Indian Journal of Traditional Knowledge
Vol. 6(4), October 2007, pp. 648-652

      Standardization of Ayurvedic polyhe...

650                        INDIAN J TRADITIONAL KNOWLEDGE, VOL 6, No. 4, OCTOBER 2007

652                       INDIAN J TRADITIONAL KNOWLEDGE, VOL 6, No. 4, OCTOBER 2007

to its sugar content, gums and resi...
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SOP on Nyagrodhadi choorna


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SOP on Nyagrodhadi choorna

  1. 1. Indian Journal of Traditional Knowledge Vol. 6(4), October 2007, pp. 648-652 Standardization of Ayurvedic polyherbal formulation, Nyagrodhadi churna KR Gopala Simha* & V Laxminarayana Sodhana Trust, Gautam Towers, Sardar Patel Road, Secunderabad 500 003, Andhra Pradesh; Received 9 September 2005; revised 5 October 2006 Ayurvedic medicine Nyagrodhadi churna, known to be effective in all types of prameha (Pramehadhikara) – polyuria, including madhumeha (Diabetes mellitus), has been standardized by following modern scientific quality control procedures both for the raw material and the finished product. The obtained values of physical and chemical parameters can be adopted to lay down new pharmacopoeial standards to be followed for traditional preparation of Nyagrodhadi churna with batch-to- batch consistency. The phytochemical constituents found to be present in the raw material used for the preparation of Nyagrodhadi churna possibly facilitate the desirable therapeutic efficacy of the medicinal formulation, and also could help in knowing the underlying mechanisms of pharmacological action. Keywords: Standardization, Nyagrodhadi churna, Ayurvedic formulation, Prameha, Polyuria, Madhumeha, Diabetes mellitus, Pharmacopoeial standards IPC Int. Cl.8: A61K36/00, A61P13/00, A61P5/00, A61P5/10, A61P5/50, A61P13/02 Nyagrodhadi churna (NC), an Ayurvedic polyherbal Methodology formulation, consists of Nyagrodha (Ficus Nyagrodhadi churna is a polyherbal formulation bengalensis) and other 27 ingredients in churna (Table 1) consisting of 28 ingredients in all, with (powder) form. It supposedly has multi-faceted action specific morphological parts of the plants (herbs) used in all 20 types of prameha (polyuria) including and each ingredient being of equal quantity. For madhumeha (Diabetes mellitus)1, Preparation of NC standardization of NC, some modifications were is based on traditional methods in accordance with the made. In place of aragwadha (Cassia fistula) stem procedures given1. Due to lack of modern bark used, fruit pulp was used as per the pharmacopoeial standards laid down and followed for recommendation of Ayurvedic Formulary of India processing of NC using traditional methods, the (AFI)2. According to Ayurveda, it is appropriate to use medicine prepared may not have the desired quality another herb with similar Ayurvedic characteristics in and batch-to-batch consistency. Hence, there is a need case the required herb is not available1. Kapittha for standardization of NC following scientific (Feronia limonia) is a fruit that is not available in all parameters including organoleptic characters, seasons of the year. Accordingly, kapittha in the chemical analysis, chromatographic pattern and traditional formulation was substituted with the roots microbiological screening. The work was undertaken of shatavari (Asparagus racemosus Willd.) known to to standardize and validate Ayurvedic medicine, Nyagrodhadi churna used in the treatment of have antidiabetic properties3, 4. The raw material was madhumeha. Standardization of NC was carried out procured from the local market or from a nearby following Good Manufacturing Practices (GMP) for forest, after a preliminary identification was made preparation of Ayurvedic medicines. Standardization based on the Ayurvedic parameters such as varna guidelines for herbal products provided by World (colour), gandha (odour), ruchi (taste), aakruti Health Organization (WHO) and European Agency (shape) and parimana (size)5-7. The material was for the Evaluation of Medicinal Products (EMEA) examined for probable adulterants and foreign matter have also been followed. adhering to the surface was removed5-7. Organoleptic evaluation was used for identification of _________ sensory characteristics like colour, odour, taste, *Corresponding author shape, size, texture and fracture. In macromorphological
