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A kind of combination method of pioglitazone hydrochloride sustained-release pellet preparation

A technology of pioglitazone hydrochloride and sustained-release pellets, which is applied in the direction of drug combination, bulk delivery, metabolic diseases, etc., can solve the problems of unsatisfactory drug compliance of patients, imperfect preparation process and equipment of double-layer osmotic pump technology, and achieve Small differences in individual bioavailability, reduced number of doses, and good absorption

Inactive Publication Date: 2016-01-27
中国人民解放军第150中心医院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

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Effect test

Embodiment 1

[0019] The pioglitazone hydrochloride sustained-release pellets are composed of three parts: a blank core, a drug-containing layer and a sustained-release layer; the drug-containing layer is composed of pioglitazone hydrochloride, a binder, and a solubilizer; the sustained-release layer is composed of a sustained-release material and a pore-forming agent; The composition weight percent is: blank pellet core 70.2-83.3%, pioglitazone hydrochloride 13.0-28.6%, binder 1.2-2.0%, solubilizer 0.05-1.2%, slow-release material 3.5-13.0%, porogen 1.2-5.0% %, the sum of the above components by weight is 100%;

[0020] The binder is hypromellose, povidone, carboxymethylcellulose, methylcellulose, ethylcellulose, polyethylene glycol, sucrose solution, sodium alginate, gelatin, one of which or a combination of several; the solubilizer is polysorbate, sorbitan fatty acid ester, sodium lauryl sulfate, wherein one or a combination of several; the slow-release material is acrylic resin Aqueous...

Embodiment 2

[0022] The composition weight percent is: blank ball core 75.2-80.3%, pioglitazone hydrochloride 20.0-23.3%, hypromellose 1.2-2.0%, sorbitan fatty acid ester 0.07-1.2%, cellulose acetate 6.5-10.0% , povidone 2.2-4.0%, the sum of the above components by weight is 100%.

Embodiment 3

[0024]The composition weight percent is: blank ball core 71.2-79.5%, pioglitazone hydrochloride 15.0-19.6%, carboxymethyl cellulose 1.2-2.0%, sodium lauryl sulfate 0.05-1.0%, ethyl cellulose aqueous dispersion product Su Lisi 3.5-11.0%, sodium chloride 1.2-3.3%, the sum of the above components by weight is 100%.

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Abstract

The invention discloses a method for compounding a pioglitazone hydrochloride controlled-release pellet preparation. A pioglitazone hydrochloride controlled-release pellet is composed of three parts, namely a blank pellet core, a drug-containing layer and a controlled-release layer, wherein the drug-containing layer is composed of pioglitazone hydrochloride, a binder and a solubilizer; the controlled-release layer is composed of a controlled-release material and a pore-foaming agent. The compound metformin hydrochloride-pioglitazone hydrochloride controlled-release pellet preparation, which is formed by mixing the pioglitazone hydrochloride controlled-release pellet with a metformin hydrochloride controlled-release pellet, 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 compounding method of 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 1 is insulin-dependent diabetes and type 2 is non-insulin-de...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4439A61K9/16A61P3/10A61K31/155
Inventor 王颖莹崔新刚梁延春高春芳
Owner 中国人民解放军第150中心医院
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