Claims:
1. An improved process for preparation of Asava-Arishta by fermentation process without using sugars comprising of following steps:-

Step (i): The following raw materials

Sl. No. Ingredients Percentage
(w/v)
Common Name Botanical Name Useful Part
1 Methi Trigonellafoenum-graecum Sd. 0.10-10.00
2 Karavallaka Momordicacharantia Frt. 0.10-10.00
3 Guduchi Tinosporacordifolia St. 0.10-10.00
4 Jambu Syzygiumcuminii Sd. 0.10-10.00
5 Kanyasara Aloe barbadensis Lf. 0.10-10.00
6 Nimba Azadirachtaindica Lf. 0.10-10.00
7 Meshasringi Gymnemasylvestre Lf. 0.10-10.00
8 Amalaki Emblica officinalis Frt. 0.10-10.00
9 Punarnava Boerhaaviadiffusa Rt. 0.10-10.00
10 Aswagandha Withaniasomnifera Rt. 0.10-10.00
11 Kalamegha Andrographispaniculata Wh. Pl. 0.10-10.00
12 Goksura Tribulusterrestris Frt. 0.10-10.00
13 Draksha Vitisvinifera Frt. 2.00-50.000
14 Tvak Cinnamomumzeylanicum St. Bk. 0.10-10.00
15 Haridra Curcuma longa Rz. 0.10-10.00
16 Tvakpatra Cinnamomumtamala Lf. 0.10-10.00
17 Lavanga Syzygiumaromaticum Fl. Bud 0.10-10.00
18 Sunthi Zingiberofficinale Rz. 0.10-10.00
19 Maricha Piper nigrum Frt. 0.10-10.00
20 Yavani Trachyspermumammi Frt. 0.10-10.00
21 Madhuka Madhucaindica Fl. 2.00-50.000
22 Dhataki Woodfordiafruticosa Fl. 0.10-5.00
23 Kinwa Saccharomyces cerevisiae -- 0.00-5.00
24 Citric Acid -- -- 0.010-5.00
25 Xanthan Gum -- -- 0.00-5.00
26 Sucralose -- -- 0.00-2.00
27 Sorbitol Solution -- -- 0.00-50.00
28 Mannitol -- -- 0.00-30.00
29 Glycerol -- -- 0.00-20.00
30 Maltitol -- -- 0.00-20.00
31 Maltodextrin -- -- 0.00-20.00
32 Malt Extract -- -- 0.00-20.00
33 Stevia glycosides -- -- 0.00-5.00

are weighed and dispensed accurately as per batch quantity, the herbal raw
materials are coarsely grinded using 10 mm screen;

Step (ii): herbal grinded raw materials are boiled with water in a suitable vessel, after completion of extraction, decoction is collected in Fermenter;

Step (iii): Draksha & Madhuka are extracted in a vessel and transferred into fermenter.

Step (iv): Dhatakipuspa is macerated in a suitable vessel, using water and small quantity of drakshadecoction, the liquid is filtered and collected into Fermenter.

Step (v): Herbal Decoction, extract of DhatakiPuspa, extract of Draksha & Madhukaand kinwa are added in fermenter mixed well and kept for fermentation for 6-10 days until desired percentage of alcohol is generated.

Step (vi): Prakshep materials are added and kept aside for 2-5 days;

Step (vii): After the desired level of percentage of self-generated alcohol is achieved fermentation is stopped by addition of Methyl paraben, Propyl paraben & Sodium benzoate followed by heating up to 60°C and cooling immediately to room temperature;

Step (viii): The bulk is filtered and transferred into a storage tank;

Step (ix): To the bulk Xanthan gum & Sucralose are added and

Step (x): Sampling is done for Quality Control checking;

Step (xi): After getting quality control release report, bulk is allowed for packing.

2. An improved process for preparation of Asava-Arishta by fermentation process without using sugars as claimed in claim 1, wherein to develop self-fermented herbal product (traditionally known as Asav-Arishta) suitable for current life-style conscious consumers.

3. An improved process for preparation of Asava-Arishta by fermentation process without using sugars as claimed in claim 1, wherein to develop Asav-Arishta without using external sugar either Crystal sugar or Jaggery for fermentation.

4. An improved process for preparation of Asava-Arishta by fermentation process without using sugars as claimed in claim 1, wherein to develop sugar free Asav-Arishta for Diabetes as well as health conscious consumers

5 An improved process for preparation of Asava-Arishta by fermentation process without using sugars as claimed in claim 1, wherein to to develop sugar free products for individual conditions like Diabetes, Obesity, Indigestion, Women Care or any other disorder requiring the benefits of Asav-Arishta but where sugar content becomes barrier.
6. An improved process for preparation of Asava-Arishta by fermentation process without using sugars as claimed in claim 1, wherein therefore, sugar free variants are required

7. An improved process for preparation of Asava-Arishta by fermentation process without using sugars as claimed in claim 1, wherein the products may be single or poly-herbal in nature where certain fruits like Grapes & Mahua may be used as substitute of Crystal sugar or Jaggery for products of Asav-Arishta during self-fermentation.

