Development of Quality Control Parameters for Herbal Formulation, Pippali churna

 

Gupta Vishvnath and Jain U.K.*

Bhopal Institute of Technology and Science-Pharmacy, Bhopal (M.P)

*Corresponding Author E-mail: umeshkjain65@yahoo.co.in, vishg1981@gmail.com

ABSTRACT:

The proper and meaningful utilization of our medical traditional heritage can only be achieved if each and every formulation mentioned in our indigenous system of medicines would be scientifically evaluated and their desired efficacy may be maintained. Pippali churna is a traditional herbal formulation, which is widely used in cough, hiccough relieving, hepatoprotective and insecticidal etc. It is one of famous ayurvedic formulation containing only one ingredient such as pippali. It is observed that the consistency and content varies from one manufactures to another, which affect its therapeutic activity. Hence, it is needed to develop a protocol for the evaluation of Pippali churna. In the present study three batches of different marketed polyherbal formulation, Pippali churna were procured from the local market and they were evaluated as per Indian Pharmacopoeia and WHO guidelines on the following parameters viz. organoleptic characteristics, extractive value, physical characteristics, moisture content, loss on drying, phytochemical evaluation etc. The result of the present study revealed that all three batches of Pippali churna were found in close proximity. This study on Pippali churna was precise, reproducible and may be considered as a protocol for its evaluation.

 

 

 

INTRODUCTION:

The recent interest in Ayurvedic system of medicine is seen by large scale manufacture of ayurvedic products. A quality ayurvedic formulation must conform to the test for identity, potency, purity, safety and efficacy. Majority of the ayurvedic formulations use whole plants either alone or in combination. It has been stated that combining herbs improves efficacy and reduces adverse effects due to the low concentration of active ingredients adequate to produce therapeutic effects but to reduce the toxicity. Inspite of the large number of ayurvedic formulation available in the market, for many of them, standard for their quality are yet to be laid. Various marketed formulation shows dose variation, content variation and lack of standardization which affect its therapeutic activity, therefore it is imperative to develop fast, sensitive and accurate methods of analysis for ayurvedic formulations which will be in alignment with modern technology^1,2.

 

This paper includes the investigation of quality control methods for three different samples of Pippali churna designated as PC1, PC2 and PC3. The formulation is official in the Ayurvedic literatures and therapeutically useful in the treatment of cough, hiccough relieving, hepatoprotective and insecticidal etc. It is one of famous ayurvedic formulation containing only one ingredient. Different manufacturing companies used different active ingredient for their preparation, which are not claimed on the container due to which their efficacy cannot be access accurately. Therefore, the present study was undertaken to evaluate Pippali churna as per Indian Pharmacopoeia and WHO guidelines.

 

MATERIALS AND METHODS:

1. Materials

A)     Churna: Three marketed formulation of Pipli churna from different manufactures (designated as PC1, PC2 and PC3) were procured for the present study.

B)     Chemicals: Alcohol, acetone, methanol, n-hexane, chloroform, 1N Hydrochloric acid, 1N sodium hydroxide (aqueous), ferric chloride, 1N nitric acid, ammonia, iodine, 1N sodium hydroxide (alcoholic), and 1N Sulphuric acid etc.

C)     Instruments: Oven, Bulk density apparatus, IR moisture balance.

2. Methods

A)     Organoleptic properties of Pippali churna: Organoleptic properties of each of three batches of Pippali churna was done by using reported method^3,4 (Table I).

B)     Extractive values: Pippali churna (5gm) from each batch for individual extraction was extracted with n-hexane, petroleum ether, methanol and distilled water separately by cold maceration method described below and their extractive values were determined as per the methods given in Indian Pharmacopoeia⁵ and WHO⁶ publication.

i)       n-Hexane and petroleum ether soluble extractives: n-Hexane and petroleum ether soluble extractives were determined by same procedure as described above and dried under reduced pressure.

ii)      Methanol soluble extractives: Pippali churna was dispersed in 100ml of methanol and allowed to stand for 24hrs with occasional shaking. Extract was filtered and evaporated.

iii)     Water soluble extractives: Pippali churna was dispersed in 100ml of water and allowed to stand for

 

24hrs with occasional shaking and filtered. The above procedure was performed for each batch and the dried water extractives of PC1, PC2 and PC3 were weighed.

iv)     The extractive values of the all three batches of Pippali churna in above solvent are given in Table II.

 

C)     Physical characteristics: The physical characteristic of the Pippali churna were determined for PC1, PC2 and PC3 in terms of the bulk density, true density and angle of repose, according to the standard procedure⁷ (Table III).

D)     Loss on drying: loss on drying was determined for all three batches of Pippali churna as per standard procedure^5,8 (Table  IV).

E)     Phytochemical evaluation: For this study, aqueous extract of Pippali churna has been employed, screening process of each batch of Pippali churna for phytochemical evaluation was done using reported methods^9,10 (Table V).

