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Introduction

Ayurveda considered as one of the world's oldest traditional systems of medicine with sound philosophical and experimental basis, which is believed to be over 3000 years old, and is still being practiced today. It is known to be a complete medical system that comprised of physical, psychological, philosophical, ethical, and spiritual health(1). Rig Veda, Sam Veda, Yajur Veda and Atharva Veda have made sound impact on evolutionary change of living a healthy life in India(2) (3). Traditional herbal formulations have importance due to their natural alternatives, affordability, safety and harmlessness as compared to modern synthetic drugs. Medicinal plants and their formulations are being used by majority of people all over world for their primary health care.(4) (5)In Ayurveda, Parijatak (Nyctanthes arbor-tristis) is widely recognized for its analgesic, anti-pyretic, and anti-inflammatory properties. There is no reference to Parijatkasava as a classical formulation. In order to determine its quality, safety, and therapeutic dependability, a novel fermented preparation was created and assessed. The most sophisticated versions of Sandhana Kalpana, known as Asava-Arishta preparations, are distinguished by the production of self-formed alcohol by natural fermentation.(6) (7).

As they are naturally fermented products that develop mild acidity and self-generated alcohol through the fermentation process(8). This alcohol works both as a preservative and an efficient carrier for phytoconstituents. Parijataka plant Flowering starts in Aug-Dec. According to some reports the ingredients of these herbal formulations are being adulterated with inferior quality drugs/ nondrug adulterants. Therefore, these formulations are not officially recognized in many countries even though these have been used in this country of origin over many years. The reason may be due to lack of proper standardization, unavailability of research data and inadequate research methodology pertaining to authentication of these herbal formulations.(9) (10)Sandhana compositions have their origins in the Vedic era, where fermented preparations like Sura and Soma Rasa were mentioned. Asava and Arishta became popular dosage forms over antiquity because of their better palatability, quicker absorption, and longer shelf life. Although several classical texts describe the preparation of fermented formulations, the distinction between Asava and Arishta was systematically explained by Sharangadhara Acharya(11).

Asava–Arishta preparations are elaborately documented in Charaka Samhita(12), Sushruta Samhita(13), Ashtanga Hridaya(14), Sharangadhara Samhita(15), Yogratnakar(16) and Bhaishajya Ratnavali(17).

Therapeutic relevance of Parijatkasava(18):-

In traditional herbal medicine, Parijatak leaves—which come from the sacred Night-flowering Jasmine tree—are well known for their many therapeutic uses. They are indigenous to South Asia, especially Nepal and India. The vivid green hue and slightly serrated edges of these leaves are well-known. These leaves, which are high in antioxidants and vital minerals like vitamins A and C, enhance immune system function and fight oxidative stress. They are useful in lowering pain and inflammation since they have analgesic and anti-inflammatory properties(19). Furthermore, Parijatak leaves are recognized to improve respiratory health by reducing bronchitis and asthma symptoms. Additionally, by preventing infections and accelerating wound healing, their natural chemicals help improve digestion, detoxify the liver, and improve skin health.

Including Parijatak leaves in wellness regimens provides a natural method of maintaining overall health. In order to establish baseline characteristics crucial for quality control and future therapeutic validation, this study focuses on the pharmaceutical preparation and physicochemical characterization of a new Parijatkasava.

Importance of Parijatak Leaves: -

• Medicinal Properties: Parijat leaves possess anti-inflammatory and analgesic qualities beneficial for pain relief.
• Traditional Healing Uses: Widely used in Ayurveda for treating fever, asthma, and skin disorders.
• Antioxidant Benefits: Rich in antioxidants that help combat oxidative stress and promote overall health.
• Wound Healing Aid: Leaves are applied topically to accelerate the healing of cuts and wounds.
• Respiratory Health Support: Used to alleviate symptoms of cough, bronchitis, and other respiratory issues.
• Anti-bacterial Effects: Contains compounds that inhibit bacterial growth, enhancing infection control.
• Anti-diabetic Potential: Helps in regulating blood sugar levels in traditional medicine practices.
• Anti-depressant Properties: Traditionally believed to improve mood and reduce anxiety symptoms.
• Natural Insect Repellent: Leaves are used to deter insects and protect stored grains naturally.
• Cultural and Religious Significance: Holds spiritual importance in various rituals and ceremonies across regions.

Aim: To develop and standardize a novel Parijatkasava based on Ayurvedic Sandhana Kalpana principles.

Instruments: Vessels, Gas-Burner,Stirring rod, measuring cylinder, Weighing balance, Cloth (for filtration), Sandhan Patra, Thermometer, Key Ingredients, Prakshepa dravyas.

Objectives: -

To develop a novel Parijataksava using Parijataka patra, jaggery, Dhatakipushpa phanta, and prakshepadravyas (Dalchini, Pippali, and Ela), and to assess its pharmaceutical and physicochemical parameters for quality assurance.

