|Year : 2021 | Volume
| Issue : 1 | Page : 68-72
Formulation and standardization of Yashtimadhu Kalpa (Granule): A novel Medhya Rasayana
Mrudul Y Chitrakar
Asso. Professor, Department of Swasthavritta and Yoga, School of Ayurveda, Nerul, Navi Mumbai, Maharashtra, India
|Date of Submission||10-May-2020|
|Date of Decision||24-Dec-2020|
|Date of Acceptance||01-Nov-2021|
|Date of Web Publication||26-Mar-2021|
Mrudul Y Chitrakar
Asso. Professor, Department of Swasthavritta and Yoga, School of Ayurveda, Nerul, Navi Mumbai, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: Ayurveda, the Indian system of medicine, is the first recorded medical science widely practiced in India since ancient times. As per Ayurveda, the drugs that help to improve and preserve intellect, i.e., Medha are termed as Medhya. Yashtimadhu (Glycyrrhiza glabra Linn.) is one among the four Medhya Rasayana (memory promotive drugs) mentioned by Acharya Charaka. In the present study, an effort was made to prepare palatable and easily administrable formulation of Yashtimadhu Churna as Yashtimadhu Kalpa (granules) and to standardize the same. Materials and Methods: Raw material was procured and preliminary physiochemical analysis was performed. Yashtimadhu coarse powder was taken in the vessel and 16 parts of water were added to it. Yashtimadhu Kwatha was prepared by reducing it to 1/8th and filtered through a cotton cloth. Coarsely powdered Sita twice of Yashtimadhu Kwatha was added in it and heated on mild fire up to100°C. Heating was continued till it attained sticky consistency before the granulation stage. The mixture was taken out of the vessel and dried in a hot air oven. Then, it was sieved in the multi mill to obtain granules. To validate the safety of Yashtimadhu Kalpa (granules) for the internal use, the final product the Yashtimadhu Kalpa was standardized and microbial analysis was done. Results: Granulation was done with the help of a granulation machine, which took 3 h 50 min for granulation; thus, a total of 5 h 50 min were required to obtain a yield of 8.5 kg. The granules of Yashtimadhu Kalpa are solid crystalline free-flowing, cream color and characteristics smell, granules, characteristic sweet, soluble in milk, palatable, and tasty. Conclusion: The novel preparation Yashtimadhu Kalpa (granules) is palatable, tasty, soluble, well preserved, and free from microbes.
Keywords: Granules, Kalpa, Medhya, standardization, Yashtimadhu
|How to cite this article:|
Chitrakar MY. Formulation and standardization of Yashtimadhu Kalpa (Granule): A novel Medhya Rasayana. J Ayurveda 2021;15:68-72
| Introduction|| |
Ayurveda, the Indian system of medicine, is the first recorded medical science widely practiced in India since ancient times. In recent years, there is a global revolution worldwide towards acceptance of this holistic science owing to its effectiveness and safety. The increasing demand at the global level has created a great need to standardize herbal medicines. 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. Most of the tests described in ancient literature appear to be based on observations and seems to be subjective without valid scientific backing. Hence, standardization and development of reliable quality protocols are important.
Yashtimadhu or Glycyrrhiza glabra Linn., commonly known as Liquorice is a perennial herb that grows up to three feet tall and has a woody, branching, brown rhizome (underground stem) that is yellow inside. Stems are several, emerging from the crown, 2–4 feet or more high, erect, stiff, solid, strongly striates, shortly pubescent, and branched. The leaves are alternate, spreading, large, stalked, with very minute deciduous stipules, impair-pinnate, leaflets opposite in 4–7 pairs. The flowers are very shortly stalked, arranged in a rather lax, erect raceme, which are 1–3 inches long and long-stalked, but falling short of the leaves; bracts linear, acute, scarious, and brown.,,
As per Ayurveda principles, the drugs that help to improve and preserve intellect, i.e., Medha are termed as Medhya. Yashtimadhu is one of the four Medhya Rasayanas (memory promotive drugs) mentioned by Acharya Charaka. Yashtimadhu Kalpa (granules) is a modified form of Ghana Kalpana (solid preparations of herbal extract) prepared by adopting reference of Vriddha Vaidya Parampara and analyzed as per guidelines in Ayurvedic Pharmacopeia of India (API). To give a contemporary touch to conventional dosage form, usage of powdered Yashtimadhu with milk is replaced by developing a novel formulation, Yashtimadhu Kalpa (granules). It is not only milk soluble but, stable, well preserved, and palatable too. In the present study, an effort was made to prepare palatable, well preserved, and easily administrable formulation of Yashtimadhu Churna as Yashtimadhu Kalpa (granules) and to standardize the same.
