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New preparation method of Ozagrel sodium powder injection

A technology of sodium ozagrel and freeze-dried powder injection, which is applied in the directions of non-active ingredient medical preparations, medical preparations containing active ingredients, powder delivery, etc., and can solve unqualified clarity, inconvenience, side effects, etc. problems, to achieve the effect of convenient clinical use, small side effects, and good appearance.

Inactive Publication Date: 2009-12-09
HARBIN PHARMA GROUP BIOLOGICAL ENG
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  • Summary
  • Abstract
  • Description
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  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The present invention aims at the problems of side effects and inconvenient use in clinical application of ozagrel sodium for injection, and studies a new preparation method to achieve convenient use of ozagrel powder injection, reduce cost, ensure curative effect and reduce side effects purpose, and at the same time solve the unqualified phenomenon of clarity caused by the application of condensed glucose in freeze-dried preparations

Method used

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  • New preparation method of Ozagrel sodium powder injection
  • New preparation method of Ozagrel sodium powder injection
  • New preparation method of Ozagrel sodium powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Add 10 mg of condensed glucose to 1 ml of sodium ozagrel solution (40 mg / ml) prepared by a citric acid buffer system with a pH value of about 8.5. After sterile filtration, the solution was divided into vials and freeze-dried. Determination of the content of ozagrel sodium in the freeze-dried product. The input amount of sodium ozagrel before freeze-drying was used as the benchmark.

Embodiment 2

[0016] Add 20 mg of condensed glucose to 1 ml of sodium ozagrel solution (80 mg / ml) prepared by a citric acid buffer system with a pH value of about 8.5. After sterile filtration, the solution was divided into vials and freeze-dried. Determination of the content of ozagrel sodium in the freeze-dried product. The input amount of sodium ozagrel before freeze-drying was used as the benchmark.

Embodiment 3

[0018] Add 30 mg of condensed glucose to 1 ml of sodium ozagrel solution (40 mg / ml) prepared by a citric acid buffer system with a pH value of about 8.5. After sterile filtration, the solution was divided into vials and freeze-dried. Determination of the content of ozagrel sodium in the freeze-dried product. The input amount of sodium ozagrel before freeze-drying was used as the benchmark.

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Abstract

The invention researches a new preparation method by aiming at the problems of side effect and inconvenient use of the clinical application of an Ozagrel sodium refrigerated dry powder injection and applies polyglucose to the Ozagrel sodium refrigerated dry powder injection for the first time, the Ozagrel sodium refrigerated dry powder injection is decolorized by active carbon and filtered by a filter film with the aperture of 0.22 micrometer so as to solve the poor appearance problem of the Ozagrel sodium powder injection, achieve the purposes of convenient use, cost reduction, curative effect guarantee and side effect reduction and solve the problem of unqualified clarity generated by applying the polyglucose to the refrigerated dry injection.

Description

technical field [0001] The invention relates to a preparation method of a novel ozagrel sodium freeze-dried powder injection, in particular to a ozagrel sodium freeze-dried preparation containing condensed glucose as an excipient. Background technique [0002] Sodium ozagrel can improve the hemorheology indicators of patients with cerebral infarction, reduce blood viscosity, accelerate thrombolysis, and improve movement disorders in patients. Years of clinical trials have proved that ozagrel is effective, safe, and has few side effects. It has a good curative effect in the treatment of acute cerebral infarction (improving neurological deficit), cerebral infarction and the movement disorders accompanying these diseases. It is a representative class of good antithrombotic drugs, with a clear pharmacological mechanism, a cure rate and marked effect of 75.5%, and a total effective rate of over 95%. The pharmacology, toxicology, pharmacodynamics, pharmacokinetics and pharmaceuti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4164A61K47/26A61P7/02
Inventor 赵华南陈玉军李郑武王忠李会成冷国庆苏宏健
Owner HARBIN PHARMA GROUP BIOLOGICAL ENG
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