Title of Invention

ANTI-DIABETIC HERBO-MINERAL COMPOSITION AND PROCESS FOR THE PREPARATION THEREOF

Abstract

A herbo-mineral composition and process for preparation there of for treatment, of diabetes, capable of being used as antioxidant and stimulant to increase sperm count, comprising a therapeutically effective combination of Swarna bhasma (1-2 wt %) , Rajata bhasma (1-3 wt %), Vanga bhasma (1-3 wt c/o), Naga bhasma (1-3 wt %), Kantaloha bhasma (1-3 wt %), Abharaka bhasma (4-6 wt %), Parvala bhasma (3-6 wt %), Moukthika bhasma (3-6 wt %), Gomutra Silajit (2-4 wt %), Panchakarpur (2-4 wt %), with Tinospora cordifolia (2-6 wt %), the percentage described herein are weight by weight to the total weight of the formulation; and pharmaceutically acceptable exipients and additives.

Full Text

ANTI-DIABETIC HERBO-MINERAL COMPOSITION (S) FIELD OF INVENTION The invention provides a novel anti-diabetic herbo-minerai composition (s) used in treatment of weakness and control of diabetes. BACKGROUND AND PRIOR ART OF THE INVENTION Diabetic mellitus is a syndrome characterized by chronic hyperglycemia and disturbances of carbohydrate, fat and protein metabolism, associated with an absolute or related deficiency in insulin secretion and/or insulin action. WHO has declared India as the "Diabetic Capital of the World". More than half of diabetics (53%) are above 60 years and more than 85% are above 45 years. In India the prevalence of Diabetes is 11% between 65-69 years age. Diabetic can accelerate cell aging by a number of subcellular events like hyperglycemia, increase sorbital pathway, oxidation stress with damage to cellular organelles, production of advanced glycosylation end products and increased activity of diacyl glycerol protein kinase C pathway with accelerated production of cell damaging cytokines. The more patients understand about the disease the better they are enabled to make good decisions on its management. Dietary therapy and exercise are critical both in preventing and managing diabetic mellitus and the results of the diabetic prevention program research group indicate that changes in life style reduced the incidence of diabetic by 58% (Knowier et al., 2002). In type 1 diabetic mellitus, where there is an absolute deficiency of insulin replacement forms a major component of treatment. In type 2 diabetic mellitus, insulin release from the pancreas is altered and may also be absolutely deficient in amount, and therefore its replacement also plays a part in management, especially when diabetic mellitus has been present for a long time. As the number of people with diabetes multiply world wide, the disease takes an ever-increasing proportion of national and international health care budgets. It is projected to become one of the world's main disablers within the next 25 years. It is very popularly known in medical history as "silent killer". Regions with greatest potential are Asia and Africa, where diabetes mellitus rates could rise to two to three-folds than the present rates. Apart from currently available therapeutic options, many herbal/minearal medicines have been recommended for the treatment of diabetes. The development of scientifically validated models of streptozocin induced- diabetic is vital to the analysis of the functional consequences of pancreatic damage and to testing the recovery efficacy of potentially therapeutic drugs. The role of medicinal plants or mineral products increasing the secretion of insulin and acting as an anti-diabetic formulation in the form of tablet is still much underestimated. The retrieval hypothesis postulates the streptozocin agents disrupt the pancreas function as the effect of streptozocin agents diminish over time by the treatment of our present herbal formulation investigation resulted in the reappearance of normal functioning of pancreas. Drugs like glibenclamide, penformin-containing substances which have a stimulant activity on diabetic and the adverse side effects or synthetic molecules can not be ruled out. Tinospora cordifolia along with bhasmas was used in synergistic combination to form a pharmaceutically effective formulation. OBJECTS OF THE INVENTION The main object of the present invention is to provide a novel anti-diabetic herbo-mineral composition (s) used in control of weakness and control of diabetes. Another objective of the present invention is to prepare and process the bhasma(s). Yet another object of the present