CN112691095A - Solid pharmaceutical composition containing metformin and vildagliptin - Google Patents
Solid pharmaceutical composition containing metformin and vildagliptin Download PDFInfo
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- CN112691095A CN112691095A CN202110081013.6A CN202110081013A CN112691095A CN 112691095 A CN112691095 A CN 112691095A CN 202110081013 A CN202110081013 A CN 202110081013A CN 112691095 A CN112691095 A CN 112691095A
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Abstract
The invention relates to a solid pharmaceutical composition containing metformin and vildagliptin, which comprises metformin, vildagliptin, rosiglitazone and B vitamins, wherein the metformin comprises the following components in parts by weight: 1-3 parts; 15-60 parts of vildagliptin; 1-3 parts of rosiglitazone; the mass portion of the B vitamins is 0.8-2. The solid pharmaceutical composition containing the metformin and the vildagliptin is a single-component tablet or a capsule. The solid pharmaceutical composition containing the metformin and the vildagliptin achieves the purposes of mechanism complementation, mutual synergy, curative effect improvement and reasonable medication through scientific combination of three different hypoglycemic drugs.
Description
Technical Field
The invention relates to the technical field of pharmaceutical compositions, and particularly relates to a solid pharmaceutical composition containing metformin and vildagliptin.
Background
The incidence of diabetes is still increasing year by year. According to data provided by the World Health Organization (WHO), the prevalence rate of diabetes in developed countries is as high as 5% -10%, and is about 3% in China, and 1.3 hundred million diabetics exist in the world; by 2030, the number of diabetics worldwide will double that of 2000. It is noteworthy that the prevalence of diabetes increases particularly rapidly in developing countries, especially those developing countries that vary from poor to rich. Diabetes is not only a rich disease, but also a real risk of developing diabetes in areas with dramatic changes in economic and living standards. Diabetes is in explosive epidemic in our country. Diabetes can occur at any age, is easy to cause histopathological damage such as systemic neuropathy, micro-vascular disease, macrovascular disease and the like along with the prolonging of the course of disease, and can cause chronic and progressive lesion of tissues and organs such as heart, brain, kidney, nerves, eyes and the like. Patients enter diabetes from Normal Glucose Tolerance (NGT) through Impaired Glucose Tolerance (IGT), often pass through a subclinical stage of a relatively long period (estimated to be 7-11 years), and then transition to the dominant clinical stage. Due to prolonged hyperglycemia without clinical symptoms, chronic complications of diabetes occur to varying degrees in approximately half of the patients to be clinically diagnosed. It is generally considered that although IGT patients do not develop chronic complications of diabetes, they have a phenomenon of increased incidence of macroangiopathy and hypertension, and once they enter the diabetic stage, the incidence of macroangiopathy, microvascular disease and neuropathy rapidly develops with the delay of disease course and the failure of blood sugar and blood fat control to meet ideal standards. The harm of diabetes mainly comes from the complications of diabetes. Diabetic complications afflict patients and medical circles, and the probability that the diabetes cannot properly control the complicated nephropathy, retinopathy, peripheral neuropathy and heart disease is high, so that the life quality is seriously influenced; the direct medical treatment cost for diabetes mellitus in China exceeds 180 hundred million each year, and accounts for 4 percent of the total medical treatment cost; despite this large number of patients, the low diagnostic rate, the chronic course of the disease, the need for combination therapy, the lack of effective oral medications for the long-term treatment of diabetes and the poor patient compliance associated with injection therapy all mean that there are still many unmet needs in this field. In recent years, medical workers have carried out a great deal of research and development work on diabetes drugs, solve some problems in diabetes treatment, and potentially change the treatment mode of the diabetes.
