Pharmaceutical preparation of Saubhagya Shunthi Churna: A herbal remedy for puerperal women

Background: In the last few decades, there has been exponential growth in the field of herbal remedies. Pharmacopoeial preparations like avleha or paka (semi-solid), swarasa (expressed juice), kalka (mass), him (cold infusion) and phanta (hot infusion), kwatha (decoction) and churna (powder) form the backbone of Ayurvedic formulations. Newer guidelines for standardization, manufacture, and quality control, and scientifically rigorous research will be necessary for traditional treatments. This traditional knowledge can serve as powerful search engine that will greatly facilitate drug discovery. Purpose: The aim of the present study is to standardize Saubhagya Shunthi Paka in churna (powder) form. The powder form makes this traditional drug more stable for long-term storage and hence, easier to preserve. Materials and Methods: Saubhagya Shunthi Paka is an ayurvedic formulation containing Shunthi (Zingiber officinalis) as one of its chief ingredients. The basic preparation of this drug is a semisolid. We checked the microbial load and nutrient values (using International Standard IS and Association of Official Analytical chemists AOAC methods) Results: The powdered form of Saubhagya Shunthi Churna yielded a weight loss of approximately 17.64% of the total weight of ingredients. The total energy of Churna (calculated based on nutrient content) was found higher over Paka. Conclusion: Saubhagya Shunthi Churna may be a good therapeutic and dietary medicine for Indian women, which may be easily prepared at home.


INTRODUCTION
Ayurveda, the herbal-based system of medicine is now well recognized not only in India, but also in the Western world. With the growing need for safer drugs, attention has been drawn to the quality, effi cacy, and standards of Ayurvedic formulations. [1] In India, Ayurveda involves the eight principal branches of medicine: Pediatrics, gynecology, obstetrics, ophthalmology, geriatrics, otolaryngology, general medicine, and surgery. During the past few decades, there has been a growing recognition of reproductive health issues particularly, in women. Every year, at the global level, some eight million women suffer pregnancy-related complications and over half a million die, 99% of them in the developing countries. [2] Problems that are specifi c to women's reproductive process can be divided into two. Firstly, problems occurring during pregnancy, delivery, and the puerperium, referred to in the medical literature as obstetric (maternal) morbidity. Secondly, problems occurring with nonpregnant women and outside the puerperal period of six weeks, known as gynecological morbidity. [3] Women's health is a basic need for society as it affects the progeny. A woman who has just given birth to a baby along with the placenta is called "Sutika" in Ayurveda. During puerperium, the woman faces many problems like fever, diarrhea, edema, colic pain, abdominal distension, loss of strength, drowsiness, anorexia, delirium, and other diseases that are caused by the vitiation of kapha as well as vata which appear during puerperium. The classical concept of Ayurveda defi nes the ways to maintain 'Vata', 'Pitta,' and 'Kapha' in a balanced state to prevent diseases. [4] These are diffi cult to cure because of the decrease in muscle tissue and strength in women during the puerperal period. Diseases associated with the puerperal period are called Sutika Roga (puerperal diseases). [5] Ayurveda mentions specifi c drugs that are given for a defi nite duration along with specifi c dietetic regimens for puerperal women. Saubhagya Shunthi Paka is an Ayurvedic herbal formulation containing Shunthi as the chief ingredient. It alleviates anxiety, stress and is a natural pain reliever known to contain about 17 crude drugs. [6] Pharmacopoeial preparations like swarasa (expressed juice), kalka (mass), him (cold infusion) and phanta (hot infusion), kwatha (decoction), and Churna (powder) form the backbone of Ayurvedic formulations. [7] Paka is a semisolid preparation of drugs prepared by the addition of jaggery or sugar. [4] Saubhagya Shunthi Paka is a classical preparation from the Ayurvedic text, "Yoga Ratnakar." It is a very useful drug for puerperal women because it contains all the nutrients which are required during this period and can be easily prepared at the home. The combination of Saubhagya Shunthi Paka with Dashamoolarishta has a potent effect on postpartum women by helping to fulfi l their body requirements and to restore their bodies to normalcy. It is known to improve digestion and relieves debility following delivery. It works well as a postnatal tonic and facilitates normal involution of the uterus, besides enhancing the production of milk.
Saubhagya Shunthi Paka, is appropriate to review is not very well known it, but because of its usefullness this traditional drug. As the paka preparation cannot be stored for long periods, we have formulated it in the Churna form, which retains the same qualities but can be preserved for longer periods. Thus, the formulation can be manufactured in large scale to be marketed as an Ayurvedic medicine.
Saubhagya Shunthi Paka consists of 17 herbal ingredients including, which have their individual health promotive effects; and their roles in puerperium have been discussed below: The objective of the present study was to develop a more stable churna formulation by using the same traditional medicinal herbs.