invention is to prepare herbal-mineral formulation(s) with a combination of the plants and bhasmas that are used in control of weakness and diabetes. SUMMARY OF THE INVENTION Accordingly the present invention provides a herbal-mineral formulation useful in the control of weakness and treatment of diabetes. The herbal- mineral composition comprising of more than one processed mineral with Tinospora cordifolia together with conventional additives to form oral dosage forms. Accordingly, the present invention provides a novel anti-diabetic herbal-mineral synergistic formulation useful for the treatment of diabetes, said formulation comprising: a) Aqueous extracts of the plant comprising Tinospora cordifolia 2 - 6wt.%, along with the processed minerals as bhasmas and conventional additives to form an oral dosage form comprises of a tablet, a capsule, a powder and a liquid. The novelty of the present investigation is (1) Preparation of a novel antidiabetic herbo-mineral composition (s) used in treatment of weakness and control of diabetes. In an embodiment of the invention, herbal-mineral composition comprising an effective amount of herbal extract with bhasmas and optionally along with pharmaceutically acceptable additives. In another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein the extracts of the plants are mixed in the ratio Tinospora cordifolia 2-6wt. %, along with bhasmas 4- 30 wt % and conventional additives to form an oral dosage form. In still another embodiment of the present invention, herbal composition(s) as claimed in claim 1, wherein the said formulation having the property of improving the anti-diabetic property and used in treatment of type II diabetes and type I diabetes. In yet another embodiment of the present invention, herbal composition(s) as claimed in claim 1, wherein the formulation is used as anti- oxidant In still another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein said composition in an oral dosage form selected from a group consisting of a tablet, a capsule, a powder and a liquid. In yet another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein the extracts of plants are aqueous or alcoholic extract. In another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein the alcohol used is ethanol. In still another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein the said composition comprises about 4-45 wt% of the total formulation. In yet another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein the extract of Tinospora cordifolia is a stem extract. In still another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein the binders used are starch, starch paste, gum acacia and carboxy methyl cellulose. In yet another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein the diluents used are lactose. In still another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein the lubricants used are from starch and lactose. In another embodiment of the present invention, herbal composition(s) a method of preparing a herbal formulation as claimed in claim 1 wherein the said method comprising: a. Obtaining the part of medicinal plants comprising aerial parts. b. Drying the plant material in shade. c. Powdering the dried plant material to a coarse powder. d. Extracting the powdered dried plant material with distilled water or aqueous ethanol at 25 - 35 °C. e. Extracting the plant material with the Aqueous alcohol in the ratio of 1:8 to 1:15 for 4-7 days f. Concentrating the obtained extract at under reduced pressure at 40-60 °C. g. Lyophilising the concentrated extract for complete removal of solvent. In another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein the said composition at a dose of 50-200 mg/kg shown a dose dependent protection in.diabetes in rats In still another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein the formulation at a higher dose of 50-200 mg/kg shown potent antioxidant activity. In yet another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein the formulation at a dose range of 50- 200 mg/kg maintains the diabetic levels to that of the normal conditions. In still another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein the formulation at a dose range of 50- 200 mg/kg shown dose dependent protection in diabetic rabbits. In yet another embodiment of the present invention, herbal composition(s) as claimed in claim 1 wherein the formulation at a dose range of 50-200 