In the aspect of oral antidiabetic drugs for treating type 2 diabetes, the chemical structures of sulfonylureas and biguanides which are treated insistently for more than 40 years are broken, and drugs with new structures, new types and new action mechanisms are continuously emerged. Vildagliptin (vildagliptin), its chemical name is: 1- [ [ (3-hydroxy-1-adamantyl) amino ] acetyl ] -2-cyano- (S) -tetrahydropyrrolidine. The molecular formula is C17H 15N 3O 2, the relative molecular mass is 303.4, and the structural formula is as follows:
vildagliptin is a selective, competitive and reversible dipeptidyl peptidase IV (DPP-IV) inhibitor, which inhibits the activity of dipeptidyl peptidase by combining with DPP-IV to form DPP-IV complex, and reduces glucagon concentration while increasing glucagon-like polypeptide-1 (GLP-1) concentration and promoting insulin production by islet beta cells, thereby reducing blood sugar. Vildagliptin has no significant effect on body weight, and its side effects are limited to hypoglycemia and edema, comparable to placebo's efficacy.
Metformin (Metformin), a hydrochloride thereof commonly used in clinical practice, is Metformin hydrochloride, the chemical name of which is 1, 1-dimethylbiguanide hydrochloride, the relative molecular mass is 165.63, the molecular formula is C4H i 1N 5 · HCl, and the structural formula is as follows:
metformin is a biguanide hypoglycemic drug, is the only oral antihyperglycemic drug widely used in developed countries in the world at present, can improve the tolerance of type II diabetes patients to sugar, and reduce the basal and postprandial plasma glucose concentration. The action mechanisms of metformin and sulfonylureas drugs are different, and hypoglycemia reaction and hyperinsulinemia are not generated in normal people and type II diabetes patients. The mechanism of metformin for reducing blood sugar comprises the following points: (1) promoting the utilization of glucose by peripheral tissue cells; (2) inhibiting hepatic gluconeogenesis, thereby reducing hepatic glucose output; (3) the product has no function of promoting fat synthesis and has no obvious effect of reducing blood sugar for normal people, so the product does not generally cause hypoglycemia. Metformin can be used for non-insulin dependent diabetes patients with unsatisfactory simple diet control, especially for obese patients, and has the effects of reducing blood sugar and reducing weight. However, biguanide hypoglycemic agents are not suitable for patients with light weight, and the most important side effect is lactic acidosis.
Jiangsu mosaic patent 201410110433.2 discloses a compound composition of vildagliptin and metformin and a preparation method thereof. The preparation method comprises the steps of adopting an organic solvent to carry out wet granulation on the metformin and the adhesive, mixing the metformin and the adhesive with the vildagliptin and other auxiliary materials, and then tabletting, or dissolving the vildagliptin in the organic solvent, carrying out wet granulation on the metformin and the adhesive by using the vildagliptin, and finally adding the other auxiliary materials for tabletting.
However, the drug prepared by combining the two components still has many side effects, so that the solid pharmaceutical composition containing the metformin and the vildagliptin is needed to be developed, and the complications of the diabetes patients can be inhibited while the sugar is reduced and controlled.
Disclosure of Invention
The invention aims to solve the technical problem of providing a solid pharmaceutical composition containing high content of metformin and vildagliptin, aiming at the existing defects, and the solid pharmaceutical composition can reduce and control sugar and inhibit the complications of diabetes patients.
In order to solve the technical problems, the invention adopts the technical scheme that the solid pharmaceutical composition containing metformin and vildagliptin comprises metformin, vildagliptin, rosiglitazone and B vitamins, wherein the metformin comprises the following components in parts by weight: 1-3 parts; 15-60 parts of vildagliptin; 1-3 parts of rosiglitazone; the mass portion of the B vitamins is 0.8-2.
