Comparative Standardization of a Polyherbal Ayurvedic Formulation: Talisadi Churna

Kamlendra Mishra*, K. Shukla, Pradeep Pal, S C Mahajan

Mahakal Institute of Pharmaceutical Studies, Ujjain 456664

*Corresponding Author E-mail: kamal_mips@yahoo.co.in

ABSTRACT:

India is a land mark for the traditional system of medicine from the past few centuries. Most of the traditional system of medicine are effective but only one major drawback is lack of standardization. So, there is a need to develop standardization technique to mingle this system of medicine in the main stream of health sciences. Centre council for research in Ayurveda and siddha has given the preliminary guideline for standardizing these conventional formulations. The present paper reports standardization of Talisadi churna an Ayurvedic formulation, from three different companies. Three marketed samples were subjected to organoleptic study, physical characterization and chromatographic study. It was observed that all the formulations are similar with their organoleptic properties and to some extend to their physical characters but they do not match quantitatively in active constituent (piperine) content which may be due to variation in raw material like geographical variation, collection time, storage etc. This study ready reference for selection of an appropriate formulation in the clinical practice and hence effective rational therapy, the overall theme of health science. The physical data obtained from various samples shows different values as they are claimed to be of same plant material in same quantities. The qualitative estimation of volatile oil shows the presence in all the formulations. The HPLC results of quantitative estimation of piperin shows considerable variation in piperine content into the formulations in which the maximum concentration was obtained in the formulation A.

KEYWORDS: Talisadi Churna, Ayurvedic Formulation, Standardization, Chromatography.

INTRODUCTION:

Herbal formulations have been used by majority of indians since ancient time. In recent years, there has been an increased inclination towards the natural sources and a healthy life style. Moreover, the complexity, side effects and costly treatment associated with the allopathic system of medicine have caused the both health practitioners and the majority of the world populations to turn toward the alternative medicine, more likely toward the herbal medicines^[1]. Herbal drug technology is used for converting botanical material into medicines, where standardization and quality control with proper investigation of modern scientific techniques and traditional knowledge is important^[2]. Botanicals constitute major part of these traditional medicines. With the emerging world wide interest, in adopting traditional practices, in the healthcare system by exploiting their potential, the evaluation of the botanicals in these systems of medicine in india is utmost essential.

The development of these traditional system of medicine with the perspective of safety, efficacy and quality will help not only to preserve this traditional heritage but also to rationalize the use of natural products in the healthcare^[3,4]. Standardization is a system to ensure that every packet of medicine that is being sold has the correct amount and will induce its therapeutic effect^[5]. The first Indian National Health Policy 1983 claims that India’s is the richest source of herbs and the drugs should be standardized. The department of AYUSH, Government of India, launched a central scheme to develop standard operating procedures for the manufacturing process to develop pharmacopeial standards for Ayurvedic preparations.In this aspect standardization of herbal formulations is essential in order to assess the quality of drugs. Talisadi churna is a classical preparation from the text Astanga Hridaya – Rajayakshma Chikitsa, which consists of five powders of Talishpatra (Taxus baccata Linn. Family – Taxaceae), Trikatu (Piper nigrum, Piper longum Linn., Family – Piperaceae, and Zingiber officinalis Rosc., Family – Zingiberaceae), in the ratio 1:1:1, Banshlochan (Bambusha arundinacea wild., Family – Poaceae), Ela (Eletteria cardamomum Maton., Family–Zingiberaceae), Dalchini (Cinnamomum zeylanicum Blum., Family – Lauraceae) and sugar. It is the best remedy in acute, chronic and allergic bronchitis. It is very useful in exacerbation of asthma. In chronic asthma it reduces the frequency and severity of asthmatic attack^[6,7].

A number of polyherbal formulations are marketed with the name of Talisadi churna calming to be very effective. But the documented reports authenticate that the plants very in the contents of secondary metabolites with the time of collection and geographical variations^[8]. Emphasizing these perplexing reports, present study was planned to evaluate the organoleptic study, physical characteristics and quantitative chemical evaluation and HPLC.

