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The preparation method of benazepril hydrochloride tablet

A benazepril hydrochloride tablet and a technology for benazepril hydrochloride are applied in the field of preparation of benazepril hydrochloride tablets, and can solve the problems of inferior anti-sticking effect as magnesium stearate, burden on enterprises, and easy occurrence of sticking and flushing. , to achieve the effect of good physical isolation and ensure product quality

Active Publication Date: 2018-01-16
SHANGHAI NEW ASIATIC PHARMA MINHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But this also brings two problems: one is that the anti-adhesive effect of hydrogenated castor oil is not as good as that of magnesium stearate, and the performance of most domestic tablet presses is not as good as that of imported tablet presses. The process is still prone to sticking and punching. If you continue to use hydrogenated castor oil, you will need to spend a lot of money to update the tablet press, which will bring a burden to the enterprise; There are bound to be insurmountable policy barriers when using hydrogenated castor oil

Method used

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  • The preparation method of benazepril hydrochloride tablet
  • The preparation method of benazepril hydrochloride tablet
  • The preparation method of benazepril hydrochloride tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038]

[0039] The preparation process is as follows:

[0040] Mix benazepril hydrochloride with the prescribed amount of microcrystalline cellulose, lactose, and crospovidone, add them to a trough mixer, stir for 20 minutes, and then add 1000 g of 2% hypromellose solution, Wet agitation for 7 minutes to obtain a soft material. The soft material is passed through a 20-mesh screen to obtain wet particles. The wet particles are dried at 60°C for 4 hours to obtain dry particles. The dry particles are passed through a 16-mesh screen for sizing. The granules obtained after sizing are coated with gastric-soluble Opadry coating powder, and the coated granules are mixed with the prescribed amount of magnesium stearate in a V-type mixer for 10 minutes to determine the intermediate content. After determining the tablet weight, press the tablet, and pack the plain tablet to get it.

Embodiment 2

[0042]

[0043] The preparation process is as follows:

[0044] Mix benazepril hydrochloride with the prescribed amount of microcrystalline cellulose, lactose, and 50g croscarmellose sodium. Use 2% hypromellose solution as a binder, and use a high-speed stirring granulator. For granulation, the wet granules are dried with a boiling dryer, and the dry granules are sized through a 16-mesh screen. The granules obtained after sizing are coated with gastric-soluble Opadry coating powder, and the coated granules are mixed with the prescribed amount of magnesium stearate and the remaining croscarmellose sodium in type V Mix in the machine for 10 minutes, determine the intermediate content, determine the tablet weight, press the tablet, and pack the plain tablet to get it.

Embodiment 3

[0046]

[0047] The preparation process is as follows:

[0048] The benazepril hydrochloride and the prescribed amount of microcrystalline cellulose, lactose, and 60 g sodium starch glycolate are mixed uniformly, and granulated by a dry granulator, and granulated by a 16-mesh sieve. The granules obtained after sizing are coated with gastric-soluble Opadry coating powder, and the coated granules are mixed with the prescribed amount of magnesium stearate and the remaining sodium starch glycolate in a V-type mixer. Minutes, determine the content of the intermediate, determine the weight of the tablet, press the tablet, and pack the plain tablet.

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Abstract

The present invention provides a kind of preparation method of benazepril hydrochloride tablet, by benazepril hydrochloride as the active ingredient of medicine, and pharmaceutical adjuvant filler, binding agent, disintegrant, lubricant magnesium stearate, The coating materials are combined into granules and made into tablets, which are characterized in that the lubricant magnesium stearate is added after the other components are granulated and coated, mixed and pressed into tablets. The invention can effectively physically separate the benazepril hydrochloride from the magnesium stearate, solves the problem that the related impurities of the variety rise too fast during storage, effectively controls the quality of the medicine, and has high use value.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of benazepril hydrochloride tablets for treating hypertension. Background technique [0002] Hypertension is the most common disease affecting human health today and an important risk factor for cardiovascular and cerebrovascular diseases. Direct complications include cerebrovascular accidents, heart failure, renal failure, and coronary heart disease. Lowering blood pressure can significantly reduce the incidence of coronary heart disease and stroke. The prevention and treatment of hypertension has always been a very important research topic, and it is also a global concern for the development of antihypertensive drugs with better curative effects and less side effects. New drugs aiming at new and more effective targets and mechanisms of action have been developed and successively approved for marketing. Each type of antihypertensive drug has its own ch...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/55A61P9/12
Inventor 曾垂宇王佩芳商鼎
Owner SHANGHAI NEW ASIATIC PHARMA MINHANG
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