COMPARATIVE PHYSICO CHEMICAL ANALYSIS OF VYOSHADIVATI– AN AYURVEDIC POLYHERBAL FORMULATION W.S.R TO MARKET SAMPLESHTML Full Text
Received on 08 February, 2014; received in revised form, 08 May, 2014; accepted, 28 June, 2014; published 01 August, 2014
COMPARATIVE PHYSICO CHEMICAL ANALYSIS OF VYOSHADIVATI– AN AYURVEDIC POLYHERBAL FORMULATION W.S.R TO MARKET SAMPLES
Arun.M.Havinal *1, R.S. Hiremath 2, M.B.Gundkalle 3 and V.S. Mannur 4
Department of Bhaishajya Kalpana *1, Department of Rasashastra 2, Central Research Laboratory 3, Shri B.M. Kankanwadi Ayurvedic Mahavidyalaya, Shahpur Belgaum, Karnataka, India
KLEU College of Pharmacy 4, Belgaum, Karnataka, India
ABSTRACT: The quality control assessment of herbal formulations is of great significance in order to justify their acceptability in modern system of medicine though the drug may be therapeutically potent. Ayurvedic formulations prepared by several manufacturers are guaranteed to carry out the quality control test as per the standards mentioned in the Ayurvedic Formulary of India. Though the standards have been followed, still the variability in their results has been observed when compared between same formulations. Vyoshadivati is one such polyherbal formulation consists of 13 drugs and treated for ailments viz. Pinasa (coryza), Pratishaya (Rhinitis), Swarabheda (Hoarseness of voice) etc. An attempt is made here to compare Vyoshadivati prepared by GMP certified pharmacies with In house preparation. Results revealed that all the samples differ in their organoleptics, pH, and physicochemical properties. Thin layer chromatographic study showed sample B, D and E have almost similar number of bands at the wavelength of 255nm and 365nm. Major difference was seen in disintegration time and hardness of sample A i.e. hardness is 7.78 but disintegrates in 22min whereas sample D hardness 2.63 but disintegrates in 78min.The physicochemical data of this comparative study assists in maintaining the standard limits of Vyoshadivati.
INTRODUCTION: Ayurveda the oldest and alternative system of medicine in the present scenario has gained its popularity and demand globally due its effective and efficacious results witnessed in various diseases and syndromes in the recent era. Herbal drugs are the core of this system of medicine and these drugs possess all the quality required to prevent and cure the disease which is the prime motto of Ayurveda.
The principles to standardize the drugs that were developed in ancient period were subjective and are based on the scientific background prevailing in those days.
Now they are to be viewed and answered looking towards the advancement of science and technology in present scenario. Hence there is prime need to validate Ayurvedic formulations with the aid of modern sophisticated instrumental and analytical techniques explained in the context of herbal medicine to justify the quality of the products. In order to meet the needs of population enormous numbers of manufacturing companies have come into existence. These manufacturers though prepare the similar formulation fails to meet the standard quality control parameters when compared.
Vyoshadivati 1is one such polyherbal formulation explained in the Ayurvedic classics which is a combination of 13 drugs and has its efficacy over Pinasa(coryza), Pratishyaya(Rhinitis), Swarabheda (Hoarness of voice), Kasa(cough), Shwasa(asthma) 1,2etc. most of which simulate to symptoms of upper respiratory tract infection. Based on the above rationale the present study is designed to compare Vyoshadivati prepared in house with different market samples based onprimary quality control parameters.
MATERIALS AND METHODS:
Raw Material Procurement
Four samples of Vyoshadivati manufactured by GMP certified pharmacy were collected from the Belgaum market and given the code as Vv-A, Vv-B, Vv-C, and Vv-D.
IN HOUSE SAMPLE PREPARATION
Vyoshadivati consists of 13 herbal ingredients. All thedrugs of Vyoshadivati were procured from GMP certified KLE Ayurveda Pharmacy Khasbag Belgaum, Karnataka and were authenticated at AYUSH approved Central Research Laboratory of KLE University’s ShriB.M.KankanwadiAyurvedMahavidhyalaya Belgaum, Karnataka, India.
METHOD OF PREPARATION –
TABLE 1: INGREDIENTS OF VYOSHADIVATI
|Sl.no.||Ingredients||Latin Name 3||Part used||Quantity|
|Marich||Piper nigrum Linn||Fruit||1part|
|Amlavetasa||RhumeemodiWall. ex Meissn||Stem||1part|
Instruments and Equipment’s
Weighing machine, Analytical balance, Pulveriser, Clean cotton cloth, Steel vessel, Mask, Cap, Apron, Sieve no 85 and 120, Gas and stove.
Preparation of Churna
The Churna(powder) was prepared as per the procedure explained in Ayurvedic Formulary of India. All drugs (exceptTamarindusindica Linn) were made into fine powder in a pulveriser. These churna are passed first through 85# mesh followed by 120 # sieve individually and then all are mixed together in specified proportions to get uniformly blended homogenous mixture.
