Title of Invention

A PROCESS TO PREPARE A NOVEL AYURVEDIC COMPOSITION AND THE COMPOSITION RESULTING THEREFROM

Abstract

A process for a novel synergistic ayurvedic composition which corrects disfunctioning of the endothelium, clears atherosclerosis, increases myocardial flow, opens up colaterals and improves arterial compliance admining terminalia arjuna bark, hemedesmus indica root, mangifera indica bark, rauwolfia serpentia root, moringe oelifera bark, achyranthes aspera root, boerhavvia diffusa root, murraya koengil leaf, piper longum fruit in the suitable excipient like cocount oil (refined or fibreless), sunflower oil (refined), kaju oil (refined), groundnut oil (refined), cow ghee (refined), linseed oil (refined), sesame oil (refined) or excipient used in the combination of any three oils mentioned above.

Full Text

FORM 2 THE PATENTS ACT, 1970 (39 of 1970) AND THE PATENTS RULES 2003 (Section 10; Rule 13) TITLE OF THE INVENTION: "A process to prepare a novel ayurvedic composition and the composition resulting therefrom. " Shree Narayan Ayurvedic Pharmacy (P) Ltd., 1184-4, Dnyaneshwar Paduka Chowk, Gokulnagar "B" Building, Fergusson College road, Shivajinagar Pune411 005, Maharashtra,India Indian Company registered under the Provisions of the Companies Act, 1956 The following specification particularly describes the nature of this invention and the manner in which it is to be performed. 28-09-2005 Present invention relates to a process to prepare a novel synergistic ayurvedic ^preparation, which correts the disfunctioning of the endothium clears atherosclerosis"! # — ■ " increases the myocardial bjood flow, opens up collaterals and improves arterial \ compliance. ^ i More particularly the present invention relates to a process for preparing a synergistic ayurvedic preparation for increasing the myocardial blood flow admining terminalia arjuna bark, hemedesmus indica root, mangifera indica bark, moringe oelifera bark, murraya koengil leaf, piper longum fruit, boerhawia diffusa root, achyranthes aspera root, rauwolfia serpentia root in the suitable excipient like coconut oil (refined or fibreless), sunflower oil (refined), kaju oil (refined), groundnut oil (refined), cow ghee (refined), linseed oil(refined), sesame oil(refined)or excipient used in the combination of any three oils mentioned above. In prior art no such or similar ayurvedic preparation are available which can really increase the myocardial blood flow and empowers/strengthen the heart muscles. Object of the present invention therefore aims at developing a process for a synergistic ayurvedic preparation for improving the myocardial blood flow, correct the . disfunctioning of the endothelium, clear atherosclerosis. It also opens up collaterals and improves arterial compliance. It is also the object of the present invention to protect the human life especially from heart aliment/attack. According to the important feature of the present invention, it increases the myocardial blood flow, empowers/strengthens the heart muscles, and reduces anginal pain. 2 In prior art the above mentioned terminalia arjuna bark, hemedesraus indica root etc. was given by ayurvedic doctors in powder form. Such powder of each ingredient was prescribed separately. These powders were administered to the patients one by one in a sequence, which would make seven doses of same medication causing patient a discomfort in taking the medicine. Due to seven different powders there were chances of escaping one by mistake and thereby defeating the purpose of medication. Above all total quantity of herbal powder which a patient used to consume in a day was S.Sogm, which is again a large quantity of medicine. The amount of active constituents present in the large quantity of powder is very low, which extended the course of treatment to an indefinite time again. Following is the comparative study of figures, which reveals the quantities of herbs, which were used in prior art. Sr. No. Ingredients Ghan form (new) Pure herbal Powder (prior art) Terminalia Arjuna Bark 3.8 kgs 19 kgs Hemedesmus Indica Root 1.8 kgs 14 kgs Mangifera Indica Bark 1.8 kgs 18 kgs Moringe Oehfera Bark 1.8 kgs 13.37kgs Murraya Koengil Leaf 1.8 kgs 13.37 kgs Piper Longum Fruit 1.8 kgs 947 kgs Boerhawia Diffusa Root 3.8 kgs 27.1jkgs Achyranthes Aspera Root 1.8 kgs 15 kgs Rauwolfia Serpentia Root 1.6 kgs 13.3 kgs The present invention uses the ingredients in the form of Ghanas (Aqueous Extracts) which result in a synergistic effect. By using the Ghanas in the new formulation 3 it was possible that concentrated form of the same medication can be given in a single dose