By adopting the technical scheme, the compatibility mechanism of the solid pharmaceutical composition containing the metformin and the vildagliptin is as follows: the sulfonylurea hypoglycemic agents widely used clinically include Glibenclamide (Glibenclamide), Glibornuride (Glibornuride), glicyclamide (glycslamide), glihexamide (Glyhexamide), glisasmide (Glisamuride), Glibenclamide (glistenide), glisomide (Glisolamide), glicinamide (glyctamide), Gliclazide (Gliclazide), Glipizide (Glipizide), Gliquidone (Gliquidone), and Glimepiride (glimepiridide). Thiazolidinedione hypoglycemic agents, also known as insulin sensitizers, include rosiglitazone (rosiglitazone), pioglitazone (pioglitazone), troglitazone (troglitazone), englitazone (englitazone), ciglitazone (ciglitazone), and the like. The medicine is a ligand of a cell nucleus peroxisome proliferator-activated receptor (PPAR-gamma), can increase the glucose clearing capacity of peripheral tissues, reduce the hepatic glucose output and increase the hepatic glucose uptake during the sugar load, thereby effectively reducing the blood sugar and improving the insulin sensitivity; the solid pharmaceutical composition containing the metformin and the vildagliptin achieves the purposes of mechanism complementation, mutual synergy, curative effect improvement and reasonable medication through scientific combination of three different hypoglycemic drugs; the B vitamins including vitamin B2 (riboflavin), vitamin B6 (pyridoxine), vitamin B12 (cyanocobalamin) and biotin are all trace nutrients indispensable to human health. For the study of B vitamins, folic acid, vitamin B12 and vitamin B6 are currently of great interest. B vitamins have important roles in metabolism, erythropoiesis, maintenance of nervous system and immune system functions, and deficiencies in B vitamins can lead to many adverse consequences, including muscle weakness, paralysis, confusion, nervous system disorders, digestive disorders, chapped and scaly skin, severe anemia, and cardiac damage; the vitamin B added in the technical scheme of the invention has the functions of reducing the harm of the metformin to the diabetic, protecting the nervous system and avoiding the side effect of vomiting after the diabetic takes the medicine.
The solid pharmaceutical composition containing the metformin and the vildagliptin is used for patients with poor blood sugar level control and insulin resistance generation in clinic, especially patients with poor postprandial blood sugar control; or for the treatment of impaired glucose tolerance, obese diabetic patients; through a large number of animal tests, good effect is obtained.
The preferable technical scheme of the invention is that the carrier also comprises 5-25 parts of a composition of polyethylene glycol, povidone and ethyl cellulose, wherein the mass ratio of the polyethylene glycol to the povidone to the ethyl cellulose is as follows: 2-3: 3-4: 4 to 5.
As a preferred technical scheme of the invention, the polyethylene glycol is a polyethylene glycol 2000 and polyethylene glycol 4000 composition; the povidone is a composition of povidone K30 and povidone K90; the ethyl cellulose is a composition of ethyl cellulose 7cp and ethyl cellulose 45 cp; wherein the mass ratio of the polyethylene glycol 2000 to the polyethylene glycol 4000 is 1: 1; the mass ratio of the povidone K30 to the povidone K90 is 1: 2; the mass ratio of the ethyl cellulose 7cp to the ethyl cellulose 45cp is 1.5: 2.
in a preferred embodiment of the present invention, the B vitamins are one or a combination of two of vitamin B2, vitamin B6, vitamin B12 and biotin.
As a preferable technical scheme, the solid pharmaceutical composition containing the metformin and the vildagliptin is a single-component tablet or a capsule.
In a preferred embodiment of the present invention, the amount of metformin/vildagliptin/rosiglitazone contained in each tablet is 50mg/1000mg/50mg in the case of tablets.
In the preferred embodiment of the present invention, in the case of capsules, each capsule contains 50mg/1000mg/50mg or 50mg/850mg/50mg of metformin/vildagliptin/rosiglitazone.
As a preferred technical scheme of the invention, the tablets comprise ordinary tablets, sustained-release tablets and enteric-coated tablets.
