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Preparation method of compound amlodipine-lisinopril tablets

The technology of amlodipine besylate and tablet is applied in the directions of non-active ingredients medical preparations, active ingredients-containing medical preparations, pharmaceutical formulas, etc., and can solve the problems affecting the stability and content uniformity of lisinopril Poor, high dust energy consumption and other problems

Active Publication Date: 2012-04-25
南京海鲸药业股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The present invention adopts tert-butanol solution as binder for wet granulation and tabletting, which solves the problems of poor content uniformity and high energy consumption of dust in the direct compression of amlodipine and lisinopril compound tablets. Effect of French granulation on the stability of lisinopril

Method used

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  • Preparation method of compound amlodipine-lisinopril tablets
  • Preparation method of compound amlodipine-lisinopril tablets
  • Preparation method of compound amlodipine-lisinopril tablets

Examples

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Effect test

Embodiment 1

[0038]

[0039] Preparation process: Dissolve tert-butanol in 50% ethanol to prepare a 50% ethanol solution of 6% tert-butanol; then weigh povidone K30 and dissolve it in the above-mentioned tert-butanol ethanol solution as a wetting agent . Mix lisinopril, amlodipine besylate, microcrystalline cellulose, and lactose with a V-shaped mixer, and add wetting agent directly into the mixed powder to obtain a soft material, which is prepared by a rocking method. The pellets were pelletized and then dried in an oven. After drying, sieve and granulate, add magnesium stearate, blend and compress into tablets.

Embodiment 2

[0041]

[0042] Preparation process: Dissolve the prescribed amount of tert-butanol in 90% ethanol to prepare a solution with a concentration of 6%; as a binder. Mix lisinopril, amlodipine besylate, microcrystalline cellulose, and sodium carboxymethyl starch, and add the binder directly into the mixed powder to obtain a soft material, which is granulated by a swing granulator, Then dry in the oven. After drying, sieve and granulate, add micropowder silica gel, mix and press into tablets.

Embodiment 3

[0044]

[0045]Preparation process: dissolving tert-butanol in absolute ethanol to prepare a solution with a concentration of 3%, and then dissolving hydroxypropyl cellulose in it. Mix Lisinopril, Amlodipine Besylate, Microcrystalline Cellulose, and Carboxymethyl Starch Sodium, add the adhesive to the mixed powder of pharmaceutical excipients to obtain a soft material, and granulate with a rocking granulator , and then dried in an oven. After drying, sieve and granulate, add magnesium stearate, blend and compress into tablets.

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Abstract

The invention discloses a prescription and a preparation technology of compound tablets containing amlodipine besylate and lisinopril. According to the invention, amlodipine besylate and lisinopril are adopted as active components, a tert-butyl alcohol solution is adopted as an adhesive, and the tablets are prepared through wet granulating and tabletting. The content uniformity of the compound tablets is relatively good. Lisinopril is stable in the preparation process, and the content of the related substances of lisinopril is low.

Description

technical field [0001] The invention relates to a method for preparing a compound tablet of lisinopril and amlodipine besylate, which is prepared by wet granulation with tert-butanol solution as a binder. The content uniformity of the two drugs is good, and the lysine Nopril remains stable during the preparation process, and its related substances are low. Background technique [0002] Hypertension is a disease with high morbidity, many complications and high disability rate. The drugs for treating hypertension include calcium antagonists, angiotensin converting enzyme inhibitors, diuretic and antihypertensive agents and so on. Most patients need to take two or more high blood pressure drugs in combination to achieve better blood pressure reduction and reduce the incidence of complications. [0003] Amlodipine besylate is a calcium antagonist antihypertensive drug with definite antihypertensive effect and relatively few adverse reactions. It is one of the antihypertensive d...

Claims

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Application Information

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IPC IPC(8): A61K38/05A61K47/10A61K9/20A61P9/12A61K31/4422
Inventor 时文祥叶靖谢晓燕相文杰张自强
Owner 南京海鲸药业股份有限公司
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