mg/kg has antioxidant property by reducing the lipid peroxidation and restoring the level of enzymatic antioxidants. As a result of intensive study conducted by the inventors with the aim of achieving aforementioned objectives, new formulations for oral ingestion were developed employing herbal drugs, which are from natural origin, incorporating them into binders and diluents to form oral dosage forms. Accordingly, the present investigation deals with the oral dosage form formulation(s). Each formulation has been described in detail giving the formula of the ingredients along with the method of preparation. The first step in the preparation of these formulations involves a process for making, the plant material suitable for formulating into a tablet/ capsule. The specified portion of the plant is collected and dried under shade at room temperature (25 -35°C) for 72 hours or until the material gets dried. The material is then powdered into a fine powdered. A specified amount of the powdered material is then extracted exhaustively with 50 % aqueous alcohol at room temperature (25-35 °C). Extraction was carried out in a closed container immersing specified amount of the plant material in specified solvent (1:8-1:15 ratio) for 4-7 days. At the end of this stage, solvent is decanted and filtered if necessary to make it free from plant debris. The solvent is then concentrated by evaporating under vacuum at less than 40-60 °C. The concentrate is then freeze dried to obtain final product in powder form. The final product is then made into oral dosage form by using it as an ingredient for making tablets and capsules. Suitable binders like starch and diluents like lactose are added to make up the formulation. Tinospora cordifolia was collected and dried in shade. The dried material (lKg) is then powdered and extracted with distilled water/hydro alcoholic extract (3 L) for 5 days. At the end of this, the solvent is decanted and filtered if necessary to remove the plant debris. The extract is then concentrated under vacuum at less than 50 °C. Then the extract is lyophilized to obtain the extract in powder form. 15 g of starch is mixed with water and heated to form a paste. The weighed quantities of the plant extract and bahamas were mixed are then blended with starch paste and then lactose is added quantity sufficient to make 100 g. The ingredients are then mixed properly with the starch paste to form a mass. The mass is then granulated in a granulator and then the dry at 104 °F and screen through 16-mesh screen. Talc is added to the dried granules and then they are punched in the tablet-punching machine to form uniform tablets. The formulation is useful for the treatment of weakness and control of diabetic. Tinospora cord/folia was collected and dried in shade. The dried material (lKg) is then powdered and extracted with aqueous solvent or hydro-alcohol (3 L) for 5 days. At the end of this, the solvent is decanted and filtered if necessary to remove the plant debris. The extract is then concentrated under vacuum at less than 50 °C. Then the extract is lyophilised to obtain the extract in powder form. The weighed quantities of the plant extracts were mixed with bhasmas as mentioned and are mixed with the diluents lactose and then are filled in hard gelatin capsules and they are dispensed. The formulation is useful for reducing cholesterol and weakness caused by diabetic. Tinospora cordifolia was collected and dried in shade. The dried material (lKg) is then powdered and extracted with aqueous solvent or hydro alcohol (3 L) for 5 days. At the end of this, the solvent is decanted and filtered if necessary to remove the plant debris. The extract is then concentrated under vacuum at less than 50 °C. Then the extract is lyophilised to obtain the extract in powder form. 15 g of starch is mixed with water and heated to form a paste. The weighed quantities of the plant extracts are then blended with starch paste and then lactose is added quantity sufficient to make 100 g. The ingredients are then mixed properly with the starch paste to form a mass. The mass is then granulated in a granulator and then the dry at 104 °F and screen through 16-mesh screen. Talc is added to the dried granules and then they are punched in the tablet-punching machine to form uniform tablets. The formulation is useful for the treatment of diabetics. ADVANTAGES 1. Prevents the weakness in diabetes 2. Reduced blood glucose and