards to help regulate quality in Ayurvedic medicines.
Herbal medicine is the use of plants or plant extracts for medicinal purposes (especially plants that are not part of the normal diet).
Phytonutrient or nutraceutical or functional food
Natural substances that aid the body to maintaining health and combating disease such as anthocyanidins, isoflavones and carotenoids.
Natural product : is biosynthetic substances produced by living cells.
Crude Drug: It’s a medically useful drug of plant or animal origin without any further processing or modification.
The document discusses adulteration of herbal drugs, including the various methods of adulteration such as substitution with inferior or exhausted drugs, artificially manufactured substances, or harmful adulterants. It also discusses the reasons for adulteration like confusion in names, high prices, or intention to increase profits. Various types of adulteration are described like direct substitution or indirect unintentional adulteration. Methods to measure adulteration are outlined, including organoleptic, microscopic, chemical, physical, biological, and analytical evaluations.
This document provides guidelines for monitoring the safety of herbal medicines. It discusses the importance of including herbal medicines in pharmacovigilance systems to understand adverse effects from combined herbal and conventional medicine use. Sources of safety reports include healthcare professionals, consumers, hospitals, and manufacturers. National regulatory agencies are responsible for communicating safety information through various channels to facilitate safe and effective herbal medicine use.
1. Asava and Arishta are traditional Ayurvedic liquid fermented medicines made by soaking herbs in a solution of sugar or jaggery in an earthen pot for 1-3 months to undergo fermentation.
2. The key difference is that Arishta is prepared from a decoction of dried herbs while Asava uses fresh dried herbs.
3. The fermentation process is initiated by the addition of flowers from the Woodfordia fruticosa plant and produces medicines that are moderately alcoholic and sweet with slight acidity and aroma.
Role of Markers in Standardization of Herbal ProductsDr-Jitendra Patel
In this Power Point Presentation the viewer will be able to know the the different markers present naturally in herbal materials. These markers may be genitally, chemically and biochemically. How markers play major role during identification, authentication, quality control, quality assurance and determination of safety and efficacy of particular medicinal plant.
Portion covered:
1. Role of markers in standardization of herbal products
2. Factor influencing identification and quality of herbal Drugs
3. Meaning of Standardization
4. Types of Markers
5. Molecular or DNA Markers
6. Chemical Markers
7. Biochemical Markers
Shelf Life of Indian System of Medicine (ISM).pptxChhavi Singh
The document discusses self life and stability studies of formulations in Indian Systems of Medicine (ISM). It provides background on the three main systems of ISM - Ayurveda, Siddha, and Unani. It then discusses the importance of stability testing and shelf life determination to ensure safety and efficacy of ISM products over time. Key concepts from classical ISM texts on shelf life are presented. Guidelines for conducting stability studies outlined in the Ayurvedic Pharmacopoeia of India are summarized, including storage conditions, testing methods, evaluation criteria and protocols.
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
Analytical profile of medicinal plant by Puja GhoshPuja Ghosh
This document provides analytical profiles for the standardization of two medicinal plants - Emblica officinalis and Psoralea corylifolia. It describes the purpose of analytical profiling which is for quality control, standardization, and authentication of herbal raw materials. For each plant, it details morphological characteristics, physicochemical analysis parameters, phytochemical screening, TLC and HPTLC fingerprints, and HPLC analysis of marker compounds. The major chemical constituents and marker compounds of each plant are also stated.
shelf life and Stability test for Ayurvedic drugs.pptxANIKETH SURVE
This document discusses shelf life and stability studies for Ayurvedic medicines. It provides guidelines on determining shelf life based on real-time stability studies as specified in the Ayurvedic Pharmacopoeia of India. Key factors that affect shelf life are discussed such as derivation of the drug, dosage form, environmental factors, and storage conditions. Specific shelf life guidelines are provided for different categories of Ayurvedic medicines based on their composition. The purpose and approaches to stability testing are explained to establish a retest period or shelf life. Testing frequency, storage conditions, evaluation criteria and what constitutes a significant change are also outlined.
Herbal medicines have gained lot of popularity, however the side effects associated have been neglected due to lack of knowledge and belief. Hence the Pharmacovigilance of herbal drugs needs to be addressed by educating the common people though campaigns.
