Journal of Ayurveda and Integrated Medical Sciences

Introduction

Vedic period is considered as the first period of documentation of references regarding the use of herbal drugs. Acharya Charaka has coined the term “Kalpana” for the pharmaceutical preparations.^[1] The raw drugs will be converted into different dosage forms by considering Roga Bala, Rogi Bala^[2] etc. Among this, few formulations are prepared instantaneously which cannot be preserved for longer duration, with some exceptions. In ancient period, our Acharyas/ Vaidyas used to prepare medicines by themselves in small scale to treat their patents, here the main objective was to achieve desired action rather than palatability/ shelf-life. But in today’s era of globalization & industrialization, leading to large scale production there is a need to determine the stability period of these Kalpanas by the guidance of certain rules mentioned in Samhitas and books. In the present era, most abundantly used Kalpana among Panchavidha Kashaya Kalpana is Kwatha Kalpana.^[3] It is used for various conditions but the shelf life of Kwatha is less, therefore this Kwatha is preserved in different ways by the manufacturers. Ex: Kwatha tablets, Ghanavati, Arishta etc. The Kalpana with short span of shelf-life is affected from various hazards like microbial contamination which lead to degradation of products. Pharmaceutical dosage forms contain carbohydrates, lipids, proteins, steroids, inorganic salts, minerals, water etc besides active drug components in it. These ingredients might serve as a nutrient for growth of various microorganisms. Government has approved to add food grade preservatives for ayurvedic formulations. But the quantity, compatibility of these preservatives varies and differs according to the formulation. Also, different formulations will have different shelf-life based on ingredients present in their process of preparation, moisture content etc. Panchavidha Kashaya Kalpana are primary pharmaceutical preparation and the most important form of Kalpana. Regarding the shelf-life of Kwatha, Acharya Yogaratnakara explains it as 1 Prahara^[4] (3hrs) & Acharya Sharangadhara explains it as Sadhyosevana.^[5] Due to very short shelf-life of Kwatha it makes inappropriate to market it to patients in current scenario & also creates inconvenience in day-to-day practice. Aqueous preparations like Kashaya, Swarasa, etc. are least resistant against microorganisms,

Later it was filled in glass container. Preservatives in different ratio are added to it & stored at room temperature.

Here, the colour of the Kwatha changed from light brown to dark brown colour. The consistency of the liquid was gradually increased. The smell of the raw drugs was appreciated, especially the smell of Shunti. The atmospheric temperature noted on the day of preparation was 22°C – 28°C and humidity was 58%.

Table 2: Final yield of Baladi Kwatha

Final yield of Baladi Kwatha: 2.1 litres

Packing and dose schedule of the preservatives

The prepared Baladi Kwatha was filled into narrow mouthed sealed glass bottles which were previously sterilized and preservatives in various concentration were added to Baladi Kwatha. After adding the preservatives, the contents in the bottle were shaken well to ensure proper mixing. Then these bottles were tightly sealed and left at the room temperature for entire course of the study. Temperature in Bengaluru was noted between 22°C – 28°C and humidity was 58%. 50ml of each sample of Kwatha was taken for the study every month. Freshly prepared Baladi Kwatha & the Kwatha with added preservatives were used for both analytical & microbiological studies. The sterility of the Kwatha was tested after adding the preservatives for microbial load at the interval of one month for 6 consecutive months. A Kwatha sample without adding preservatives served as control.

Observation and Results

Table 3: Preparation of samples^[8]

of this was adjusted to 7.3 using digital pH meter and make up the volume to 1000ml. finally we have to add 15g of agar to the media and autoclaved at 121°C for 20 mins.

Total aerobic microbial count by plate count method:

Materials required: Weighing balance, Petri dish, Jar, Stirrer, Spatula, Laminar air flow, Loop, Single burner, Autoclave, Incubator, Micro titre pipette.

Procedure: Clean the working place in laminar airflow using 70% ethanol and switch on the UV for 20 mins. After cooling, 15ml of casein soya bean agar media of 45°C was poured into 100mm petri dishes. 1ml of undiluted Baladi Kwatha was added into the petri dish containing the media. Plates were gently rotated in a circular motion to achieve uniform distribution of the sample and the media was allowed to solidify. All the petri dishes were incubated for 5 days at 28°C in BOD incubator. All the experiment was carried out in triplicate. Number of colonies were counted using digital colony counter. One batch was taken for microbial load and conducted by same person. 50ml of each of the undiluted Baladi Kwatha sample were used to the study. Freshly prepared Kwatha and Kwatha with preservatives, both were used. The sterility of the Kwatha was tested after adding the preservatives for microbial load at the intervals as explained in the table.

Results of Microbial Load

The above study shows that the freshly prepared Baladi Kwatha had no microbial growth when tested at 0hr but when tested for 3hr and 12 hr it showed slight growth.

The above study shows that the sample C and sample E were found to be equally effective after 30 days of the study. There was no significant microbial growth in all the samples to consider it as spoilt.

There was a significant microbial growth in sample B which was considered as spoilt on 60^th day. All the other samples were not considered as spoilt. Sample C and Sample E were found to be equally effective.

There was significant microbial growth in sample C and it was considered as spoilt. But the sample D had microbial growth but it was under permissible limit so it was not considered as spoilt. Sample E did not have any microbial growth.

of microbial load. It has been observed that the taste of both sodium benzoate and methyl paraben was sweet and the propyl benzoate was slightly sweet. As the glass bottle is inert, the Kwatha should be preferably stored in this.

Conclusion

Preservatives as sodium benzoate in permitted amounts could only preserve acidic Kwatha for a shorter period, hence marketing Baladi Kwatha with sodium benzoate cannot be properly stabilized by 0.1% & was observed that at least 0.2% is required to preserve the Kwatha for 60 days free from microbial contamination. It was observed that as per the permissible limit, the preservatives when used in combination sodium benzoate 0.2%, methyl paraben 0.05% propyl paraben 0.05%, has passed the shelf-life for 3 months when the reduction of Kwatha was 1/8^th.

References

1. Agnivesha, Charaka samhitha revised by Charaka and Dhridabala with Ayurveda Deepika commentary of Chakrapanidatta, edited by Jadavji Trikamji Acharya, Published by Chaukambha Orientalia 2009, Varanasi, Sutrasthan 4/7, Pp: 738, p:31

2. Vriddajivaka, Kashyapa Samhitha, preached by Maharshi Maricha Kashyapa, commented and translated by P.V Tewari, Published by Chaukambha Vishwabharati Edition 1, 2002, Khila sthana Pp 792, p:454

3. Agnivesha, Charaka samhitha revised by Charaka and Dhridabala with Ayurveda Deepika commentary of Chakrapanidatta, edited by Jadavji Trikamji Acharya, Published by Chaukambha Orientalia 2009, Varanasi, Sutrasthan 4/7, Pp: 738, p:31

4. Yogaratnakara, Indradev Tripathi, Krishnadas Academy, Varanasi, first edition, 1998, Pp:894 p:158

5. Sharangadhara, Sharangadhara samhitha with the commentaries of Adhamalla Deepika and krishnaram Gudartha Deepika, Parashuram Shastry Vidyasagar, Choukambha publication, Varanasi, Seventh edition, 2008, Pp: 398, p:145

6. Haritha, Haritha samhitha with Nirmala Hindi Commentary, Vaidya Jayamini Pandey Chaukambha Vishwabharati, Varanasi, 1^st edition, Pp:544, p:187