Ozagrel sodium drug combination for injection

A technology of ozagrel sodium and its composition, which is applied in the field of ozagrel sodium pharmaceutical composition and its preparation, which can solve the problems of inconvenient use, storage and transportation, etc., and achieve the reduction of market risk, the method is simple and easy, and there is no allergic reaction Effect

Inactive Publication Date: 2013-01-02
TIANJIN SONGRUI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The ozagrel sodium pharmaceutical composition produced in the prior art has very strict requirements on storage and protection from light, and is inconvenient in use, storage and transportation

Method used

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  • Ozagrel sodium drug combination for injection
  • Ozagrel sodium drug combination for injection
  • Ozagrel sodium drug combination for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] The ozagrel sodium pharmaceutical composition described in every 1000 bottles, its formula consists of:

[0062]

[0063] Preparation process: Take 70% of the prescribed amount of water for injection, at a temperature of 50-60°C, add the prescribed amount of mannitol and anhydrous sodium bicarbonate, stir and dissolve; add the prescribed amount of ozagrel sodium, stir until completely dissolved; measured Initial pH value, according to the initial pH value, use 4% sodium hydroxide solution to adjust the pH value range to 7.7-8.7; add 0.05% medicinal charcoal to the mixture, stir at 50-60 °C for 30 minutes; suction filter, add water for injection to Full volume, mixed evenly; fine filtration; filling; freeze-drying: put the filled glass bottle into a freeze-drying box that has been cooled down to 5°C, quickly cool down to -40°C, keep warm and freeze for 3 hours, and then vacuumize , raise the temperature to -5°C within 3 hours, maintain the time at -5°C for 10-15 hours...

Embodiment 2

[0065] The ozagrel sodium pharmaceutical composition described in every 1000 bottles, its formula consists of:

[0066]

[0067] Preparation process: with embodiment 1.

Embodiment 3

[0069] The ozagrel sodium pharmaceutical composition described in every 1000 bottles, its formula consists of:

[0070]

[0071] Preparation process: with embodiment 1.

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PUM

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Abstract

The invention discloses an ozagrel sodium drug combination for injection. The ozagrel sodium injection solution consists of ozagrel sodium, mannitol and anhydrous sodium carbonate, wherein each piece contains 20-80 mg of ozagrel sodium, 20-80 mg of mannitol and 5-15 mg of anhydrous sodium carbonate. The drug combination is prepared by a method comprising the following steps: taking a recipe quantity of injection water, adding the mannitol and the anhydrous sodium carbonate and stirring until the mannitol and the anhydrous sodium carbonate are dissolved; adding the ozagrel sodium, and stirring until the ozagrel sodium is fully dissolved; regulating a pH value between 7.7 and 8.7; adding medicinal carbon and stirring; leaching, replenishing the injection water to a full quantity and uniformly mixing; finely filtering; encapsulating; freeze-drying; inspecting with a light; and warehousing to obtain the ozagrel sodium drug combination. The ozagrel sodium drug combination has good stability. The production rate of the product is increased, the cost is lowered, and industrialization is realized. The drug combination can be better applied in clinic and has more remarkable advantages.

Description

technical field [0001] The invention relates to medicines in the field of medicine, in particular to a pharmaceutical composition of ozagrel sodium for injection and a preparation method thereof. Background technique [0002] Ozagrel Sodium [0003] Chemical name: Sodium (E)-3-[4-(1H-imidazole-1-methyl)phenyl]-2-acrylate; [0004] Molecular formula: C 13 h 11 N 2 NaO 2 ; [0005] Molecular weight: 250.25; [0006] Properties: This product is white crystal or crystalline powder. Soluble in water, slightly soluble in methanol, almost insoluble in ethanol (99.5%). [0007] Pharmacological type: This product is Thromboxane A 2 (TXA 2 ) synthase inhibitors. [0008] Mechanism of action: This product can block prostaglandin (PGH 2 ) to generate TXA 2 , promote platelet-derived PGH 2 Turns to endothelial cells, which synthesize prostacyclin (PGI 2 ), while improving TXA 2 and PGI 2 Abnormal balance of platelets, thereby inhibiting the aggregation of platelets and d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4174A61K47/10A61K47/02A61P9/10
Inventor 张昊
Owner TIANJIN SONGRUI MEDICAL TECH
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