1. To prepare Parijatkasava using Parijataka Patra, Dhatakipushpa phanta, jaggery, and selected prakshepadravyas.

2. To document the pharmaceutical procedures involved in formulation development.

3. To evaluate physicochemical parameters including pH, specific gravity, total solids, total residue, and alcohol content.

4. To assess organoleptic characteristics of the prepared formulation.

5. To establish preliminary quality standards for optimizing future production.

Material and methods: -

Materials: -

Ayurvedic Properties

1)Rasa (Taste): - Tikta (bitter), Kashaya (astringent)

2)Guna (Quality): - Laghu (light), Ruksha (dry)

3)Virya (Potency): - Ushna (hot)

4)Vipaka (Post-digestive effect): - Katu (pungent)

Dosha effect: - Pacifies Vata and Kapha

Side Effects / Adverse Effects

1)Gastric irritation

2)Bitter taste intolerance

3)Allergic reaction (rare)

4)Overdose effects can cause abdominal pain

Method:

The formulation was prepared following standard Asava–Arishta procedures with controlled natural fermentation. Physicochemical parameters—total solids, total residue, specific gravity, pH, and alcohol content—were evaluated using established pharmacopeial methods.

The methodology of the present study involves four stages:

1. Preparation of Parijatka patrakwatha.

2. Preparation of Dhataki Pushpa Phanta.

3. Preparation of Parijatkasava.

4. Addition of Prakshepa Dravyas.

A.Preparation of Parijatkapatra Kwatha: -

1. To get ready the Parijatkasava fermentation medium. The Kwatha Kalpana standard technique described in the Samhita was followed in the preparation of Parijatak patra kwatha.

2. To prepare the decoction for this Process, 10 kg of fresh Parijatak leaves were chosen, carefully cleaned, and processed.

3. After properly cleaning the leaves to get rid of dirt and contaminants, they were coarsely crushed (Yavakuta) to make it easier to extract the active components.

4.The crushed material was transferred into a stainless-steel vessel, and 8 times water (80 litres) was added.

5. A controlled flame was then used to heat the vessel. The mixture was brought to a boil while stirring periodically, and the heating process was carried out until the volume was reduced to 1/4th. producing 20 liters of Patrakwatha Parijatka.

6.When the desired reduction was achieved, the decoction was removed from the fire and filtered through a clean muslin cloth to obtain a clear, uniform Kwatha.

7.The freshly prepared 20 litres of Parijatakapatra Kwatha were immediately used as the primary liquid medium for preparing ParijatkAsava.

B. Preparation of Dhataki Pushpa Phanta: -

1.For preparing the fermentation inoculum, 1kg of Dhatakipushpa (Woodfordiafruticosa) were taken, cleaned, and placed in a stainless-steel vessel.

2.To this, 4 litres of freshly boiled hot water were added to prepare the classical Phanta kalpana(hot infusion).

3. To fully extract the active ingredients and the naturally occurring fermentative microbes found in Dhataki flowers, the container was covered with a fresh cloth and left undisturbed for four to six hours.

4.After the infusion period, the mixture was filtered through a clean muslin cloth to obtain 4 litres of clear Dhataki Pushpa Phanta, which was used immediately for the preparation of Parijatkasava.

C. Preparation of Parijatkasava: -

1. The previously acquired 20 liters of Parijatak patra Kwatha were moved into a dry, clean Sandhana Patra (fermentation vessel) in order to prepare the Asava.

2.To this, 12 kg of jaggery (powdered and filtered) was added and stirred thoroughly until completely dissolved.

3.After complete dissolution of jaggery, 4 litres of freshly prepared Dhataki Pushpa Phanta were added to serve as the natural fermentative catalyst.

4. The Sandhana Patra's mouth was covered with a clean, tightly tied cloth to permit anaerobic fermentation while avoiding external contamination, and the material was thoroughly swirled to ensure uniform mixing.

5.The vessel was kept in a warm, shaded, and undisturbed location for 30 days.

Periodic observations were made for classical fermentation signs such as:

· Froth formation

· Bubbling or effervescence

· Development of characteristic aroma

· Clarity of the upper layer

· Subsidence of fermentation activity

The Asava was carefully decanted to separate the clear supernatant and leave behind the sedimented material once the natural fermentation process was confirmed to be complete.

D. Addition of Prakshepadravyas:-

1.After fermentation, the clear fermented liquid was decanted and filtered using a clean muslin cloth.

2. For additional processing, the filtered Asava was moved to a stainless-steel vessel. To improve palatability and stabilize the final formulation, an extra 2 kg of jaggery was added at this point.

3.The jaggery was mixed thoroughly until completely dissolved.

4.Subsequently, the powdered Prakshepadravyas were added in the following quantities:

• Twak (Dalchini) – 125 g
• Ela (Cardamom) – 125g
• Pippali – 125 g
• Nagkeshar-125g

5.The mixture was stirred thoroughly to ensure uniform dispersion of the aromatic and therapeutic additives.

