Development of quality control parameters of an ayurvedic formulation: ‘Ashwagandhadi Churna’

Mukesh Sharma¹, Nisha Amit², Kushagra Nagori¹, Sonam Soni¹, Shoyeb¹, Khushboo¹

¹Rungta College of Pharmaceutical Science and Research, Kurud, Bhilai-490026 (Chhattisgarh) India.

²Kalyan PG College, Sec-7, Bhilai, 490006 (Chhattisgarh) India.

ABSTRACT:

Ayurveda is known as the oldest healing science. Ashwagandhadi Churna is important in management of digestive and respiratory disturbances of all body types. It is useful for any imbalance in the muscles as it both reduces inflammation and strengthens muscle tone. It is having different ingredient which are having a wide range of uses in health maintenance. The quality control of Ashwagandhadi Churna which will assist the regulatory authorities, scientific organizations and manufacturer in developing standards.

Ashwagandhadi Churna (AC1) is consist of the fine powders of Ashwagandha and Vidhara in the ratio of 1:1. It is best remedy in tissues Debility, low body weight, emaciation, deficient haemoglobin, anaemia, post-convalescent weakness, athletic exertion. Ashwagandhadi Churna sample was prepared in laboratory according to Ayurvedic formulary.

This was evaluated by comparative analysis with the marketed formulations (AC2 and AC3) for their extractive values (ethanol and distilled water), Micromeritic parameters (bulk density, true density, angle of repose and Carr’s Index) and Phytochemical evaluation. We also found the extractive values of Ashwagandhadi Churna (AC1, AC2 and AC3) in water and ethanol respectively indicating the presence of almost polar and semi polar constituents in Ashwagandhadi Churna. These analytical findings and data analysis revels that parameters like extractive values, presence of phytoconstituents and micromeritic parameters all remains in close proximity for each batch of the Ashwagandhadi Churna.

KEYWORDS: Quality control, Ayurvedic formulation, Ashwagandhadi Churna.

INTRODUCTION:

Ayurveda, the health care system indigenous to India, has an impressive evolutionary history that spans a period of many thousands of years. With the advent of biomedicine, Ayurveda was relegated to the background and there was a time when it looked as though the final word had been said about it. Recently, Ayurveda is getting worldwide attention albeit the nature of the role it can play in contemporary health care scenario is not well defined.¹

Ashwagandhadi Churna is an Ayurvedic medicine, in herbal powder form, used in the Ayurvedic treatment of respiratory and digestive conditions. Ashwagandhadi Churna is a classical preparation from the text Astanga Hridaya-Rajayakshma Chikitsa. It is best remedy in acute, chronic and allergic bronchitis. It is very useful in acute exacerbation of asthma. In chronic asthma it reduces the frequency and severity of asthmatic attacks.²

Table: 1 List of Pharmacological and traditional indication and uses of Ashwagandha.

