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| PHARMACEUTICAL STANDARDIZATION |
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| Year : 2015 | Volume
: 36
| Issue : 4 | Page : 416-420 |
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Pharmaceutical standardization of Kamsaharitaki granules
Nidhi Khemuka1, R Galib2, Biswa Jyoti Patgiri2, Pradeep Kumar Prajapati2
1 Department of Rasashastra and Bhaishajya Kalpana, Govt. Ayurved College, Jabalpur, Madhya Pradesh, India
2 Department of Rasashastra and Bhaishajya Kalpana Including Drug Research, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India
| Date of Web Publication | 16-Sep-2016 |
Correspondence Address:
Nidhi Khemuka
Lecturer, Department of Rasashastra and Bhaishajya Kalpana, Govt. Ayurved College, Jabalpur - 282 002, Madhya Pradesh
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/0974-8520.190698
 Abstract | | |
Introduction: Kamsaharitaki Avaleha is a well-known ayurvedic preparation. Considering certain inconveniences of Avaleha, an attempt has been made to convert it into granules that are convenient in handling, dispensing, and storage. Aim: To convert Kamsaharitaki Avaleha into granules form and develop standard manufacturing procedure. Materials and Methods: Seven pilot batches were prepared to fix the ratio of formulation composition. The procedure was repeated for 14 times to ensure the process validation. Results: Converting into granules in presence of jaggery and Haritaki pulp is found to be difficult. Replacing these two with Khanda Sharkara and Haritaki powder yielded desired characteristics of granules. Conclusion: This modified proportion of ingredients can be considered as standard in preparing Kamsaharitaki Avaleha granules. As no manufacturing and physicochemical properties are available for Kamsaharitaki granules; the current findings can be considered as standard for future studies. Keywords: Granules, Kamsaharitaki Avaleha, Khanda Paka, standardization
How to cite this article:
Khemuka N, Galib R, Patgiri BJ, Prajapati PK. Pharmaceutical standardization of Kamsaharitaki granules. AYU 2015;36:416-20 |
| Introduction | |  |
Conversion of formulations into various dosage forms to achieve added benefits keeping intact the therapeutic properties has gained momentum in recent past that has great importance in the market. In addition, standardization, quality control, and shelf life of final products are also other major issues. Shelf life of the formulation always depends on the pharmaceutical procedure and nature of the formulation. Granules are convenient in handling, dispensing, and storage. [1] Considering this, it has been planned to convert Kamsaharitaki Avaleha[2] into granules and develop standard manufacturing procedure (SMP).
| Materials and Methods | | |
All the herbal drugs and honey were procured from the Pharmacy,Gujarat Ayurved University, Jamnagar. Yavakshara was prepared in the Department of Rasashastra and Bhaishajya Kalpana, Institute for Postgraduate Teaching and Research in Ayurveda, Jamnagar. Khanda Sharkara (sugar candy) and Guda (jaggery) were procured from local market of Jamnagar. All the herbal drugs were authenticated in Pharmacognosy Laboratory of the institute. Formulation composition of granules is placed at [Table 1].
Pharmaceutical procedure
Preparation of Churna (powder)
Dried herbal drugs (Haritaki, Sunthi, Pippali, Maricha, Twak, Ela, and Patra) were powdered individually in a mixer and sieved through #72 to obtain fine powders. Yavakshara was prepared by Yava Panchanga.[3]
Preparation of Kwatha (decoction)
Three hundred and eighty-four grams of coarse powder of Dashamoola was taken in a stainless steel container of 5 L capacity. Three thousand and seventy-two millilitre of potable water was added to it and allowed to soak overnight. Next day morning, the contents were subjected to heat and stirred continuously throughout the process till the volume reduced to a quarter i.e., 768 ml. Throughout procedure of Kwathana (boiling), the temperature was maintained in between 85- 95°C. It took 4 h to prepare the Kwatha.
Preparation of granules
The general method of preparation emphasized for Khanda Paka[4] is followed for the preparation of Kamsaharitaki granules (KHG). Ingredients of granules were same as Avaleha.[5] Seven pilot batches were prepared for fixing the proportion of formulation. Out of these, initial six batches prepared with Guda and Haritaki were pulp failed to get converted into granules. They were replaced with Khanda Sharkara and Haritaki powder in seventh pilot batch. It fulfilled the desired characteristic features of granules. This ratio of ingredients was adopted in further 14 batches of granules to ensure the process validation of KHG.