Detailed Description
Example 1: the solid pharmaceutical composition containing the metformin and the vildagliptin comprises the metformin, the vildagliptin, the rosiglitazone and B vitamins, wherein the metformin comprises the following components in parts by weight: 1 part; 20 parts of vildagliptin; 1 part of rosiglitazone; the mass portion of the B vitamins B6 is 1 portion; 20 parts of a carrier; wherein the polyethylene glycol is 4 parts, and the povidone is 6 parts; 10 parts of ethyl cellulose; the polyethylene glycol is a composition of polyethylene glycol 2000 and polyethylene glycol 4000; the povidone is a composition of povidone K30 and povidone K90; the ethyl cellulose is a composition of ethyl cellulose 7cp and ethyl cellulose 45 cp; wherein the mass ratio of the polyethylene glycol 2000 to the polyethylene glycol 4000 is 1: 1; the mass ratio of the povidone K30 to the povidone K90 is 1: 2; the mass ratio of the ethyl cellulose 7cp to the ethyl cellulose 45cp is 1.5: 2.
the preparation process comprises the following steps: weighing the raw materials according to the proportion (wherein the raw materials are purchased and existing), sieving metformin, vildagliptin and rosiglitazone by 100 meshes respectively, sieving vitamin B6 by 90 meshes, sieving polyethylene glycol, povidone and ethyl cellulose by 80 meshes, putting all the sieved raw materials into a fluidized bed, uniformly mixing, carrying out hot melt granulation, controlling the water content to be 3-5%, putting the prepared granules to room temperature, detecting the content, putting the granules into a tablet press to be pressed into tablets after the granules are qualified, packaging, and storing in a dark place. The fluidized bed hot melting granulation process does not need drying, is a preparation process integrating granulation and mixing, improves the compressibility of the metformin and the vildagliptin, avoids the contact of the vildagliptin and moist heat, and has the advantages of simplicity and easiness in operation, reduction in production cost, improvement of product quality and the like. Compared with the hot-melt extrusion process, the method has the advantages of cheap and easily-obtained equipment and simple and convenient operation; compared with wet granulation, the method saves the operation procedures of preparing adhesive, drying and the like, saves the production cost of equipment, materials, working hours and the like, and reduces the labor intensity.
Example 2: the solid pharmaceutical composition containing the metformin and the vildagliptin comprises the metformin, the vildagliptin, the rosiglitazone and B vitamins, wherein the metformin comprises the following components in parts by weight: 1.5 parts; the mass part of vildagliptin is 25.5 parts; 1 part of rosiglitazone; 1.5 parts of B vitamins B6; 25 parts of a carrier; wherein the polyethylene glycol is 4 parts, and the povidone is 6 parts; 10 parts of ethyl cellulose; the polyethylene glycol is a composition of polyethylene glycol 2000 and polyethylene glycol 4000; the povidone is a composition of povidone K30 and povidone K90; the ethyl cellulose is a composition of ethyl cellulose 7cp and ethyl cellulose 45 cp; wherein the mass ratio of the polyethylene glycol 2000 to the polyethylene glycol 4000 is 1: 1; the mass ratio of the povidone K30 to the povidone K90 is 1: 2; the mass ratio of the ethyl cellulose 7cp to the ethyl cellulose 45cp is 1.5: 2.
the preparation method is the same as example 1.
Example 3: the solid pharmaceutical composition containing the metformin and the vildagliptin comprises the metformin, the vildagliptin, the rosiglitazone and B vitamins, wherein the metformin comprises the following components in parts by weight: 2 parts of (1); the mass part of vildagliptin is 40 parts; 1 part of rosiglitazone; the mass portion of the B vitamins B6 is 2; 25 parts of a carrier; wherein the polyethylene glycol is 4 parts, and the povidone is 6 parts; 10 parts of ethyl cellulose; the polyethylene glycol is a composition of polyethylene glycol 2000 and polyethylene glycol 4000; the povidone is a composition of povidone K30 and povidone K90; the ethyl cellulose is a composition of ethyl cellulose 7cp and ethyl cellulose 45 cp; wherein the mass ratio of the polyethylene glycol 2000 to the polyethylene glycol 4000 is 1: 1; the mass ratio of the povidone K30 to the povidone K90 is 1: 2; the mass ratio of the ethyl cellulose 7cp to the ethyl cellulose 45cp is 1.5: 2.
the preparation method is the same as example 1.
