This document contains an assessment activity from LNBC Institute of Pharmacy in Satara, India for a Herbal Drug Technology subject. It includes 3 questions with multiple parts assessing students' knowledge of herbal drugs. Question 1 has 10 short answer questions on topics like the definitions of herbs and herbal medicine, herbal cosmetics, determination methods for crude drugs, and differences between genotype and phenotype. Question 2 has 7 longer answer questions requiring descriptions of herbal formulation methods and importance. Question 3 has 2 essay questions about nutraceuticals and assessing herbal drug quality according to WHO guidelines.

1. LNBC INSTITUTE OF PHARMACY, RAIGAON, SATARA
ASSESSMENT ACTIVITY (ANSWERS)
Subject: HERBAL DRUG TECHNOLOGY
TOTAL: 75 MARKS DATE: 13th
to 15th
April 2020
Q.No.1 Solve 10 questions (2x10=20Marks)
1. What are Herb& Herbal Medicine
ANS: “Herb”: herb generally refers to the leafy green or flowering parts of a plant, while
spices are usually dried & produced from other parts of the plant including seeds, bark,
roots, and fruits & herb also have aromatic property used in medicinal purpose &
garnishing food.
“Herbal Medicine”: The art or practice of using herbs & herbal preparations to
maintain health & to prevent or curedisease.
2. Write inbrief about herbal cosmetics
ANS: It is a product, are formulated, using various permissible cosmetic ingredients to form
the base in which one or more herbal ingredients are used to provide cosmetics benefits
only & these products also possess desirable physiological activity such as skin, healing,
smoothening, appearance, enhancing & conditioning properties with the help of herbal
ingredients.
3. Write inbrief about ASH value
ANS: ASH value is a criterion to judge the identity or purity of the crude drug & it can be
determined on the ash content means the remaining residue after incineration of the drug
(i.e. inorganic salts of carbohydrates, phosphates, silicates of sodium, potassium, calcium &
magnesium).

2. 4. How the sweeling index determinationis done for crude drug
ANS:Procedure:
i. Take 1 gm of crude drug.
ii. Transfer into a 25 ml stoppered measuring cylinder.
iii. Fill the measuring cylinder upto 20 mark with specified sweeling agent.
iv. Agitate gently occasionally during 24 hour & allow to stand.
v. Then finally measure the volume occupied by the swollen.
5. Write onNutraceuticals
ANS: Term nutraceuticals derived from nutrition & it refers to food having a
medical effect on health of human beings, it consist of food supplements, herbal
products, probiotics & prebiotics, medical foods meant for prevention &
treatment of diseases.
It’s defined as the: ‘A food or part of food or nutrient, which provides health
benefits, including the prevention & treatment of a disease.’
6. Differentiate betweengenotype &phenotype
ANS:
Genotype Phenotype
1. Genotype refers to the genetic code
of the individual. This is all the
information that is found inside the
individual cell.
1. Phenotype is the expression of the
genotype.
2. Genotype is the genetic composition
of a particular trait.
2. Phenotype is the physical expression
of a particular trait.
3. Genotype remains the same
throughoutthe lifetime.
3. Phenotype may changes with time.

3. 4. It can be determined by observing
DNA by genotyping methods.
4. It can be determined by observing
outward characters.
5. Genotype is the genetic makeup of
an organism.
5. Phenotype is the morphology,
properties & behavior of an organism.
7. How Ayurvedic medicines differ fromHerbal medicines
ANS:
Ayurvedic Medicines Herbal Medicines
1. Ayurvedic medicines are prepared on
the principalof science of Ayurveda
1. Herbal medicines are prepared from
aqueous extract taken fromherbs.
2. In Ayurvedic medicine content the
herbal ingredients & also it content
heavy earth metals such as silver, tin
etc.
2. In Herbal medicine content only the
herbal ingredients are sourced from
plants only.
3. The effectiveness of Ayurvedic
products is easily boosted by
complementing them with diet & yoga.
3. The effectiveness of Herbal products
cannot be complemented by yoga.
4. Ayurvedic medicines aim at healing
you from inside & the outside.
4. Herbal products lay emphasis on
curing aspect.
8. Discuss Indiansystemof Medicine
ANS: In that write different types of Indian system medicines means AYURVEDIC,
SIDDHA, UNANI, HOMEOPATHY, NATUROPATHY
9. Write any 4 names of sweeteners&binders usedinherbal cosmetics
ANS:SWEETENERS:I. Stevia II. Xylitol III. Erythritol IV. Lacitol
BINDERS:I. Acacia II. Gelatine III. Lactose IV. Mannitol