For granules prepared Dashamoola Kwatha (768 ml) was shifted into a stainless steel vessel and was added with 1200 g of Khanda Sharkara. The contents were heated at 90–95°C until complete dissolution of Khanda Sharkara. This solution was filtered through a clean cotton cloth to separate undissolvable impurities (if any) and further heated until appearance of Avaleha Siddha Lakshanas. At this stage, the vessel was removed from the fire and stirred continuously. When the temperature of the contents was reduced to 56–60°C Madhu and fine powders of Haritaki and later Prakshepa Dravyas were added with thorough stirring to get a homogenous blend. The blended mass was passed through #10 sieve to obtain granules and kept for drying at room temperature. The dried granules were packed in airtight container [Figure 1]. | Figure 1: Preparation of Kamsaharitaki granules; (a) Dashamoola Kwatha Dravya soaked, (b) Dashamoola Kwatha preparation, (c) filtration of Dashamoola Kwatha, (d) sugar candy, (e) Paka of Dashamoola Kwatha and sugar till Avaleha Siddhi, (f) one thread stage of Paka, (g) four thread stage, (h) Apsu Majjana, and Pratitastu na Shiryate, (i) honey, (j) addition of Haritaki and Prakshepa Dravyas gradually, (k) passing through sieve (l) packaging of granules in airtight container
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| Observations and Results | | |
Seven pilot batches were prepared for converting Avaleha into granules. Preparing granules of Kamsaharitaki Avaleha by classical reference is not possible. Khanda Sharkara and Haritaki powder were used in the place of jaggery and Haritaki pulp to prepare granules. Average 54% Haritaki Churna detained and percentage yield of Prakshepa Dravyas (Sunthi, Pippali, Maricha, Twak, Ela, and Patra) were found 78.70%, 83.60%, 84.67%, 84.70%, 62.60%, and 82.50%, respectively. During the procedure of granules, the temperature was maintained in between 90°C and 100°C and observed Darvipralepa at 93°C, Tantumatvam at 94°C, Apsumajjanam at 94°C and Sthiratvam at 95°C. Average yield was found 1497.5 g. It took 7.5 h to complete the preparation of granules. Details of powdering of herbal drugs, results of pilot batches and final batches, and chief desired characteristics of KHG are placed at [Table 2],[Table 3],[Table 4],[Table 5],[Table 6], respectively. | Table 4: Results obtained during preparation of pilot batches of Kamsaharitaki granules
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 | Table 5: Results obtained during preparation of final batches of Kamsaharitaki granules
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| Discussion | | |
The proportion of Dashamoola and water for the preparation of Dashamoola Kwatha is not specified in the text. Considering the Madhyama character (moderate hardness) of Dashamoola; eight times of water was added, boiled, and reduced to a quarter.[6] The quantity of Prakshepa Dravya to be added is also not specified in the text; Ayurvedic Formulary of India (AFI) reference is followed for this. In an attempt to convert Avaleha into granules, seven pilot batches of KHG were prepared. Initial attempt (KHGp1) with classical proportion of ingredients did not yield desired characteristics. It was converted into lump. It may be due to the stickiness of Guda (jaggery). Decreased proportion of Guda (half and one-fourth to classical proportion) in KHGp2 and KHGp3 also formed into lump. In the other two pilot batches (KHGp4, KHGp5) instead of Guda, Khanda Sharkara (sugar candy) was used as the sweetening base with the same ratio of Kamshaharitaki Avaleha. However, failed to convert in to granules, it may be due to using of Haritaki pulp. In KHGp6, Haritaki powder was used instead of Haritaki pulp and proportion of Guda was used ¼ but was also not converted into granules. All these six pilot batches yielded lump like product difficult to convert into granules with characteristic flavour. In the seventh batch, (KHGp7) jaggery and Haritaki pulp were replaced with Khanda Sharkara and Haritaki powder, respectively. This was easily converted into granules. Finally, these ingredients and ratio were considered in the preparation of further 14 batches to ensure the process validation.
Four thread consistency of sugar syrup was prepared to obtain desired characteristics of granules. As most of the Praksepa Dravya contains volatile principles, they were added in increments at the end of the procedure with constant stirring to get homogenous blend and to prevent volatilization. Honey was added at 60°C just before adding the powders for getting the perfect consistency of granules.
| Conclusion | | |
Converting Avaleha into granules help in fixing the dose, easy to administer, and also increases the shelf life. The pilot batches reveal that Khanda Sharkara and Haritaki powder should be used instead of jaggery and Haritaki pulp while preparing granules. As there is no standard published data on this formulation, a comparison is not possible and the current observations may be referred in future studies.
Financial support and sponsorship
IPGT and RA, Gujarat Ayurved University, Jamnagar, Gujarat.
Conflicts of interest
There are no conflicts of interest.
| References | | |
| 1. | Paneliya AM, Patgiri B, Galib R, Bedarkar P, Prajapati PK. Pharmaceutical development of granules of vasa avaleha. Ann Ayurvedic Med 2013;2:16-21.  |
| 2. | Acharya YT, editor. Charaka Samhita of Agnivesha, ChikitsaSthana. Ch. 12, Ver. 50-52. Reprint Edition. Varanasi: Chaukhamba Prakashan; 2004. p. 366. |
| 3. | Shastri AD, editor. Sushruta Samhita of Sushruta, Sutra Sthana. Ch. 11, Ver. 13. Reprint Edition. Varanasi: Chaukhamba Sanskrit Sansthan; 2003. p. 47. |
| 4. | Vyas Harikrishna B. Shastri Sankardaji Pade, Aryabhishak, Bhrihatapaka Samgraha. 29 th ed. MumbaiSastu Sahitya Vardhaka Karyalaya; 2009. p. 758-9. |
| 5. | Annonymous. The Ayurvedic Formulary of India, Part-I. New Delhi: Department of Indian System of Medicine and Homoeopathy, Ministry of Health and Family Welfare GOI; 2001. p. 40. |
| 6. | Shastri P, editor. Sharangadhara Samhita of Sharangadhara, Madhayama Khanda. Ch. 9, Ver. 3, Reprint Edition. Varanasi: Choukhambha Orientalia; 2002. p. 212. |
[Figure 1]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]
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