maintains the normal blood glucose levels 3. Useful as an poweful antioxidant. intraperitonealy in a volume of 1 ml/kg. After five days of streptozocin injected animals exhibited massive glycosuria and hyperglycemia within five days (Siddique et al 1989). Diabetes was confirmed in STZ rats by measuring the fasting blood glucose concentration after the injection of STZ. The rats with blood glucose level > 250 mg/dl were considered to be diabetic and were used in the experiment. Separated and divided into four groups of six animals each. Group I served as a diabetic control and was given distilled water. Group II-IV was treated orally with different formulation(s) at a dose of 50,100 and 200mg/kg, respectively. Blood samples were collected from the tail vein just prior to and 1 and 3h after formulation(s) administration. And same procedure repeated for effect of formulation with and with out on streptozocin- induced rats (Vijay et al., 2005). Effect of formulation on glucose tolerance in rats: Fasted rats were divided into four groups of six rats each. Group I served as a control and received distilled water. Group II-IV was treated orally with different formulation(s) at a dose of 50,100 and 200mg /kg respectively. After 30 min of different formulation(s) administration the rats of all groups were orally treated 2g/kg of glucose. . Blood samples were collected from the tail vein just prior to glucose administration and at 30 and 90 min after glucose loading. Serum was separated and blood glucose levels were measured immediately by glucose-oxidase method (Venkatesh et al., 2003). Effect of formulation on glucose tolerance in rabbits: The experimental animals used were New Zealand male adult rabbits weighing from 2.5 to 3.5 kg, and water ad libitum. Prior to each study, the animals were subjected to fasting for 18 h. Fasted rats were divided into four groups of six rabbits each. Group I served as a control and received distilled water. Group II-IV was treated orally with different formulation(s) at a dose of 50,100 and 200mg /kg respectively. After 30 min of different formulation (s) administration the rabbits of all groups were Subcutaneously treated 2g/kg of glucose. A 50% glucose was applied twice subcutaneously (2 g glucose/kg for turn) in each GTT, at time 0, 30 and 90 min. Blood samples were collected from the marginal ear vain just prior to glucose administration and at 30 and 90 min after glucose loading. Serum was separated and blood glucose levels were measured immediately by glucose-oxidase method (Alarcon-Aguilar et al., 1997). Values are mean ± S.D. for six rats; Pa Formulation (F) contains Tinospora cordifolia, Swarna bhasma, Rajata bhasma, Vanga bhasma, Naga bhasma, Kantaloha bhasma, Abharaka bhasma, Parvala bhasma, Moukthika bhasma, Rassindura, Gomutra Silajit and Panchakarpur. The results of the present study of table-Ill shows a significant decrease in blood glucose level at lh at a dose 200mg/kg and the percentage protection in controlling the increased level of blood glucose were significant at dose range 50-200mg/kg at 14 day and percentage protection ranged 6.43 -51.22 percent. Formulation (F) contains Tinospora cordifolia, Swarna bhasma, Rajata bhasma, Vanga bhasma, Naga bhasma, Kantaloha bhasma, Abharaka bhasma, Parvala bhasma, Moukthika bhasma, Rassindura, Gomutra Silajit and Panchakarpur. Note: No mortality/ gross abnormality were observed in the animals during the treatment of formulation F. Values are mean ± S.D. for six rats; P a The results showed a significant effect with the formulation (F) containing Tinospora cordifolia, Swarna bhasma, Rajata bhasma, Vanga bhasma, Naga bhasma, Kantaloha bhasma, Abharaka bhasma, Parvala bhasma, Moukthika bhasma, Rassindura, Gomutra Silajit and Panchakarpur at 90 min and the levels were revealed near to the normal values in the scientifically validated model of glucose tolerance test in rats. The results showed a significant effect with the formulation (F) containing Tinospora cordifolia, Swarna bhasma, Rajata bhasma, Vanga bhasma, Naga bhasma, Kantaloha bhasma, Abharaka bhasma, Parvala bhasma, Moukthika bhasma, Rassindura, Gomutra Silajit and Panchakarpur at 90 min and the levels were revealed near to the normal values in the scientifically validated model of glucose tolerance test in rabbits and percentage protection ranged 53.07 - 69.03. The results showed a significant effect with the formulation (F) containing