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A kind of nifedipine sustained-release tablet and preparation method thereof

A technology of nifedipine and sustained-release tablets, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as difficult bioequivalence and unstudied release behavior, and achieve The effect of increasing the dissolution rate

Active Publication Date: 2020-11-03
南京百思福医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The nifedipine sustained-release tablets prepared by the above-mentioned patents did not study the release behavior under multi-media conditions, and a large number of hydrophilic gel materials were used, resulting in a release phenomenon different from that of Adalat-L. It was found that its in vitro release behavior was inconsistent with Adalat-L, making it difficult to be bioequivalent

Method used

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  • A kind of nifedipine sustained-release tablet and preparation method thereof
  • A kind of nifedipine sustained-release tablet and preparation method thereof
  • A kind of nifedipine sustained-release tablet and preparation method thereof

Examples

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Effect test

Embodiment 1

[0069] 20mg nifedipine sustained-release tablet prescription (300,000 / batch) and preparation method thereof:

[0070]

[0071] Preparation Process:

[0072] Pass the prescribed amount of microcrystalline cellulose, hypromellose, and hypromellose through an 80-mesh sieve, and control the particle size of ethyl cellulose to D 90 200 ~ 300um, standby; hypromellose, hypromellose, ethyl cellulose mixed uniformly as blocker composition; blocker composition, anhydrous calcium hydrogen phosphate and raw materials (D 90 5 ~ 10um) into the wet granulator, after stirring at speed I for 10 minutes, add microcrystalline cellulose and continue stirring for 5 minutes; add an appropriate amount of 95% ethanol to dissolve Tween 80, stir at speed I and chop at speed II during the liquid addition process 4min, out of the pan; after drying in an oven at 30°C for 1h, increase the temperature to 50°C and continue drying for 1h until the water content is lower than 3%, and granulate; add dry gr...

Embodiment 2

[0074] 20mg nifedipine sustained-release tablet prescription (300,000 / batch) and preparation method thereof:

[0075]

[0076] Preparation Process:

[0077] Pass the prescribed amount of microcrystalline cellulose, hypromellose, and hypromellose through an 80-mesh sieve, and control the particle size of ethyl cellulose to D 90 200 ~ 300um, standby; hypromellose, hypromellose, ethyl cellulose mixed uniformly as blocker composition; blocker composition, anhydrous calcium hydrogen phosphate and raw materials (D 90 5 ~ 10um) into the wet granulator, after stirring at speed I for 10 minutes, add microcrystalline cellulose and continue stirring for 5 minutes; add an appropriate amount of 95% ethanol to dissolve Tween 80, stir at speed I and chop at speed II during the liquid addition process 4min, out of the pan; after drying in an oven at 30°C for 1h, increase the temperature to 50°C and continue drying for 1h until the water content is lower than 3%, and granulate; add dry gr...

Embodiment 3

[0079] 20mg nifedipine sustained-release tablet prescription (300,000 / batch) and preparation method thereof:

[0080]

[0081] Preparation Process:

[0082] Pass the prescribed amount of microcrystalline cellulose, hypromellose, and hypromellose through an 80-mesh sieve, and control the particle size of ethyl cellulose to D 90200 ~ 300um, standby; hypromellose, hypromellose, ethyl cellulose mixed uniformly as blocker composition; blocker composition, anhydrous calcium hydrogen phosphate and raw materials (D 90 5 ~ 10um) into the wet granulator, after stirring at speed I for 10 minutes, add microcrystalline cellulose and continue stirring for 5 minutes; add an appropriate amount of 95% ethanol to dissolve Tween 80, stir at speed I and chop at speed II during the liquid addition process 4min, out of the pan; after drying in an oven at 30°C for 1h, increase the temperature to 50°C and continue drying for 1h until the water content is lower than 3%, and granulate; add dry gra...

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Abstract

The invention discloses a nifedipine sustained release tablet and a preparation method thereof. The grain diameter D90 of nifedipine is 5-10 mu m, and a tablet core is prepared from, in percentage byweight, 25% of nifedipine, 5%-10% of retardant composition, 0.5%-1.5% of tween 80 and the balance of other auxiliary materials. In order to guarantee the storage quality of the tablet core, the tabletis colored and coated, and the weight gain of a coat is 4%-5%. Initiative formula composition is adopted, a sustained release mode is innovated, and the nifedipine sustained release tablet capable ofcontinuously releasing a drug within 12 h is prepared, two times of human body pre-BE (bioequivalence) (12 cases, empty stomach / full stomach) research prove the BE of the product, and besides, a dissolution method related in vitro and in vivo is developed. The drug release principle and process monopoly of the nifedipine sustained release tablet are broken through, the adopted formula and preparation process are simpler and more controllable, facilitate industrial production in China and provide more clinic choices for patients and doctors, and the medication burden of the patients is reduced.

Description

technical field [0001] The invention relates to the technical field of sustained-release preparations for treating hypertension and angina pectoris, in particular to a composition of nifedipine sustained-release tablets and a preparation method thereof. Background technique [0002] Nifedipine (Nifedipine) was first developed and listed by Bayer Company of Germany. It is the first generation calcium ion antagonist, which is almost insoluble in water. However, because of its obvious antihypertensive effect and small side effects, it is still one of the first-choice drugs for the clinical treatment of hypertension and angina pectoris. The Bayer company made nifedipine into sustained-release tablets, which can effectively solve the shortcomings of short duration of drug effect and large side effects of ordinary nifedipine tablets, and occupy a dominant position in the domestic market. Due to its special preparation process, its imitation is difficult Very big. In 2016, there ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K9/22A61K47/38A61K31/4422A61P9/12A61P9/10
CPCA61K9/2054A61K9/2866A61K31/4422
Inventor 李学明陈卫王永禄王栋孙小虎
Owner 南京百思福医药科技有限公司
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