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

A technology of pioglitazone hydrochloride and sustained-release pellets, which is applied in the direction of pharmaceutical formulations, drug combinations, and medical preparations of non-active ingredients, etc., and can solve the problem of unsatisfactory drug compliance of patients and the imperfect preparation process and equipment of double-layer osmotic pump technology and other problems, to achieve the effect of reducing the number of medications, improving compliance, and good mobility

Inactive Publication Date: 2013-12-25
中国人民解放军第150中心医院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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

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

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Embodiment 1

[0028]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 percentage is: blank ball core 70.2-83.3%, pioglitazone hydrochloride 13.0-28.6%, binder 1.4-2.0%, solubilizer 0.1-1.2%, slow-release material 3.8-13.0%, porogen 1.2-5.0% %, the sum of the above components by weight is 100%.

Embodiment 2

[0030] Adhesives purchased from the market are hypromellose, povidone, carboxymethylcellulose, methylcellulose, ethylcellulose, polyethylene glycol, sucrose solution, sodium alginate, gelatin "one of one or a combination of several”; the solubilizer purchased from the market is polysorbate, sorbitan fatty acid ester, sodium lauryl sulfate “one or a combination of several”; the slow-release agent purchased from the market The material is acrylic resin aqueous dispersion Eudragit, ethyl cellulose aqueous dispersion product Surelease, cellulose acetate and lipid material "one or a combination of several"; the porogen purchased from the market is hydroxypropyl Methylcellulose, polyvinyl alcohol, sodium chloride, povidone, mannitol, lactose, sodium lauryl sulfate "one or a combination of several".

Embodiment 3

[0032] Mix pioglitazone hydrochloride, solubilizer and binder evenly, prepare pioglitazone hydrochloride drug-containing pellet cores by applying medicine to blank pellet cores, preheat the pioglitazone hydrochloride drug-containing pellet cores, and spray the sustained-release layer coating solution on pioglitazone hydrochloride-containing pellet cores. On the pill core, it is prepared into pioglitazone hydrochloride sustained-release pellets.

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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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4439A61K47/38A61K47/20A61P3/10A61K31/155
Inventor 崔新刚王颖莹梁延春高春芳
Owner 中国人民解放军第150中心医院
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