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PHARMACEUTICAL STANDARDIZATION
Year : 2014  |  Volume : 35  |  Issue : 2  |  Page : 184-186  

Shelf-life evaluation of Rasayana Churna: A preliminary study


1 Om Ayuh: Ayurved and Panchkarma Chikitsalya, Bhavnagar, India
2 Department of Rasa Shastra and Bhaishajya Kalpana, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India

Date of Web Publication5-Dec-2014

Correspondence Address:
Priyanka Verma
Om Ayuh: Ayurved and Panchkarma Chikitsalya, 103, Eva Surabhi Complex, Opposite to Aksharwadi Temple, Waghawadi Road, Bhavnagar - 364 001, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0974-8520.146247

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   Abstract 

Background: Concept of Saviryta Avadhi (shelf-life) of Ayurvedic dosage forms is well-defined in classics of Ayurveda. Information on this is scattered in initial classics of Ayurveda like Charaka Samhita, but focused well after 13 th Century AD in texts such as Vangasena Samhita, Sharangadhara Samhita and Yogaratnakara. Though the concepts have a strong background; considering the pharmaceutical development, a need is felt to re-evaluate the age old concepts by following current norms. Aim: To evaluate shelf-life of two samples of Rasayana Churna. Materials and Methods: Raw material was procured from The Pharmacy, Gujarat Ayurved University and authenticated at Pharmacognosy Laboratory. Individual drugs were powdered and blended in specified ratio to obtain Rasayana Churna (RC). RC was levigated with decoction of Amalaki, Guduchi and Gokshura to prepare Bhavita Rasayana Churna (BRC). Both the samples were subjected to accelerated stability studies by following standard guidelines. Results: Both the samples are bitter and astringent with characteristic odor. RC is creamish brown in colour, while BRC is dark blackish brown. These Organoleptic characters were unchanged till the 6 th month of study. On comparision, BRC is found to be more stable than RC. Conclusion: This signifies that, Bhavana not only incorporates additional therapeutic attributes, but also helpful in increasing shelf-life.

Keywords: Accelerated stability, Bhavana, Churna, Rasayana, Saviryta Avadhi, shelf-life


How to cite this article:
Verma P, Galib, Patgiri B, Prajapati PK. Shelf-life evaluation of Rasayana Churna: A preliminary study. AYU 2014;35:184-6

How to cite this URL:
Verma P, Galib, Patgiri B, Prajapati PK. Shelf-life evaluation of Rasayana Churna: A preliminary study. AYU [serial online] 2014 [cited 2019 Jun 27];35:184-6. Available from: http://www.ayujournal.org/text.asp?2014/35/2/184/146247


   Introduction Top


Shelf-life is the length of time, after which all substances starts to degrade in their qualities and become unsuitable for consumption or sale. To precise, shelf-life of a product guarantees potency of a drug. Most of the medications continue to be effective and safe for a time after the expiry date. It is often mathematically modeled around a parameter such as concentration of a chemical compound, a microbiological index, or moisture content, etc. [1]

Significance of shelf-life is highly appreciated and recognized in classics like Charaka Samhita. But the information is hidden in verses and scattered. To refer, it has been said that the drug can be utilized for therapeutic purposes until it retains its fragrance, color, and taste etc. [2] Seers of later period attempted compiling information pertaining to this concept and succeeded in proposing Saviryta Avadhi, which reflected in Vangasena Samhita, [3] Sharangadhara Samhita, [4] and Yogaratnakara, [5] etc.

Considering the changing scenario in pharmaceutical development and storage techniques; classical concepts of Saviryta Avadhi cannot be implemented today. Hence, a need is felt to re-establish these concepts following the current guidelines. Published reports on this aspect are very few. With this background, it has been planned to evaluate shelf-life of two samples of Rasayana Churna (RC). [6] It is a poly herbal formulation composed of fine powders of Amalaki (Emblica officinalis Linn.), Guduchi (Tinospora cordifolia Linn.), and Gokshura (Tribulus terrestris Linn.) in equal quantities.


   Materials and Methods Top


Preparation of drug

Components of the RC were procured from the Pharmacy, Gujarat Ayurved University, Jamnagar. Physical impurities were removed manually; botanical identity has been authenticated in the Pharmacognosy Laboratory. Fine powders (# 72) of individual components were prepared and blended together to prepare RC.

In the other batch, RC was subjected to three Bhavanas (levigation) with freshly prepared Kwatha (decoction) of RC ingredients. At the end of three levigations, the product was allowed to dry completely that is labeled as Bhavita Rasayana Churna (BRC).

Packing

The final products (RC and BRC) in required quantities were packed in low-density polyethylene containers.

Sample quantity

Five containers of the final products (RC and BRC) of 50 g each were packed and stored in accelerated stability study chamber.

Storage conditions in the stability chamber

Samples were stored at 40°C ± 2°C, and 75 ± 5% relative humidity.

Frequency of withdrawal

Samples were withdrawn at the intervals of 01, 03, and 06 months.

Parameters of evaluation

Basic analytical parameters including loss on drying at 110°C, [7] ash value, [8] pH value [9] water soluble extractives, [10] methanol soluble extractives, [11] percentage of tannins, bitterness, alkaloids and saponins were evaluated at regular intervals.


