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Oral preparations of ivabradine or the medical salt thereof

A technology of oral preparations and medicinal salts, which is applied in the field of medicine and can solve problems such as atrioventricular block

Inactive Publication Date: 2008-01-02
PHARMA RES INST OF BENCAO TIANYUAN OF BEIJING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are many contraindications to the application of β-blockers, including airway obstruction, atrioventricular block, decompensated heart failure, symptomatic peripheral vascular disease, etc.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

experiment approach 1

[0023] Experimental scheme 1: take ivabradine or its medicinal salt, pulverize and sieve, take filler and disintegrating agent respectively, pulverize and sieve, mix evenly, add ivabradine or its medicinal salt in equal amount, mix well, and prepare Soft material, granulation, granulation, adding lubricant, and preparing preparations according to the conventional pharmaceutical preparation methods of photographic preparations, capsules, and granules;

[0024] Experimental results: The fluidity of the granules prepared by the above experimental scheme is relatively good, but the granules obtained are loose and fragile, and require high pressure when tableting, which is also not conducive to the preservation of granules and capsules, and qualified finished products cannot be prepared formulation, and no binder was added in the above experimental protocol, therefore, further modification of the experimental protocol was required;

experiment approach 2

[0025] Experimental scheme 2: take ivabradine or its medicinal salt, pulverize and sieve, take the filler, disintegrating agent, and binder, respectively pulverize and sieve, mix evenly, add ivabradine or its medicinal salt in equal amount, Mix evenly, make soft materials, granulate, granulate, add lubricant, and prepare preparations according to the conventional pharmaceutical preparation methods of photographic preparations, capsules, and granules;

[0026] Experimental results: The above-mentioned experimental scheme has good particle formation and is not fragile, but the fluidity is not good, and the angle of repose is large, so it is impossible to prepare qualified finished preparations, which reminds us to continue to improve the experimental scheme;

experiment approach 3

[0027] Experimental scheme 3: take ivabradine or its medicinal salt, pulverize and sieve, take filler and binder, respectively pulverize and sieve, mix evenly, add ivabradine or its medicinal salt in equal amount, mix well, and prepare Soft material, granulation, granulation, adding lubricant, and preparing preparations according to the conventional pharmaceutical preparation methods of photographic preparations, capsules, and granules;

[0028] Experimental results: the above experimental scheme does not add disintegrants, the granules produced have good fluidity, the angle of repose is 29 degrees, and the dissolution rate meets the requirements, suggesting that this may be related to the physical properties of ivabradine or its pharmaceutically acceptable salts and disintegrants. The chemical properties are related. Without adding disintegrants, the preparation meets all requirements and can produce qualified finished preparations. Therefore, we believe that only fillers, bin...

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PUM

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Abstract

The invention discloses a kind of oral product of ivabradine (Procoralan)or its medical salt, which can be produced into tablet, capsule and granule dosage form, which is characterized in that medical findings comprises filling agent, adhesive agent and lubricating agent, the weight ratio between ivabradine or its medical salt and medical filling agent is 1: 20-40; weight ratio between ivabradine or its medical salt and adhesive agent is 1: 1-2, and ivabradine or its medical salt and lubricating agent is 1: 0.2-0.4. It is showed by pharmacological experiment that the pharmacological action of ivabradine is very good.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an oral preparation of ivabradine or a medicinal salt thereof. Background technique [0002] Chronic stable angina pectoris is the most common clinical manifestation in patients with chronic coronary heart disease. Early treatment focuses on alleviating symptoms, that is, relieving and avoiding angina pectoris attacks. Nitrate drugs were used in the early stage. Sublingual nitroglycerin can quickly relieve the onset of angina pectoris, and long-acting nitrate preparations can prevent angina pectoris. In the 1960s and 1970s, β-receptor blockers and calcium antagonists came out successively, and together with nitrates, they formed the three most commonly used anti-angina drugs in clinical practice. The antianginal effects of these three classes of drugs are similar, and there is a lack of evidence that they can reduce mortality in patients with angina or reduce major cardiovascul...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/55A61K9/16A61K9/20A61K9/48A61P9/10
Inventor 顾群孙学伟金治刚张士花
Owner PHARMA RES INST OF BENCAO TIANYUAN OF BEIJING
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