8. An improved process for preparation of Asava-Arishta by fermentation process without using sugars as claimed in claim 1, wherein the process defining the ration of grapes & Mahua in any or all proportion or Grapes or Mahua in any proportion suitable for production of required amount of Alcohol during the self-fermentation process in sugar free Asav-Arishta, these sugar free Asav-Arishtas are suitable for using in any condition requiring low sugar or no sugar including Diabetes Mellitus metabolic syndrome or its components and suitable for using by all gender and all the age groups.

, Description:
FIELD OF INVENTION

The present invention relates to the exploration of a crude herbal raw material as a source of sugar for fermentation and particularly the present invention relates to an improved process for preparation of Asava-Arishta by fermentation process without using Sugars. More specifically the invention provides a non-sugar ingredient as a source of new matrix other than sugar.

The invention provides novel ingredient as a source of Sugar for fermentation as non-sugar ingredient to produce alcohol during fermentation and a method for the preparation of oral herbal formulations, especially those mentioned in Ayurvedic literature and falling under the category "Asava-Arishta' and any other proprietary formulations falling under the same category using the yeast strains. DB-07 is a combination of herbs having antidiabetic property/ activity used in the unique dosage form i.e., Arista which transforms bitter herbs into palatable liquid form. The novel method introduces a non-sugar based ingredient in place of sugar consumed in conventional methods for generation of alcohol during fermentation. Also, the novel method maintains the inherent natural quality and efficacy of this/these formulation/formulations.

PRIOR ART

In general, the range of Asava-Arishta formulations are produced as per the process laid down in the ancient and medieval texts. Over a period of time, stainless steel containers replaced the earthen pots and modern methods are adopted to maintain process temperatures required for fermentation. Except for these minor modifications in the systems, nothing further was altered. Academic research institutes in India conducted few studies on the ancient process methodology for Asava-Arishta manufacturing.

Study reported that Jaggery/Sugar is the most suitable nutrient for fermentation. Subsequently Woodfordiafruticosa was proved to have its role in fermentation to produce alcohol. It was observed that the flower was capable of carrying out alcoholic fermentation as normally achieved by the use of pure yeast culture.

The prior art of this study is to explore Madhuka (Madhucaindica)Flower which contains 40.0 % - 60.0 % total sugar as a natural source of sugar for fermentation to produce alcohol in place of Jaggery/Sugar to manufacture Asava-Arishta based products for treatment of diabetes. The novelty of this study is to use the ingredients which will contribute substrate/nutrient for fermentation and also not to use sugar/Jaggery for fermentation; though in Ayurvedic Literature Jaggery has always been recommended for fermentation.

BACKGROUND OF INVENTION

The background provides clear understanding of Asava-Arishta an alcohol based liquid formulation with some therapeutic activity. In conventional Ayurvedic method for preparation of Asava-Arishtas, Jaggery (Guda) has been prescribed as substrate of fermentation. In current practice in almost all Ayurvedic Licensed Industries ‘Sugar’ is being used as substrate of fermentation and portion of the same is used as well for improvement of palatability of the product. But considering the concern of sugar consumption of Diabetic patient or for the consumers who are cautious about taking sugar containing products which may lead to diabetes or diabetic disorders an approach has been taken to use such ingredient which will act as substrate for fermentation. Already one patent is there where in the finished product there is 4.0-5.0% w/v sugar as sucrose. This Asava-Arishta based formulation was prepared with the help of sugar as substrate for fermentation and at the end of the process 4.0-5.0 % w/v sugar was found in the product which cannot be claimed as ‘Sugar Free’ anyway. So, the objective of this invention was to find out and explore such a ingredient which will be a matrix other than sugar but will contribute substrate for fermentation. There are many a fruits containing this kind of substrate but all are not suitable for fermentation as there are certain criteria during fermentation for preparation of Asava-Arishtas which may not be addressed by these fruits. Based on a study Draksha (Vitisvinifera) fruit and Madhuka (Madhucaindica) flower have been found to have the properties to have not only substrate for fermentation but also suitable for fermentation.

