Method for preparing metformin hydrochloride controlled-release pellet preparation

Abstract

The invention relates to a method for preparing a metformin hydrochloride controlled-release pellet preparation. A metformin hydrochloride controlled-release pellet is composed of a drug-contained pellet core and a controlled-release layer. The drug-contained pellet is composed of metformin hydrochloride, a filling agent and an adhesive. The controlled-release layer is composed of a controlled-release material and a pore-foaming agent. The metformin hydrochloride controlled-release pellet is mixed with pioglitazone hydrochloride controlled-release pellets to obtain the compounded metformin hydrochloride / pioglitazone hydrochloride controlled-release pellet preparation which achieves the ideal effect of regulating a blood sugar level, can reduce toxic and side effects of drugs, can achieve the effect of continuously and stably reducing the blood sugar level in the body, and facilitate improvement of the compliance of a patient. The compounded metformin hydrochloride controlled-release pellet preparation has high bioavailability and stable blood concentration. Clinical effects are effectively improved and a better dosage regimen and a better treatment effect 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 compounding method of metformin 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 insulin-dependent diabetes and ty...

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