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Platelet aggregation inhibition preparation and preparation method thereof

An anti-platelet aggregation and preparation technology, which is applied in the field of biomedicine, can solve the problems of unstable active ingredients of eptifibatide, and achieve the effect of maintaining stability, good stability, and good stability

Inactive Publication Date: 2010-07-21
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The active ingredient of eptifibatide is often unstable in the injection solution for a long time

Method used

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  • Platelet aggregation inhibition preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Aptiferin 10.00g

[0024] Citric acid 5.25g

[0025] Sodium citrate 5.25g

[0026] Add water for injection to 5000ml

[0027] Made 1000 pieces

Embodiment 2

[0029] (2) Embodiment 2

[0030] Aptiferin 10.00g

[0031] Citric acid 5.25g

[0032] Sodium citrate 8.75g

[0033] Add water for injection to 5000ml

[0034] Made 1000 pieces

Embodiment 3

[0036] Aptiferin 10.00g

[0037] Citric acid 5.25g

[0038] Sodium citrate 15.75g

[0039] Add water for injection to 5000ml

[0040] Made 1000 pieces

[0041] 2 process

[0042] Dissolve citric acid and sodium citrate in sterilized water for injection respectively, prepare a solution with a final concentration in the range of 0.5 mg / ml to 50 mg / ml, perform primary filtration and ultrafiltration; then use citric acid ultrafiltrate to dissolve Wash the Eptifatid into the liquid preparation tank, stir to completely dissolve the Eptifacin, add sodium citrate ultrafiltrate, and dilute to the specified volume with water for injection, and control the pH value at 4.5-6.0. The concentration is controlled within the range of 0.1 mg / ml to 50 mg / ml, the solution is sterilized and the filtrate is collected into sterile containers, and then packed. The active ingredient described in this example is eptifibatide.

[0043] 3. Stability test

[0044] 25°C Accelerated June Inspection R...

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Abstract

The invention discloses a platelet aggregation inhibition preparation, which belongs to the technical field of biomedicine. The platelet aggregation inhibition preparation comprises active ingredients and an auxiliary material, wherein the concentration of the active ingredients is 0.1-50 mg / ml, and the active ingredients are eptifibatide and pharmaceutically-acceptable eptifibatide derivatives; the auxiliary material is a buffer system of citric acid and sodium citrate; and in the buffer system, the concentrations of the citric acid and the sodium citrate are respectively 0.5-50 mg / ml and 0.5-50 mg / ml. The six-month accelerated test and the 24-month long-term stability test prove that the active ingredients are stable in the injection prepared from the eptifibatide preparation. In particular, the small volume injection prepared from the eptifibatide preparation has the advantages of good stability and accurate curative effect, and can maintain good stability during storage and transportation.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to an anti-platelet aggregation preparation and a preparation method thereof. Background technique [0002] Eptifibatide (English name: Epifibatide, chemical name: N6-(aminoiminomethyl)-N2-(3-mercapto-1-oxopropyl)-L-lysyl-glycyl-L-α -Aspartyl-L-tryptophanyl-L-prolyl-L-cysteinamide ring (1 6-disulfide); is a compound consisting of six amino acid residues and a mercaptopropionyl (de Aminocysteine) constitutes a cyclic heptapeptide compound, which is formed by cysteine ​​residues and mercaptopropionyl by means of intramolecular disulfide bonds. The active ingredient of eptifibatide often exists in an unstable and long-term injection The existence of time. Contents of the invention [0003] The study found that, as a new type of platelet glycoprotein IIb / IIIa receptor antagonist, Aptifertide is indicated for the treatment of acute coronary syndrome (unstable angina p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/08A61K47/12A61P7/02
Inventor 聂涛陶安进龙镭李红玲马亚平袁建成
Owner HYBIO PHARMA
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