Metformin hydrochloridetablet composition and preparation method thereof

Abstract

The invention belongs to the technical field of medicine preparations, and particularly relates to a metformin hydrochloridetablet composition. The metformin hydrochloridetablet composition is characterized by being prepared from metformin hydrochloride, dextrin, hydroxypropylcellulose, a hydroxypropyl methylcellulosealcohol solution, magnesium stearate and talcum powder. The composition is highly consistent with an original trituration in dissolution curve, and has good stability.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a metformin hydrochloride tablet composition. Background technique [0002] Metformin Hydrochloride Tablets are biguanide hypoglycemic agents. Instead of stimulating the islet β cells to increase the concentration of insulin, it directly acts on the metabolic process of sugar, promotes the anaerobic glycolysis of sugar, and increases the uptake and utilization of glucose by peripheral tissues such as muscle and fat, thereby protecting the damaged islets β-cell function is protected from further damage, which is beneficial to the long-term control of diabetes. It inhibits intestinal absorption of glucose, inhibits hepatic gluconeogenesis, reduces glycogen output, can reduce blood sugar and glycosylated hemoglobin in diabetic patients, has no effect on promoting fat synthesis, and has no obvious hypoglycemic effect on normal people. Compared with sulfonylurea hypoglycemic agent...

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Problems solved by technology

[0003] The original research product of Metformin Hydrochloride Tablets was developed by Bristol-Myers Squibb. At present, there are many imitation manufacturers of Metformin Hydrochloride Tablets in China. Due to the large dosage of Metformin Hydrochloride Tablets per tablet, there are relatively few excipients that can be added. Therefore, how to ensure drug formation on the basis of , controlling the dissolution of the drug is the key factor. Some studies ("Comparison of the dissolution rate of domestic and imported metformin tablets", "Pharmaceutical Herald", Vol. 24, No. 6) show that the dissolution of imported metformin tablets is faster than that of domestic ones; "Quality Evaluation of Metformin Hydrochloride Tablets Available in the Market", "Chinese Journal of New Drugs", Vol. Whether the bioavailability and clinical effect of the original research product are consistent with the original research product is doubtful, and for domestic generic drugs, how to screen out products that can ensure that the bioavailability and dissolution of the original research product are consistent is also the key to its quality. The actual feedback is often that it is difficult for domestic varieties to achieve the curative effect of the original product, because it is relatively easy to achieve the dissolution limit value of the original product as a whole, but it is necessary to choose the combination of various types of drug excipients and the choice of dosage to achieve the same level as the original product. It is often very difficult to have basically the same dissolution rate, and it is also difficult to achieve by conventional comparative tests

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