METHODOLOGY:

The samples were collected from Ayurvedic retailers of Ujjain (Mahakal Ayurved Bhawan), of three companies namely Dabur (A), Vyas Pharmaceuticals (B) and Lion – Narayan Pharmaceuticals (C). Standard piperine was purchase from SK Traders, Indore and Piper nigrum was purchased from the local market and authentified by Dr. S. K. Billore (Professor and Head of Department), of Madhav Science College, Ujjain (MP) and voucher specimen of (MIPS/P/001/2012) Piper nigrum Linn. was deposited in the of department of Pharmacognosy, Mahakal Institute of Pharmaceutical Studies, Ujjain (MP). Organoleptic characters such as colour, odour and taste of all samples were recorded. Physical analysis for total ash, water soluble ash, acid insoluble ash, extractive values and qualitative estimation of volatile oil is carried out in triplicates in all three samples of Talisadi churna according to the prescribed method as per CCRAS guidelines^[9].

HPLC chromatogram profiles were obtained in all the samples. Chromatographic separation was performed on Yongline acme 9000 pump, Shimadzu system controller and Shimadzu UV-VIS 1700 detector. The column used was C-18 and Autochrom 3000 software was used as integrator. For sample preparation 4 gms of samples were refluxed for 1 hr with methanol, filtered and concentrated.

The chromatograms were obtained by injecting sample solutions (20µL) into the column (C-18 silica gel). Methanol: water in the ratio of 69:31 were used as mobile phase. A flow rate of 1.5 ml/min was maintained and the eluents were monitored for UV absorption at 343 nm were used for quantitative estimation.

Table-1 Organoleptic characters of various samples of Talisadi churna.

S.No	Formulation	Appearance	Color	Odor	Taste
1.	Formulation –A	Powder	Whitish brown	Fragrant	Sweetish
2.	Formulation-B	Powder	Whitish brown	Fragrant	Sweetish
3.	Formulation-C	Powder	Whitish brown	Fragrant	Sweetish

Table -2 Ash values and extractive values of various samples of Talisadi churna.

S.No	Formulation	Total ash	Water soluble ash	Acid insoluble ash	Water soluble extractive	Alcohol soluble extractive
1.	Formulation-A	3.5%	5.5%	1.3%	15.25%	11.2%
2.	Formulation-B	2.3%	4.0%	1.4%	16.75%	13.45%
3.	Formulation-C	2.9%	6.0%	1.2%	21.25%	15.6%

Values are in mean of three determinations.

Table -3 Physical evaluations of various samples of Talisadi churna

S.No	Formulation	Bulk density	Tapped density	Angle of repose	Hausner’s ratio
1.	Formulation-A	0.58g/cm²	0.76g/cm²	23.4^o	1.31
2.	Formulation-B	0.55g/cm²	0.66g/cm²	28.5^o	1.20
3.	Formulation-C	0.52g/cm²	0.71g/cm²	26.7^o	1.36

Table-4 Qualitative estimation of volatile oil in various samples of Talisadi churna.

S.No	Formulation	Experiment	Inference	Observation
1.	Formulation-A	Powder + ferric chloride solution	Pale green color	+ve
2.	Formulation-B	Powder + ferric chloride solution	Pale green color	+ve
3.	Formulation-C	Powder + ferric chloride solution	Pale green color	+ve

Table -5 HPLC Analysis of various samples of Talisadi churna.

S No	Formulation	Name	RT[min]	Area[mV*S]	Height[mV]	Amount[ug/ml]
1.	Formulation-A	Piperine	7.9333	504.3728	20.7332	7.0484
2.	Formulation-B	Piperine	7.8667	225.3619	9.4996	3.1494
3.	Formulation-C	Piperine	7.8667	190.3846	5.1209	2.6606

RESULT:

Talisadi churna samples of different manufacturers were subjected to qualitative and quantitative evaluation. Organoleptic evaluation of all samples shows that all are whitish brown in colour with pleasant odour and sweet taste, fine powders. From the result outlined from table number 1-4, the followings can ne deduced. The physical data obtained from various samples shows different values as they are claimed to be of same plant material in same quantities. The qualitative estimation of volatile oil shows the presence in all the formulations. The HPLC results (Table 5) of quantitative estimation of piperin shows considerable variation in piperine content into the formulations in which the maximum concentration was obtained in the formulation A.