The document discusses guidelines for quality control and standardization of herbal medicines provided by the World Health Organization (WHO). It defines key terms like quality, safety, purity and potency. It outlines the need for quality control to reduce adulteration and ensure proper authentication, validation of claims, and safety. The WHO guidelines provide standardization procedures for herbal drugs, including definitions, authentication, absence of contaminants, microscopic and chromatographic analysis. It also discusses analytical procedures like botanical, physicochemical, biological and toxicological parameters for testing herbal medicines.
The document discusses the evaluation of herbal drugs. It explains that evaluation is necessary to identify herbs, determine quality and purity, and detect adulteration. Various evaluation methods are described, including organoleptic, microscopic, physical, chemical, and biological methods. Standards and limits are set by organizations like WHO to ensure the safety of herbal medicines with regards to contaminants and residues. Proper identification, testing, and storage of herbal drugs is important for stability and quality.
Dr.Lavanya.S.A - standardization of herbal drugsDr.Lavanya .S.A
The document discusses the standardization of herbal drugs. It begins by introducing the growth of herbal medicine and the need for standardization. It then defines herbs, herbal drugs, and what standardization of herbal drugs refers to. The document outlines some of the key procedures for standardizing herbal drugs, including authentication, physical and chemical analysis, and microbiological and residue testing. It also discusses identifying crude drugs through systematic study, microscopic identification of features like stomata and veins, and various quantitative studies that can be done on crude drugs. Overall, the document provides an overview of the importance and processes involved in standardizing herbal medicines.
Formulation development of ayurvedic medicinesSwati Wadhawan
The document discusses Ayurvedic formulations including Arishtas, Avalehas, Churnas, and Gutikas. It provides examples of common Ayurvedic medicines like Jirakadyarishta and Amritadi churna. It outlines the ingredients, manufacturing process, quality parameters for testing, therapeutic uses and dosages of these Ayurvedic formulations. Classical Ayurvedic formulations are prepared according to texts like Charaka Samhita while proprietary medicines are developed by companies. The quality of finished products is evaluated using organoleptic, physical, chemical and microbiological parameters.
Research Guidline safety & efficacy of herbal drug.pptxEasy Concept
The Research guidelines for evaluating the safety and efficacy of herbal medicines are intended to facilitate the work of research scientists and clinicians in this field and to furnish some reference points for the governmental, industrial and non-profit organizations that provide financial support for their work.
It must be emphasized that these guidelines are offered as a summary of scientific standards governing various aspects of the study of herbal medicines.
This document describes various types of herbal and Ayurvedic formulations used in traditional Indian medicine. Some key formulations mentioned include decoctions (kvatha), powders (churna), pastes (kalka), oils (taila), medicated ghee (ghrita), pills/tablets (vatika, gutika), bhasmas (calcined metals), and rasa formulations (containing minerals). The document provides examples of common formulations for each type.
Standardization of herbal drugs refers to “confirmation of its identity and determination of its quality, purity and detection of nature of adulterant by various parameters”.
03 b. Preparation and Standardization of Ayurvedic Formulationphcognosy
This document discusses various Ayurvedic dosage forms and how they are standardized. It begins by categorizing Ayurvedic dosage forms into solid, semi-solid, liquid and powder forms. Examples of specific forms are provided like Asavas, Aristas, Vati, Gutika, Churna, Avaleha and Bhasmas. The document then describes the methods of preparation, characteristics and preservation of these various forms. It emphasizes the importance of standardizing both raw materials and manufacturing processes for Ayurvedic medicines. Parameters for standardizing extraction methods, solid dosages, semi-solids and finished products are outlined. The goal of standardization is to ensure safety, quality, and efficacy of Ayur
The Ayurvedic Pharmacopoeia of India is the official book of standards for single drugs and formulations in Ayurveda. It was established in 1962 and provides standards for identity, purity, strength and quality to ensure uniformity of finished formulations. It has published 8 volumes describing over 500 single drugs and 635 compound formulations. The Pharmacopoeia Laboratory for Indian Medicines was established in 2010 to analyze samples and provide reference standards to help regulate quality in Ayurvedic medicines.
Herbal medicine is the use of plants or plant extracts for medicinal purposes (especially plants that are not part of the normal diet).
Phytonutrient or nutraceutical or functional food
Natural substances that aid the body to maintaining health and combating disease such as anthocyanidins, isoflavones and carotenoids.
Natural product : is biosynthetic substances produced by living cells.
Crude Drug: It’s a medically useful drug of plant or animal origin without any further processing or modification.
