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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 clopidogrel and its salt submicroemulsion injection and its preparation method

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

Embodiment 1

[0051] prescription

[0052] Clopidogrel bisulfate (calculated as clopidogrel) 0.075 g Medium Chain Fatty Acid Triglycerides for Injection 5.0 g Soybean Oil for Injection 5.0 g egg yolk lecithin 1.2 g Poloxamer F-68 0.2 g Tween-80 0.2 g Glycerin for Injection 2.5 g Water for Injection to 100 mL

[0053] Preparation:

[0054] Step 1: Dissolve the formula amount of egg yolk lecithin in medium-chain fatty acid triglycerides for injection and soybean oil for injection, then add the formula amount of clopidogrel bisulfate, heat in a water bath to 60-80°C, and stir to make it Completely dissolved to obtain an oil phase;

[0055] Step 2: Dissolve the prescribed amount of glycerin for injection, poloxamer F-68, and Tween-80 in water for injection, heat in a water bath to 60-80°C, and stir to completely dissolve to obtain an aqueous phase;

[0056] Step 3: Mix the oil phase and the water phase at a speed of 16,000 rpm under th...

Embodiment 2

[0060] prescription

[0061] Clopidogrel bisulfate (calculated as clopidogrel) 0.075 g Medium Chain Fatty Acid Triglycerides for Injection 5.0 g Soybean Oil for Injection 5.0 g egg yolk lecithin 1.2 g Poloxamer F-68 0.2 g Tween-80 0.2 g Vitamin E 0.002 g Glycerin for Injection 2.5 g Water for Injection to 100 mL

[0062] Preparation:

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

[0064] Step 2: Dissolve the prescribed amount of glycerin for injection, poloxamer F-68, and Tween-80 in water for injection, heat in a water bath to 60-80°C, and stir to completely dissolve to obtain an aqueous phase;

[0065] Step 3: Mix the oil phase and the water pha...

Embodiment 3

[0069] prescription

[0070] Clopidogrel bisulfate (calculated as clopidogrel) 0.075 g Medium Chain Fatty Acid Triglycerides for Injection 5.0 g Soybean Oil for Injection 5.0 g egg yolk lecithin 2.0 g Vitamin E 0.002 g Glycerin for Injection 2.25 g Water for Injection to 100 mL

[0071] Preparation:

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

[0073] Step 2: Dissolve the formulated amount of glycerin for injection in water for injection, heat in a water bath to 60-80°C, and stir to completely dissolve it to obtain an aqueous phase;

[0074] Step 3: Mix the oil phase and the water phase at a speed of 16,000 rpm under the stirring of a high-shear disperser, ...

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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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