Assembly method and preparation technology of compound metformin hydrochloride and pioglitazone hydrochloride slow-release micro-pellet preparation

A technology of compound metformin hydrochloride pioglitazone hydrochloride and metformin hydrochloride, which is applied in the direction of pharmaceutical formulas, drug combinations, medical preparations containing active ingredients, etc., can solve the problem of imperfect preparation process and equipment of double-layer osmotic pump technology, and poor drug compliance of patients Ideal and other issues, to achieve the effect of small differences in individual bioavailability, reduce the number of medications, and improve the curative effect

Inactive Publication Date: 2013-12-18
崔新刚
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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

Method used

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  • Assembly method and preparation technology of compound metformin hydrochloride and pioglitazone hydrochloride slow-release micro-pellet preparation
  • Assembly method and preparation technology of compound metformin hydrochloride and pioglitazone hydrochloride slow-release micro-pellet preparation

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Experimental program
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Effect test

Embodiment 1

[0032] Metformin hydrochloride sustained-release pellets are composed of drug-containing pellet core and sustained-release layer. The drug-containing pellet core is composed of metformin hydrochloride, filler and binder, and the sustained-release layer is composed of sustained-release materials and porogens; pioglitazone hydrochloride sustained-release The micropill is composed of three parts: a blank pellet core, a drug-containing layer and a sustained-release layer. The drug-containing layer is composed of pioglitazone hydrochloride, a binder, and a solubilizer, and the sustained-release layer is composed of a sustained-release material and a pore-forming agent; the composition weight percentage For: metformin hydrochloride 20.0-35.0%, used for the filler of metformin hydrochloride sustained-release pellets 15.0-37.5%, used for the binder of metformin hydrochloride sustained-release pellets 0.2-2.5%, used for metformin hydrochloride sustained-release pellets 2.3-8.4% of susta...

Embodiment 2

[0034] The fillers purchased from the market are microcrystalline cellulose, lactose, sucrose, and starch "one or a combination of several"; the binders purchased from the market are hypromellose, povidone, and carboxymethyl cellulose cellulose, methyl cellulose, ethyl cellulose, polyethylene glycol, sucrose solution, sodium alginate, gelatin "one or a combination of several"; Alcohol fatty acid esters, sodium lauryl sulfate "one or a combination of several"; the slow-release materials purchased from the market are acrylic resin water dispersion Eudragit, ethyl cellulose water dispersion product Su Lisi, Cellulose acetate and lipid materials "one or a combination of several"; porogens purchased from the market are hypromellose, polyvinyl alcohol, sodium chloride, povidone, mannitol, lactose, ten Sodium dialkyl sulfate "one or a combination of several".

Embodiment 3

[0036] Mix metformin hydrochloride, fillers and binders evenly to make a soft material, prepare metformin hydrochloride drug-containing pellet cores by extrusion spheronization or centrifugal granulation, preheat the metformin hydrochloride drug-containing pellet cores, and place the slow-release layer The coating solution is sprayed onto metformin hydrochloride drug-containing pellet cores to prepare metformin hydrochloride sustained-release pellets; pioglitazone hydrochloride, solubilizer and binder are mixed evenly, and pioglitazone hydrochloride drug-containing pellet cores are prepared by applying medicine to blank pellet cores. Preheat the pioglitazone hydrochloride drug-containing pellet core, spray the sustained-release layer coating solution on the pioglitazone hydrochloride drug-containing pellet core to prepare pioglitazone hydrochloride sustained-release pellets; do drug release for metformin hydrochloride sustained-release pellets and pioglitazone hydrochloride sust...

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Abstract

The invention discloses an assembly method and a preparation technology of a compound metformin hydrochloride and pioglitazone hydrochloride slow-release micro-pellet preparation. The preparation technology comprises the following steps: respectively preparing metformin hydrochloride slow-release micro-pellets and pioglitazone hydrochloride slow-release micro-pellets; mixing the metformin hydrochloride slow-release micro-pellets with the pioglitazone hydrochloride slow-release micro-pellets, and carrying out a drug release experiment; mixing qualified products according to the assembly weight percent, so as to prepare the compound metformin hydrochloride and pioglitazone hydrochloride slow-release micro-pellet preparation; loading into hard capsules or pressing into tablets. Therefore, the hypoglycemic effect is ideal; the toxic and side effects of the drug can be reduced; the sustained and steady hypoglycemic effect can be achieved inside a body; the compliance of a sufferer is improved; the preparation has high bioavailability and stable blood concentration; the clinical treatment effect can be effectively improved; better dosage regimen and curative effect are provided for diabetes 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 a preparation process of a compound metformin hydrochloride 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 div...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4439A61P3/10A61K31/155
Inventor 崔新刚王颖莹陈洪轩梁延春高春芳
Owner 崔新刚
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