Metformin hydrochloride enteric-coated tablets quality control method

Abstract

The invention discloses a quality control method of metformin hydrochloride enteric coated tablet, comprising the aspects of character, identification, examination and content measurement; wherein, release examination comprises the release quantity examination of acid in hydrochloric acid solution of 0.1 mol / l and the release quantity examination in phosphate buffer with the pH value of 6.8; the examination of relevant substances comprises the following steps: dicyandiamide is taken as reference, sulfonic group cation exchange bonded silica is taken as filler, ammonium dihydrogen phosphate solution of 1.7 percent with the pH value of 3 is mobile phase and the high performance liquid chromatography is used for examining the relevant substances. The invention controls the release quantity of the metformin hydrochloride enteric coated tablet in gastric juice strictly, reduces the adverse reaction of patients effectively, improves the release quantity of the metformin hydrochloride enteric coated tablet in the buffer solution (simulated intestinal juice) and ensures the dissolution of the enteric coated tablet in the intestinal juice effectively; the invention also adds the examination of dicyandiamide impurity under the examination item and enhances the safety of the medicine.

Description

technical field [0001] The invention relates to metformin hydrochloride enteric-coated tablets, in particular to a quality control method for metformin hydrochloride enteric-coated tablets. Background technique [0002] Metformin hydrochloride enteric-coated tablets are hypoglycemic drugs, which can reduce fasting and postprandial hyperglycemia in patients with type II diabetes, and HbAlc can be reduced by 1% to 2%. For patients with hyperinsulinemia, this drug not only has the effect of lowering blood sugar, but also has the effect of reducing body weight and hyperinsulinemia. It can be effective for some patients with poor curative effect of sulfonylureas, such as combined with sulfonylurea hypoglycemic agents, small intestinal glycosidase inhibitors or thiazolidinedione hypoglycemic agents, the effect is better than that of each alone. It can also be used in patients on insulin therapy to reduce the dosage of insulin. The preparation method of metformin hydrochloride is...

AI Technical Summary

Problems solved by technology

[0015] At present, the quality control of Metformin Hydrochloride Enteric-Coated Tablets adopts the standard of "Metformin Hydrochloride Tablets" in the 2005 edition of "Chinese Pharmacopoeia". There is no quantitative indicator for the amount of acid released in each tablet in the existing standard, only visual fuzzy indicators are used, and there is no set of related substance inspection items

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