Example 4: the solid pharmaceutical composition containing the metformin and the vildagliptin comprises the metformin, the vildagliptin, the rosiglitazone and B vitamins, wherein the metformin comprises the following components in parts by weight: 1.5 parts; the mass portion of the vildagliptin is 30 portions; 1 part of rosiglitazone; 1.5 parts of B vitamins B2; 25 parts of a carrier; wherein the polyethylene glycol is 4 parts, and the povidone is 6 parts; 10 parts of ethyl cellulose; the polyethylene glycol is a composition of polyethylene glycol 2000 and polyethylene glycol 4000; the povidone is a composition of povidone K30 and povidone K90; the ethyl cellulose is a composition of ethyl cellulose 7cp and ethyl cellulose 45 cp; wherein the mass ratio of the polyethylene glycol 2000 to the polyethylene glycol 4000 is 1: 1; the mass ratio of the povidone K30 to the povidone K90 is 1: 2; the mass ratio of the ethyl cellulose 7cp to the ethyl cellulose 45cp is 1.5: 2.
the preparation method is the same as example 1.
Example 5: the solid pharmaceutical composition containing the metformin and the vildagliptin comprises the metformin, the vildagliptin, the rosiglitazone and B vitamins, wherein the metformin comprises the following components in parts by weight: 1 part; the mass part of vildagliptin is 17 parts; 1 part of rosiglitazone; the mass portion of the B vitamins B12 is 1 portion; 25 parts of a carrier; wherein the polyethylene glycol is 4 parts, and the povidone is 6 parts; 10 parts of ethyl cellulose; the polyethylene glycol is a composition of polyethylene glycol 2000 and polyethylene glycol 4000; the povidone is a composition of povidone K30 and povidone K90; the ethyl cellulose is a composition of ethyl cellulose 7cp and ethyl cellulose 45 cp; wherein the mass ratio of the polyethylene glycol 2000 to the polyethylene glycol 4000 is 1: 1; the mass ratio of the povidone K30 to the povidone K90 is 1: 2; the mass ratio of the ethyl cellulose 7cp to the ethyl cellulose 45cp is 1.5: 2.
the preparation method is the same as example 1.
Example 6: animal experiments; white mice weighing about 200g (weight deviation is plus or minus 10g) are fed with high-fat high-sugar feed (5% of protein, 60% of carbohydrate, 30% of cane sugar and 32% of fat, and 30% of refined lard) in the male and female halves; after 4 weeks, the white mice were fasted for 18 h; the injection is administered by intraperitoneal injection of 30mg/kg of 0.6% Streptozotocin (STZ), which is dissolved in 0.1mol/L citric acid-sodium citrate buffer solution at pH4.0, and the dosage is consumed within 10min each time. The rats in the blank group were normally fed with an equal volume of citric acid-sodium citrate buffer by intraperitoneal injection. After 5 days, the whole blood sugar is measured by cutting off the tail and taking blood, and the model is successfully made when the blood sugar level is more than 10.0 mmol/L.
Randomly dividing the successfully molded rats into a model group and a positive control group according to the blood sugar level, wherein the positive control group is respectively a metformin group, a vildagliptin group, a rosiglitazone group, metformin, vildagliptin and a rosiglitazone compound group, the metformin, the vildagliptin, the rosiglitazone and a B vitamin compound group, and each group is 8; the raw materials of the above examples 1-5 were administered to each group by intragastric administration, and the same volume of physiological saline was administered to the blank group and the control group; once daily for 10 weeks; blood sampling was performed to determine fasting plasma glucose, blood glucose 2h after feeding, and glycated hemoglobin (HbAlc).