Preparation of VyoshadiVati4
Step 1 – Weigh the jaggery in specified quantity and pound it.
Step 2 – 1part of Tamarind soaked in 6parts of water for an hour later maceratedand filtered through muslin cloth.
Step 3 –Jaggery syrup was prepared by heating the jaggery and q.s (10ml) wateralong with tamarind juice till it gets 2 thread consistency.
Step 4 – Stop heating and add the homogenous mixture of churna to Jaggery syrup with continuous stirring.
Step 5 –Round pillswere prepared and dried in shade.
Step 6 –Vati’s are then stored in air tight container.
In house sample has given the code Vv-E.
To carryout Physico-chemical analysis, standard parameter has been applied as per Standards of Ayurvedic Pharmacopoeia of India. Analytical study was carried out in AYUSH approved Central Research Laboratory of Shri B.M.K. Ayurveda Mahavidyalaya Belgaum. Microbial Limit Test was carried out in Microbiology Laboratory of KLE University’s Shri B.M. Kankanwadi Ayurveda Mahavidhyalaya Belgaum, Karnataka, India.
The samples had been analyzed for Organoleptic characters, Moisture content, Extractive values, Ash values,5, 6 Qualitative Estimation through TLC 5, Physical test for Tablet i.e. Hardness, Disintegration and Uniformity of weight7, Phytochemical analysis and Microbial Limit Test.8
RESULTS AND DISCUSSION:
Physicochemical analysis of Vyoshadivati market samples and in house preparation has been carried out and the results are shown in tables. Ayurvedic formulations claimed to be made according to CCRAS guidelines are effective but it is very difficult to maintain uniformity in formulations which is may be due to natural heterogeneity, the quality of herbal starting material obtained from wild collection shows more and more fluctuations which can be depicted from our experimental data9.
ORGANOLEPTIC STUDY Organoleptic of samples reveals adequate differences observed in the presentation of the formulation and their taste i.e. sample A and B are punched tablet indicates about addition of some binders and are light brown in colour whereas sample D and E are handmade round pills and are dark brown and brown in colour. Drawback of Sample C is its irregular shape for which the analysis of physical test for tablet doesn’t apply. This might be because as some references in classic mention the dosage form as Vataka which is synonym for both Vatikalpana and Avalehakalpana.
MOISTURE CONTENT Moisture content in a drug is an important tool for a stability of any formulation. If moisture is high, it provides healthy environment for microbial growth. Sample C and E have least and sample B has high moisture content i.e. 12%.
ASH VALUE- Ash value represents amount of non-physiological components present in the drug 10. Lesser the amount ash, less the impurities. Sample E and sample C has lesser ash value when compared to other samples i.e. 4.597%w/w and 3.53% w/w.
EXTRACTIVE VALUES Extractive value explains the amount of constituents that are extracted from a drug in a given solution. As the Vatiis administered along with water as a common anupana, maximum extraction must be observed in aqueous extract. All the samples have shown high aqueous extractive value.
PH VALUE pH determines acidity or alkalinity of a drug. The pH for sample C is 5.52 whereas sample E had 4.05 and other samples are between D and EpH. Sample E is acidic compared to other samples.
PHYSICAL CHARACTERISTICS FOR TABLETS The physical test for tablets i.e. Weight variation test where 20 tablets are randomly selected and weighed. The mean and standard deviation was calculated. Here in this study sample 1 and 2 had shown less deviation whereas sample 4 and 5 has shown significant difference in their weight. This might be due to the pills prepared were handmade. The disintegration time and hardness of tablet are important tools for physical stability and absorption rate.
Both procedures must be directly proportional to each other. But in this study the hardness of sample A is 7.78kg/cm3 but disintegration time is22min. Whereas hardness of sample D is 2.63kg/cm3 and disintegration time is 78min. Disintegration test of both samples were done for 18 tablets. Such change affects the bioavailability of the drug to withstand in the body and show its efficacious results. Hardness of sample E is2.1kg/cm3 and disintegration time is 15min.
THIN LAYER CHROMATOGRAPHY
Qualitative analysis i.e. TLC study is carried out on 60F254pre-coatedTLC plates under the solvent system Toulene and Ethyle acetate in the ratio 7:3 after various trial and errors. Ethanol extracts of all the samples have been taken and visualized under UV light chamber at the range of 255nm and 365nm. This parameter gives idea about qualitative estimation presence of various components of drugs. Results of TLC are shown in Table 6.
Sample E has shown highest number of bands i.e. at 255 nm 10 bands and at 365nm 18 bands. When compared sample B, D and E having almost similar number of bands in long wavelength.
MICROBIAL LIMIT TEST: Microbial limit test has been carried out for all the samples andstudy reveals all samples were within the limits as per Indian Pharmacopeia Standard.