   Results Top


Organoleptic characters and physico-chemical profiles were evaluated initially and at the end of 1, 3, and 6 months. Both the powders have characteristic odor, bitter and astringent taste. RC is creamish brown in colour, while BRC is dark blackish brown. These Organoleptic characters were unchanged till the 6 th month of study. Results obtained in both the drugs are shown in [Table 1]. Bitterness, tannins, alkaloids, and saponins were estimated in both groups initially and at the end of 6 th month [Table 2]. Based on the values obtained at different stages; intercept, slope, expected time (in months) for 10% of degradation [Table 3] were calculated for individual parameters of both drugs. As India falls in Zone III; the mean obtained of these months was multiplied with 3.3 to extrapolate shelf-life [Table 4].
Table 1: Physico-chemical profile of BRC and RC at different intervals

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Table 2: Functional groups and bitterness in BRC and RC at different intervals

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Table 3: Intercept, slope, 10% degradation and months of both the formulations for different parameters

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Table 4: Extrapolation of shelf life in both BRC and RC

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   Discussion Top


On comparison, no changes in organoleptic characters were found in both the drugs at all the levels of investigations. RC was found to be creamish brown in color with characteristic odor and bitter and astringent in taste. BRC was dark blackish brown in color with characteristic odor with bitter and astringent taste. Insignificant differences were observed in basic physico-chemical profiles in both the drugs at different stages of analysis. Water soluble extractive was found to be slightly higher (34.4%) in BRC than RC (26.3%). On overall observation of all the parameters, except alcohol soluble extractive, other areas were found to be more stable in BRC than RC. Stability of bitterness was maximum in BRC (60) in comparison to all other parameters. Analysis revealed that the drug BRC has more shelf-life than RC. Though studies have been reported on conceptual aspects, [12] and shelf-life of different Ayurvedic formulations, [13] impact of Bhavana has not been so far attempted. The current study provided some leads in this direction.


   Conclusion Top


Shelf-life defined for Churna at Rule 161-B, Drugs and Cosmetics Act is 2 years. In the current study, RC found to have shelf-life of 2 years 11 months, while the BRC is found to have more stablility with a shelf-life of 5 years 3 months. This implies that, Bhavana not only attributes therapeutic qualities in a product, but also helps in keeping the product more stable for longer duration. Though, the current attempt is a primitive one; extensive studies focusing on the exact mechanism and changes that take place during the process of Bhavana are needed.

 
   References Top

1.
Azanha AB, Faria JA. Use of mathematical models for estimating the shelf-life of cornflakes in flexible packaging. Packaging Technol Sci; 18:171-8.  Back to cited text no. 1
    
2.
Agnivesha, Caraka, Drindhabala. Caraka Samhita, Siddhi Sthana, Vaman Virechana Vyapata Adhyaya, 6/16, edited by Yadavji Trikamji Acharya, reprint ed. Chaukhambha Orientalia, Varanasi, 2011; 704.  Back to cited text no. 2
    
3.
Vangasen. Vangasen Samhita, Jwara Chikitsa 1/810. Commentatory by Shaligram GV, 1 st ed. Khemraj Shrikrishnadass Publication, Mumbai, 2003; 73.  Back to cited text no. 3
    
4.
Sharangadhara. Sharangadhara Samhita, Poorva Khanda, 1/55, edited by Parashuram Shastri, 4 th ed. Choukhamba Orientalia, Varanasi, 2000; 14.  Back to cited text no. 4
    
5.
Anonymous. Yogaratnakara, Jwara Chikitsha, edited by Shastri L, 1 st ed. Chaukhamba Sanskrita Samsthana, Varanasi, 2005; 203.  Back to cited text no. 5
    
6.
Vagbhata, Astanga Hridaya, Uttara Sthana, Rasayana Adhyaya, 39/160, Hindi Commentary by Kashinath Shastriand edited by. Tripathi I, Tripathi S, 1 st ed. Krishnadas Academy, Varanasi, 1994; 637.  Back to cited text no. 6
    
7.
Anonymous. Indian Pharmacopeia, Vol. II, Appendix 8 (8.6). New Delhi: Govt. of India, Ministry of Health and Family Welfare, The Controller of Publication; 1996. pp. A-89.  Back to cited text no. 7
    
8.
Anonymous. The Ayurvedic Pharmacopoeia of India., Vol. VI, Part 1, Appendix-2 (2.2.3). 1 st ed. New Delhi: Govt. of India, Ministry of Health and Family Welfare; 2008. pp. 242.  Back to cited text no. 8
    
9.
Anonymous. Indian Pharmacopeia. Vol. II, Appendix 8 (8.11). New Delhi: Govt. of India, Ministry of Health and Family Welfare, The Controller of Publication; 1996. pp. A-95.  Back to cited text no. 9
    
10.
Anonymous. The Ayurvedic Pharmacopoeia of India, Vol. VI, Part 1, Appendix-2 (2.2.8). 1 st ed. New Delhi: Govt. of India: Ministry of Health and Family Welfare; 2008. pp. 243.  Back to cited text no. 10
    
11.
Ibidem. The Ayurvedic Pharmacopoeia of India, Vol. VI, Part 1. Appendix-2 (2.2.7). pp. 243.  Back to cited text no. 11
    
12.
Gupta A, Jaiswal M, Prajapati PK. Shelf life of Ayurvedic dosage forms-Traditional view, the current status and prospective need. Indian J Tradit Knowledge 2011;10:672-7.  Back to cited text no. 12
    
13.
Deepa P, Kannappan N. Comparative stability study of formulated Ayurvedic health supplement and marketed product. Der Pharma Chemica 2012;4:2068-72.  Back to cited text no. 13
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]


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