| Materials and Methods|| |
A pathway for getting standard product out of raw material
Raw material, i. e., roots of Yashtimadhu (Glycyrrhiza glabra) and Sita (candy sugar) were purchased from authentic sources. The roots of Yashtimadhu were converted to a coarse powder in a pulverizer. The authentication and standardization of the raw drug was done in premier institutes of Mumbai in the department of botany.
Physiochemical analysis of raw drug namely.viz, appearence,color,odor,test,texture,moisture content, ash value, water soluble ash(WSE), acid insoluble ash(AIA), water soluble extractive value(WSE), alcohol soluble extractive value(ASE), were performed given in [Table 1].
|Table 1: Raw drug standardization (raw drug analysis for Yashtimadhu Churna)|
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Procedure of preparation of Yashtimadhu Kalpa (granules)
The preparation of Yashtimadhu Kalpa (granules) was completed by adopting reference from Vriddha Vaidya Parampara and analyzed as mentioned in API. Pilot preparation of Yashtimadhu Kalpa (granules) as carried out in in-house pharmacy of D. Y. Patil Deemed to be University School of Ayurveda, Navi Mumbai. The final preparation of Yashtimadhu Kalpa (granules) was done at a Good Manufacturing Practices (GMP) certified Ayurvedic pharmacy in two batches.
In order to study the practicability and palatability of the preparation of granular form or Ghana of Yashtimadhu, a pilot batch was prepared. Coarse Yashtimadhu Churna (250 g) was taken in a vessel and 4 l of water (16 parts) were added to it. The decoction of Yashtimadhu was prepared by reducing it to 500 ml (1/8th) and filtered through a cotton cloth. 1000 g Sita (twice of Yashtimadhu Kwatha) was added in the decoction and heated on mild heat up to 100°C. It became sticky before attaining the granulation stage [Figure 1]. At this point, heating was discontinued and the mixture was stirred continuously till granules were formed [Figure 2].
|Figure 2: Sticky mixture of Yashtimadhu and Sita before the formation of granules|
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The block diagram of the procedure is shown in [Figure 3].
Method of final preparation at Good Manufacturing Practices certified pharmacy
For the preparation of Yashtimadhu Kwatha, the general procedure described in Sharangadhara Samhita was followed as standard. 2 kg Yashtimadhu coarse powder was taken in a vessel and 16 parts, i.e., 32 L of water were added to it. Yashtimadhu Kwatha was prepared by reducing it to 1/8th, i.e., 4 L, and filtered through a cotton cloth. 8 kg coarsely powdered Sita (twice the Kwatha of Yashtimadhu) was added in Kwatha and heated on mild fire up to 100°C. Heating was continued till it attained sticky consistency before the granulation stage. The mixture was taken out of the vessel and dried in a hot air oven for 3 h 30 min. Then, it was sieved in the multi mill to obtain granules [Figure 4].
| Observation and Results|| |
The raw material was procured and standardized as per the protocol. The results obtained by standardization are as follows:
Analytical study of Yashtimadhu Kalpa
Analytical study of the final product
To standardize and validate the safety of Yashtimadhu Kalpa (granules) for the internal use, the final product The Yashtimadhu Kalpa was standardized and tested for organoleptic parameters such as color, odor, test, and consistency, Phytochemical test, physicochemical analysis, and microbial analysis were done for yeast and mold count and bacterial contaminants namely Escherichia coli, Staphylococcus aureus, Salmonella, and Pseudomonas aeruginosa. All these analyses were done in certified laboratories and reputed institutes of research and development to standardize and validate the safety of Yashtimadhu Kalpa for the internal use [Table 2].