Estimation of moisture content routine procedure
The moisture content of the raw materials used in preparation of the Soubhagya Shunthi was estimated as follows: 1. Weights of raw material samples and weights of Petri-plates were taken separately. 2. The fresh samples were taken in the Petri-plates. 3. The Petri-plates were incubated in the oven for 24 hours at 105ЊC. 4. The samples were removed from the oven and cooled to room temperature. 5. Again the weights of the raw material along with the Petri-plates were measured.
Moisture content was calculated by using the formula Weight of Petri-plates Weight of raw material Weight of o oven-dried sample Weight of oven-dried sample ×100

Preparation of Saubhagya shunthi churna
All the raw materials required for the preparation were weighed in grams [ Table 1] and powdered separately in a pulverizer and then weighed again.

Shelf-life analysis of Saubhagya shunthi churna and paka
This test was performed to check the microbial load of both the samples in our own laboratory. The samples were incubated in Yeast Extract Mannitol (YEM) medium for 36 hours along with plain YEM medium as a control.

RESULTS
The color of Shunthi was yellowish at the start and during the process and became brown after completion of the process. The weight loss of the ingredients after pulverizing into the powder form was 12.7% [ Table 2]. Shunthi absorbed almost the entire amount of Goghrita at the start.
When all the contents were mixed with the fried condensed milk and the Shunthi fried with Goghrita, the fi nal preparation of the drug was observed to be brown in color.
The total weight loss of the drug during the fi nal preparation was 17.64% (this means that 4.94% of the weight loss was recorded during the formulation of the drug) [ Table 3]. Moisture content of Pippali was found to be the highest (3.55) whereas it was the lowest in Krishna jeeraka (1.49). The moisture content of two ingredients showed negative values: Ϫ6.00 and Ϫ2.85 for Vidang and Tejpatra respectively [ Table  4].
The total energy of Churna (489.0 Kcal/100 g) was higher than that of Paka (426.0 Kcal/100 g) because the carbohydrate value of Churna is 41 g more than that of Paka. Calcium content was approximately the same for both preparations whereas iron and protein were higher in Churna in comparison with Paka [ Table 5].
In the shelf-life, we found no contamination in either of the samples. (Churna preparation was two years old, the Paka was only four months old) [ Figure 1].

DISCUSSION
Ayurveda is practised widely in India, Sri Lanka, and other countries, and has a sound philosophical and experiential    basis. [26,27] Atharvaveda (around 1200 BC), Charak Samhita, and Sushrut Samhita [28] (1000-500 BC) are the main classics that give a detailed description of over 700 herbs. Today the Government of India has formed stringent to regulate issues related to quality, safety, effi cacy, and practice of herbal medicine. [29] With a unique holistic approach, Ayurvedic medicines are usually customized to the individual's constitution. [30] Standardization and development of reliable quality protocols for Ayurvedic formulations using modern techniques of analysis is extremely important. [31] Standardization should be done by using appropriate amounts of raw materials, followed by in-process control and shelf-life analysis with authentic clinical trials. [32] Shunthi is used in folk medicine for relief from many ailments, especially nausea, motion sickness, and other gastrointestinal disorders. [33] Churna and paka kalpana both have similar effect in sutika kala. However the present study was focused on churna kalpana because of the short shelf-life of paka kalpana. According to the 'Ayurvedic Formulary of India', the Paka (Avaleha) should be used within one year only, [34] whereas Churna is safe for use even after two years. The nutritive value is also an important reason for the preference of Churna to Paka. In light of this information, Saubhagya Shunthi Churna to be used for this study was prepared from the same ingredients as those described in Yoga Ratnakar.

CONCLUSION
Saubhagya Shunthi can be prepared in both forms, i.e., churna (Powder) and paka (semisolid). Although both preparations show the same effect in Sutika Kala, the churna can be seen to be better than the paka form due to its longer shelf-life  The design of a new drug necessitates the study of the effects of a drug. Thus, the clinical benefi ts of this ayurvedic drug over standard therapy should be extremely convincing. Hence, there is a need for further study to evaluate the effects of the drug by a case control study and to elucidate its complete mechanism of action.