4. 10. Write the formulationmethodof Asava
ANS:1. Infusion procedure: water + sugar or honey or jiggery = BOILED
2. Cooled & transferred to fermentation vessel + fine powder of crude drug
& other ingredients.
3. Sealed the edges of container & placed for specific period.
4. Finally filtered.
Q.No.2 Solve 07 questions (5x07=35Marks)
1. Enumerate the importance of Herbal therapies
ANS:Write this answer onthe following points:
 Low cost
 No side effect
 Easily available
 Permanent relief
 Increaseresistance
 Cultivation high profitable
 Taken as fresh & dried in both forms
2. Describe any 4 official herbs usedas Nutraceuticals
ANS:1. Ginseng: Synonym- Ninjin
Source- Dried roots of panax ginseng
Constitution- Triterpenoid saponin glycosides: Ginsenoside,
protopanxotriol, Glycan: Panaxan, panaxydol
Uses- Improvementof concentration, resistanceto stress &
disease, anaemia, diabetes, gastritis

5. Marketed formulations- Re-vital (Ranbaxy), Panaxan
(Phytopharma)
2. Harde: Syn- Haritaki
Source- Dried fruits of Terminalia chebula
Constituent- 30% hydrosylabletannin, Phenolic
compounds: chebulinic acid, free tannin acid, gallic acid, ellagic acid,
anthraquinoline glycosides, sennoside
Use- Antiseptic, chronic ulcer, wound, piles, dental
preparation
Marketed formulation- Constivac (Lupin herbal), Pilect
(Alimil P’ceuticals)
3. Bahera: Syn- Baheda
Source- dried ripe fruits of Terminalia belerica
Constitution- 20-30% Tannin, Phenolic compounds:
Gallic acid, Ellagic acid, tannins, phyllembelic acid, phyllembelin
Uses- Astringent, diarrhea, purgative, digestive
systemdisorder
Marketed formulation- Sage triphala syrup (Sage
herbals), Triphala (Himalayas)
4. Ashwagandha: Syn- Withania
Source- dried roots & stems of withania
somnifera

6. Constitution- tropine, pseudotropine,
anaferine, steroidal lactones: withanolides, withaferin
Uses- antistress, adaptogenic- improve
physical& mental fitness, anti-inflammatory, asthma, uterine sedative, relaxant,
antispasmodic
Marketed formulation- Mentat (Himalaya),
Tentax forte ( Himalaya)
3. Mention2 herbal formulations available inthe market withtheir composition
ANS:1. NeemShampoo
Composition:
i. Gram flour- 1 kg
ii. Sandalwood powder- 250 g
iii. Neemleaves powder- 160 g
iv. Shikakai powder- 1kg
2. Pranda Gutika
Composition:
i. Simmarouba (QuassiaExcesia) Leaves powder-
500mg
ii. Preservatives- q.s.
Use- Anti-viral tablets

7. 4. Write anote on stability study of herbal drugs
ANS:Types of stability study
1. Physical stability study:- The original physical properties namely appearance,
uniformity, palatability, dissolution, andsuspendability are maintained.
2. Chemical stability study:- Eachand every active ingredient retains its chemical
integrity as well as potency specifiedonlabel, withinthe specifiedlimits. It
involves drug assay and determinationof drug degradation.
Material used for stability studies:-
1. Active Pharmaceutical ingredient (API)
2. Finished pharmaceutical products
Stages in stability testing:-
1. Preformulation
2. Final product
3. Post marketing
3. Microbiological stability study:- Sterility or resistancetomicrobial growthis
maintainedas per the specifiedrequirements.
4. Therapeutic stability study:- The therapeutic effectremains unaltered.
5. Toxicological stability study:- Novalidincrease intoxicity shouldoccurs.
In that alsowrite about markers, different chromatographic methods
5. Write anote on patent & IPR for natural products
ANS:

