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Development of Quality Control Methods for Polyherbal Formulation, Chyawanprash

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Development of Quality Control Methods for Polyherbal Formulation, Chyawanprash Researth Artitle Development of quality control methods for polyherbal formulation, Chyawanprash RaIlul P Kasar1, K S Laddha1*,Jayesh Chaudhary2 and Anil Shulda2 IMedicinal Natural Products Research Laboratory, Pharmaceutical Division University Institute of Chemical Technology, N M Parikh Marg, Matunga (E), Mumbai- 400 019, Maharashtra, India 2VedicLife Sciences, 118 Morya House, OffNew Link Road, Andheri (W), Mumbai-400 053 *Correspondent author, E-mail: [email protected]; [email protected] Received 22 March 2005; Accepted 12 September 2005 Abstract the harmful effectof stress2• In the modern Chyawanprash is a traditional polyherbal formulation, which is widely used as tonic, time it cures cough, asthma and act as an rejuvenator, anabolic, immunomodulator and memory enhancer. Chyawanprash contains the pulp immunomodulator and memory of Emblka officinalis Gaertn. as the prime ingredient, along with powder and extract of enhancer3,4. It promotes growth in several other herbs. It is observed that the consistency and taste varies from one manufacturer to chUdren, increases the sexual power and another. Even these variations are observed in the same pharmaceutical company in different manufacturing batches. Hence, it is the need of the hour to standardize the raw materials to obtain digestive fire. The entire Indian product consistency. With the advent of new analytical tools and sophisticated instrmpental Chyawanprash market stands around 50• technology, the quality assurance profile for a crude drug or its bioactive constituents can be made 60 tonnes5, even though only very few possible. 'I\voin-house batch ofChyawanprash was prepared according to the procedure described quality control methods for its evaluation in text Charaksamhita and one Chyawanprash sample was procured from market. These have been attempted6-8• Due to lack of batches were evaluated by physicochemical methods and its bio-efficacywas determined byvarious biological methods like antioxidant study and microbial contamination study and finally stability suitable quality control standards of study was performed on the formulation according to the ICH guidelines. Ayurvedic drugs it is difficult to ensure The results of two in-house batches were found in close proximation with the marketed uniformity of their composition and batch. The method used for determination of quality control of Chyawanprash was found to be consequently the efficacy of final precise and reproducible and can be used for quality control of other marketed formulations. products9• Even the reported official Keywords: Chyawanprash, Phytoconstituents, Physicochemical Parameter, Standardization, methods for quality assurance of Stabilitystudy. Chyawanprash do not include complete analysis parameters10• IPe code; Int. d.7 - A61K 35/78 Chyawanprash falls, by virtue of Introduction The word Chyawanprash its consistency and dosage form, under composed of two words, 'Chyawana' the category ofAwaleha-paka group of and 'Prasha'. The former stands for the Ayurvedic formulationsll. Generally Chyawanprash is very commonly Chyawanprash includes four class of used health supplement and medicine name of a sage. The word also denotes herbal drugs: Dashmula Class (ten since centuries. It is a jam preparation, "degenerative change". The later word denotes a drug or diet, which is fit for roots); Chaturjata Class (four aromatic which contains 35-40 natural ingredients. ingestion. Chyawanprash is otherwise plant); substitution of Ashtavarga In general, the formulation has a sweet known as Balya, which increases the (Ashtavarga, orchids herbal drug which and tangy taste with a fine aroma. Since anabolism I. Apart from this, it is helpful are not commercially available in modern the day ofits known inception dating back era) and general class (other than former 1500 BC to the age of technology it in kshaya (emaciation). It is also remained in the hearts of Indians reputed as an anxiolyticand nervine tonic classes). The main plants used in the in Ayurveda.It is geriatric tonic and is an preparation of Chyawanprash are givenin irrespective of political, cultural and adaptogenic progeny and hence prevents Table 1. scientific upheavals. Vol 5(1) January-February 2006 ---'m Researth Arl;tle In the present work, chamber and Camag TLC scanner III Chyawanprash was prepared strictly equipped with CATS,V.4.06 softwareused. according to the method quoted in the UVspectrum was recorded on MisJasco, ancient Aymvedictext 'Charaksamhita' .. Kjeldhals apparatus. under the supervision of an Ayurvedic expert. This paper reports the Methods characteristic features and phytochemical evaluation of the finished products Morphological, physical and Piper languID samples prepared by Medicinal Natural chemical evaluation including qualitative Product Research Laboratory, VICT, Mumbai. 