|Table 2: Microbial analysis Yashtimadhu Kalpa (Glycyrrhiza glabra formulation)|
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Some important observations from organoleptic, physiochemical, phytochemical, and microbial assay tests are as follows:
- The granules of Yashtimadhu kalpa are of cream color and characteristics smell, solid crystalline granules, characterized sweet taste, soluble in milk, palatable and tasty. This is represented in [Table 3]
- The various physicochemical properties revealed that successive extract includes the value of moisture – 2.5%, pH – 6.26, acid insoluble ash – 0.32%, water-soluble extract – 64%, alcohol soluble extract – 22.03%, bulk density – 0.642 g/ml, tab density – 0.810 g/ml, compressibility index – 26%, and carbohydrate content – 13 g/100 g. This is represented in [Table 4]
- Phytochemical screening of Yashtimadhu kalpa revealed the presence of alkaloids, steroids, saponins, flavonoids, and carbohydrates tabulated in [Table 5].
|Table 3: Average result of organoleptic parameters Yashtimadhu Kalpa (granules)|
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It was observed that conversion of the mixture of Yashtimadhu decoction and Sita to a granular form took more time than the preparation of decoction. It was noted that it took 1 h 30 min to prepare decoction and further 2 h 15 min to attain dry granules. It was also observed that continuous stirring was required throughout due to sticky nature of the mixture. The quantity of ingredients and yield obtained in the pilot study preparation of Yashtimadhu Kalpa (granules) in pilot preparation is depicted in [Table 6].
|Table 6: Quantity of ingredients and yield obtained in pilot study preparation of Yashtimadhu Kalpa (granules) in pilot preparation|
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During final preparation in a GMP certified pharmacy, 2 h was required to prepare decoction and after adding Sita, continuous stirring was again essential. The fizzy solution was observed which subsided and then, thickening of the mixture was observed in three stages. The stage-wise observations were: first stage-sticky like syrup, second stage-jelly like structure like jelly chocolate, and third stage stickiness gone and converting toward dryness structure. The heating was stopped at this stage. Granulation was done with the help of a granulation machine, which took 3 h 50 min for granulation; thus, a total of 5 h 50 min were required to obtain a yield of 8.5 kg [Table 7].
|Table 7: Quantity of ingredients and yield obtained in the preparation of Yashtimadhu Kalpa (granules) in final preparation|
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| Discussion|| |
Yashtimadhu has been a coveted herb used in Ayurveda since ages. Conventional Medhya Rasayana of Yashtimadhu consists of Powdered Yashtimadhu with milk. Due to low palatability and patient compliance, it was thought to be modified. Through this study, an effort was made to replace the conventional form by the novel Yashtimadhu Kalpa (granules). As Yashtimadhu root is hard in nature, so the Kwatha (decoction) was prepared with 32 times water and heated it so as remaining up to 1/8th part to get an extract. After adding sugar, continuous stirring was important for the formation of desired consistency. It was also useful for soaking of moisture and forming of dry granules. In this preparation, the quantity of candy sugar (Sita) was used twice as that of decoction as Yashtimadhu. This quantity was fixed considering the very sweet taste of Yashtimadhu. Candy sugar is used to prepare granules as it helps to preserve granules and it improves taste and is soothing to the body and beneficial.
The pilot preparation was useful to set process standard for further final preparation in GMP certified pharmacy. The final preparation was done in two batches with the help of a granulation machine. The final product analysis and standardization was carried out of this preparation. All required safety, hygienic care was taken while preparation using a sterilized instrument, and microbial assessment. It was evident from the absence of total yeast and mold count, E. coli, Salmonella, and P. aeruginosa in the microbial assay.
| Conclusion|| |
The novel preparation Yashtimadhu Kalpa (granules) is soluble, well preserved, and free from microbes. Total hygiene was maintained while making coarse powder up to the last stage i.e., granule formation. The standards and procedure of preparation of Yashtimadhu Kalpa are not mentioned anywhere and in API. Hence, this study can be used as a benchmark for future pharmacological, animal, and clinical studies related to Yashtimadhu Kalpa (granules).
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]