Tinospora cordifolia, Swarna bhasma, Rajata bhasma, Vanga bhasma, Naga bhasma, Kantaloha bhasma, Abharaka bhasma, Parvala bhasma, Moukthika bhasma, Rassindura, Gomutra Silajit and Panchakarpur. The results showed a significant effect with the formulation (F) containing Tinospora cordifolia, Swarna bhasma, Rajata bhasma, Vanga bhasma, Naga bhasma, Kantaloha bhasma, Abharaka bhasma, Parvala bhasma, Moukthika bhasma, Rassindura, Gomutra Silajit and Panchakarpur. Table VII: per se effect of the formulation F (50, 100 and 200 mg) on SGOT (U/l), SGPT (U/l) and SALP (U/l) and liver superoxide dismutase, SOD (units/mg of protien), catalase, CAT (units/mg of protien), glutathione peroxidase, GSH (mmol/g tissue) and lipid peroxidation, LPO (MDA nmoles/mg of protien) in rats. References Cited Bhatnagar, D., Current Sciene, 78: 1087 (1998) Reddy, K. S. Wld. Hlth. StatQ., 46: 101, (1993) Sushma Mengi, Indian J. Natural Prod,, 19(1): 49 (2003) Foster et al., J. Consult. Clinical. Physiol 65: 79-85 (1992) Butrum et al., American J. Clin. Nutr., 48(3): 888-895 (1988) Remington, The science and practice of pharmacy, 19th edition, Vol II. pp. 1635, 1995 Anonymous. Indian Pharmacopoeia. Govt of India, 1996. Claims We claim: 1. A novel synergistic herbo-mineral composition (s) used in treatment of weakness and control of diabetes 2. Herbal-mineral composition comprising an effective amount of herbal extract with bhasmas and optionally along with pharmaceutically acceptable additives, 3. Herbal-mineral composition(s) as claimed in claim 1 wherein the extracts of the plants are mixed in the ratio Tinospora cordifolia 2-6wt. %, along with bhasmas 4- 30 wt % and conventional additives to form an oral dosage form, 4. Herbal composition (s) as claimed in claim 1, wherein the said formulation having the property of improving the anti-diabetic property and used in treatment of type II diabetes and type I diabetes. 5. Herbal composition (s) as claimed in claim 1, wherein the formulation is used as anti- oxidant 6. Herbal composition(s) as claimed in claim 1 wherein said composition in an oral dosage form selected from a group consisting of a tablet, a capsule, a powder and a liquid. 7. Herbal composition(s) as claimed in claim 1 wherein the extracts of plants are aqueous or alcoholic extract. 8. Herbal composition(s) as claimed in claim 1 wherein the alcohol used is ethanol. 9. Herbal composition(s) as claimed in claim 1 wherein the said composition comprises about 4-45 wt% of the total formulation. 10.Herbal composition(s) as claimed in claim 1 wherein the extract of Tinospora cordifolia is a stem extract. 11.Herbal composition(s) as claimed in claim 1 wherein the binders used are starch, starch paste, gum acacia and carboxy methyl cellulose. 12.Herbal composition(s) as claimed in claim 1 wherein the diluents used are lactose. 13.Herbal composition(s) as claimed in claim 1 wherein the lubricants used are from starch and lactose. 14.A method of preparing a herbal formulation as claimed in claim 1 wherein the said method comprising: a. Obtaining the part of medicinal plants comprising aerial parts. b. Drying the plant material in shade. c. Powdering the dried plant material to a coarse powder. d. Extracting the powdered dried plant material with distilled water or aqueous ethanol at 25 - 35 °C. e. Extracting the plant material with the Aqueous alcohol in the ratio of 1:8 to 1:15 for 4-7 days f. Concentrating the obtained extract at under reduced pressure at 40- 60 °C. g. Lyophilising the concentrated extract for complete removal of solvent. 15.Herbal formulation(s) as claimed in claim 1 wherein the said composition at a dose of 50-200 mg/kg shown a dose dependent protection in diabetes in rats 16.Herbal formulation(s) as claimed in claim 1 wherein the formulation at a higher dose of 50-200 mg/kg shown potent antioxidant activity. 17.Herbal formulation(s) as claimed in claim 1 wherein the formulation at a dose range of 50- 200 mg/kg maintains the diabetic levels to that of the normal conditions. 18.Herbal formulation(s) as claimed in claim 1 wherein the formulation at a dose range of 50- 200 mg/kg shown dose dependent protection in diabetic rabbits. 19.Herbal composition(s) as claimed in claim 1 wherein the formulation at a dose range of 50-200 mg/kg has antioxidant property by reducing the lipid peroxidation and restoring the level of enzymatic antioxidants.

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