6. After that, the vessel was left undisturbed for seven days, which allowed the Prakshepa Dravyas' volatile oils and active compounds to be sufficiently extracted into the fermenting liquid.

7.After the 7-day maceration period, the final Parijatkasava was filtered again through clean muslin cloth to achieve a clear, uniform product.

8.The finished Asava was then stored in airtight,amber-coloured glass bottles for further evaluation and analysis.

Analytical Profiling: -

The prepared Parijatkasava was evaluated for quality, stability, and compliance with traditional criteria using organoleptic and physicochemical characteristics.

Organoleptic Properties: - As per the standards described in the Ayurvedic Pharmacopoeia of India (API), the Parijatkasava was evaluated for:

1. · Colour
2. · Odour
3. · Taste
4. · Appearance/Consistency

These parameters help in confirming the characteristic sensory profile of a properly processed Asava.

Physicochemical evaluation of Parijatkasava included the following tests:

· pH

· Specific gravity

· Total solids

· Total residue

· Alcohol content

These parameters provide insight into the fermentation efficiency, stability, and overall pharmaceutical quality of the formulation.

Observation and Result: -

1.Decrease of the sugar content and increase in alcohol content was the indication of active fermentation. The pH range of 3-5 was considered as the most favorable condition for growth and fermentation activity of yeast.

2.At the initial stage specific gravity was more due to addition of jaggery and honey. Subsequently the content of total solid and specific gravity was decreased in the final product indicating utilization of sugar with an increase in alcohol generation.

3.The reduction of self-generated alcohol might be due to vaporization on opening of the container. Therefore, Asava and Arista preparations must have to be consumed within a shorter period of time or formulation could be prepared in smaller volume containers in divided doses.

4.It was observed that the formulations became acidic on storage and the acidity was further enhanced on long storage(20).

5.Physico-chemical study of these formulations revealed that formulation prepared in glass container showed less acidic (pH 4.2) and higher specific gravity (1.14) than the earthen container.

6.From this study, it was inferred that the pot filled up to 3/4th capacity was most suitable for fermentation of  Parijatkasava(21).

7.Growth of fungus was observed in after prolong incubation.(22)

8.The color of the formulation changed from brown to dark brown due to low extraction of phytoconstituents from the ingredients used in the preparation.

9.Change in fragrance indicated the extraction of phytochemicals. Initially taste was sweet due to the presence of bulk volume of jaggery but subsequently it changed to astringent due to utilization of sugar by the microorganisms.

10.Free amino acids were continuously decreased during the fermentation process. Concentration of starch gradually decreased in successive stages of fermentation. These changes might be due to the growth and metabolic activity of microbes present in the formulation.

11.The acids produced during the fermentation process and storage (oxidation of alcohols) was responsible for the sour taste of preparations.

12.End of fermentation was indicated by the stoppage of alcohol generation and no further consumption of residual sugar.

13.The study of physico-chemical parameters of has been carried out according to the WHO (world health organization) guidelines.

Result: -

1.The prepared Parijatkasava exhibited the characteristic dark brown colour, pleasant aroma, and mildly astringent taste expected from a fermented Parijatka based formulation. 2.Physicochemical evaluation showed: total solids 18.4%, total residue 3.3%, specific gravity 1.01777, pH 3.49, and alcohol content 9.6%, all falling within acceptable limits for Asava preparations, indicating proper fermentation, stability, and satisfactory quality of the formulation.

Discussion

1. In this study, Parijatka Leaves kwatha, together with jaggery, Dhatakipushpaphanta, and certain Prakshepadravyas, were used as the principal liquid medium to formulate and analyze Parijatkasava.

2. The fermentation process went easily and without any unwanted deviations, and the preparation procedure closely adhered to the ancient principles of Sandhana Kalpana.

3. Proper and full fermentation was proven by the formation of a distinctive scent, mild acidity, clarity in the top layer, and sporadic effervescence.

4. Because of its natural microbial flora and beneficial components, the addition of Dhatakipushpa phanta was essential in starting and sustaining fermentation. bioactive components and the natural microbial flora.

5. Twak, Ela, and Pippali were added to the formulation after fermentation, which improved its palatability and added digestive and carminative qualities. The created Parijatkasava is pharmaceutically stable and meets the main quality standards required of Asava preparations, according to the overall analytical results.

6. This study offers a fundamental pharmacological and analytical profile of Parijatkasava, which will be helpful in the future.

7. To confirm its therapeutic claims and promote its broader medical applicability, more sophisticated research is advised, including HPTLC fingerprinting, phytochemical quantification, stability analysis, and pharmacological/clinical assessments.

Conclusion

The unique Parijatkasava's pharmaceutical and physicochemical profile is successfully established in this work, demonstrating its suitable fermentation technique and offering a solid scientific basis for upcoming pharmacological, clinical, and stability investigations.