  2. 2. SIMHA & LAXMINARAYANA: STANDARDIZATION OF AYURVEDIC POLYHERBAL FORMULATION 649 Table 1⎯Ingredients of Nyagrodhadi churna Plant name Sanskrit name Parts used Anogeissus latifolia Wall. ex Bedd. Dhava Stem bark Baliospermum montanum Muell.-Arg. Danti Root Buchanania lanjan Spreng. Priyala Seed (Kernel) Cajanus cajan (Linn.) Millsp. Adhaki Root Cassia fistula Linn. *Aragwadha Fruit pulp Crataeva nurvala Buch.-Ham. Varuna Stem bark Emblica officinalis Gaertn. Amalaki Fruit (seed removed) Erythrina variegata Linn. var orientalis (Linn.) Merrill Paribhadra Stem bark Syzygium cuminii (Linn.) Alston Jambu Seed (Kernel) † Feronia limonia Swingle Kapittha Fruit pulp Ficus bengalensis Linn. Nyagrodha Stem bark Ficus glomerata Roxb. Udumbara Stem bark Ficus religiosa Linn. Aswattha Stem bark Glycyrrhiza glabra Linn. Yashtimadhu Root Gymnema sylvestre R. Br. Meshasringi Leaf Holarrhena antidysenterica (Linn.) Wall. Kutaja Stem bark Madhuca indica Linn. Madhuka Flower Mangifera indica Linn. Amra Seed (Kernel) Oroxylum indicum Vent. Shyonaka Stem bark Plumbago zeylanica Linn. Chitraka Root Pongamia pinnata Pierre Karanja Seed Pterocarpus marsupium Roxb. Vijayasara Stem (Heartwood) Semecarpus anacardium Linn. f. Bhallataka Seed (Kernel) Symplocos racemosa Roxb. Lodhra Stem bark Terminalia arjuna (Roxb.) Wight & Arn. Arjuna Stem bark Terminalia bellirica Roxb. Vibhitaki Fruit (seed removed) Terminalia chebula Retz. Haritaki Fruit (seed removed) Trichosanthes dioica Roxb. Patola Leaf Note: The nomenclature for the above 28 ingredients has been adopted from the compendium Medicinal Plants Used in Ayurveda, (Rashtriya Ayurveda Vidyapeeth, Govt. of India, New Delhi), 1998. *For Aragwadha, Bhaishajya Ratnavali mentions use of stem bark but fruit pulp has been used as per the recommendation of AFI. †’Kapittha’ is a seasonal fruit and the fruit pulp was not available. Shatavari (Asparagus racemosus) roots were used as a substitute. evaluation, the plants were arranged according to their of the ingredients9 (Table 2). Thin layer chromatography morphological characteristics and identification of the (TLC) was performed and Rf values were calculated5-7. correct part of the plant to be used was done. Quantitative analysis of the raw material was done Microscopic evaluation and cytomorphological for standardization parameters including foreign evaluation were not done as detailed phytochemical organic matter, water soluble extractive, methanol analysis was performed. The plant material was soluble extractive, total ash and acid insoluble cleaned by sorting out pebbles, etc., using a cloth ash7,10. Their values were calculated and found to duster to remove dust; and air blowing to remove be well within the available standard ranges. Other minute sand particles. The ingredients of the parameters, moisture content, pH, ether soluble formulation were individually treated with water extractive and crude fiber were also assessed 7, 10. containing the antimicrobial agents, potassium meta Microbiological screening was done for the finished bi-sulphite (0.1%) and isopropyl alcohol (70 %)8. The product. The approved raw material was packed in material was dried and then considered for quality sterilized airtight polybags with proper labeling and analysis. stored in a cool place2. Hygienic conditions were Active phytochemical constituents like glycosides, maintained by regular disinfecting of the work areas flavonoids, alkaloids, acids, gums, tannins, were and weekly fumigation11. The ingredients (except identified through qualitative chemical analysis in each priyala, madhuka, bhallataka) were individually
  3. 3. 650 INDIAN J TRADITIONAL KNOWLEDGE, VOL 6, No. 4, OCTOBER 2007 Table 2⎯Phytochemical constituents of Nyagrodhadi churna ingredients Ingredients Phytochemical constituents Sanskrit name Plant Name Glycosides Flavonoids Alkaloids Acids Gums Tannins Fixed oils Resins Nyagrodha Ficus bengalensis Linn. + + + + Udumbara Ficus glomerata Roxb. + + + + Aswattha Ficus religiosa Linn. + + + + Shyonaka Oroxylum indicum Vent. + + + Aragwadha Cassia fistula Linn. + + + Vijayasara Pterocarpus marsupium + + + + Roxb. Amra Mangifera indica Linn. + + + Shatavari Asparagus racemosus Willd. + Jambu Syzygium cuminii (Linn.) + + + + + + Alston Priyala Buchanania lanjan Spreng. + + Arjuna Terminalia arjuna (Roxb.) + + + + + Wight & Arn. Dhava Anogeissus latifolia Wall. ex + + + + + Bedd. Madhuka Madhuca indica J.F.Gmel. + + + Yashtimadhu Glycyrrhiza glabra Linn. + + + + + + Lodhra Symplocos racemos Roxb. + + + + Varuna Crataeva nurvala Buch.