STANDARDIZATION OF ERANDAMOOLADI KWATHA CHURNA - A COMPOUND FORMULATION USED IN MEDICATED ENEMA THERAPY (BASTI KARMA)

Abstract

To assure therapeutic efficacy and safety, the standardization of Ayurvedic compound plays an important role. Erandamooladi Kwatha Churna is a poly herbal formulation widely used in Ayurveda clinical practice with multi fold benefits like Agni Deepana (improving digestive fire), Ama Pachaka (digestion of undigested material) Sroto Shodhana (cleansing of micro channels) specifically to management of Gridhrasi (Sciatica). There are no work on the standardisation aspect of this formulation though individual herbs used for the preparation has been studied. This study highlights physico-chemical characterization, HPTLC and densitogram profile of Erandamooladi Kwatha Churna which can be applied for authentication of this poly herbal formulation. Formulation were prepared by combining all the drugs and subjected for detailed physico-chemical and HPTLC analyses. The results obtained are considered as tools for assistance to the regulatory authorities and manufacturers for developing standard formulation aiming for great efficacy. [PUBLICATION ABSTRACT]

Headnote

ABSTRACT

To assure therapeutic efficacy and safety, the standardization of Ayurvedic compound plays an important role. Erandamooladi Kwatha Churna is a poly herbal formulation widely used in Ayurveda clinical practice with multi fold benefits like Agni Deepana (improving digestive fire), Ama Pachaka (digestion of undigested material) Sroto Shodhana (cleansing of micro channels) specifically to management of Gridhrasi (Sciatica). There are no work on the standardisation aspect of this formulation though individual herbs used for the preparation has been studied. This study highlights physico-chemical characterization, HPTLC and densitogram profile of Erandamooladi Kwatha Churna which can be applied for authentication of this poly herbal formulation. Formulation were prepared by combining all the drugs and subjected for detailed physico-chemical and HPTLC analyses. The results obtained are considered as tools for assistance to the regulatory authorities and manufacturers for developing standard formulation aiming for great efficacy.

KEY WORDS: Erandamooladi Kwatha Churna, sciatica, poly herbal formulation, high performance thin layer chromatography, standardization

INTRODUCTION

Ayurveda, Indian system of medicine is the first recorded medical science. In recent years there is global revolution worldwide towards acceptance of this holistic science owing to its effectiveness and safety. The increasing demand has created great need to standardize herbal medicines for scientific base of acceptance. The earliest references of drug standardizations are mentioned in Ayurveda classics under the specialty of Bhaishajya Kalpana and Rasa Shastra which exclusively deal with drug formulation and manufacturing. Hence standardization and development of reliable quality protocols are important (Anantanarayana DB, 2002).

The methods though crude but specify the required standards of the raw drugs as well as best quality of Ayurveda medicine. Sharngadhara, who pioneered Ayurvedic pharmacy has given best qualities of medicine along with the methodology of preparation of specified formulation such as Gutika (tablets), Ghrita (medicated ghee), Taila (medicated oils) Avaleha (medicated elixirs), (Parashurama Shastri, 2000), and so on. In fact, it constitutes the first ever described good manufacturing practice and standard methods of quality control. Hence standardization and development of reliable quality protocols are important.

Plant material when used in bulk quantity may vary in its chemical content and therefore, in its therapeutic effect according to different batches of collection. It may depend on the collection in different season and/or collection from sites with different environmental surrounding or geographical location. The increasing demand and persisting stage, authentic raw materials have made it incumbent, to maintain uniformity in the manufacture of Ayurvedic medicines so as to promise the quality control and quality assurance (WHO, 1992). Various formulations are described in Ayurvedic texts to treat Gridhrasi (sciatica). Erandamuladi Niruha Basti (medicated enema) is one among them.

Considering therapeutic utility of the Erandamooladi Niruha Basti, a thought was given to standardize the same for multiple usage as Agni Deepana (improving digestive fire), Ama pachaka (digestion of undigested material) Sroto Shodhana (cleansing of micro channels of the body) and specifically to management of Gridhrasi (Sciatica). Development of a composite standardization protocol for Erandamooladi Niruha Basti was aimed in this study.