Immunity	Auto-immune conditions, neutropenia, rheumatoid and osteo arthritis, cancer, and chronic connective tissue disorders. As a painkiller and anti-inflammatory it is commonly used in swollen or painful arthritic conditions. It can strengthen a weakened immune system and protect it from becoming depleted due to immunosuppressive drugs or lifestyle. Improves white blood cell counts. It appears to have both immunosuppressive and immunotonic abilities and is therefore a ‘true’ adaptogen.⁵
Lungs	Asthma, cough and allergic conditions from low immunity with high kapha and vata. Useful in hayfever, allergic rhinitis from aggravated vata and kapha.⁶
Nerves	Neurosis, insomnia, anxiety, ‘hyper’ symptoms and ADHD. Very useful in all conditions caused by ‘stress’ as it has a specific affinity for the majja dhatu and helps to regulate the movement of vyana vayu in the heart. Its tropism for the nervous system benefits Multiple sclerosis. It both relaxes frayed nerves and tonifies the central nervous system to enhance tolerance to stress.⁷
Reproductive	Its rejuvenating effect on shukra dhatu helps to alleviate asthenospermia (increasing sperm motility), oligospermia (increasing sperm count), poor sexual performance and helps to reduce impotence. Its unique action or prabhava is to promote sexual potency and sperm production. External application of Ashwagandha oil is used for impotence.⁸
Gynaecology	Excellent tonic to the uterine muscles. Used in menstrual imbalance caused by a deficient condition with an aggravation of vata and uterine spasms; dysmenorrhoea , amenorrhoea, weakness.⁹
Thyroid	Very useful in hypothyroid to regulate thyroid activity.⁹
Anti inflammatory activity	The alcoholic extract of the root exhibited statistically significant anti-inflammatory activity against granuloma formation technique in albino rats which comparable to acetylsalicylic acid. The extract did not show much activity against formalin induced arthritis in rats.¹⁰
Antiviral activity	The extract of the plant and fruits had interferon-like antiviral activity against vaccinia virus in CAM cultures, but was devoid of any activity against Ranikhet disease virus.¹¹
Antibacterial activity	The alcoholic extract of the leaves revealed antibacterial activity against staphylococcus aureas,^[61] the seed oil was found to possess in vitro antibacterial activity against Klebsiella sp., Escherichia coli, Pseudomonas aeruginosa and Bacillus anthracis.^11,12
Central nervous system activity	The n-hexane (n-HF), chloroform (CF), ethyl acetate (EAF) and water (WF) fractions of hydroalcoholic extract of roots of A. speciosa were tested on the central nervous system. All the fractions (100, 200 and 500 mg/kg, p.o.) were evaluated for neuro-pharmacological activity using spontaneous motor activity and pentobarbital-induced sleeping time in mice. Chlorpromazine was used as a positive control. Central nervous system depressant activity was observed with all the fractions as indicated by the results in which they reduced spontaneous motor activity and potentiated pentobarbital induced hypnosis in mice.¹³
Uses of whole Plant	In stomach complaints, sores on foot, small pox, syphilis, dysentery and diarrhea.¹⁴
Uses of Leaf	Antiphlogistic, emollient, poultices of wounds, externally for skin disease, gleet, gonorrhoea and chronic ulcers. Also used as a local stimulant and rubefacient. ^[45][65] Externally used in the treatment of ringworm. Eczema, itch and other skin diseases.^15,16
Uses of Root	Appetitiser, anaemia, aphrodisiac, anti–inflammatory, brain-tonic, cardiotonic, cerebral disorders, diabetes, expectorant, obesity, syphilius, tuberculosis, ulcers and wounds.^17,18

Ashwagandhadi Churna having ingredients of Ashwagandha (Withania somnifera) and Vidhara (Argyreia nervosa).³

Indications:

It is a specific rasayana for mamsa dhatu and it is an anabolic muscle builder. As it benefits all muscle tissue it is used as a heart tonic, uterine tonic, lung tonic as well as for increasing muscle weight and tone in convalescents, slow developing children and the elderly.⁴

MATERIALS AND METHODS:

Ashwagandhadi Churna named AC1 (Lab Preparation) was prepared accordance with Ayurvedic Formulary of India. This was evaluated by comparative analysis with the marketed formulations of Baidyanath and Dhootapeshwar named as AC2 and AC3 respectively.