Before entering into the brief of ideation of invention an overview on Asava-Arishtas will help to understand the idea properly. 'Asava' stands for fermented infusions and 'Arishta' stands for fermented decoctions or herbal extracts. These are commonly used terms in 'Ayurveda', a traditional system of medicine using herbs or theirextracts for treatment of diseases. Asavas and Arishtas comprise an important group of liquid orals mentioned in ancient Ayurvedic literature. This group of products represents one of the highly evolved dosage forms, which offer the advantages of accessibility, palatability and product stability over the traditionally used decoctions, which are primitive in their nature. This particular group of liquid orals finds their use not only in Ayurveda but also in other traditional systems of medicine practiced in neighboring oriental countries like Sri Lanka, Tibet, China and Bhutan. Few hundreds of Ayurvedic formulations described in ancient and mediaeval Ayurvedic literature fall under this group. Various Ayurvedic pharmaceutical companies in India do manufacture almost 50-60 different formulations falling under this range and some of these formulations are also being exported to other countries.

OBJECT OF INVENTION

The main object of the invention is to provide a novel composition of liquid oral dosage form having self-generated alcohol (Asava-Arishta). Traditionally sugar containing ingredients have been used for conducting fermentation. Most common ingredients for making Asava and Arishtas are cane sugar derived products like jaggery and crystal sugar apart from honey. A range of plant material having high quantities of plant sugar may also be used as source of sugar for fermentation but these ingredients produce Asava-Arishta which are not so palatable. In the present invention we have used combination of plant material and sweeteners to provide palatable and good tasting herbal products for diabetes and other lifestyle conditions. Madhuka (Madhucaindica) Flower in addition with Draksha (Vitisvinifera) fruit has been proven to produce 1.0-20.0% v/v alcohol during manufacturing of Asava-Arishtas. This is a unique platform technology for manufacturing of Asava-Arishtas without using sugar as source of substrate which can be claimed as ‘Sugar Free’ and will be beneficial for preparation of Sugar Free Asava-Arishtas. Likewise Sugar Free Pancharishta for treating digestive ailments of Diabetic patients or calorie conscious people and another product for treating diabetes has been designed.

Summary of the Invention:

According to the present invention there is provided an improved process for preparation of Asava-Arishta by fermentation process without using sugars comprising of following steps:-

Step (i): The following raw materials

Sl. No. Ingredients Percentage
(w/v)
Common Name Botanical Name Useful Part
1 Methi Trigonellafoenum-graecum Sd. 0.10-10.00
2 Karavallaka Momordicacharantia Frt. 0.10-10.00
3 Guduchi Tinosporacordifolia St. 0.10-10.00
4 Jambu Syzygiumcuminii Sd. 0.10-10.00
5 Kanyasara Aloe barbadensis Lf. 0.10-10.00
6 Nimba Azadirachtaindica Lf. 0.10-10.00
7 Meshasringi Gymnemasylvestre Lf. 0.10-10.00
8 Amalaki Emblica officinalis Frt. 0.10-10.00
9 Punarnava Boerhaaviadiffusa Rt. 0.10-10.00
10 Aswagandha Withaniasomnifera Rt. 0.10-10.00
11 Kalamegha Andrographispaniculata Wh. Pl. 0.10-10.00
12 Goksura Tribulusterrestris Frt. 0.10-10.00
13 Draksha Vitisvinifera Frt. 2.00-50.000
14 Tvak Cinnamomumzeylanicum St. Bk. 0.10-10.00
15 Haridra Curcuma longa Rz. 0.10-10.00
16 Tvakpatra Cinnamomumtamala Lf. 0.10-10.00
17 Lavanga Syzygiumaromaticum Fl. Bud 0.10-10.00
18 Sunthi Zingiberofficinale Rz. 0.10-10.00
19 Maricha Piper nigrum Frt. 0.10-10.00
20 Yavani Trachyspermumammi Frt. 0.10-10.00
21 Madhuka Madhucaindica Fl. 2.00-50.000
22 Dhataki Woodfordiafruticosa Fl. 0.10-5.00
23 Kinwa Saccharomyces cerevisiae -- 0.00-5.00
24 Citric Acid -- -- 0.010-5.00
25 Xanthan Gum -- -- 0.00-5.00
26 Sucralose -- -- 0.00-2.00
27 Sorbitol Solution -- -- 0.00-50.00
28 Mannitol -- -- 0.00-30.00
29 Glycerol -- -- 0.00-20.00
30 Maltitol -- -- 0.00-20.00
31 Maltodextrin -- -- 0.00-20.00
32 Malt Extract -- -- 0.00-20.00
33 Stevia glycosides -- -- 0.00-5.00

are weighed and dispensed accurately as per batch quantity, the herbal raw
materials are coarsely grinded using 10 mm screen;

Step (ii): herbal grinded raw materials are boiled with water in a suitable vessel, after completion of extraction, decoction is collected in Fermenter;

Step (iii): Draksha & Madhuka are extracted in a vessel and transferred into fermenter;

Step (iv): Dhatakipuspa is macerated in a suitable vessel, using water and small quantity of drakshadecoction, the liquid is filtered and collected into Fermenter;

Step (v): Herbal Decoction, extract of DhatakiPuspa, extract of Draksha & Madhukaand kinwa are added in fermenter mixed well and kept for fermentation for 6-10 days until desired percentage of alcohol is generated;

Step (vi): Prakshep materials are added and kept aside for 2-5 days;

Step (vii): After the desired level of percentage of self-generated alcohol is achieved fermentation is stopped by addition of Methyl paraben, Propyl paraben & Sodium benzoate followed by heating up to 60°C and cooling immediately to room temperature;

Step (viii): The bulk is filtered and transferred into a storage tank;

Step (ix): To the bulk Xanthan gum & Sucralose are added and

Step (x): Sampling is done for Quality Control checking;

Step (xi): After getting quality control release report, bulk is allowed for packing.

