A kind of preparation technology of pioglitazone hydrochloride sustained-release pellet preparation

Abstract

A compounding method and preparation process of pioglitazone hydrochloride sustained-release pellet preparation, mixing pioglitazone hydrochloride, solubilizer and adhesive uniformly, preparing pioglitazone hydrochloride drug-containing pill cores by applying medicine to blank pill cores, and pioglitazone hydrochloride drug-containing pills The core is preheated, and the sustained-release layer coating solution is sprayed on the pioglitazone hydrochloride-containing pill core to prepare pioglitazone hydrochloride sustained-release pellets; the compound metformin hydrochloride pioglitazone hydrochloride sustained-release pellets prepared by mixing Pill preparations have an ideal hypoglycemic effect, can reduce the toxic and side effects of drugs, can achieve a sustained and stable hypoglycemic effect in the body, and are conducive to improving patient compliance. They have high bioavailability and stable blood drug concentration, and can Effectively improve the clinical curative effect, and provide better drug regimen and curative effect for diabetic patients at home and abroad.

Description

technical field [0001] The invention relates to the technical field of diabetes pharmacy, in particular to a preparation process of pioglitazone hydrochloride sustained-release pellet preparation. Background technique [0002] Diabetes (diabetes) is a sugar, protein, Syndrome of a series of metabolic disorders including fat, water and electrolytes. Clinically, hyperglycemia is the main feature. In typical cases, symptoms such as polyuria, polydipsia, polyphagia, and weight loss may appear, namely three excesses and one deficiency. , feet and other parts of the exhaustion, and can not be cured; diabetes has become a common and frequently-occurring disease in my country and the world, and has become one of the diseases with the highest morbidity and mortality. Diabetes is divided into two types, type 1 is insulin-dependent diabetes and type 2 is non-insulin-dependent diabetes. Among them, type Ⅱ non-insulin-dependent diabetes patients are in the majority, accounting for more...

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Problems solved by technology

[0005] The patent document with the patent application number 20101051.527.0 discloses a compound preparation composed of pioglitazone hydrochloride and metformin hydrochloride double-layer osmotic pump controlled-release tablet, which consists of a drug-containing layer and a booster layer in sequence from the inside to the outside in terms of structural composition Tablet core, isolation coat layer, controlled-release coating film with release holes, pioglitazone hydrochloride immediate-release layer and optional aesthetics coat, the invention adopts double-layer osmotic pump controlled-release technology to improve the later release of metformin hydrochloride, but The preparation process and equipment of the existing double-layer osmotic pump technology are still not perfect, and the invention has the feasibility problem of industrial production, and the addition of the booster in the double-layer osmotic pump tablet limits the content of each active drug. The effective dose can only be achieved by taking multiple tablets, which is not ideal in improving patients' compliance with medication

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