of capsule. This single dose supplied all active constituents in the required quantity to get the desired effect of medicine in shorter time_span as compared-to the oldetvone. The method of using Gfaanas in place of pure herbal powder has, thus simplified the administration of medicine to get quicker and well defined results to get rid of heart diseases. The following table gives the strength and weights of ingredients of the synergistic composition of the invention. Ingredients Strength Weight Terminalia ariuna bark 2:80 3.8 kgs Hemedesmus indica root 1.35: 10 1.8 kgs Mangifera indica bark 1 :50 1.8 kgs Moringe Oelifera Bark 1.35 : 50 1.8 kgs Murraya Koengil Leaf 1.35 : 50 1.8 kgs Piper longum Fruit 1.9 :20 1.8 kgs Boerhaavia Diffusa root 1.4:20 3.8 kgs Achyranthes Aspera Root 1.2: 10 1.8 kgs Rauwolfia Serpentia root 1.3 : 10 1.6 kgs According to this invention therefore, a process for a synergistic ayurvedic preparation which corrects dis&nctioning of endothelium, clears atherosclerosis, increases myocardial flow, opens up collaterals and improves arterial compliance comprises of the following steps : i. taking the ingredients (a) terminalia arjuna bark in proportion 2 : 80, (b) hemedesmus indica root in proportion 1.35 : 10 , (c) magnifera indica bark in the proportion 1 :50, d) rauwolfia serpentia root in the proportion 1.3 ; 10, e) moringe oelifera bark in the proportion 1.35 : 50, f) achranthes aspera root in the proportion 1.2 :10, g) boerhaavia diffusa root in the proportion 1.4:20, h) murraya koengil leaf in the proportion 1.35 : 50, J) piper longum--in the proportion 1.9:20. 4 ii. Slow cooking the ingredient a) with one of the suitable thereof in equal proportion in stainless steel mixer at about lOOdeoree Cjbr 60 minutes all the above ingredients are cooked and blended at the same time in their above order. iii. transferring the blend of step ii) in a separate vessel; iv. repeating step ii) and iii) for ingredients b),c),d),e), f), g), h) and J) separately. v heating the mass so obtained from steps ii), iii) and iv) with direct heating in a vessel at about 30 degree C for about 10 hrs. vi transferring the heated mixture of step v) into another vessel through a filtration pump; yii transferring the filtered content into the plastic container for encapsulation. The process according to the present invention is illustrated in the following example. Ingredients Strength Weight Terminalia arjuna bark 2:80 3.8 kgs Hemedesmus indica root 1.35 : 10 1.8 kgs Mangifera indica bark 1 : 50 1.8 kgs Moringe Oelifera Bark 1.35 : 50 1.8 kgs Murraya Koengu Leaf 1.35 : 50 1.8 kgs Piper longum Fruit 1.9:20 .1.8 kgs Boerhaavia Diffusa root 1.4:20 4 3.8 kgs Achyranthes Aspera Root 1.2: 10 1.8 kgs Rauwolfia Serpentia root 1.3 : 10 1.6 kgs The above ingredients are weighed accurately and mixed in stainless steel mixer (blender) separately with the same weight of the excipient like coconut oil (refined or fiberless), sunflower oil (refined), kaju oil (refined), groundnut oil (refined), cow ghee (refined), Unseed oil(refined), sesame oil (refined) or excipient used in the combmation of 5 Any three oils mentioned above at 100 degree C for 60 minutes, one by one and then transferred to main processing vessel and processing is done at 30 degree C for 10 hrs for stirrer function. Then filtered and transferred to container and capsulation is carried out. CLINICAL DATA BACKGROUND: A Synergistic Ayurvedic preparation (present invention) using the extracts of multiple herbs has been reported to have beneficial effects in patients with ischemic heart disease in small, open studies. METHOD: Thirty-six individuals with chronic stable angina (NHYA class ll-lll) administered by the invented Synergistic Ayurvedic preparation in the dose of capsules in two divided doses for a duration of either two or three months. They underwent a 3 dimensional cardiovascular cartography before and the end of the therapy. The global myocardial blood was assessed explained in following steps. Step I: Applying a paired simple t-test, it is interesting that the flow value after treatment is always greater than before. The mean value of increase is 14.47 units. The associated SD value is 10.49. The p-value for the t-test is practically zero (4.6117E-10). Hence the treatment has a statistically significant effect. Step II: Following graph may be useful to visualize the effect of treatment. The pink straight line indicates the situation in which treatment has absolutely no effect on flow. Dark blue points indicate individual patients. Three such points seem to have fallen on the line itself. Treatment has not improved flow in their case. These are S1-8, S1-12, and S2-9. 