And (3) measurement of blood sugar: after successfully molded rats are randomly grouped, the rats are gavaged according to the dose and fed for 10 weeks continuously and are normally raised. All rats had their tail vein blood taken weekly for Fasting Blood Glucose (FBG) and 2h post-feeding blood glucose (PBG) within 4 weeks before and after treatment, respectively. Placing the blood sample into protein precipitant, standing at room temperature for 7min, centrifuging for 5min (3000r/min), collecting supernatant, and measuring total blood sugar by glucose oxidase method.
The experimental results are as follows: compared with a model group, the metformin group, the vildagliptin group, the rosiglitazone group, the metformin, the vildagliptin and rosiglitazone compound group, the metformin, the vildagliptin, the rosiglitazone and B vitamin compound group have extremely significant differences no matter fasting blood sugar or 2h blood sugar after meal, and the results show that the metformin, the vildagliptin, the rosiglitazone and B vitamin compound group can effectively reduce the blood sugar after meal and reduce the influence of the metformin on diabetes.
Finally, it is also noted that the above-mentioned lists merely illustrate a few specific embodiments of the invention. It is obvious that the invention is not limited to the above embodiments, but that many variations are possible. All modifications which can be derived or suggested by a person skilled in the art from the disclosure of the present invention are to be considered within the scope of the invention.
Claims (8)
1. The solid pharmaceutical composition containing metformin and vildagliptin is characterized by comprising metformin, vildagliptin, rosiglitazone and B vitamins, wherein the metformin is prepared from the following components in parts by weight: 1-3 parts; 15-60 parts of vildagliptin; 1-3 parts of rosiglitazone; the mass portion of the B vitamins is 0.8-2.
2. The solid pharmaceutical composition containing metformin and vildagliptin according to claim 1, further comprising 5-25 parts of a carrier, wherein the carrier is a composition of polyethylene glycol, povidone and ethylcellulose, and the mass ratio of the polyethylene glycol, povidone and ethylcellulose is: 2-3: 3-4: 4 to 5.
3. The solid pharmaceutical composition containing metformin and vildagliptin according to claim 2, wherein the polyethylene glycol is a polyethylene glycol 2000 and polyethylene glycol 4000 composition; the povidone is a composition of povidone K30 and povidone K90; the ethyl cellulose is a composition of ethyl cellulose 7cp and ethyl cellulose 45 cp; wherein the mass ratio of the polyethylene glycol 2000 to the polyethylene glycol 4000 is 1: 1; the mass ratio of the povidone K30 to the povidone K90 is 1: 2; the mass ratio of the ethyl cellulose 7cp to the ethyl cellulose 45cp is 1.5: 2.
4. the solid pharmaceutical composition containing metformin and vildagliptin according to claim 2, wherein the B vitamin is one or two of vitamin B2, vitamin B6, vitamin B12 or biotin.
5. The solid pharmaceutical composition containing metformin and vildagliptin according to claim 2, wherein the solid pharmaceutical composition containing metformin and vildagliptin is a single tablet or capsule.
6. The solid pharmaceutical composition containing metformin and vildagliptin according to claim 5, wherein in the case of tablets, metformin/vildagliptin/rosiglitazone is contained in an amount of 50mg/1000mg/50mg per tablet.
7. The solid pharmaceutical composition containing metformin and vildagliptin according to claim 5, wherein in the case of capsules, each capsule contains 50mg/1000mg/50mg or 50mg/850mg/50mg of metformin/vildagliptin/rosiglitazone.
8. The solid pharmaceutical composition containing metformin and vildagliptin according to claim 6, wherein the tablet comprises a plain tablet, a sustained release tablet and an enteric tablet.
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| CN101304993A (en) * | 2005-11-07 | 2008-11-12 | Irm责任有限公司 | Compounds and compositions as ppar modulators |
| CN101897696A (en) * | 2009-05-27 | 2010-12-01 | 北京奥萨医药研究中心有限公司 | Sugar-lowering drug composition and application thereof |
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Application publication date: 20210423 |