Glimepiride tablet composition preparation and preparation method thereof

Abstract

The invention provides a glimepiride tablet composition preparation and a preparation method thereof. The glimepiride tablet is prepared from glimepiride, lactose, microcrystalline cellulose, copovidone, crospovidone and magnesium stearate. According to the glimepiride composition preparation, the dissolving and releasing behaviors of glimepiride tables can be effectively ensured in vitro by sufficiently utilizing the hydrogen bond effect among the crospovidone, povidone and glimepiride, the defects of low yield, large energy consumption, high cost and the like caused by micronizing glimepiride in the prior art can be overcome. The preparation process is simple, has good reproducibility and good stability, is suitable for industrial production, and has relatively high economic and social magnificence.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a glimepiride tablet composition preparation and a preparation method thereof. Background technique [0002] Glimepiride is a sulfonylurea drug that can be used together with insulin. It lowers blood sugar by stimulating insulin secretion. The structural formula is as follows: [0003] [0004] Developed by the Sanofi-Aventis company of the United States, it was first launched in Sweden in September 1995. It was approved by the FDA to enter the US market in November of the same year. It is used to treat type Ⅱ diabetes that cannot be controlled by diet and exercise. In view of its stable and effective hypoglycemic effect, and less adverse reactions, clinical application is becoming more and more extensive. However, glimepiride is a BCS Ⅱ drug, that is, a low-solubility and high-osmosis drug, and ensuring its solubility is the key to ensuring that the drug reaches an effective ...

AI Technical Summary

Problems solved by technology

Although this preparation method improves the dissolution rate of glimepiride tablets, it uses a second-class solvent (chloroform), which increases potential safety risks; Chinese patent 201510056193.7 discloses a glimepiride tablet, which is a combination of glimepiride, Hydroxypropyl cellulose is dissolved in diethylene glycol monoethyl ether, added with fumed silica for adsorption, then mixed evenly with pharmaceutically acceptable excipients, and compressed by direct compression technology. Diethylene glycol monoethyl ether is a solvent, but the solvent has a high boiling point and is difficult to remove, and animal experiments have shown that the solvent has an anesthetic effect and kidney damage

[0008] The test found that glimepiride is easy to produce degraded impurities during wet granulation and high-temperature drying, and the tablet has moisture absorption during storage, resulting in a decrease in the in vitro dissolution rate;

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