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, efficacy, 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 specific 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 defines the ways to maintain ‘Vata’, ‘Pitta,’ and ‘Kapha’ in a balanced state to prevent diseases.[4] These are difficult 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 specific drugs that are given for a definite duration along with specific 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]

Soubhagya shunthi churna: An overview

Ayurveda uses various formulations such as solid dosage forms (pills, powders), liquid dosage forms (asavas, aristhas), and semisolid dosage forms (ghritas, avlehas, and paka). 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 fulfil 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:

Goghrita (cow's ghee)

Khoya (concentrated milk)

Sita (jaggery) (Saccharum officinarum)

Shunthi (Zingiber officinale)

Mishriya (Foeniculum vulgare)

Mustaka (Cyperus rotundus)

Javitri (Myristica fragrans)

Krishna-jeeraka (Bunium persicum)

Sweta-jeeraka (Cuminum cyminum)

Nagkeshar (Mesua ferra)

Marica (Piper nigrum)

Dhanyaka (Coriandrum sativum Linn.)

Pippali (Piper longum)

Indrjaua (Holarrhena antidysenterica)

Vidang (Embelia ribes)

Tejpatra (Cinnamomum tamala)

Ela (Elattaria cardamom)

The objective of the present study was to develop a more stable churna formulation by using the same traditional medicinal herbs.

MATERIALS AND METHODS

Estimation of moisture content routine procedure

The moisture content of the raw materials used in preparation of the Soubhagya Shunthi was estimated as follows:

Weights of raw material samples and weights of Petri-plates were taken separately.

The fresh samples were taken in the Petri-plates.

The Petri-plates were incubated in the oven for 24 hours at 105°C.

The samples were removed from the oven and cooled to room temperature.

Again the weights of the raw material along with the Petri-plates were measured.

Moisture content was calculated by using the formula

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.

Table 1

Ingredients of Saubhagya shunthi churana

Materials	Weight (g)
Cow's ghee	1000
Khoya	1000
Khand	2500
Shunthi	450
Mishreya	250
Dhanyaka	150
Vidanga	50
Maricha	50
Swetajeeraka	50
krishnajeeraka	50
Javitri	50
Pippali	50
Ela	50
Tejpatra	50
Nagkeshar	50
Indrajau	50
Musta	50

Khoya was taken in a vessel and heated with “Madhyanagni” (medium intensity fire) with the addition of a little Goghrita until it became brown in color.

Goghrita was taken in another vessel and mixed with the powder of Shunthi before frying the preparation properly.

All the Prakshepya Dravya drugs were taken in their powdered forms, i.e., Khand (jaggery), Mishreya (Foeniculum vulgar), Dhanyaka (Coriandrum sativum), Vidanga (Embelia ribes), Maricha (Piper nigrum), Swetajeeraka (Cuminem cyminum), Krishnajeeraka (Nigella sativa), Javitri (Myristica fragrans), Pippali (Piper longum), Ela (Elattaria cardamom), Tejpatra (Cinnamomum tamala), Nagkeshar (Mesua ferra), Indrajau (Holarrhena antidysenterica), Musta (Cypurus rotundus) along with the fried Khoya (condensed milk) and fried “Shunthi preparation”.

All the contents were properly mixed to obtain Saubhagya Shunthi Churna.

Assessment of nutritive value of churna and paka preparations of Saubhagya shunthi

The samples of both the forms (Churna and Paka) of the drug were sent to the ‘Regional food and Research Analysis Centre, Lucknow’, where certain tests were performed to investigate their nutritional value. They used the ‘IS method’ and ‘AOAC Method’ as follows:

Calculation of Total Energy = (Estimated value of Protein × 4) + (Estimated value of Fat × 9) + (Estimated value of Carbohydrate × 4)

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.

Table 2

Weight loss of ingredients during grinding of herbs

Name of ingredients	Initial weight (g)	Final weight (g)	Loss of weight (g)
Shunthi	450	425	25
Mishreya	250	220	30
Dhanyaka	150	110	40
Vidanga	50	45	5
Maricha	50	45	5
Swetajeeraka	50	40	10
Krishnajeeraka	50	45	5
Javitri	50	40	10
Pippali	50	45	5
Ela	50	47	3
Tejpatra	50	35	15
Nagkeshar	50	40	10
Indrajau	50	35	15
Musta	50	40	10
Total powdered herbs	1400	1212	188

When all the contents were mixed with the fried condensed milk and the Shunthi fried with Goghrita, the final preparation of the drug was observed to be brown in color.

The total weight loss of the drug during the final 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: –6.00 and –2.85 for Vidang and Tejpatra respectively [Table 4].

Table 3

Total loss of weight of ingredients during preparation of drug

Name of ingredients	Initial weight (g)	Final weight (g)	Loss of weight (g)
Powdered herbs	1400	1212	188
Condensed milk	1500	1000	500
Cow's butter	1000	1000	0
Total	3900	3212	688

Table 4

Total loss of moisture content of ingredients

Sample	Wt. of FS1 (g)	Wt. of PP2 (g)	Wt. of ODS3 (g)	Moisture content (%)
Shunthi	29.44	47.67	75.2	2.539894
Marica	29.89	29.56	57.56	3.28353
Dhaniya	12.63	41.52	52.85	2.459792
Indrajau	12.36	38.73	50.29	1.590774
Jeera	10.64	33.64	43.61	1.536345
Krishna jeeraka	12.01	50.59	61.68	1.491569
Soufa	14.16	36.56	49.35	2.776089
Motha	18.09	41.81	58.51	2.375662
Ila	19.28	36.6	47.74	17.05069
Nagkesher	11.22	38.23	48.56	1.832784
Pippali	15.85	40.48	54.4	3.547794
Vidang	10.01	44.16	57.63	–6.00382
Tejpatra	4.49	15.96	21.05	–2.85036
Javatri	5.72	15.96	21.19	2.312412

Weight of fresh sample (raw material used in drug preparation)-Wt. FS; Weight of Petri-plates-Wt. PP; Weight of oven dry sample-Wt. ODS

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].

Table 5

Estimation of nutritive value of Saubhaguya Shunthi Paka and Churna: A comparative analysis

Nutrients	Saubhagya Shunthi Paka (delivery/per gram)	Saubhagya Shunthi Churna (delivery/per gram)
Iron	10.5 mg	17.04 mg
Protein	6.8 g	7.15 g
Fat	25.7 mg	14.11 mg
Carbohydrate	42.5 g	83.5 g
Calcium	212.02 mg	211.39 mg
Vitamin B12	0.5 mcg	0.5 mcg/100 g
Total Energy	426.0 Kcal	489.6 Kcal/100 g

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].

Figure 1

shelf-life study of Saubhagya shunthi churna and paka after 36 hour incubation

DISCUSSION

Ayurveda is practised widely in India, Sri Lanka, and other countries, and has a sound philosophical and experiential basis.[2627] 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, efficacy, 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 and comparatively higher total energy. Saubhagya Shunthi Churna may be a good therapeutic and dietary medicine for Indian women, which may be prepared at home easily. This traditional formulation can provide novel insights into the drug discovery and development process., This drug can be useful for the pharmaceutical companies searching for economically valuable natural products.

The design of a new drug necessitates the study of the effects of a drug. Thus, the clinical benefits 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.