1. Organoleptic evaluation:

Organoleptic evaluation was used for identification of sensory characteristics like colour, odour, taste, size, texture and fracture.¹⁹

2. Water-soluble Extractives:

Ashwagandhadi Churna was dispersed in 100 ml of water and allowed to stand for 24 hours with occasional shaking and filtered and water was evaporated. The above procedure was performed for each baACh and the dried water extractive (Wext) of AC1, AC2 and AC3 were weighed.²⁰

3. Ethanol Soluble Extractives:

Ashwagandhadi Churna was dispersed in 100 ml of ethanol and allowed to stand for 24 hours with occasional shaking and filtered and ethanol was evaporated. The above procedure was performed for each baACh and the dried ethanol extractive (Eext) of AC1, AC2 and AC3 were weighted.²¹

4.Micromeritics parameter:

The physical characteristics of the formulation were determined for the true density, bulk density and angle of repose in accordance with method given in Pharmacopoeia of India.²¹

5.Thin Layer Chromatography ( TLC ):

The adsorbents like silica gel G is coated to a thickness of 0.3mm on clean TLC plates which are than activated at 105⁰c for 30 min and used. The selection of mobile phase depends upon the type of constituents to be analysed. The resolved spots are revealed by spraying with suitable detecting agent.²¹

Rf = Distance travelled by solute

Distance travelled by solvent

6. Fluorescence analysis:

Fluorescence characters of powdered plant material with different chemical reagents were determined under ordinary light. 9.1 mg of the Polyherbal sample was taken in a glass slide and treated with various reagents for the presence of their fluorescence characters.²¹

RESULT:

Table:2 Organoleptic Evaluation

Properties	AC1	AC2	AC3
Colour	Buff Green	Buff	Creamis White
Odour	Odourless	Odourless	Odourless
Taste	Tasteless	Tasteless	Tasteless
Texture	Fine Powder	Fine Powder	Fine Powder

Table:3 Extractive values of three batches of Ashwagandha Churna:

No.

Extractives

Extractive Values* % W/W (Mean+SD)

AC 1

AC 2

AC 3

Water soluble

Ethanol soluble

51.4

35.6

50.8

34.4

50.2

33.4

Table-4: Micromeretic Parameters of three batches of Ashwagandha Churna:

S.No	Parameters	(Mean+SD)
S.No	Parameters	AC 1	AC 1	AC 1
1	Bulk Density	0.33 (gm/ml)	0.35 (gm/ml)	0.45 (gm/ml)
2	True density	0.58 (gm/ml)	0.56 (gm/ml)	1.11 (gm/ml)
3	Angle of Repose	39.99	38	38.65
4	Carr’s Index	43.33%	35.71%	59.09%

Table-5: Phyto-constituents present in three batches of Ashwagandha Churna:

S.No.

Phyto-constituents

AC 1

AC 2

AC 3

Alkaloids

Glycosides

Phytosterols

Steroid

Tannins

Saponins

Carbohydrate

CONCLUSION:

Ashwagandha churna sample was prepared in laboratory according to Ayurvedic formulary. This was evaluated by comparative analysis with the marketed formulations for their extractive values (ethanol and distilled water) (Tabel-3), Micromeretic parameters (bulk density, true density, angle of repose and Carr’s Index) (Tabel-4) and Phytochemical evaluation. (Tabel-5)

The extractive values of Ashwagandha churna (AC1, AC2 and AC3) in water and ethanol is (50.8 and 34.5) respectively, indicating the presence of almost polar and semi polar constituents in Ashwagandha churna.

These analytical findings and data analysis revels that parameters like Extractive values, Presence of Phytoconstituents and micromeretic parameters all remains in close proximity for each batch of the Ashwagandha churna. Hence these parameters and the developed methods for their determination considered as the tool for the quality control of Ashwagandha churna which will also assist the regulatory authorities, scientific organizations and manufacturer in developing standards. These analytical findings and data analysis shows revels that parameters like Extractive values, Presence of Phytoconstituents and micromeretic parameters all remains in close proximity for each batch of the Ashwagandhadi Churna. Hence these parameters and the developed methods for their determination considered as the tool for the quality control of Ashwagandhadi Churna which will also assist the regulatory authorities, scientific organizations and manufacturer in developing standards.

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Received on 05.03.2013

Modified on 21.03.2013

Accepted on 02.04.2013

Research Journal of Pharmaceutical Dosage Forms and Technology. 5(2): March- April, 2013, 91-94