The document discusses adulteration of herbal drugs, including the various methods of adulteration such as substitution with inferior or exhausted drugs, artificially manufactured substances, or harmful adulterants. It also discusses the reasons for adulteration like confusion in names, high prices, or intention to increase profits. Various types of adulteration are described like direct substitution or indirect unintentional adulteration. Methods to measure adulteration are outlined, including organoleptic, microscopic, chemical, physical, biological, and analytical evaluations.
This document provides guidelines for monitoring the safety of herbal medicines. It discusses the importance of including herbal medicines in pharmacovigilance systems to understand adverse effects from combined herbal and conventional medicine use. Sources of safety reports include healthcare professionals, consumers, hospitals, and manufacturers. National regulatory agencies are responsible for communicating safety information through various channels to facilitate safe and effective herbal medicine use.
1. Asava and Arishta are traditional Ayurvedic liquid fermented medicines made by soaking herbs in a solution of sugar or jaggery in an earthen pot for 1-3 months to undergo fermentation.
2. The key difference is that Arishta is prepared from a decoction of dried herbs while Asava uses fresh dried herbs.
3. The fermentation process is initiated by the addition of flowers from the Woodfordia fruticosa plant and produces medicines that are moderately alcoholic and sweet with slight acidity and aroma.
Role of Markers in Standardization of Herbal ProductsDr-Jitendra Patel
In this Power Point Presentation the viewer will be able to know the the different markers present naturally in herbal materials. These markers may be genitally, chemically and biochemically. How markers play major role during identification, authentication, quality control, quality assurance and determination of safety and efficacy of particular medicinal plant.
Portion covered:
1. Role of markers in standardization of herbal products
2. Factor influencing identification and quality of herbal Drugs
3. Meaning of Standardization
4. Types of Markers
5. Molecular or DNA Markers
6. Chemical Markers
7. Biochemical Markers
Shelf Life of Indian System of Medicine (ISM).pptxChhavi Singh
The document discusses self life and stability studies of formulations in Indian Systems of Medicine (ISM). It provides background on the three main systems of ISM - Ayurveda, Siddha, and Unani. It then discusses the importance of stability testing and shelf life determination to ensure safety and efficacy of ISM products over time. Key concepts from classical ISM texts on shelf life are presented. Guidelines for conducting stability studies outlined in the Ayurvedic Pharmacopoeia of India are summarized, including storage conditions, testing methods, evaluation criteria and protocols.
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
Analytical profile of medicinal plant by Puja GhoshPuja Ghosh
This document provides analytical profiles for the standardization of two medicinal plants - Emblica officinalis and Psoralea corylifolia. It describes the purpose of analytical profiling which is for quality control, standardization, and authentication of herbal raw materials. For each plant, it details morphological characteristics, physicochemical analysis parameters, phytochemical screening, TLC and HPTLC fingerprints, and HPLC analysis of marker compounds. The major chemical constituents and marker compounds of each plant are also stated.
shelf life and Stability test for Ayurvedic drugs.pptxANIKETH SURVE
This document discusses shelf life and stability studies for Ayurvedic medicines. It provides guidelines on determining shelf life based on real-time stability studies as specified in the Ayurvedic Pharmacopoeia of India. Key factors that affect shelf life are discussed such as derivation of the drug, dosage form, environmental factors, and storage conditions. Specific shelf life guidelines are provided for different categories of Ayurvedic medicines based on their composition. The purpose and approaches to stability testing are explained to establish a retest period or shelf life. Testing frequency, storage conditions, evaluation criteria and what constitutes a significant change are also outlined.
Herbal medicines have gained lot of popularity, however the side effects associated have been neglected due to lack of knowledge and belief. Hence the Pharmacovigilance of herbal drugs needs to be addressed by educating the common people though campaigns.
The document discusses guidelines for quality control and standardization of herbal medicines provided by the World Health Organization (WHO). It defines key terms like quality, safety, purity and potency. It outlines the need for quality control to reduce adulteration and ensure proper authentication, validation of claims, and safety. The WHO guidelines provide standardization procedures for herbal drugs, including definitions, authentication, absence of contaminants, microscopic and chromatographic analysis. It also discusses analytical procedures like botanical, physicochemical, biological and toxicological parameters for testing herbal medicines.
