A kind of combination method and preparation process of compound metformin hydrochloride pioglitazone hydrochloride sustained-release pellet preparation

Abstract

The invention discloses an assembly method and a preparation technology of a compound metformin hydrochloride and pioglitazone hydrochloride slow-release micro-pellet preparation. The preparation technology comprises the following steps: respectively preparing metformin hydrochloride slow-release micro-pellets and pioglitazone hydrochloride slow-release micro-pellets; mixing the metformin hydrochloride slow-release micro-pellets with the pioglitazone hydrochloride slow-release micro-pellets, and carrying out a drug release experiment; mixing qualified products according to the assembly weight percent, so as to prepare the compound metformin hydrochloride and pioglitazone hydrochloride slow-release micro-pellet preparation; loading into hard capsules or pressing into tablets. Therefore, the hypoglycemic effect is ideal; the toxic and side effects of the drug can be reduced; the sustained and steady hypoglycemic effect can be achieved inside a body; the compliance of a sufferer is improved; the preparation has high bioavailability and stable blood concentration; the clinical treatment effect can be effectively improved; better dosage regimen and curative effect are provided for diabetes patients at home and abroad.

Description

technical field [0001] The invention relates to the technical field of diabetes pharmacy, in particular to a composition method and a preparation process of a compound metformin hydrochloride 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 can occur, namely "three excesses and one deficiency". Once diabetes (blood sugar) is not well controlled, it will cause complications and lead to Diabetes, eyes, feet and other parts of the failure of the disease, 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...

AI Technical Summary

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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