Clopidogrel and salt submicron emulsion injection thereof as well as preparation method of same

A technology of clopidogrel and injection, which is applied in the field of medicine, can solve the problems such as the preparation method of clopidogrel and its salt submicroemulsion injection, and achieve the effects of avoiding and covering up bad smell, low solubility and convenient medication

Inactive Publication Date: 2012-10-03
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] Through literature search, there is no report about clopidogr

Method used

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  • Clopidogrel and salt submicron emulsion injection thereof as well as preparation method of same
  • Clopidogrel and salt submicron emulsion injection thereof as well as preparation method of same
  • Clopidogrel and salt submicron emulsion injection thereof as well as preparation method of same

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0050] Example 1:

[0051] prescription

[0052] Clopidogrel hydrogen sulfate (calculated as clopidogrel)0.075 g Medium-chain fatty acid triglycerides for injection5.0 g Soybean oil for injection5.0 g Egg Yolk Lecithin1.2 g Poloxamer F-680.2 g Tween-800.2 g Glycerin for Injection2.5 g Water for Injection To 100 mL

[0053] Preparation:

[0054] Step 1: Dissolve the formulated amount of egg yolk lecithin in the medium-chain fatty acid triglyceride for injection and soybean oil for injection, then add the formulated amount of clopidogrel bisulfate, heat it to 60~80℃ in a water bath, and stir to make it Completely dissolve to obtain oil phase;

[0055] Step 2: Dissolve the glycerin for injection, poloxamer F-68, and Tween-80 of the formula in the water for injection, heat the water bath to 60~80℃, and stir to completely dissolve it to prepare the water phase;

[0056] Step 3: Under the stirring of the high-shear disperser, the oil phase and the water phase are mixed at a rotati...

Example Embodiment

[0059] Example 2:

[0060] prescription

[0061] Clopidogrel hydrogen sulfate (calculated as clopidogrel)0.075 g Medium-chain fatty acid triglycerides for injection5.0 g Soybean oil for injection5.0 g Egg Yolk Lecithin1.2 g Poloxamer F-680.2 g Tween-800.2 g Vitamin E0.002 g Glycerin for Injection2.5 g Water for Injection To 100 mL

[0062] Preparation:

[0063] Step 1: Dissolve the formula amount of vitamin E and egg yolk lecithin in the medium-chain fatty acid triglyceride for injection and soybean oil for injection, then add the formula amount of clopidogrel bisulfate, heat it to 60~80℃ in a water bath, and Stir to dissolve completely to obtain the oil phase;

[0064] Step 2: Dissolve the glycerin for injection, poloxamer F-68, and Tween-80 of the formula in the water for injection, heat the water bath to 60~80℃, and stir to completely dissolve it to prepare the water phase;

[0065] Step 3: Under the stirring of the high-shear disperser, the oil phase and the water phase...

Example Embodiment

[0068] Example 3:

[0069] prescription

[0070] Clopidogrel hydrogen sulfate (calculated as clopidogrel)0.075 g Medium-chain fatty acid triglycerides for injection5.0 g Soybean oil for injection5.0 g Egg Yolk Lecithin2.0 g Vitamin E0.002 g Glycerin for Injection2.25 g Water for Injection To 100 mL

[0071] Preparation:

[0072] Step 1: Dissolve the formula amount of vitamin E and egg yolk lecithin in the medium-chain fatty acid triglyceride for injection and soybean oil for injection, then add the formula amount of clopidogrel bisulfate, heat it to 60~80℃ in a water bath, and Stir to dissolve completely to obtain the oil phase;

[0073] Step 2: Dissolve the formula amount of glycerin for injection in the water for injection, heat the water bath to 60~80°C, and stir to make it completely dissolved to prepare the water phase;

[0074] Step 3: Under the stirring of the high-shear disperser, the oil phase and the water phase are mixed at a rotation speed of 16,000 rpm, and stirr...

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Abstract

The invention belongs to the technical field of medicine and relates to clopidogrel and salt submicron emulsion injection thereof as well as a preparation method of the clopidogrel and the salt submicron emulsion injection thereof. Particularly, the invention provides clopidogrel, salt submicron emulsion injection including clopidogrel, salt, oil for injection, assistant emulsifier, isoosmotic adjusting agents, pH adjusting agents and water for injection, and a preparation method of the clopidogrel and the salt submicron emulsion injection. 100 mL of the injection comprises clopidogrel, 0.05 g to 0.15 g salt (measured according to clopidogrel), 5 g to 30 g of oil for injection, 0.5 g to 3.4 g of emulsifier, 0 g to 1 g of assistant emulsifier, 2.0 g to 4.0 g of isoosmotic adjusting agents, and 7.0 g to 9.0 g of pH adjusting agents, and 100 mL of water for injection is added. The clopidogrel and the salt submicron emulsion injection thereof, provided by the invention, have the physical chemical property conforming to the requirement of drug for intravenous use and are suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a submicroemulsion injection of clopidogrel and its salt and a preparation method thereof. Background technique [0002] Clopidogrel, the second thienopyridine drug, is an adenosine diphosphate (ADP) receptor inhibitor. Its chemical name is (S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetic acid methyl ester. The chemical structural formula is as follows: [0003] [0004] Clopidogrel is a platelet aggregation inhibitor, which can selectively and irreversibly inhibit the binding of adenosine diphosphate (ADP) to its platelet receptor and the secondary ADP-mediated activation of the glycoprotein GPⅡb / Ⅲa complex, thereby inhibiting Mutual aggregation of platelets. In addition, clopidogrel can also block the platelet activation expansion caused by ADP release, thereby inhibiting platelet aggregation induced by other agonists. [0005] Clopidogrel can be used t...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/4365A61P7/02
Inventor 潘卫三艾秀丽杨星钢
Owner SHENYANG PHARMA UNIVERSITY
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