The document discusses the evaluation of herbal drugs. It explains that evaluation is necessary to identify herbs, determine quality and purity, and detect adulteration. Various evaluation methods are described, including organoleptic, microscopic, physical, chemical, and biological methods. Standards and limits are set by organizations like WHO to ensure the safety of herbal medicines with regards to contaminants and residues. Proper identification, testing, and storage of herbal drugs is important for stability and quality.
The document discusses standardization of herbal formulations, which is essential to ensure quality, safety, and efficacy. It outlines various techniques used for standardization, including authentication of raw materials, assessment of identity, purity, and content/assay. Key aspects of standardization addressed are quality control procedures, stability assessment and shelf-life determination, and safety and efficacy evaluation. The World Health Organization provides guidelines for quality control of herbal drugs and standardized herbal formulations.
This document provides a review of standardization techniques for herbal formulations. It discusses the importance of standardizing herbal drugs to ensure quality, safety, and efficacy. Various parameters for standardization are described, including authentication of raw materials, assessment of purity, content/assay, stability testing, safety evaluation, and efficacy assessment. Techniques used for standardization include pharmacognostic evaluation, physico-chemical analysis, chemical characterization, chromatographic methods, toxicity testing, and clinical trials. The World Health Organization guidelines for quality control of herbal drugs are summarized. Several examples of standardized Indian herbal formulations are also mentioned. Overall, the document outlines the key factors and analytical methods used in the standardization of herbal medicines.
WHO guidelines provide criteria for assessing quality, safety, and efficacy of herbal medicines. Key steps include authentication of plant materials, testing for contaminants like heavy metals and microbes, and ensuring consistency of finished products through identification of active constituents. Quality is evaluated through parameters like microbial limits, extractive values, and chromatography. Safety assessment considers traditional use and toxicology studies. Efficacy depends on intended use and documentation of traditional experience or medical history. Proper identification, manufacturing, and stability testing help ensure herbal medicines meet quality standards.
It's about the Standardization of herbal drugs.
It's includes
# Definition of herbs
# Herbal drugs definition
# Herbal technology
# Standardization definition
# Methods of Standardization of herbal drugs
Standardization of Poly Herbal Siddha Medicine Eladhi Chooranaminventionjournals
International Journal of Pharmaceutical Science Invention (IJPSI) is an international journal intended for professionals and researchers in all fields of Pahrmaceutical Science. IJPSI publishes research articles and reviews within the whole field Pharmacy and Pharmaceutical Science, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
The WHO guidelines provide technical guidance for monitoring the safety of herbal medicines within pharmacovigilance systems. They were developed to enhance monitoring of herbal medicine safety within current pharmacovigilance systems. The guidelines define key terms related to herbal medicines and contaminants. They provide guiding principles for assessing herbal medicine safety with regards to contaminants and residues, including determining levels of toxic metals, radioactive contaminants, aflatoxins, and microbiological contaminants. The objectives are to provide guidance on quality assessment criteria and methods to control herbal medicine quality relating to safety.
75%-90% of the population in developing nations rely on herbal medicine as their only health care.
Medicinal herbs are sold alongside vegetables in village markets.
Practitioners of herbal medicine undergo extensive training to learn the plants, their uses, and preparation of remedies.
The European Medicines Agency and regulatory authorities in the EU prepare scientific guidelines to help applicants for herbal medicine marketing authorization. The guidelines provide a harmonized approach across EU states for demonstrating quality, safety, and efficacy of herbal medicines. They include guidelines on good practices for herb cultivation and collection, quality control of herbal substances and preparations, assessing genotoxicity and clinical safety/efficacy of herbal medicines, and public statements on allergic risks and contamination issues.
The World Health Organization (WHO) Herbal Guideline is a comprehensive and authoritative document intended to provide standardized recommendations and principles for the safe and effective use of herbal medicines worldwide. This guideline is developed by a panel of experts in herbal medicine, pharmacology, and public health, amalgamating the most up-to-date research, traditional knowledge, and clinical evidence available.
Role of chemical & biological marker.pptxEasy Concept
Standardization and quality control of herbal medicines requires the use of markers. There are three main types of markers - DNA markers, biochemical markers, and chemical markers. DNA markers can be used for authentication of medicinal plants, genetic variation, herbal drug technology, and more. Biochemical markers like isozymes are useful for distinguishing closely related species. Chemical markers indicate quality and can be used for authentication, differentiation, determining harvesting times, and assessing extraction methods. Markers have various applications including identification of adulterants and determination of lead compounds.