 

 

 

Table I: Organoleptic properties of different formulations of Pippali churna

 

S. NO.	Different Formulations	Appearance	Colour	Taste	Odor
1.	PC1	Powder	Brownish yellow	AromaticBitter	Characteristic odor
2.	PC2	Powder	Brownish yellow	AromaticBitter	Characteristic odor
3.	PC3	Powder	Brownish yellow	AromaticBitter	Characteristic odor

 

Table II: Extractive values of Pippali churna

S. No.	Extractive	Values* %W/W (Mean ±SD)
		PC1	PC2	PC3
1.	Water soluble	32.4±0.26	32.2±0.40	32.02±0.03
2.	Methanol soluble	16.06±0.05	16.62±0.03	16.20±0.34
3.	n-Hexane	1.07±0.05	1.96±0.06	2.15±0.08
4.	Petroleum Ether	2.05±0.07	3.19±0.04	1.01±0.01

* Values of mean of three experiments

 

Table III: Physical characteristics of different formulations of Pippali churna

 

S. No.	Parameters	Values* % (Mean ±SD)
		PC1	PC2	PC3
1.	Bulk density	0.62± 0.0004(gm/ml)	0.62± 0.01(gm/ml)	0.62± 0.01(gm/ml)
2.	True density	0.70± 0.001(gm/ml)	0.70± 0.0008(gm/ml)	0.70± 0.003(gm/ml)
3.	Angle of repose	8.51± 0.025°	9.12± 0.032°	10.07± 0.36°

* Values of mean of three experiments

 

Table IV: Loss on drying of Pippali churna

S. No.	Samples	Values* % (Mean ±SD)
1.	PC1	1.68±0.44
2.	PC2	1.94±0.04
3.	PC3	2.00±0.20

* Values of mean of three experiments

 

Table V: Phytochemical evaluation of Pippali churna

S. No.	Phytoconstituents	PC1	PC2	PC3
1.	Alkaloids	+	+	+
2.	Glycosides	-	-	-
3.	Carbohydrate	+	+	+
4.	Steroids	-	-	-
5.	Tannins	+	+	+

(+) Present, (-) Absent

RESULTS AND DISCUSSION:

Pippali churna (three batches, PC1, PC2 and PC3) was evaluated in the laboratory according to standard procedures. They were evaluated by comparative analysis for their organoleptic properties, extractive values (n-Hexane, Petroleum Ether, methanol and water), physical characteristics, loss on drying, phytochemical evaluation.

Organoleptic studies revealed that all the three batches (PC1, PC2 and PC3) of Pippali churna were brownish-yellow in color, having charcterstic odor and aromatic bitter taste (Table I).

 

Extractive values are reported in Table II. The Extractive values (%W/W) of Pippali churna (Mean±SD of PC1, PC2 and PC3) in n-hexane and Petroleum Ether were found to be 1.07±0.05 and 2.05±0.07 respectively and that in water and methanol were 32.4±0.26 and 16.06±0.05 respectively, indicating the presence of polar and semipolar constituents in Pippali churna.

 

The physical characteristics of all the samples of Pippali churna were shown in Table III. Low values of angle of repose show the poor flowability for all samples. The results of the three batches were found to be comparable. The % loss on drying values of Pippali churna are reported in Table IV.

 

The investigations of phytochemical evaluation are shown in Table V, which shows the presence of different phytoconstituent. The data analysis reveals that all parameters remain in close proximity for each batch of Pippali churna.

 

Since so far no attention has been paid to evaluate a polyherbal formulation by comparative analysis. The calculated parameters and the developed methods for their determination can be considered as the protocol for the evaluation of Pippali churna, which will assist the regulatory authorities, scientific organizations and manufacturers in developing standards. The method used for evaluation is found to be precise and reproducible and help to produce uniform standard products, which will restore faith in Ayurvedic system. The present study is a building step towards the development of quality control methods for herbal formulation, Pippali churna.

 

REFERENCE:

1.       Eapen Saumy MS and Grampurohit ND: Chemical evaluation of Navayasa churna, Indian Drugs, 39(2), 2002, 101-105.

2.       Karch S.B., Toxicology and Clinical Pharmacology of Herbal Products, Melanine John’s Cupp, Human Press, New Jersy, 2000.

3.       Brain K.R. and Turner T.D., The practical evaluation of phyto-pharmaceuticals, Wright-Scientechnica, Bristol, 1975, 36-102.

4.       Kokate C.K., Practical Pharmacognosy, Vallabh Prakashan, 3^rdEd., Reprint 1992, 115-121.

5.       Pharmacopoeia of India, Ministry of Health and family Welfare, Govt. of India, New Delhi, Vol. II, 1996, A-53, 54, 89, 95. 

6.       W.H.O., Quality control methods for medicinal plant materials, Geneva, 1998, 9, 22-24, 33.

7.       Martin A.J., Physical Pharmacy, 4^th Ed., 1994, 423-452.

8.       The Ayurvedic Pharmacopoeia of India, Part 1, Vol. III, 1^st Ed., Ministry of Health and family Welfare, Govt. of India, Dept. of Health, New Delhi, 2001, 234-235.

9.       Mukherjee P.K., Quality Control of Herbal Drugs, 1st Ed., 2002, 247-378.

10.     Trease and Evans W.C., Pharmacognosy, 15^th Ed., 2005, 253-254.

 

 

 

 

Received on 01.05.2010        Modified on 14.05.2010

Accepted on 24.05.2010        © AJRC All right reserved