Method for compounding drug-containing layer of pioglitazone hydrochloride controlled-release pellet preparation

Abstract

The invention provides a method for compounding a drug-containing layer of a pioglitazone hydrochloride controlled-release pellet preparation. The drug-containing layer comprises the following components according to weight percentage: 60.0%-98.0% of pioglitazone hydrochloride, 1.0%-15.0% of a binder and 0.1%-4.0% of a solubilizer, and the sum of the weight percentages of all the components is 100%. The compound metformin hydrochloride-pioglitazone hydrochloride controlled-release pellet preparation, which is formed by mixing the drug-containing layer with other medicinal materials, has an ideal effect of regulating blood sugar level, is capable of reducing the toxic and side effects of drugs and achieving a continuous and stable blood sugar level reduction effect in vivo, is advantageous for improving the compliance of a patient, has high bioavailability and stable blood concentration, and is capable of effectively improving the clinical curative effect, and therefore, good dosage regimens and curative effects are provided for domestic and overseas diabetics.

Description

technical field [0001] The invention relates to the technical field of diabetes pharmacy, in particular to a method for assembling a drug-containing layer of a pioglitazone hydrochloride sustained-release pellet preparation. [0002] Background technique [0003] 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 occur, namely "three excesses and one deficiency". Once diabetes (blood sugar) is not well controlled, it will cause complications and lead to kidney disease 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 1 is i...

AI Technical Summary

Problems solved by technology

[0006] 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