This document discusses quality control of herbal drugs. It begins by defining quality control and quality assurance, noting that QA aims to prevent defects by focusing on the production process, while QC focuses on identifying defects in the final product. Several parameters for quality control of herbal drugs are then outlined, including organoleptic evaluation, microscopic evaluation, ash value testing, determining heavy metal contamination, testing for microbes and aflatoxins, screening for pesticides and fumigants, and checking for radioactive material. The document stresses the importance of quality control to ensure herbal drugs are efficacious and safe.
This document discusses biological and chemical markers for quality control of herbal medicines. It notes that careful selection of plant material and a standardized manufacturing process are needed to keep herbal medicine constituents constant for reproducible results. DNA-based molecular markers and chemical markers are described as tools for identifying plants, detecting adulteration, assessing quality, and standardizing herbal medicines. The document outlines various applications of both DNA and chemical markers in herbal drug technology, authentication, identification, and quality control.
Quality Control methodologies for standardization of herbal medicines: an ass...RAJA CHAKRAVERTY
This document discusses quality control methodologies for standardizing herbal medicines. It outlines several key procedures for standardization, including authentication of the plant species, assessment of physical parameters, quantitative and qualitative chemical analysis, and microbiological and toxic contaminant testing. The World Health Organization has established guidelines for herbal drug standardization that reference identity, physicochemical characteristics, pharmacological properties, toxicity, and microbiological quality. Proper standardization of herbal medicines is important to ensure their safety, efficacy and consistency from batch to batch.
In this pdf, you will get information about manufacturing , standardization , validation , processing , etc. for herbal drugs followed by the WHO guidelines.
This document provides an overview of the regulatory aspects of herbal medicines in India, Europe, and the United States. It discusses the key regulatory bodies and guidelines around herbal medicines in each region. In India, herbal medicines are regulated by the Ayush Ministry, ICMR, and Drugs and Cosmetics Act. In Europe, herbal medicines fall under European directives and are evaluated by the EMA and HMPC. In the US, herbal products are classified and regulated differently depending on if they are considered a dietary supplement, food, or drug.
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Travel Clinic Cardiff: Health Advice for International TravelersNX Healthcare
Travel Clinic Cardiff offers comprehensive travel health services, including vaccinations, travel advice, and preventive care for international travelers. Our expert team ensures you are well-prepared and protected for your journey, providing personalized consultations tailored to your destination. Conveniently located in Cardiff, we help you travel with confidence and peace of mind. Visit us: www.nxhealthcare.co.uk
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central19various
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
pathology MCQS introduction to pathology general pathology
Standar who obat tradisional.ppt
1. WHO Guidelines for Quality
Control & Standardization of
Herbal Drugs
By: Sandeep Kumar Singh
Pre Ph.D. Course work
Enrol No. Ph.D./PHR/12/033
Guru Ghasidas Vishwavidyalaya, Bilaspur
2. Contents
− Definitions of relevant terms
− Need of quality control
− Safety in quality management
− Ishikawa diagram
− Constraints in quality control of herbal drugs
− Three pillars of ideal herbal drug and their rational use
− World health organization
− Guidelines provided by WHO for herbals
− Standardization of herbal drugs crude plant Parts/plant material
− Processed plant materials/non-plant materials
− Flow diagram standardization
− Analytical procedures
− References
2
3. Herbal medicines are the oldest form of
healthcare known to humanity and has been used in
all cultures throughout history
3
4. 4
The definitions of terms that will be encountered in the
discussion are given:
Quality : status of a drug that is determined by identity,
purity, content, and other chemical, physical or biological
properties
Safety : to assure the drug didn’t have any hazardous effect
Purity: not contaminated with potentially harmful substances
Potency: is the content of active constituents within the
defined limits?
Identity: is the herb the one it should be?