The combination of the drugs mentioned in Table 1 are used to prepare the Kashaya (decoction) to be used for the administration of Niruha Basti (rectal route administration of medicine) with a wide range of applications on different conditions. Most of the drugs used in this formulation possess the properties like Ushna Veerya (hot in potency), Laghu (light), Ruksha (dryness) Gunas and does Deepana (digestive) and Lekhana Karma (scraping effect). It is indicated in pain in Janga (knee), Uru (leg region), Pada (foot) and Prusta (low back region and in Kapha-avrutha (channels obstructed by phlegm) conditions. The Erandamooladi formula acts as a Maruthanigrahana (controls movements), in case of Mala-mutra Sanga (obstruction to fecal and urine), Arsha (piles) Anaha (flatulence) and Admana (distention of abdomen) (Trikamji Yadavji, 2009).

MATERIALS AND METHODS

Instrumentation and techniques: High performance thin layer chromatography (HPTLC) studies were done at SDM Centre for Research in Ayurveda and Allied Sciences, Kuthpady, Udupi, Karnataka, India as per standard procedure (I Stahl, 1969; PD Sethi, 1996; Khandelwal KR, 2005).

Plant materials: Required plant medicines were collected from authorized raw drugs suppliers of Chaitahanya Pharmaceuticals Bellary, Karnataka, India. The raw materials were first identified and authenticated by a team of botanists at Chaitahanya Pharmaceuticals, Bellary, Karnataka, India

Preparation of Erandamooladi Kwatha churna (EKC): As per the textual description (Parashurama, 2000) and guidelines in Ayurvedic formulary of India (AFI, 2003) the all drugs described above were powdered separately and mixed equally (Trikamji Yadavji, 2009). 1kg of final output of powder was obtained after 10% of loss during processing. All the sample powders were passed through 80 mesh size.

Instrumentation and techniques (Anonymous, 2003).

1. Loss on drying at 105°C: 10 g of sample was placed in tared evaporating dish. It was dried at 105°C for 5 hours in hot air oven and weighed. The drying was continued until difference between two successive weights was not more than 0.01 after placing in desiccator. Percentage of moisture was calculated with reference to weight of the sample.

2. Total Ash: 2 g of sample was incinerated in a tared platinum crucible at temperature not exceeding 450°C until carbon free ash is obtained. Percentage of ash was calculated with reference to weight of the sample.

3. Acid insoluble Ash: To the crucible containing total ash, add 25ml of dilute HCl. Collect the insoluble matter on ashless filter paper (Whatman 41) and wash with hot water until the filtrate is neutral. Transfer the filter paper containing the insoluble matter to the original crucible, dry on a hot plate and ignite to constant weight. Allow the residue to cool in suitable desiccator for 30 minutes and weigh without delay. Calculate the content of acid insoluble ash with reference to the air dried drug.

4. Alcohol soluble extractive: Weigh accurately 4 g of the sample in a glass stoppered flask. Add 100 ml of distilled Alcohol (approximately 95%). Shake occasionally for 6 hours. Allow to stand for 18 hours. Filter rapidly taking care not to lose any solvent. Pipette out 25ml of the filtrate in a pre-weighed 100 ml beaker. Evaporate to dryness on a water bath. Keep it in an air oven at 105°C for 6 hours, cool in a desiccator for 30 minutes and weigh. Calculate the percentage of Alcohol extractable matter of the sample. Repeat the experiment twice, and take the average value.

5. Water soluble extractive: Weigh accurately 4 g of the sample in a glass stoppered flask. Add 100 ml of distilled water, shake occasionally for 6 hours. Allow to stand for 18 hours. Filter rapidly taking care not to lose any solvent. Pipette out 25ml of the filtrate in a pre-weighed 100 ml beaker. Evaporate to dryness on a water bath. Keep it in an air oven at 105°C for 6 hours. Cool in a desiccator and weigh. Repeat the experiment twice. Take the average value.