-Ham. + + Paribhadra Erythrina variegate Linn. var. + + + + orientalis (Linn.) Merrill Patola Tricosanthes dioica Roxb. + + + Meshasringi Gymnema sylvestre R.Br. + + + + Danti Baliospermum montanum + + + Mull.-Arg. Chitraka Plumbago zeylanica Linn. + + + + Adhaki Cajanus cajan (Linn.) Millsp. + Karanja Pongamia pinnata Pierre + + + + Haritaki Terminalia chebula Retz. + + + Vibhitaki Terminalia bellirica Roxb. + + + + Amalaki Emblica officinalis Gaertn. + + + Kutaja Holarrhena antidysenterica + + + + (Linn.) Wall. Bhallataka Semecarpus anacardium + + + + + Linn. f. + Present pulverized and sieved (100 mesh) to obtain respective the above powder mixture of 25 ingredients. This fine powders of 25 ingredients that were thoroughly material, along with priyala and madhuka of fine mixed together and the mixture was kept aside. Two consistency, was blended in a mixer to obtain a herbal ingredients, priyala and madhuka – were homogenous mixture. The composite mixture was sieved pounded in a metallic mortar and separately crushed (100 mesh) to obtain a fine powder of the finished in a domestic mixer till fine consistency. Bhallataka is product Nyagrodhadi churna. The finished product used in Ayurvedic preparations only after purification. thus obtained, was subjected to chemical treatment Cleaned bhallataka kernels were cut into small similar to that given to the raw material to inhibit pieces, soaked in coconut water for 24 hrs and then microbial growth. It was then dried at 600C. cleaned with distilled water. This process was Nyagrodhadi churna obtained in powder form was repeated twice. The material was then dried at 600C to packed in sterilized polythene pouches, labeled, obtain purified bhallataka, which was later powdered (60 coded and stored inside cool & dry shelves. The mesh). The purified bhallataka powder was added to above detailed procedures were adopted for 6 batches
  4. 4. SIMHA & LAXMINARAYANA: STANDARDIZATION OF AYURVEDIC POLYHERBAL FORMULATION 651 of NC prepared. Statistical analysis was done; physical and chemical parameters and also subjected to ‘Mean’, ‘Standard Deviation (SD)’ and ‘Standard microbiological screening through quality control Error (SE)’ values are given as also ‘Range’ and measures. Quality tests (Table 3) for NC were ‘Median’ values wherever applicable. performed for moisture content, water soluble extractive, methanol soluble extractive, ash content, Results and discussion and acid insoluble ash, and were found to be within As part of standardization procedure, all 6 batches of standard ranges12. Values of pH and ether soluble the finished product of NC were tested for relevant extractive, sulphated ash and crude fiber were assessed11,13,14. In addition, TLC was done (Fig. 1) with methanol extract of Nyagrodhadi churna5,12,15. Ethyl acetate and toluene (3:7) was used as the mobile phase and iodine vapors as visualizing agent. Rf values (Table 3) were calculated. For 6 batches of NC, microbiological analysis was done6. Pathogens E. coli, S. aureus, salmonella, shigella and P. aeruginosa were found to be absent. Total aerobic count was done; and bacteria (range 725, median 787), fungi (yeast: 0; moulds: range 10, median 10) and coliforms (range 3, median 3) were found to be within limits. Standardization of Nyagrodhadi churna was possible by considering various scientific parameters concerning the quality of the raw material used, keeping intact procedures in accordance with Ayurvedic System. In this work, shuddhi (purification) of bhallataka with coconut water has been done. This is expected to reduce the undesirable effects of bhallataka like mucosal irritation and make it suitable for medicinal use, as it was found the organoleptic character ruchi (taste) both before and after purification, confirming the need for purification of bhallataka. The separate pulverization procedure adopted for priyala was due to its oil content and gums and to avoid undesirable formation of small lumps. Madhuka Fig. 1⎯TLC of Nyagrodhadi Churna in methanol extract was also pounded separately, for a similar reason, due Table 3 – Quality tests for the finished product, Nyagrodhadi Churna Batch 1 Batc 2 Batch 3 Batch 4 Batch 5 Batch 6 Mean (SD) Parameter S.V. O.V. O.V. O.V. O.V. O.V. O.V. Moisture content (%) ≤10 1.31 2.14 2.14 2.43 3.25 3.02 2.38 (0.70), SE 0.28 Water soluble extractive (%) 10 to 20 18.90 22.19 22.53 22.73 20.90 21.40 21.44 (1.42), SE 0.58 Methanol soluble extractive (%) 15 to 20 20.40 20.51 19.80 16.49 15.87 18.19 18.54 (2.02), SE 0.82 Ash content (%) 7 to 11 7.45 7.40 7.66 9.53 10.00 10.67 8.79 (1.45), SE 0.59 Acid insoluble ash (%) ≤2 0.96 1.00 1.02 1.31 1.07 0.50 0.98 (0.26), SE 0.11 pH - 4.98 4.88 4.84 4.76 4.85 4.92 4.87 (7.5E-02), SE 3.06E-02 Ether soluble extractive (%) - 6.45 6.05 6.12 5.09 5.25 5.24 5.70 (0.57), SE 0.23 Sulphated ash (%) - 12.14 12.43 12.56 14.35 13.98 14.26 13.29 (1.01), SE 0.41 Crude fiber (%) - 20.85 23.70 22.86 22.31 23.75 23.00 22.75 (1.08), SE 0.44 TLC (observed no of spots) - 12 12 12 12 12 12 Rf values (calculated) 0.04; 0.07; 0.09; 0.17; 0.27; 0.56; 0.66; 0.71; 0.78; 0.85; 0.92; 1.00 SV = Standard Value ; OV = Obtained Value
