Compound pioglitazone hydrochloride/metformin hydrochloride bilayer osmotic pump controlled release preparation and preparation method thereof

Abstract

The invention provides a compound preparation of pioglitazone hydrochloride and metformin hydrochloride bilayer osmotic pump controlled release tablets. The compound preparation structurally comprises the following parts from inside to outside in sequence: a tablet core comprising a drug layer and a digestive layer, an insulation coating layer, a controlled release coating film with drug release holes, a rapid pioglitazone hydrochloride release layer and an unnecessary attractive coating. The invention also provides a preparation method of the compound preparation of pioglitazone hydrochloride and metformin hydrochloride bilayer osmotic pump controlled release tablets. The preparation method comprises the following steps of: (1) preparing the drug layer; (2) preparing the digestive layer; (3) tabletting the tablet core; (4) coating insulation coating layer; (5) coating the controlled release coating; (6) punching the coated tablet: (7) coating the rapid pioglitazone hydrochloride release layer; and (8) coating the attractive coating.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a compound pioglitazone hydrochloride / metformin hydrochloride double-layer osmotic pump controlled-release preparation and a preparation method thereof. Background technique [0002] Diabetes mellitus is a metabolic disease of multiple etiologies characterized by chronic hyperglycemia accompanied by disturbances in carbohydrate, fat and protein metabolism due to defects in insulin secretion and / or action. Diabetes is one of the most common chronic diseases. With the improvement of people's living standards, the aging population and the increase in the incidence of obesity, the incidence of diabetes is increasing year by year. According to the prediction of international authoritative diabetes epidemiology experts, by 2010, there will be 240 million people with diabetes in the world, and the number will increase to 300 million in 2025. [0003] Diabetes can be divided into type 1 diabetes...

AI Technical Summary

Problems solved by technology

[0016] Chinese patents CN1308520A, CN1681496A, CN1852703 and CN101222912A are the patents of Takeda Company on the compound preparation of pioglitazone hydrochloride / metformin hydrochloride. It is mentioned that "the preparation does not substantially have any gel or swelling polymer", which is different from the double-layer osmotic pump controlled release tablet prepared by the present invention

However, simply using high-molecular-weight polyoxyethylene as the main auxiliary material of the booster layer also has some inherent disadvantages: (1) high-molecular-weight polyoxyethylene has poor thermal stability. Polymers are prone to degradation and molecular weight decline, which affects the release of controlled-release tablets to a certain extent, causing greater changes in release and drug release kinetics; (2) high-molecular-weight polyoxyethylene has poor thermoplasticity and is prone to It leads to the phenomenon of "curling" in the process of tablet compression, which leads to weak points in the coating process, which affects the safety of product use

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