Figure 1- Calibration graph of standard peperine.

Figure 2- HPLC chromatogram of Standared piperine.

Figure 3- Chromatogram of crude Pepper nigrum extract.

Figure 4- Chromatogram of extract of sample A.

Figure 5- Chromatogram of extract of sample B.

Figure 6- Chromatogram of extract of sample C.

Figure 7- Overlay chromatogram of three samples ( A, B, C ).

(A-Red, B-Brown and C-Black)

Figure 8- Overlay chromatogram of samples with crude drug extract and standard piperine.

Std (S), Crude (Crd), Mkt. (A, B, C)

DISCUSSION:

Ayurvedic formulations claimed to be made according to CCRAS guidelines are effective but it is very difficult to maintain the uniformity within formulations which may results due to the natural heterogeneity, the quality of herbal raw materials obtained from the wild shows more and more variations. Which can be depicted from experimental data. Organoleptic data are showing the similarity while physical data are showing that there is no uniformity in collection of crude drugs for the manufacturing of all the formulations. Qualitative estimation have shown the presence of volatile oil in all the formulations which can be further subjected for quantitative estimation of it. The analytical data obtained from the HPLC shows much quantitative variation within the formulations which may be due to the qualitative and quantitative difference in the raw materials used.

CONCLUSION:

The result of the present study clearly indicates that there is no uniformity within the formulations which may be due to the difference in geographical conditions, a great deal in the adulteration or substitution in commercial market etc. The present study is an indicative towards the care need to be taken before the selection and collection of the raw material for the manufacturing of formulations. As the formulations vary quantitatively so, further, they may be subjected for the comparative pharmacological evaluation too.

REFERENCE:

1. Raffeeudin M, Rao NV, Shanta KSM and Bheemachari J, Comparative efficacy of four Ayurvedic antidiabetic formulations in alloxan-induced diabetic rabbits, Acta Pharm. Sci., 51 (2009) 33-38.

2. Yadav NP and Dixit VK, Recent Approaches in Herbal Drug Standardization, Int J Bio.l, 2 (2008), 195-203.

3. Mukherjee PK and Wahile A, Integrated Approaches towards drug development from Ayurveda and other Indian System of medicine, J. Ethnopharmacol., 103 (2006), 25-35.

4. Mukherjee PK, Exploring Botanicals in Indian System of Medicine-Regulatory Perspectives, Ciln. Res. Affairs, 20 (2003), 249-264.

5. Caudhury RR, Herbal Medicines for Human Health (World Health Organization, New Delhi, India), 1992, 400.

6. Shrikumar S, Maheshwari U, Sughanti A, Ravi TK .WHO guidelines for standardization of herbal drugs. Pharminfo.net 2006; 2: 78-81.

7. Kalaiselvan V, Kalpeshkumar SA, Patel FB, Shah CN, Kalaivani M, Rajasekaran A. Quality assessment of different marketed brands of Dasamoolaristam, an Ayurvedic formulation. Int J Ayurvedic Res 2010;1(1):10-13.

8. Fgueiredo AC, Barroso JG, Pedro LG and Scheffer JJC, Factors Affecting Secondary metabolite production in Plants, Volatile components and essential oils, Flav Frager J, 23 (2008), 213-226.

9. Anonymous, Pharmacopoeial Standards for Ayurvedic Formulations, Appendix-I (Central Council for Research in Ayurveda and Siddha, Ministry of Health and Family walfare, New Delhi), 2008, 437-457.

Received on 30.10.2014 Modified on 11.11.2014

Res. J. Pharmacognosy & Phytochem. 7(1): Jan.-Mar. 2015; Page 34-37

DOI: 10.5958/0975-4385.2015.00008.4