  5. 5. 652 INDIAN J TRADITIONAL KNOWLEDGE, VOL 6, No. 4, OCTOBER 2007 to its sugar content, gums and resins. Values obtained Nyagrodhadi churna, to obtain optimal efficacy of after conducting tests for moisture content, water soluble the medicine. extractive, methanol soluble extractive, ash content, acid insoluble ash for NC were in conformance with the Acknowledgement standards laid down for herbal material. The ‘Mean’ The work was supported by Byrraju Foundation, value obtained for each parameter was found to be Hyderabad. Authors gratefully acknowledge the consistent across 6 batches with minimum ‘SD’. Also, valuable inputs including statistical analysis provided the corresponding value of ‘SE’ was found to be low, by Dr B Anand during the course of preparation of the showing batch-to-batch consistency. For pH, ether manuscript. soluble extractive, sulphated ash, crude fiber, there References are no standard ranges available. The ‘Mean’ value 1. Govind Das, Bhaishajya Ratnavali, (Motilal Banarasidas obtained for each of these parameters was also found Publishers, New Delhi), 2002, 461. to be consistent across 6 batches with minimum ‘SD’. 2. The Ayurvedic Formulary of India (AFI), Part I, 1st edn, Further, the corresponding value of ‘SE’ was found to (Government of India, Ministry of Health & Family Welfare, New Delhi), 1976. be low. So, the inclusion of these 4 parameters along 3. Pandey GS, Bhavaprakash, (Chowkhamba Bharati Academy, with their respective obtained values could be Varanasi), 1999, 392, 565. considered for laying down new pharmacopoeial 4. Erra Venkataswami, Vasthu Guna Dipika, 10th edn, (ABS standards while preparing Nyagrodhadi churna Publishers, Rajahmundry), 1995. 5. European Community, European Agency for the Evaluation according to traditional methods. The occurrence of of Medicinal Products, EMEA/HMPWG/25/99, 56 spots at the same respective locations in TLC (Fig. 1) 6. Anonymous, Quality Control Methods for Medicinal Plant Material, obtained for all 6 consecutive batches confirms the (World Health Organization), 2002. batch-to-batch consistency of the finished product. 7. The Ayurvedic Pharmacopoeia of India, Vols. I, II & III, The absence of pathogens in all 6 batches of the (Government of India, Ministry of Health & Family Welfare, New Delhi), 2002. finished product Nyagrodhadi churna assures the 8. Mahindru SN, Food Additives, (Tata McGraw-Hill quality of NC as also its presumed safety. Publishing Co Ltd, New Delhi), 2000, 6. Phytochemical constituents in Nyagrodhadi churna, 9. Shah CS & Qadry JS, A Text Book of Pharmacognosy, 8th like glycosides, flavonoids, alkaloids, acids, gums, reprint, (BS Shah Prakashan, Ahmedabad), 1990-1991. 10. Mukerji B, India Pharmaceutical Codex, Vol. I, (CSIR, New tannins could have pharmacological action on their Delhi), 1953 own or in conjunction with body fluids, in terms of 11. Sharma PP, How to practice GMPs, 3rd edn, (Vandana efficacy, to possibly help the body to help it to reckon Publications, New Delhi), 2001. with ailments. 12. Anonymous, Pharmacopeial Standards for Ayurvedic Formulations, (Central Council for Research in Ayurveda and Siddha, Government of India, Ministry of Health & Conclusion Family Welfare, New Delhi), 1987, 85. Ayurvedic medicine, Nyagrodhadi churna has 13. Paech K & Tracey MV, Modern Methods of Plant Analysis, Vol been standardized by intervention with modern I, (Springer, Verlag), 1956. scientific quality control measures in the traditional 14. Mukerjee PK, Quality Control of Herbal Drugs, (Business Horizons Pharmaceutical Publishers), 2002, 192-193. preparation described in Bhaishajya Ratnavali. The 15. General Guidelines for Methodologies on Research and results obtained could be used to lay down a set of Evaluation of Traditional Medicine, (World Health new pharmacopoeial standards for the preparation of Organisation), WHO/EDM/TRM/2000, 1, 23.