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Solid medicine composition of lercanidipine and benazepril

A technology of lercanidipine and its composition, which is applied in the field of medicine, can solve problems affecting drug absorption speed and degree, affecting drug safety and effectiveness, and unsatisfactory dissolution rate, so as to reduce treatment costs, improve clinical application value, Good synergistic antihypertensive effect

Inactive Publication Date: 2014-01-15
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dissolution of the lercanidipine hydrochloride and benazepril hydrochloride composition tablet provided by this patent application is not ideal enough, which will directly affect the absorption speed and degree of the drug, and will also affect the concentration of the drug in the plasma of the patient. Ultimately, it will affect the safety and effectiveness of the drug, and affect the application of the drug

Method used

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  • Solid medicine composition of lercanidipine and benazepril
  • Solid medicine composition of lercanidipine and benazepril
  • Solid medicine composition of lercanidipine and benazepril

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Calculate and weigh lercanidipine hydrochloride, benazepril hydrochloride, appropriate amount of filler and disintegrant, put them into separate marked containers, transfer the above drugs and auxiliary materials to the stirring granulator in turn, and use a low speed Stir and shear mix for 5 minutes to obtain a mixture. The mixture was passed through a 40-mesh sieve, and the sieved mixture was again sheared and mixed in a stirring granulator.

[0051] Prepare the binder into a 70% ethanol-water (w / w) solution, then mix the binder solution with the sieved material, use a granulator to granulate, pass through a 24-mesh sieve and dry at 50°C.

[0052] The dried granules are passed through a 20-mesh sieve, the amount of lubricant is calculated and weighed, mixed with the dry granules, and compressed with a tablet machine to obtain tablets.

[0053] About tablet coating: 1) Prepare coating powder: hypromellose (65%, w / w, viscosity: 6cps), titanium dioxide (20%, w / w); talc ...

Embodiment 2

[0055] According to the method described in Example 1, benazepril hydrochloride and lercanidipine hydrochloride with a weight ratio of 10:3.3 were mixed with the following excipients to obtain tablets of the pharmaceutical composition of lercanidipine and benazepril.

[0056] Benazepril Hydrochloride

Embodiment 3

[0058] According to the method described in Example 1, benazepril hydrochloride and lercanidipine hydrochloride with a weight ratio of 10:3.3 were mixed with the following excipients to obtain tablets of the pharmaceutical composition of lercanidipine and benazepril.

[0059] Benazepril Hydrochloride

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Abstract

The invention relates to a solid medicine composition system and a preparation method thereof, wherein the solid medicine composition system contains lercanidipine which is an antihypertensive drug, pharmaceutical acceptable salts of lercanidipine, benazepril which is also an antihypertensive drug, pharmaceutical acceptable salts of benazepril, and a disintegrating agent which is capable of ensuring release of lercanidipine and benazepril. A certain amount of the disintegrating agent is added, so that the solid medicine composition is excellent and stable in dissolution rate, and is capable of maintaining stable plasma concentration, drug administration frequency is reduced, drug administration intervals are prolonged, and treatment cost is reduced. The solid medicine composition is capable of increasing medicine compliance of patient, and reducing production cost. In addition, compared with combined utilization of lercanidipine and benazepril, addition amount of auxiliary materials is reduced.

Description

technical field [0001] The invention belongs to the field of medical inventions, and in particular relates to a solid pharmaceutical composition system comprising lercanidipine and benazepril, which are drugs for reducing blood pressure, and a disintegrating agent for ensuring the release of the two drugs, and a preparation method thereof. Background technique [0002] Lercanidipine is a third-generation dihydropyridine calcium channel blocker. The chemical name of its compound is: (±)-3-{2-[(3,3-diphenylpropyl)methylamino]-1, 1-Dimethylethyl}-5-methyl ester-1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridine dihydroxy acid, the chemical structure is as follows : [0003] [0004] The mechanism of action of lercanidipine is similar to that of similar drugs: it reversibly blocks the Ca of L-type calcium channels in the membrane of vascular smooth muscle cells. 2+ Influx, expansion of peripheral blood vessels and lower blood pressure. [0005] This product has high l...

Claims

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Application Information

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IPC IPC(8): A61K31/55A61P9/12A61K31/4422
Inventor 徐文进张姝李洪
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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