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Preparation method of simvastatin tablet and simvastatin tablet obtained therefrom

A technology of simvastatin and tablet, which is applied in the field of simvastatin tablet and preparation of simvastatin tablet, can solve the problems of difficult control of the production process, excessive addition of excipients, high production cost, etc., and achieve the solution of dissolution rate and Problems in stability, improvement of particle size and specific surface area, effects of enhancing bioavailability

Active Publication Date: 2021-06-29
TOPFOND PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The purpose of the present invention is to provide a preparation method of simvastatin tablets, which can solve the problem of excessive and harmful addition of excipients in the prior art, poor product stability, complicated process operation, difficult control of the production process, and difficulty in realizing large-scale continuous production. The problem of high production and production costs

Method used

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  • Preparation method of simvastatin tablet and simvastatin tablet obtained therefrom
  • Preparation method of simvastatin tablet and simvastatin tablet obtained therefrom
  • Preparation method of simvastatin tablet and simvastatin tablet obtained therefrom

Examples

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Embodiment 1

[0032] Embodiment 1: the preparation method of simvastatin tablet

[0033] Components used:

[0034] components Dosage (weight%) Function Simvastatin 9.1 active ingredient pregelatinized starch 31.8 fillers, binders Hypromellose 7.3 filler lactose 41.1 filler Carboxymethyl Starch Sodium 10 disintegrant Magnesium stearate 0.7 lubricant

[0035] The preparation method comprises the steps of:

[0036] (1) Simvastatin is carried out by a supersonic jet mill to pulverize simvastatin to obtain simvastatin superfine powder, and the specific surface area of ​​the gained simvastatin superfine powder is 2000m 2 / kg, Dv(50)=4.0um, Dv(90)=10um;

[0037] (2) The simvastatin and pregelatinized starch after the micropowder are pulverized by a self-cooling dust-free pulverizer, and passed through a 100-mesh sieve together; wherein, the simvastatin superfine powder and the pregelatinized starch are first mixed according to an e...

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Abstract

The invention discloses a preparation method of a simvastatin tablet. The steps include: jet crushing the simvastatin to obtain a simvastatin superfine powder; pulverizing the simvastatin superfine powder and pregelatinized starch, and sieving; The pulverized mixture is boiled and granulated together with fillers, and spray-dried; the granules are mixed with pharmaceutical excipients, and pressed into tablet cores; the tablet cores are film-coated to obtain simvastatin tablets. The present invention adopts the micronization technology, so that the particle size and specific surface area of ​​simvastatin are greatly improved, which is conducive to improving the in vitro dissolution rate and the uniformity of the dissolution rate of simvastatin tablets; the pregelatinized starch used can be used simultaneously As a filler and binder, there is no need to add any antioxidants, acid-causing agents, etc., and no new impurities will be introduced. The resulting simvastatin tablet has low impurity content, and the simvastatin tablet has passed the test and has good stability. Moreover, the process of the invention is simple to operate, the production process is easy to control, and large-scale continuous production can be realized.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a preparation method of a simvastatin tablet and the obtained simvastatin tablet. Background technique [0002] The chemical name of simvastatin is: [1S-[1a,3a,7b(2S*,4S*)8ab]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl -8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthyl-2,2-dimethylbutyrate for Lowers elevated total cholesterol, LDL cholesterol and apolipoprotein B. Simvastatin is used as a hydroxymethylglutaryl coenzyme A (HMG-COA) reductase inhibitor, inhibits the synthesis of endogenous cholesterol, and is a blood lipid regulator. Literature data show, have the content of total cholesterol (TC) in reducing hyperlipidemia rabbit serum, liver, aorta, reduce very low-density lipoprotein cholesterol (VLDL-C), low-density lipoprotein cholesterol (LDL-C) level effect. [0003] At present, simvastatin tablets are one of the first-choice drugs for the treatment of hyperl...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K9/16A61K47/36A61K31/366A61P3/06
CPCA61K9/1652A61K9/2059A61K9/28A61K31/366A61P3/06
Inventor 吴严毛新付张宏周窦建华赵臻年蓓蕾陈琦武妍杰李青霞黄鸳鸯任真
Owner TOPFOND PHARMA CO LTD
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