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Benazepril hydrochloride tablets and preparation method thereof

A benazepril hydrochloride tablet, a technology of benazepril hydrochloride, applied in the direction of pharmaceutical formula, medical preparation of non-active ingredients, pill delivery, etc., can solve the storage stability of benazepril hydrochloride tablet, etc. Achieve the effects of ensuring safe use and long-term storage, improving stability, and strong product stability

Inactive Publication Date: 2017-06-13
HUAYI PHARMA ANHUI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The invention provides a benazepril hydrochloride tablet and a preparation method thereof, which solves the storage stability problem of the existing benazepril hydrochloride tablet

Method used

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  • Benazepril hydrochloride tablets and preparation method thereof
  • Benazepril hydrochloride tablets and preparation method thereof
  • Benazepril hydrochloride tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] This embodiment provides a kind of benazepril hydrochloride tablet, is made of the following components by weight: benazepril hydrochloride 1.02kg, β-cyclodextrin 4kg, microcrystalline cellulose 12kg, cornstarch 1.3kg , magnesium stearate 0.2kg.

[0024] The preparation method of above-mentioned benazepril hydrochloride sheet, comprises the following steps:

[0025] (1) Weigh benazepril hydrochloride, β-cyclodextrin, microcrystalline cellulose, cornstarch and magnesium stearate according to the prescription quantity and pass through a 100-mesh sieve respectively for subsequent use;

[0026] (2) Add benazepril hydrochloride into a saturated cyclodextrin aqueous solution, stir and mix for 30 minutes, filter, dry under reduced pressure, and control the water content to 1.5%;

[0027] (3) The cyclodextrin inclusion compound of benazepril hydrochloride is pulverized and passed through an 80-mesh sieve;

[0028] (4) The cyclodextrin inclusion compound of benazepril hydrochl...

Embodiment 2

[0031] This embodiment provides a kind of benazepril hydrochloride tablet, is made of the following components by weight: benazepril hydrochloride 1.02 parts, β-cyclodextrin 3kg, microcrystalline cellulose 15kg, cornstarch 0.6kg , magnesium stearate 0.3kg.

[0032] The preparation method of above-mentioned benazepril hydrochloride sheet, comprises the following steps:

[0033] (1) Weigh benazepril hydrochloride, β-cyclodextrin, microcrystalline cellulose, cornstarch and magnesium stearate according to the prescription quantity and pass through a 100-mesh sieve respectively for subsequent use;

[0034] (2) Add benazepril hydrochloride into a saturated cyclodextrin aqueous solution, stir and mix for 30 minutes, filter, dry under reduced pressure, and control the water content to 1.7%;

[0035] (3) The cyclodextrin inclusion compound of benazepril hydrochloride is pulverized and passed through an 80-mesh sieve;

[0036] (4) The cyclodextrin inclusion compound of benazepril hydr...

Embodiment 3

[0039] This embodiment provides a Benazepril hydrochloride tablet, which is made of the following components by weight: 1.02 parts of Benazepril hydrochloride, 5 kg of β-cyclodextrin, 10 kg of microcrystalline cellulose, and 1.8 kg of corn starch , magnesium stearate 0.1kg.

[0040] The preparation method of above-mentioned benazepril hydrochloride sheet, comprises the following steps:

[0041] (1) Weigh benazepril hydrochloride, β-cyclodextrin, microcrystalline cellulose, cornstarch and magnesium stearate according to the prescription quantity and pass through a 100-mesh sieve respectively for subsequent use;

[0042] (2) Add benazepril hydrochloride into a saturated cyclodextrin aqueous solution, stir and mix for 30 minutes, filter, dry under reduced pressure, and control the water content to 1.4%;

[0043] (3) The cyclodextrin inclusion compound of benazepril hydrochloride is pulverized and passed through an 80-mesh sieve;

[0044] (4) The cyclodextrin inclusion compound ...

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Abstract

The invention discloses benazepril hydrochloride tablets and a preparation method thereof and belongs to the technical field of pharmaceutical preparations. The benazepril hydrochloride tablets are prepared from the following components in parts by weight: 1.02 parts of benazepril hydrochloride, 3 to 5 parts of beta-cyclodextrin, 10 to 15 parts of microcrystalline cellulose, 0.6 to 1.8 parts of corn starch and 0.1 to 0.3 part of magnesium stearate. According to the benazepril hydrochloride tablets, the benazepril hydrochloride is subjected to inclusion protection by adopting a cyclodextrin inclusion technology, so that a condition that the acidic benazepril hydrochloride is in direct contact with the alkaline magnesium stearate is avoided; the problem that the content of benazeprilat and other impurities is improved, caused by the fact that the benazepril hydrochloride and the magnesium stearate have slow chemical reaction, is effectively avoided.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a benazepril hydrochloride tablet and a preparation method thereof. Background technique [0002] Benazepril Hydrochloride (Benazepril Hydrochloride) is used as a drug for the treatment of high blood pressure. It is oral and long-acting, without sulfhydryl ACE inhibitors. It was first launched in Denmark in 1990, and has been marketed in dozens of countries such as the United States, Japan, Germany, and France. It has also been approved for the treatment of heart failure as a congestive heart failure patient with poor response to digitalis and diuretics. adjuvant therapy. [0003] At present, benazepril hydrochloride tablets have been sold on the market in my country, and its main component is benazepril hydrochloride, and its chemical name is: (1'S,3S)-3-{[1'-(ethoxycarbonyl)-3 '-Phenylpropyl]-amino}-2,3,4,5-tetrahydro-2-oxo-1H-1-benzoazepine-1-acetic acid m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/69A61K47/38A61K47/36A61K47/12A61K31/55A61P9/12A61P9/04
CPCA61K9/2059A61K9/2054A61K31/55
Inventor 高煜操铖
Owner HUAYI PHARMA ANHUI CO LTD
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