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Injectable composition of clopidogrel and its salt and preparation method thereof

A clopidogrel and composition technology, applied in the field of injectable compositions of clopidogrel and its salts and their preparation, can solve problems such as troublesome clinical use, increased cost and the like, and achieve simplified operation, cost saving, and reduced injection irritation. Effect

Active Publication Date: 2009-11-25
CHINA RESOURCES SAIKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method brings trouble to clinical use, and increases cost

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Freeze-dried powder for injection

[0033] prescription:

[0034] Clopidogrel Sulfate 98mg

[0035] Tween 80 588mg

[0036] Polyoxyethylene castor oil 196mg

[0037] L-Methionine 174mg

[0038] Mannitol 700mg

[0039] 10ml citrate buffer pH4.5

[0040] Process:

[0041] Add the prescribed amount of Tween 80 into the glass container, weigh the prescribed amount of clopidogrel sulfate raw material into it, mix the two evenly, and set aside. Add the prescribed amount of mannitol and L-methionine to the citrate buffer salt with the prescribed amount of pH4.5, and stir to obtain a clear solution. This clear solution was added to the above mixture and stirred to obtain a clear solution. The resulting solution was filtered and freeze-dried to obtain the desired freeze-dried powder.

Embodiment 2

[0043] concentrated solution for injection

[0044] prescription:

[0045] Clopidogrel Sulfate 98mg

[0046] Tween 80 784mg

[0047] L-cysteine ​​141mg

[0048] Mannitol 300mg

[0049] 10ml citrate buffer pH4.5

[0050] Process:

[0051]Add the prescribed amount of Tween 80 into the glass container, weigh the prescribed amount of clopidogrel sulfate raw material into it, mix the two evenly, and set aside. Add the prescribed amount of mannitol and L-cysteine ​​to the prescribed amount of citrate buffered saline at pH 4.5, and stir to obtain a clear solution. This clear solution was added to the above mixture and stirred to obtain a clear solution. The obtained solution is filtered and sterilized to obtain the desired concentrated solution for injection.

Embodiment 3

[0053] big infusion

[0054] prescription:

[0055] Clopidogrel Sulfate 98mg

[0056] Tween 80 515mg

[0057] Polyoxyethylene castor oil 171mg

[0058] L-Methionine 105mg

[0059] Citrate buffer pH 4.5 to 500ml

[0060] Process:

[0061] Add the prescribed amount of Tween 80 and polyoxyethylene castor oil into a glass container, weigh the prescribed amount of clopidogrel sulfate raw materials into it, mix the two evenly, and set aside. Add the prescribed amount of mannitol and L-methionine to 500ml of citrate buffered saline with pH 4.5, and stir to obtain a clear solution. This clear solution was added to the above mixture and stirred to obtain a clear solution. The resulting solution is filtered and sterilized to obtain the required infusion solution.

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PUM

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Abstract

The present invention relates to an injectable composition of clopidogrel and a salt thereof and a preparation method thereof, more precisely an injectable composition of clopidogrel and a salt thereof having an excellent effect of inhibiting platelet aggregation and a preparation method thereof. The composition comprises a solubilizing agent, Cosolvent and buffer solution; the injectable composition of clopidogrel and its salt provides medical effect higher than known composition, not only shows lower toxicity, but also shows excellent clopidogrel solubility and stability at room temperature, Soluble or fine particle-containing intravenous injections can be obtained.

Description

technical field [0001] The invention relates to a pharmaceutical composition for injection of an anti-platelet aggregation drug clopidogrel or a pharmaceutically acceptable salt thereof and a preparation method thereof. The composition contains clopidogrel and its salt, solubilizer, cosolvent and buffer solution. Background technique [0002] Clopidogrel and its salts are anti-platelet aggregation drugs similar to ticlopidine. The mechanism of action is similar to that of ticlopidine, but the intensity of action and tolerance are higher than those of ticlopidine. Clopidogrel and its salts are more favorable than ticlopidine in terms of side effects, and their overall tolerability is similar to that of aspirin. It is clinically used in the treatment of atherosclerotic diseases, acute coronary syndrome, prevention of in-stent restenosis and thrombotic complications after coronary stent implantation, etc., and is an excellent anti-platelet aggregation drug. [0003] Because t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/4365A61K47/30A61K47/18A61P7/02
Inventor 赵巧玲王文峰王雪彬
Owner CHINA RESOURCES SAIKE PHARMA