TABLE 2: ORGANOLEPTIC CHARACTERS
|1||Vv-A||Light Brown||Characteristic||Sweet, Pungent||Punched Tablet|
|2||Vv-B||Light Brown||Characteristic||Pungent, Slight Bitter||Punched Tablet|
|3||Vv-C||Browm||Characteristic||Sweet, Pungent||Irregular shape|
|4||Vv-D||Dark Brown||Characteristic||Sweet, Bitter, Pungent||Round pills|
|5||Vv-E||Brown||Characteristic||Sweet, Sour, Pungent||Round pills|
TABLE 3: DETERMINATION OF MOISTURE CONTENT, ASH VALUES AND EXTRACTIVE VALUES
|Sl.no.||Samples||Moisture content||Total Ash||Acid Insoluble Ash||Alcoholic Extract||Aqueous Extract||pH|
|3||Vv-C||3.49% w/w||4.597%w/w||1.087% w/w||17.6% w/w||76.4% w/w||5.52|
|4||Vv-D||12% w/w||7.65% w/w||2.522% w/w||25.9% w/w||41.4% w/w||4.45|
|5||Vv-E||4.09% w/w||3.53% w/w||0.846% w/w||34.16% w/w||86.9% w/w||4.05|
TABLE 4: STATISTICAL ANALYSIS OF WEIGHT VARIATION TEST
|Sl. No.||Samples||Number of Samples||Mean||S.D.||S.E.M|
S.D – Standard deviation, S.E.M – Standard error mean
TABLE 5: DETERMINATION OF TABLET DISINTEGRATION AND HARDNESS
* Monsanto’s Hardness Tester
**Tablet Disintegration Apparatus - Solution – Distilled water, Temperature – 390C,
Oscillations – 30/min
TABLE 6: DETERMINATION OF TLC STUDY
||Vv – A||255nm||0.03, 0.07, 0.16, 0.37, 0.47, 0.52, 0.58, 0.62|
|364nm||0.03, 0.07, 0.11, 0.37, 0.49, 0.55, 0.62, 0.69, 0.86, 0.96|
||Vv – B||255nm||0.03, 0.05, 0.1, 0.16, 0.3, 0.34, 0.49, 0.56, 0.65|
|364nm||0.02, 0.05, 0.1, 0.13, 0.24, 0.32, 0.39, 0.50, 0.54, 0.56, 0.61, 0.72, 0.77, 0.88, 0.92, 0.96|
||Vv – C||255nm||0.03, 0.08, 0.1, 0.15, 0.34, 0.43,, 0.50, 0.57, 0.66|
|364nm||0.03, 0.08, 0.13, 0.17, 0.20, 0.30, 0.37, 0.50, 0.54, 0.58, 0.63, 0.9|
||Vv – D||255nm||0.01, 0.05, 0.09, 0.16, 0.21, 0.29, 0.43, 0.52, 0.56, 0.66|
|364nm||0.01, 0.05, 0.09, 0.13, 0.21, 0.30, 0.37, 0.50, 0.53, 0.57, 0.63, 0.71, 0.8, 0.83, 0.90, 0.93, 0.96|
||Vv – E||255nm||0.03, 0.06, 0.10, 0.16, 0.24, 0.33, 0.43, 0.50, 0.56, 0.64|
|364nm||0.03, 0.07, 0.10, 0.13, 0.24, 0.32, 0.37, 0.50, 0.53, 0.56, 0.62, 0.70, 0.77, 0.83, 0.87, 0.9, 0.94, 0.96|
*0.24 - The standard Rf- value of purified Piperine12
TABLE 7: MICROBIAL LIMIT TEST
|Sl.no||Microbial Organism||Limit as per IP||V.V -A||V.V -B||V.V -C||V.V -D||V.V –E|
CONCLUSIONS: Vyoshadivati is a polyherbal formulation treated for the ailments pinas, swarabheda, pratishyaya, kasa, shwasa. Being the same formulation prepared by various manufacturers yet there is difference observed when markets samples and inhouse preparation are compared through standard quality control parameters as per Ayurvedic Pharmacopeia of India. Hence it is the need of hour that the Ayurvedic formulations are to be standardized in order to make them potent and therapeutically efficient.
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How to cite this article:
Havinal AM, Hiremath RS, Gundkalle MB and Mannur VS:Comparative Physico Chemical Analysis of Vyoshadivati– An Ayurvedic Polyherbal Formulation W.S.R to Market Samples.Int J Pharmacognosy 2014; 1(8) 528-533: .doi: 10.13040/IJP. 0975-8232.1(8).528-533.
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Arun.M.Havinal*, R.S. Hiremath , M.B.Gundkalle and V.S. Mannur
Department of Bhaishajya Kalpana *, Shri B.M. Kankanwadi Ayurvedic Mahavidyalaya Shahpur Belgaum, Karnataka, India
08 February, 2014
08 May, 2014
28 June, 2014
01 August, 2014