6. High Performance Thin Layer Chromatography (HPTLC): 1g of powder was extracted with 20 ml of alcohol with successive method (Lala, 1993) 15 and 30 micro liter µl of the above extract was applied on a precoated silica gel F254 on aluminum plates to a band width of 8 mm using Linomat 5 TLC applicator. The plate was developed in Toluene: Ethyl acetate: Formic acid (6: 2: 1.8). The developed plates were visualized in UV 254, 366 and after derivatisation with vanillin-sulphuric acid and scanned under UV 254, 366, and at 540 nm. Rf values, colour of the spots and densitometric scan were recorded.

RESULTS & DISCUSSION:

The results of the Physico-chemical parameters of EKC has been tabulated in Table 2.

Thin layer chromatography (TLC):

TLC fingerprint profile is a systematic representation of all the constitution of samples resolved in the given chromatographic system. TLC photo documentation of EKC is presented in Figure 1.

High Performance Thin Layer Chromatography (HPTLC):

HPTLC fingerprint of butanol soluble portion of EKC has been developed. The purity of the band in the sample extracts was confirmed by comparing the absorption spectra recorded at start, middle, and end positions of the band. The video densitometric images of chromatoplate are depicted. HPTLC densitometric scan at UV 254, 366, 620 nm are presented in Figure 2. The Rf values are tabulated in Table 3. Rf values of the spots and their colour by TLC photo-documentation of EKC extracts have been developed. Chloroform extract of EKC at 254 nm showed 10 spots (0.12 Green, 0.18 Green, 0.32 D green, 0.39 Green, 0.43 Green, 0.53 Green, 0.57 Green, 62 Green,-0.69 Green, 0.82 D green) whereas under 366 nm it showed 5 spots (0.29 F.Blue, 0.43 F. Green, 0.48 F.Blue, 0.62 F.Blue, 0.65 F.Blue, 0.72 F.Green, 0.78 F.Pink, 0.91 F.Blue) and 8 spots (0.12 Violet, 0.18 Violet, 0.32 Yellowish brown, 0.39 Blue, 0.51 Blue, 0.53 Pink, 0.65 Blue, 0.69 Pink, 0.76 D blue, 0.82 D blue) after derivatisation using toluene: methyl acetate (6.5:2.5) as solvent system.

CONCLUSION

Despite the advent of modern technology in standardization of compound formulations, only a few Ayurvedic poly herbal medicines have been standardized so for. This study was aimed at authentication of ingredients used in the sample and chemical characterization using advanced methodology. Considering its wide range of age, EKC was selected for study. Physico-chemical standardization of EKC was carried out. Individual ingredients of the formulation were authenticated and standardized as per WHO criteria on herbal pharmacopeia. TLC photo documentation of EKC with its ingredients was carried out. HPTLC fingerprint of chloroform and alcohol extract (successive) of EKC was developed. The product EKC was analyzed for its fingerprint in comparison with its ingredients. The current investigation can be used as standardization test for this compound formulation. Further, detailed macro & microscopic examination of the raw drug individually and powdered form would add to the standardization test of EKC.

ACKNOWLEDGEMENT

Authors are highly grateful to our revered President, Dr. D. Veerendra Heggade and Dr. B. Yashoverma, Secretary, SDM Educational Society, Ujire, Karnataka, India for their encouragement. Authors greatly regard the constant support of Dr. Prasanna N Rao, Principal, SDM College of Ayurveda & Hospital, Hassan, Karnataka, India and Dr. B. Ravishankar, Director, SDM Centre for Research in Ayurveda and Allied Sciences, Udupi, Karnataka, India for providing the facilities and for their help in carrying out the studies.

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Cite this article:

Lohith. B. A., Sunil Kumar. K. N., Girish. K. J., (2013), STANDARDIZATION OF ERANDAMOOLADI KWATHA CHURNA - A COMPOUND FORMULATION USED IN MEDICATED ENEMA THERAPY (BASTI KARMA), Global J Res. Med. Plants & Indigen. Med., Volume 2(10): 709-715

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