A kind of nifedipine controlled-release tablet composition and preparation method thereof

Abstract

The invention relates to a nifedipine controlled-release tablet composition, comprising the following components in percentage by weight: 4.0-35.0% of nifedipine, 5.0-20.0% of polyoxyethylene, 5.0-30.0% of high-viscosity hydrophilic matrix material, 5.0-20.0% of a hydrophobic retarder, 20.0-60.0% of a filling agent, 0-10.0% of an adhesive solution, and 0.5-1.0% of a lubricant. A preparation method of the composition comprises the following steps: micronizing raw materials under a dark condition until the fineness ensures the powder to pass through a 200-mesh sieve, and screening an auxiliary material through a sieve with 80-100 meshes; adding the medicinal raw materials into the adhesive solution, and stirring uniformly for later use; and weighing a formula amount of polyoxyethylene, hydroxypropyl methylcellulose, the retarder namely ethyl cellulose and the filling agent, mixing uniformly, adding the prepared adhesive solution to prepare a soft material, and performing granulation, drying, straightening, addition of the lubricant, total blending, tabletting and package to obtain the composition. The nifedipine controlled-release tablet composition has the advantages that the preparation process is simple and easy, the production cost is low, and the production cycle is short.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a nifedipine controlled-release tablet composition and a preparation method thereof. Background technique [0002] Nifedipine is the first generation of calcium antagonists. It is an antihypertensive and angina pectoris drug. It is one of the best-selling drugs in the world. Controlled-release preparations can prolong the drug effect time, reduce the peak-valley phenomenon of blood drug concentration, and increase patient compliance, so it is necessary to make nifedipine into controlled-release preparations. Internationally renowned pharmaceutical companies Bayer and Pfizer have both developed nifedipine controlled-release tablets, with trade names of ADALAT® and PROCARDTA respectively. In recent years, Shanghai Modern Pharmaceutical Co., Ltd., Beijing Honglin Pharmaceutical Co., Ltd. and other domestic and foreign pharmaceutical companies are vying to imitate...

AI Technical Summary

Problems solved by technology

Nifedipine push-pull osmotic pump controlled-release tablet is composed of a double-layer tablet core composed of a drug-containing layer and a booster layer and a semi-permeable membrane controlled-release coating. Lasers are used to make small holes for drug release on the drug-containing coating film. The preparation process is complicated, the production equipment is expensive, the precision is high, the operation is inconvenient, the production cycle is long, the production cost is high, and materials that are harmful to the body and the environment such as pigments and acetone are used in the production process

[0003] Polyoxyethylene (PEO) is a hydrophilic polymer material. For the poorly soluble drug nifedipine, the matrix is ​​mainly eroded, and it has attracted more and more attention from the pharmaceutical community in oral gel matrix tablets. There are some inherent disadvantages: the water absorption rate and hydration rate of polyoxyethylene are slow, so the time lag of drug release is long, so that the drug cannot take effect quickly after taking it; polyoxyethylene does not have ideal thermal stability, and the dosage The large granulation process is easy to absorb moisture, sticky and difficult to granulate, and the drying temperature requirement is low, and the drying time is long

This causes certain blood drug fluctuations after the drug enters the body

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