1\vobatches ofthe product were test and quantitative analysis of Mumbai and coded as CU-l and CU-2in prepared as per the procedure described phytoconstituents were done. Biological collaboration with Potdar Ayurvedic in Ayurvedic text 'Charaksamhita'. evaluation for free radical scavenging Medical College, Mumbai, respectively They were named as CU-l and CU-2, (anti-oxidant) activityand microbiological and marketed formulation coded as M-1. respectively and one marketed test (e.g. Bioburden level) along with formulation of Chyawanprash (Ml) was stability study were carried. Materials and Methods procured for the study. Morphological characteristics Materials Colour, odour, taste, consistency Herbs and texture of the product vary from one Theplants used in Chyawanprash manufacturer to another. Hence, these were collected from local market of parameters are also important for quality Mumbai and identified by Botany control. The samples prepared during this Department. of Zandu' Pharmaceutical study are brownish black, semisolid, Limited, Mumbai and voucher specimen sweet, astringent, granulated, rough in were deposited in MNPR Lab, VICT, texture and possess sweet aroma. Awala fruits Physical and chemical evaluation Solvents and chemicals For physical and chemical evaluationl2.14 allthree samples (lOg each) Hexane, toluene, ethanol, ethyl were extracted separately with n-hexane, acetate, acetic acid, formic acid, methanol methanol and distilled water by cold of HPLCand as AR grade were used. Piperine, epicatechin, catechin and gallic acid, DPPH (Sigma) chemicals were used in experimental part. Instruments Camag HPTLC system Mesua ferrea employing Linomate IV,1\vintrough Adhatoda vasica m--- ~Natural Product Radiance Researlh Artille Table 1: Plants used in Chyawanprash3, 5, 28 SNo. ~oJanicai name' Coronion name d "279,1719273513153134232529303361620281214212224268'105A '3 Dashmula Class 381811 . Cj-:: .. ' ~. ' 32363739 1 '-Aegle '~armelos Corr. ex Roxb. Bel, Bilva Desmodium gangeticum DC. Shalparni, Sarivan Gmelina arborea Roxb. Gambhari, Kashmarya Oroxylum indicum Vent. Shyonaka, Sonapatha, Aralu Premna integrifolia Linn. Arani, Aagnimantha Solanum indicum Linn. Brihat Kantkari, Vanbhantha Solanum xanthocarpum Schrad. &Wendl. Laghu kantakari, Kashtakari Stereospermum suaveolens DC. Patha, Padhal, Patal Tribulus terrestris Linn. Gokharu, Gokshura Uraria picta Desv. Pithwan, Prishniparni, Devala General Class Adhatoda vasica Nees Aduso ki patti, Vasa Aquilaria agallocha Roxb. Agarkashta, Agar, Kalaagar Bambusa arundinacea (Retz.) Roxb: Vanshalochan Boerhaavia dijfusa Linn. Punainava, Gadhapuran Curcuma zedoaria Rose. Kachur, Sathi kchora Cyperus rotundus Linn. Mustak, Nagarmotha, Motha: Ef1Jblica officinalis Gaertn. Amla,Awala - (Averagewt # 21g) lnula racemosa Hook f. Pushkarmool, pohkarrrlul Leptadenia reticulata Wight & Am. Jeevanti Martynia diandra Glox. Kakakshi, Kaknasa, Kauathodi Nymphaea stellata Willd. Neelkamal Phaseolus trilobus Ait. Van-mug, Mataki, Mudgaparni Phyllanthus amarus Schum. Bhueawala, Bhumyamalaki , Piper longum Linn. Pippali Pistacia integerrima Stew. ex Brandis Kakad singi, Sringi, Karkatshringi Santalum album Linn. Safed chandan, Chandansaar Sida cordifolia Linn. Bala, Bariyara Teramnus labialis Spreng. Mashparni, Van-uqadh, Mashvan Terminalia chebula Retz. Harad, Haritaki, Abhaya. Tinospora cordifolia Meirs. Guduchi, Amrita Vitis vinifera Linn. Draksha Chaturjata Class Cinnamomum tamala Nees & Eberm. Tejpatta, Patra, Tamalpatra Cinnamomum zeylanicum Blume Dalchini Elettaria cardamomum Maton Elaichi Mesuaferrea Linn. Nagakeshar Substitution of Ashtavarga Asparagus racemosus Willd. Shatawari (Substitution for Meda, Mahameda) Dioscorea bulbifera Linn. Barahikand, Varahikand (Substitution for Rddhi, Vridhi) Pueraria tuberosa DC. Vidarikand .. (Substitution for Jivak, Risabhaka) Withania somnifera Dunal Ashwagandha (Substitution for Kakoli, Kshirkakoli) Vol 5(1) January-February 2006 m Resear,h Art;,'e maceration. The extractive value, angle of (ii) Quantitative determination of batches was extracted separately with rotation, ester value and free fatty acid phytoconstituents 21,22 distilled water till exhaustion. The value were determined by method solution was illtered and diluted to 100ml described in Indian Pharmacopoeia. Chromatographic Analysis: with distilled water. Allthe three batches Chyawanprash (5g) from each batch was HPTLCanalysiswas performed on a Camag were studied spectrophotometrically for extracted separately with 100 ml distilled HPTLCsystem. The plate used was HPTLC spectrum measurement, colourimetric water by maceration and their pH, 254 silica gel 60 (E. Merck). Camag analysis like total tannin by folin-denis refractive
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