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Pharmaceutically stable hemostatic compositions

A composition and stable technology, applied in the field of medicine, can solve problems such as unsatisfactory safety and unsatisfactory efficacy

Inactive Publication Date: 2004-09-01
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, among these agents, the former agent is unsatisfactory in terms of safety, and the latter agent is unsatisfactory in terms of efficacy

Method used

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  • Pharmaceutically stable hemostatic compositions
  • Pharmaceutically stable hemostatic compositions
  • Pharmaceutically stable hemostatic compositions

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Embodiment 1

[0024] In order to study the stability of the FVIIa / FX mixture in the buffer solution, the buffer solution (without CaCl 2 0.4 mg / mL FVIIa and 1.0 mg / mL FX were mixed together in 100 mM MES, 100 mM NaCl), and the mixture was incubated at 37°C. The respective activities of FVIIa, FX and FXa in the sample are measured at each prescribed time, and the measurement is carried out in a system in which the above-mentioned factors do not affect each other. FVIIa used here is a blood product prepared in the manner described in Japanese Patent Laid-Open No. 155797 / 1991.

[0025] As a result, both FVIIa and FX retained greater than 90% of their activity after 24 hours of incubation at each pH value of the buffer tested. FXa content is calculated based on its specific hydrolysis activity to a synthetic substrate (S2222), the molar ratio of FXa content to FX figure 2 shown. No increase in FXa content was observed in the pH 5.6 and 6.0 buffers, whereas a significant increase in FXa conte...

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Abstract

A novel hemostatic composition and a hemostatic pharmaceutical preparation are provided. A pharmaceutically stable hemostatic liquid composition comprising a mixed solution of activated blood coagulation factor VII (FVIIa) and blood coagulation factor X (FX) in a single container. The mixed solution is maintained at pH ranging from 5.0 to 6.5.

Description

field of invention [0001] The invention belongs to the field of medicine, and relates to a novel hemostatic composition containing plasma protein and a pharmaceutical preparation thereof. More specifically, the present invention relates to a therapeutic drug comprising a mixed solution of activated blood coagulation factor VII (hereinafter also referred to as "FVIIa") and blood coagulation factor X (hereinafter also referred to as "FX") in a single container. Background technique [0002] Hemostasis in hemophiliacs with inhibitors has been controlled by the use of activated prothrombin complex concentrate (APCC) or recombinant activated factor VII (rFVIIa). However, among these agents, the former agent is unsatisfactory in terms of safety, and the latter agent is unsatisfactory in terms of efficacy. In order to overcome these drawbacks, the present inventors disclosed in Japanese Patent Laid-Open No. 2001-181204 (Japanese Patent Application No. 368122 / 1999) that a pharmaceu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/48A61L24/10A61P7/04
CPCA61K9/19A61K38/4846A61L2400/04A61L24/108A61K9/0019A61P7/04A61K38/36
Inventor 荒木辰也友清和彦中富靖K·手岛中垣智弘