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Injection ozagrel sodium freeze-dried powder for treating cerebral infarction

A technology for ozagrel sodium and injection, which is applied in the field of medicine, can solve problems such as unstable quality of ozagrel sodium freeze-dried powder for injection, non-standard step control process, increased risk of clinical use, etc., to achieve suitable The effect of large production requirements, stable and controllable quality, and fewer types of auxiliary materials

Inactive Publication Date: 2016-01-27
南京多宝生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, ozagrel sodium for injection is mainly stored in the form of lyophilized powder. However, in the preparation process of ozagrel sodium lyophilized powder for injection, the step control process is not very standardized, and the parameter control is not accurate enough. The quality of the obtained ozagrel sodium freeze-dried powder for injection is not stable, so the shelf life has a large fluctuation range, and the risk of clinical use is relatively high. In addition, in order to improve the stability of drug performance, the side effects caused by adding various excipients are also Increased risk of clinical use

Method used

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  • Injection ozagrel sodium freeze-dried powder for treating cerebral infarction
  • Injection ozagrel sodium freeze-dried powder for treating cerebral infarction
  • Injection ozagrel sodium freeze-dried powder for treating cerebral infarction

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Embodiment 1: Preparation of sodium ozagrel crystals

[0014] (1) Grind the crude sodium ozagrel, pass through a 90-mesh sieve, add it to 45% N-methylacetamide aqueous solution, and heat up to 30°C while stirring; mix the crude sodium ozagrel with 45% N- The weight ratio of methyl acetamide aqueous solution is 1:10; the stirring speed is 180 rpm; add activated carbon, stir for 50 minutes and then sterile filter; (2) add ether while stirring, and lower the temperature to -15°C at the same time; the stirring speed Be 240 revs / min; The weight of ether is 7 times of the mixed solution weight of ozagrel sodium, 45% N-methylacetamide aqueous solution weight, and adding speed is 95 milliliters / minute; Cooling speed is 10 ℃ / hour; (3 ) After adding the mixed solvent, the obtained crystals were left to stand for crystallization; filtered, washed, and vacuum-dried for 6 hours to obtain the sodium ozagrel compound.

[0015] The prepared sodium ozagrel crystal is measured by powder...

Embodiment 2

[0016]Embodiment 2: get ozagrel sodium 30g, mannitol 60g, meglumine 10g, water for injection and add to 6000ml, make 1000 bottles altogether, its preparation process is: take prescription quantity ozagrel sodium and put in pressure vessel, add The water for injection with a total volume of 80%, under the condition that the relative pressure is 0.06MPa, heat and adjust the water temperature to 105°C, and stir for 0.5 hour to obtain a sodium ozagrel solution, then add 2% of the total mass of the solution and stir for 2.5 hours. Filtrate with a 0.45 μm microporous membrane under heat preservation conditions, add 5% sodium hydroxide solution to the obtained filtrate to adjust the pH value to 11.5 under the condition of heat preservation at 85 ° C, and lower it to room temperature, add the prescribed amount of mannitol and meglumine, and use Dilute to the full volume with water for injection, filter it with a 0.22 μm microporous membrane under aseptic conditions, fill it in a vial, ...

Embodiment 3

[0017] Embodiment 3: get ozagrel sodium 30g, mannitol 70g, meglumine 15g, water for injection and add to 6000ml, make 1000 bottles altogether, its preparation process is: take prescription quantity ozagrel sodium and put in pressure vessel, add The water for injection with a total volume of 80%, under the condition that the relative pressure is 0.07MPa, heat and adjust the water temperature to 115°C, and stir for 0.5 hour to obtain a sodium ozagrel solution, then add activated carbon with 2% of the total mass of the solution and stir for 2.5 hours. Filtrate with a 0.45 μm microporous membrane under heat preservation conditions, add 5% sodium hydroxide solution to the obtained filtrate to adjust the pH value to 11.5 under the condition of heat preservation at 85 ° C, and lower it to room temperature, add the prescribed amount of mannitol and meglumine, and use Dilute to the full volume with water for injection, filter it with a 0.22 μm microporous membrane under aseptic conditio...

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Abstract

The invention discloses injection ozagrel sodium freeze-dried powder for treating cerebral infarction, and belongs to the technical field of medicines. The ozagrel sodium is a crystal, and the novel crystal form of ozagrel sodium, provided by the invention, is different from a crystal structure of the prior art, and experiments prove that the novel crystal form compound is high in purity, good in fluidity and stability and low in impurity content, cannot absorb moisture easily, is safe and reliable in clinical application; and a powder injection prepared by using the novel crystal form compound is good in stability after being compatible with a solvent and extremely low in insoluble micro-particle content, and is very suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a ozagrel sodium freeze-dried powder for injection for treating cerebral infarction. Background technique [0002] Sodium ozagrel, chemical name: trans-3-4-(1H-imidazolyl-1-methyl)phenyl-2-propenoic acid sodium. This product is a thromboxane (TX) synthase inhibitor, which can prevent prostaglandin H2 (PGH2) from generating thromboxane A2 (TXA2), and promote the transfer of PGH2 derived from platelets to endothelial cells. Endothelial cells are used to synthesize PGI2, thereby improving the abnormal balance of TXA2 and prostaglandin PGI2. In theory, it can inhibit the aggregation of platelets and dilate blood vessels. This product can improve the movement disorder in the acute stage of cerebral thrombosis, improve the circulation disorder in the acute stage of cerebral ischemia and improve the abnormal energy metabolism in cerebral ischemia. Animal experiments have shown that in...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4174C07D233/56A61K47/10A61K47/26A61P9/10A61P7/02
Inventor 李洋
Owner 南京多宝生物科技有限公司
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