Quality control : it refers to processes involved in
maintaining the quality and validity of a manufactured
product
Definitions of relevant terms
5. 5
Definition continued…
Herbal preparations
are preparations obtained by scientific treatments such as
extraction, distillation, fractionation, purification, or
fermentation. These include comminuted or powdered herbal
substances, tinctures, extracts, essential oils and processed
exudates
Herbal substances
are precisely defined by the plant part used (leaves,
stems, rhizomes, roots and bark)
Certain exudates that have not been subjected to a
specific treatment are also considered to be herbal substances
Markers
are chemically defined constituents or groups of
constituents of a herbal substance, which are of interest for
control purposes, independent of whether they have any
therapeutic activity
6. Need of quality control
– Quality control and standardization
– Reduce adulterations with substandard drugs
– Improper authentication
– Scientific validation of the therapeutic claims
– Identity, purity, efficacy and safety
– Customer satisfaction and confidence
6
7. Adulteration with other
medicines
Mistaken use of wrong
species
Incorrect dosing
Poor quality products
Toxicity
Interactions with other
medicines
Problems
Misconception that all
herbs are safe
Misuse of herbal drugs
Safety in quality management
8. Ishikawa cause and effect diagram for content
variation of herbal drugs
8
*Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality control principles to
herbal drugs. International Journal of Phytomedicine 1(2009); p. 4-8.
9. Regulatory Aspects
Adulteration/
Substitution
No Certification of Raw
Materials
Pharmacovigilence Data
Not Collected
Herbal Pharmacopoeia?
Lack of Public Test Houses
Lack of Safety Evaluation
Facility
Poor Investment In R&D Of
HMP
Constraints in Quality
Control of Herbal Drug
Products
Main Dependence on
Wild Sources
Lack of Trained Man
Power
Constraints in quality control of herbal drugs
10. Three pillars of ideal herbal drug and their
rational use
QUALITY
EFFICACY
SAFETY
AVAILABILITY
ACCESSABILITY
QUALITY
SAFETY
EFFICACY
Appropriate use of
herbal drug
10
11. World Health Organization
− The World Health Organization (WHO) is a
specialized agency of the United Nations (UN) that is
concerned with international public health
− It was established on 7 April 1948, with its headquarters
in Geneva, Switzerland
− WHO is a member of the United Nations Development
Group (UNDP)
− World Health Organization, provides guidelines for
prevention, control, safety, efficacy as well as
evaluation and standardisation of herbal materials (e.g.
WHO, 2005, 2002a,b, 1999a,b, 1998a,b, 1996a,b, 1990,
1981, 1979)
11
13. Guidelines provided by WHO for herbals
A set of guideline for the assessment of
herbal remedies has been published by
WHO. These guidelines specify criteria to
be used in evaluating commercial crude
drugs intended for use (WHO Traditional
Medicine Strategy 2002-2005).
WHO guidelines on safety monitoring of
herbal medicines in pharmacovigilance
systems (2004).
14. Quality control methods for medicinal
plant materials (1998).
WHO Guidelines on good
manufacturing Practices (GMP) for
Herbal Medicines (2005).
Guidelines continued…
16. WHO Guidelines For Assessing
Quality of Herbal Medicine With
Reference to Contaminants and
Residues (2007).
Basic tests for drugs – Pharmaceutical
substances, Medicinal plants materials
and dosage forms (1998).
Guidelines continued…
17. General Guidelines for
Methodologies on Research and
Evaluation of Traditional Medicine
(2000).
WHO Guidelines on GACP for
Medicinal Plants (2003).
Guidelines continued…
18. Research Guidelines for Evaluating the
Safety and Efficacy of Herbal
Medicines (1993).
Regulatory Situation of Herbal
Medicines - A Worldwide Review
(1998).
Guidelines continued…
19. Standardization of herbal drugs crude plant
parts/plant material
Definition:
− name of plant
− part of plant
− Nature/condition of material: whole, powdered, fresh, dried, etc
Authentication/confirmation of:
− Correct geographical origin
− Correct stage of growth
Absence of foreign matter:
− other plant parts or materials
− soil, stones, dust
− insects and other animal matter (as determined by microscopy, macroscopy, chromatography)
Microscopic characteristics confirming identity:
− qualitative features
− quantitative features, (e.g. stomatal number)
Radioactive contamination limits: arising from environmental pollution or microbial
decontamination procedures
Assay: for materials containing constituents of known therapeutic activity, or known unique (marker)
compounds. Non-specific assay methods for groups of compounds may be used where specific
assay methods are not available for single compounds
19
20. Processed plant materials/non-plant materials (extracts,
tinctures, comminutions etc.)
