A pharmaceutical composition containing ozagrel sodium and its preparation method

A technology for sodium ozagrel and the composition is applied in the field of pharmaceutical compositions containing ozagrel and its preparation, which can solve the problems of local pain, poor stability of ozagrel, vascular irritation and the like, and achieve process improvement, The effect of improving the stability of medicines

Active Publication Date: 2019-01-22
HARBIN ZHENBAO PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The deficiency of the existing ozagrel injection is that it has blood vessel irritation during injection, and even causes local pain. At the same time, because the existing ozagrel sodium is particularly stable in aqueous solution, in order to further improve the ozagrel sodium injection stability, the present invention is proposed

Method used

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  • A pharmaceutical composition containing ozagrel sodium and its preparation method
  • A pharmaceutical composition containing ozagrel sodium and its preparation method
  • A pharmaceutical composition containing ozagrel sodium and its preparation method

Examples

Experimental program
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Effect test

Embodiment 1

[0032] The pharmaceutical composition containing ozagrel sodium is an injection, which is made into 1000mL, and its raw materials include 38g of ozagrel, 6g of sodium hydroxide, 10g of mannitol, 10g of dextran, 20g of arabinose, and water for injection to make up to 1000mL.

[0033] The preparation method of this injection comprises the following steps:

[0034] Take dextran and add 30% of the total weight of the prepared solution into water for injection, stir in water for injection, boil to dissolve, and cool down to 40-50°C; add the prescribed amount of sodium hydroxide, stir to dissolve, add ozagrel, stir to dissolve; add mannitol Stir to dissolve; use 2mol / L hydrochloric acid solution to adjust the pH value of the liquid to 8.0-9.3; add arabinose, stir to dissolve; add water for injection to the total amount of preparation, add 3‰ of the total weight of the preparation solution of medicinal charcoal, stir and absorb 10 Minutes, after removing charcoal, adjust the volume t...

Embodiment 2

[0036] The pharmaceutical composition containing ozagrel sodium is an injection, which is made into 1000mL, and its raw materials include 40g of ozagrel, 8g of sodium hydroxide, 12g of mannitol, 12g of dextran, 22g of arabinose, and water for injection to make up to 1000mL.

[0037] The preparation method of this injection is with embodiment 1.

Embodiment 3

[0039] The pharmaceutical composition containing ozagrel sodium is an injection, which is made into 1000mL. Its raw materials include 39g of ozagrel, 7g of sodium hydroxide, 11g of mannitol, 11g of dextran, 21g of arabinose, and make up to 1000mL with water for injection.

[0040] The preparation method of this injection is with embodiment 1.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and relates to a pharmaceutical composition containing ozagrel sodium and a preparation method thereof. The pharmaceutical composition comprises the following components by weight ratio, ozagrel: sodium hydroxide: mannitol: dextran: arabinose=(38-40):(6-8):(10-12):(10- 12): (20‑22). Adding an appropriate amount of arabinose in the prescription of the ozagrel in the present invention can greatly reduce blood vessel irritation, and can significantly reduce nausea, vomiting, diarrhea, loss of appetite and fullness. After the preparation method of the present invention is improved, it is more conducive to improving the stability of the drug.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a pharmaceutical composition containing ozagrel sodium and a preparation method thereof. Background technique [0002] Ozagrel is a selective thrombosis A2 (TXA2) synthetase inhibitor, which has anti-platelet aggregation and blood vessel expansion effects, and can inhibit cerebral thrombosis and cerebral vasospasm. It can be used to improve the symptoms of vasospasm and cerebral ischemia after subarachnoid hemorrhage operation. It entered the market for the first time in Japan in 1988 as an antithrombotic drug. [0003] The deficiency of the existing ozagrel injection is that it has blood vessel irritation during injection, and even causes local pain. At the same time, because the existing ozagrel sodium is particularly stable in aqueous solution, in order to further improve the ozagrel sodium injection Stability, especially propose the present invention. Co...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4174A61K47/26A61K9/08A61K9/19A61P7/02A61P9/10A61P9/08
CPCA61K9/0019A61K9/08A61K9/19A61K31/4174A61K47/26
Inventor 方同华崔玉海周广红范玉奇贾文娟
Owner HARBIN ZHENBAO PHARMA
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