Combination method and preparation process of pioglitazone hydrochloride sustained-release pellet preparation

Abstract

The invention relates to a combination method and a preparation process of a pioglitazone hydrochloride sustained-release pellet preparation. The method comprises the following steps: mixing pioglitazone hydrochloride, a solubilizing agent and an adhesive uniformly; applying an medicine to a blank pellet core to prepare a pioglitazone hydrochloride medicine-containing pellet core; preheating the pioglitazone hydrochloride medicine-containing pellet core; and spraying sustained-release layer coating liquid onto the pioglitazone hydrochloride medicine-containing pellet core to prepare a pioglitazone hydrochloride sustained-release pellet. A compound metformin hydrochloride pioglitazone hydrochloride pellet preparation prepared by mixing the pioglitazone hydrochloride sustained-release pellet and a metformin hydrochloride sustained-release pellet achieves an ideal blood sugar reducing effect, can reduce toxic or side effects of the medicine, can reach a sustained and stable blood sugar reducing effect in a human body, is favorable for improving the compliance of patients, has high bioavailability and stable blood concentration, and can effectively improve the clinical curative effect, thereby providing a better dosage regimen and curative effect to diabetic 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 preparation process of 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 insuli...

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

Images