Definition: liquid, solid, etc
Organoleptic characteristics:
− Macroscopy
− Smell
− Taste
− Texture
− Colour
Chromatographic profile using more than one method:
− to confirm presence of unique compounds (markers)
− to confirm characteristic TLC chromatogram
− to confirm characteristic HPTLC chromatogram (TLC + densitometry = HPTLC)
Water content (for hygroscopic materials):
Ash values: indicate extent of contamination with inorganic material. Determined by
incineration. Values include acid insoluble and sulphated ash
Volatile matter: for plants containing volatile oils:
− Determined by steam
− Distillation
Powdered material: test method and acceptable limits for particle size, distribution
20
21. continued...
If the product is a mix of plant materials, the supplier must provide evidence that
each
component plant has been individually tested.
Heavy metal limits: from environmental pollution and pesticides
Microbial contamination limits: microbial contamination arises from cultivation,
harvesting, processing and storage:
− confirmation of absence of E. coli, S. aureus, P. aeruginosa and
− Salmonella
− limits for aflatoxins (fungal toxins)
Residual solvents from processing
Pesticide residue limits: arising from cultivation (FAO and WHO limits)
Extractive values: extraction by different solvents indicates proportion of polar and
non-polar components
Assay: for materials containing constituents of known therapeutic activity, or known
unique (marker) compounds;
− Non-specific assay methods for groups of compounds may be used where
specific assay methods are not available for single compounds
21
23. Analytical procedures
Botanical parameters:
– Sensory evaluation: including visual macroscopy/
touch/odour/taste
– Foreign matter: including foreign plants, foreign
animals, foreign minerals, etc.
– Microscopy: including histological observation and
measurements
23
*Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.
** Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier Pub., 2006.
24. continued…
Physico-chemical methods:
− Ash values: Total, acid insoluble, water soluble
− Extractive values: in hot water, cold water and ethanol,
− Volatile matter: Loss on drying,
− Volatile oils: by steam distillation.
− Determination of crude fibers,
− Determination of moisture content.
24
25. continued…
Biological parameters:
− Bitterness value: unit equivalent bitterness of standard
solution of Quinine HCI
− Hemolytic property: on ox blood by comparison with
standard reference solution of saponin
− Astringent property: tannins that bind to standard
Frieberg Hide powder
− Swelling index: in water
− Foaming index: foam height produced by 1g material
under specified conditions
25
26. continued…
Toxicological parameters:
These include the various identification procedures:
− Arsenic: stain produced on HgBr2 paper in comparison
to standard stain
− Pesticide residues: including total organic chloride and
total organic phosphorus
− Heavy metals: like cadmium, mercury and lead
− Microbial contaminations: total viable aerobic count of
pathogens; viz. Enterobacteriaceae, E. Coli, Salmonella,
P. aeruginosa, S. aureous, (e.g. Mellilotus officinalis)*
− Aflatoxins: by TLC using standard aflatoxins (B1, B2, G1
and G2)
− Radioactive contaminations
26
*Warude D., Patwardhan B. Quality and Regulatory Issues. Journal of Scientific and
Industrial Research. Vol. 64, Feb 2005; p. 83-92.
27. References
− Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.
− EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional
Medicinal Products, EMEA/CVMP/814OO Review. European Agency
for the Evaluation of Medicinal Products (EMEA), London, 2005.
− Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to
Evaluation of Botanicals. Business Horizons Publishers, New Delhi,
India, 2002.
− Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I ,
Carrier Pub., 2006.
− Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality
control principles to herbal drugs. International Journal of Phytomedicine
1(2009); p. 4-8.
− WHO. Quality Control Methods for Medicinal Plant Materials, World
Health Organization, Geneva, 1998. WHO. Guidelines for the
Appropriate Use of Herbal Medicines. WHO Regional Publications,
Western Pacific Series No 3, WHO Regional office for the Western
27
28. continued…
− WHO. The International Pharmacopeia, Vol. 2: Quality Specifications,
3rd edn. World Health Organization, Geneva, 1981.
− WHO. Quality Control Methods for Medicinal Plant Materials. World
Health Organization, Geneva, 1999.
− WHO. WHO Global Atlas of Traditional, Complementary and
Alternative Medicine. 2 vol. set. Vol. 1 contains text and Vol. 2, maps.
World Health Organization, Geneva, 2005.
− WHO. Guidelines on Good Agricultural and Collection Practices
(GACP) for Medicinal Plants. World Health Organization, Geneva, 2004.
− Warude D., Patwardhan B. Batanicals: Quality and Regulatory Issues.
Journal of Scientific and Industrial Research. Vol. 64, Feb 2005; p. 83-92.
28