To develop self-fermented herbal product (traditionally known as Asav-Arishta) suitable for current life-style conscious consumers.

To develop Asav-Arishta without using external sugar either Crystal sugar or Jaggery for fermentation.

To develop sugar free Asav-Arishta for Diabetes as well as health conscious consumers

To develop sugar free products for individual conditions like Diabetes, Obesity, Indigestion, Women Care or any other disorder requiring the benefits of Asav-Arishta but where sugar content becomes barrier.

Therefore, sugar free variants are required

The products may be single or poly-herbal in nature where certain fruits like Grapes & Mahua may be used as substitute of Crystal sugar or Jaggery for products of Asav-Arishta during self-fermentation.

The process defining the ration of grapes & Mahua in any or all proportion or Grapes or Mahua in any proportion suitable for production of required amount of Alcohol during the self-fermentation process in sugar free Asav-Arishta, these sugar free Asav-Arishtas are suitable for using in any condition requiring low sugar or no sugar including Diabetes Mellitus metabolic syndrome or its components and suitable for using by all gender and all the age groups.

We shall now describe the manufacturing process procedure of DB-07 which is given by way of example but does not restrict the scope of present invention:-

Presently, herbal formulations, classified as 'Arishta' or 'Asava' are manufactured in accordance with the procedures laid down in ancient texts. This procedure involves mainly three phases: 1) Extraction 2) Preparation of fermentation medium 3) Inoculation and fermentation.

These three phases are summarized as below:

Extraction Phase: Water is used as solvent for extraction purposes. For Asavas, the extraction procedure involves a cold infusion technique, wherein the coarse powder of herbal material is soaked in water for a fixed duration at room temperature and a filtrate is obtained.

In case of Arsihtas, the extraction procedure involves an Open Pan Boiling Technique, wherein, coarsely ground herbal material is charged to a boiling pan along with required quantity of water. This mixture is then heated using steam or firewood or some other fuel. The filtrate is then collected discarding the herbal marc.

Preparation of fermentation medium: To grow any microorganism nutrients are necessary. As the extract mainly contains active constituents coming from herbs, Jaggery was suggested as a source of complex nutrition in ancient literature. Accordingly, the Fermentation medium is to be prepared by dissolving Jaggery in the herbal extract obtained either by cold infusion for Asavas or by means of Open Pan Boiling Technique for Arishtas.

More specifically to grow microorganism and for generation of alcohol nutrient in terms of sugar (in sucrose/monosaccharide form) is necessary. Thus the prior art incorporate natural source of sugar/monosaccharide not as Jaggery/Sugar which will provide nutrients to microorganism for their growth and alcohol generation.

Inoculation & Fermentation: Ancient literature recommends Woodfordiafruticosa(Dhataki) as the inoculum bearing herbs. Thisinoculum-bearing herb and other aromatic herbs in form of fine powders are topped to the fermentation medium. Fermentation is carried out in a closed fermentation vessel, under controlled temperature conditions, at 30-35°C. Depending upon the type of herbal formulation, this phase of process may take anywhere between 30-45 days. To accelerate fermentation process Kinwa (Saccharomyces cerevisiae) has been mentioned in some literature which will lead to 5-12 days for producing desired quantity of alcohol percentage.The end product is expected to contain a self-generated alcohol in range of 7 to 14% v/v (volume/volume).

The herbal product range produced as per the above process is termed as Asava or Arishta as the case may be. The product line has certain specific advantages from clinical application and stability points of view and the same can be summarized as under:

?These preparations are generally palatable for the user with a good taste combined with a fine spicy aroma, which masks the unacceptable taste and odor of the active, herbal ingredients.

? Apart from the aqueous extract of the prime ingredients, the preparation brings the hydro-alcoholic extract of supportive ingredients used as powders added during fermentation
.
?The process also brings the extract of inoculum bearing herbs, which is considered to potentiate the activity of prime ingredients.

?The self-generated alcohol content in the product acts as a preservative and contributes for its prolonged shelf life.

? Self-generated alcohol is considered to enhance the bioavailability of all the herbal ingredients contained in the formulation.