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Pharmaceutically stable hemostatic compositions

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

Inactive Publication Date: 2006-05-03
KM BIOLOGICS CO
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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

Examples

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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 MES buffer: 100mM MES, 100mM NaCl) 0.4mg / mL FVIIa and 1.0mg / mL FX were mixed together, 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 performed in a system in which the aforementioned factors do not affect each other. FVIIa used here is a blood product prepared as described in Japanese Patent Publication 155797 / 1991.

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

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Abstract

The present application provides novel hemostatic compositions or hemostatic preparations. There is provided a pharmaceutically stable hemostatic composition in solution, characterized by comprising activated coagulation factor VII (FVIIa) and coagulation factor X (FX) mixed together in a single container. The pH value of the mixed solution is maintained at 5.0-6.5.

Description

Invention field [0001] The invention belongs to the field of medicine and relates to a novel hemostatic composition containing plasma proteins and a pharmaceutical preparation thereof. More specifically, the present invention relates to a therapeutic drug, which contains a mixed solution of activated coagulation factor VII (hereinafter also referred to as "FVIIa") and coagulation factor X (hereinafter also referred to as "FX") in a single container. Background technique [0002] By using activated prothrombin complex concentrate (APCC) or recombinant activated coagulation factor VII (rFVIIa), hemostasis in hemophilia patients with inhibitors can be controlled. However, among these reagents, the former reagent is not satisfactory in terms of safety, and the latter reagent is not satisfactory in terms of efficacy. In order to overcome these disadvantages, the present inventors disclosed in Japanese Patent Publication No. 2001-181204 (Japanese Patent Application No. 368122 / 1999) tha...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/43A61K9/08A61K9/19A61P7/04A61K38/48A61L24/10
CPCA61K9/0019A61K9/19A61K38/4846A61L24/108A61L2400/04A61P7/04A61K38/36
Inventor 荒木辰也友清和彦中富靖K·手岛中垣智弘
Owner KM BIOLOGICS CO
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