Pharmaceutical composition and preparation method and application thereof

A composition and drug technology, applied in the field of medicine, can solve the problems of use restriction, can not affect the pharmacokinetic level, weaken the efficacy of clopidogrel hydrogen sulfate, etc., and achieve the effect of reducing the risk of gastric injury

Active Publication Date: 2014-07-09
ZHAOKE PHARMA GUANGZHOU
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In conclusion, the combination of clopidogrel bisulfate and aspirin increases the risk of gastrointestinal injury and should be reduced, but the use of PPI is limited and may weaken the efficacy of clopidogrel bisulfate and has no reduction effect on intestinal injury, so , there is an urgent need to develop a new pharmaceutical composition that can reduce the occurrence of gastrointestinal damage without affecting the pharmacokinetic levels of the two main drugs

Method used

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  • Pharmaceutical composition and preparation method and application thereof
  • Pharmaceutical composition and preparation method and application thereof
  • Pharmaceutical composition and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: Preparation of the pharmaceutical composition of the present invention

[0031] Mix pure ethanol (purity ≥99.5%, 20ml) with soybean lecithin (Phosal35SB, a type of soybean lecithin, 1.75g, phospholipid concentration 37%) in advance at 75°C using a homogenizer; after 5 minutes , add 750 mg of clopidogrel bisulfate and 1.0 g of aspirin, and continue to mix for 15 minutes; then cool to room temperature, and filter with a filter with a pore size of 0.2 microns; finally, lyophilize to remove ethanol to obtain the pharmaceutical composition.

Embodiment 2

[0032] Embodiment 2: Preparation of the pharmaceutical composition of the present invention

[0033] Mix pure ethanol (purity ≥99.5%, 20ml) with soybean lecithin (Phosal35SB, a type of soybean lecithin, 0.875g, phospholipid concentration 20%) in advance at 75°C using a homogenizer; after 5 minutes , add 375 mg of clopidogrel bisulfate and 0.5 g of aspirin, and continue mixing for 15 minutes; then cool to room temperature, and filter with a filter with a pore size of 0.2 microns; finally, lyophilize to remove ethanol to obtain the pharmaceutical composition.

Embodiment 3

[0034] Embodiment 3: Preparation of the pharmaceutical composition of the present invention

[0035] Mix pure ethanol (purity ≥99.5%, 20ml) with soybean lecithin (Phosal35SB, a type of soybean lecithin, 17.5g, phospholipid concentration 10%) in advance at 75°C using a homogenizer; after 5 minutes , add 375 mg of clopidogrel bisulfate and 0.5 g of aspirin, and continue mixing for 15 minutes; then cool to room temperature, and filter with a filter with a pore size of 0.2 microns; finally, lyophilize to remove ethanol to obtain the pharmaceutical composition.

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PUM

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Abstract

The invention relates to the field of medicine, and discloses a pharmaceutical composition and a preparation method and an application thereof. The pharmaceutical composition disclosed by the invention includes an effective treatment dosage of clopidogrel hydrogen sulfate and aspirin, as well as a non-water vector containing phospholipid. In the invention, the aspirin and the clopidogrel hydrogen sulfate, as well as the phospholipid, are prepared into the brand new pharmaceutical composition, the pharmaceutical composition is used for greatly reducing the risk of gastrointestinal injury generated by drug combination of clopidogrel hydrogen sulfate and aspirin without changing the pharmacokinetic level of the two active ingredients, and can be used for preparing drugs of various forms for preventing and treating cardiovascular and cerebrovascular diseases..

Description

technical field [0001] The invention relates to the field of medicine, in particular to a pharmaceutical composition and its preparation method and application. Background technique [0002] Aspirin is the first choice for the prevention and treatment of patients with cardiovascular diseases. At present, the second drug that inhibits platelet aggregation, clopidogrel bisulfate, is generally added in clinical practice, so that it can be combined with aspirin to improve the therapeutic effect, but this combination also brings Some hidden dangers of stomach injury (such as stomach bleeding and other symptoms) are eliminated. The results of the study showed that, compared with the aspirin + placebo group, the clopidogrel bisulfate + aspirin group had a lower risk of cardiovascular events (p<0.01), but at the same time had a higher risk of major bleeding events (p<0.01). [0003] Although some researchers or institutions recommend the use of PPIs (proton pump inhibitors) t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/616A61K47/24A61P9/00A61K31/4365
Inventor 叶文锐戴向荣李小羿张国辉
Owner ZHAOKE PHARMA GUANGZHOU
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