6 ^ Please refer to Graph 1 and Graph 2: Referring to graph 1, The region below pink line denoted by the letter W indicates worsening of the patient condition. There is no case falling in this region. This graph shows that all but three patients have improved. Step 3: One question that may arise is whether this change is attributable to any factors other than treatment (like sex, age, initial value of flow etc.). if so we have to discount impact of these factors before drawing conclusion in the favour of drug. To check this we have carried out multiple regression analysis with change in flow as the dependent variable and the above factors as independent variables. The results are given below. Referring to graph 2, It is noted that at lower initial flow values the response is more variable. At high initial flow values, the response is small but there is less variability. CONCLUSION: Thus, the present invention when administered to the patients of coronary artery disease, in the form of soft gelatinous capsules, improved their status by increasing global myocardial blood flow. 7 Diff flow= 98.0- 0.201 ,Age -21.6, BSA -0.550 initial flow. Predictor Coef Stdev t-ratio p Constant 97.99 29.58 3.31 .002 Age -0.2011 0.1594 -1.26 0.216 BSA -21.56 12.35 -1.75 0.091 Initial Flow -0.5499 0.1189 -4.62 0.000 S= 8.302 R.Sq= 41.4% Rsq (adj) =35.7% Analysis of variance SOURCE DF SS MS F p Regression 3 1508.14 502.71 7.29 0.001 Error 31 2136.62 68.92 Total 34 3644.76 SOURCE DF SEQ SS Age 1 18.75 BSA 1 16.05 Initial Flow 1 1473.34 Variables age and BSA are retained in the equation for technical reasons. But the real explanatory variable is Initial flow. The regression coefficient is negative. If initial flow value is high, the increment in flow is smaller. WE CLAIM: 1. A process to prepare a novel synergistic ayurvedic composition which corrects disfunctioning of endothelium and increases myocardial flow, comprising the following step :. i) taking the ingredients (a) terminalia arjuna bark in proportion 2 : 80, (b) hemedesmus indica root in proportion 1.35 ; 10 , (c) magnifera indica bark in the proportion 1 :50, (d) rauwolfia serpentia root in the proportion 1.3 : 10, (e) moringe oelifera bark in the proportion 1.35 : 50, (f) achyranthes aspera root in the proportion 1.2 : 10, (g) boerhaavia diffusa root in the proportion 1.4 : 20, (h) murraya loengil leaf in the proportion 1.35 : 50, (i) piper longum fruit in the proportion 1.9 : 20. ii) slow cooking the ingredients a) with one of the suitable excipient or mixture thereof in equal proportion in stainless steel mixer (blender) at about 100 degree C for 60 minutes all the above ingredient are cooked and blended at the same time in the above order. iii) transferring the blend of step (ii) in a separate vessel; iv) repeating step (ii) and (iii) for ingredients (b), (c), (d), (e), (f), (g), (h) and (i) separately. v) heating the mass so obtained from steps (ii), (iii) and (iv) with direct heating in a vessel at about 30° C for aboutIO hours. vi) transferring the heated mixture of step (v) into another vessel through a filtration pump. 9 vii) transferring the filtered content into the plastic container for encapsulation. 2. The novel synergistic ayurvedic composition as prepared by process as claimed in claim 1. 3. The process as claimed in claim I wherein the excipients are - coconut oil (refined or fibreless) sunflower oil (refined) kaju oil (refined) groundnut oil (refined) cow ghee (refined) linseed oil (refined) sesame oil(refined) or excipient used in the combination of any three oils mentioned above.. 4. The process as claimed in claim I and the novel synergistic Ayurvedic composition as claimed in claim II such as herein described with reference to the example of the accompanying specification. Dated this 12tn Day of May 2004 (ANAND DESHPANDE) AGENT FOR APPLICANT

Documents:

611-mum-2004-abstract(28-09-2005).doc

611-mum-2004-abstract(28-09-2005).pdf

611-mum-2004-cancelled pages(28-09-2005).pdf

611-mum-2004-claims (granted)-(28-09-2005).pdf

611-mum-2004-claims(granted)-(28-09-2005).doc

611-mum-2004-correspondence(ipo)-(04-10-2005).pdf

611-mum-2004-correspondence-1-(15-12-2005).pdf

611-mum-2004-correspondence-2-(28-09-2005).pdf

611-mum-2004-drawing(28-09-2005).pdf

611-mum-2004-form 1(27-05-2004).pdf

611-mum-2004-form 19(18-08-2004).pdf

611-mum-2004-form 2(granted)-(28-09-2005).doc

611-mum-2004-form 2(granted)-(28-09-2005).pdf

611-mum-2004-form 26(27-05-2004).pdf

611-mum-2004-form 3(28-09-2005).pdf

611-mum-2004-power of authority(02-06-2004).pdf

abstract1.jpg