8. 6. Discuss the source &descriptionof herbal origins for usedinherbal cosmetics
as protective agent &fixedoil
ANS:In that write about:
Amla oil, Sandalwood oil, coconut oil
7. Write downthe different methods use for determinationof
i. Pesticide residues
ii. Extractable matter
ANS:i. Pesticide residues : (Write indetail)
A. Multiresidue method(MRMs)
B. Single residue method(SRMs)
C. Semiquantitative &Qualitativemethod
D. Quantitative method
ii. Extractable matter: (Write indetail)
A. Hot extractionmethod
B. Coldextractionmethod

9. Q.No.3 Solve 02 questions (10x02=20Marks)
1. What is Nutraceuticals? Describe any four official herbs usedas nutraceuticals
2. How the herbal drug assessedfor their qualitiesas per WHO guidelines
discuss indetail
ANS:Assessment of
 Quality
 Safety
 Efficacy
 Intendeduse
Pharmaceutical assessment:this part shouldcover all important aspects of
the quality assessment of herbal medicines.However,if apharmacopoeia
monograph exists it shouldbe sufficient tomake reference tothis monograph.
If no such monograph is avaliable, a momograph must be suppliedand should
be set out in the same way as in an official pharmacopoeia.
All procedures shouldbe inaccordance with Good Manufacturing Practices
[GMP].
Crude plant material:The botanical definition,including genus,species and
authority shouldbe giventoensure correct identificationof a plant.A definition
and descriptionof the part of the plant from which the medicine is
made[eg;leaf,flower,root]has tobe providedas well as an indicationas to
whether fresh, driedor traditionally processedmaterial is used.The activeand
characteristics constituentsshouldbe specifiedandif,possible, content limits
shouldbe defined.Foriegnmatter,impurities andmicrobial content shouldbe
definedor limited.vocher specimen,representing eachlot of plant material
processed,shouldbe authenticatedby a qualifiedbotanist and shouldbe store
for at least a tenyear period.A lot number shouldbe assignedand this should
appear on the product lable.

10. Plant Preparations:
 Plant preparationshouldinclude powderedplant materials,
extracts,tintures,fatty or essential oils,expressedjuices andpreparations
whose productioninvolves afractionation, purificationor concentration
process.The manufacturing process shouldbe describedindetail.If any
other substance is addedduring the manufacture,toadjust the plant
preparationtoa certainlevel of active or characteristic constituents or
for any other purpose,the addedsubstsnce shouldbe mentionedinthe
procedure description.
 A methodfor identification, andwhere possible assay of plant
preparationshouldbe added.Ifthe identificationof an active principle is
not possible,itshouldbe sufficient toidentify acharacteristic substance
or mixture of substances(eg;chromatographic fingerprint)toensure
consistent quality of preparation
Finishedproducts:
• The manufacturing procedure and formulaincluding the amount of
excipients shouldbe describedindetail.
• A methodof identification,andwhere possible quantification,of the plant
material inthe finishedproduct shouldbe defined.
• If the identificationof an active principle is not possible,itshouldbe sufficient
to identify acharacteristic substsance or mixture of
substance(eg,chromatographic fingerprinting)toensure consistent quality of
the product.
• For important finishedproduts,confirmationof regulatory status inthe
country of the originshould be required;the WHO certificationscheme onthe
quality of the pharmaceutical products moving in International Commerce
shouldbe applied.
Stability:

11. The physicsal and chemical stability of the product inthe final marketing
container shouldbe testedunder definedstorage conditionsandthe shelf-life
shouldbe established.
Safety assessment:This part shouldcover all the relavent aspects of the safety
assessment of amedicinal product has beentraditionally usedwithout
demonstratedharmno specific restrictiveregulatory actionshouldbe
undertakenunless newevidence demands arevisedrisk-benefit assessment.
Toxicological studies:If any toxicological studies are available, they shouldbe
part of the assessment.If atoxicological risk is known, toxicity datahave to be
submited.Risk assessment, whether it is independent of dose (eg,special
danger allergies) ,or whether it is afunctionof dose should be documented
Assessment of Efficacy and Intendeduse:
This part shouldcover all the important aspects of efficasy assessment.A
review of the relavent literature shouldbe carriedout and copies providedof
the original articles or proper referencestothem.
--------------------THANK YOU-----------------------
Mr. R.R.Patil