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Injectio for inhibiting platelet aggregation and its preparation process

A technology for platelet aggregation and injection, which is applied in blood diseases, pharmaceutical formulations, extracellular fluid diseases, etc. It can solve the problems of easy generation of insoluble particles, and achieve the effect of inhibiting platelet aggregation and stabilizing platelet aggregation.

Active Publication Date: 2007-06-27
GRAND PHARM (CHINA) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, we believe that the use of citrate buffered injections for intravenous injection has the following disadvantages: citrate buffer is still a substance that is more likely to produce insoluble particles

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0010] Embodiment 1 prescription large volume injection of the present invention

[0011] Tirofiban Hydrochloride 5.618g

[0012] Sodium chloride 900g

[0013] Water for injection up to 100000ml

[0014] A total of 1000 bottles of injection were made

[0015] Preparation Process:

[0016] Preparation of liquid medicine:

[0017] Weigh sodium chloride according to the prescription amount, add it to 5000ml of water for injection, stir until completely dissolved; weigh 0.3% activated carbon in solution, stir well, heat and boil for 15 minutes, after cooling, filter out the activated carbon; accurately weigh according to the prescription amount Dissolve tirofiban hydrochloride completely with water for injection, add it to the above sodium chloride solution, and add water for injection to nearly full amount; use 0.1% hydrochloric acid to adjust the pH to 5.5-6.5, add water for injection to the specified amount, and measure the intermediate content It should be 93.0% to 107.0%...

test approach 1

[0048] The test samples were tested before and after sterilization, and then operated according to the following method: put the samples into the constant temperature sample retention observation box, store them at 60°C, take out the samples on the 5th and 10th days respectively, and conduct a full inspection.

[0049] Under the heating condition of 60°C, the injection stability comparison between the prescription of the present invention and the prescription containing citrate buffer

[0050]

test approach 2

[0052] Test the test samples before and after sterilization, and then operate according to the following method: keep the samples at room temperature for observation, take out the samples at 24 months, and check the pH and clarity.

[0053] Under the condition of 24 months, the injection stability comparison of the prescription of the present invention and the prescription containing citrate buffer

[0054]

[0055] Conclusion: the comparison between the prescription of the present invention and the prescription containing citrate buffer. In the test of heating at 60°C for 10 days, the appearance, content, pH, related substances and clarity are all qualified. However, in the investigation of insoluble particles, it was found that the number of particles in the formulation of the present invention was less than that of the formulation containing citrate buffer after 24 months.

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PUM

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Abstract

The invention relates to an injection for inhibiting platelet aggregation and its preparation process, wherein the injection comprises Tirofiban Hydrochloride, water and sodium chloride, and is prepared through the steps of, weighing sodium chloride by formula amount, charging into 5000ml water, stirring to complete dissolving, weighing activated charcoal 0.3% of the solution amount, and homogenizing, heating and boiling for 15 minutes, cooling down, filtering the activated charcoal, accurately weighing Tirofiban Hydrochloride by formula amount, dissolving completely with water, charging into the sodium chloride solution, and watering to near total amount, adjusting the pH to 5.5-6.5 with hydrochloric acid, watering to specified amount, filtering with 0.45 um microporous filtration film, split charging into bottle, sterilizing 35 minutes through hot compression at 115 deg. C.

Description

technical field [0001] The invention relates to an injection for inhibiting platelet aggregation and a preparation method thereof. Background technique [0002] Tirofiban hydrochloride (English name: Tirofiban hydrochloride, chemical name: (S)-N-(n-butylsulfonyl)-0-[4-(4-piperidinyl)butane]-L-tyrosine Hydrochloride monohydrate) is a salt compound of a platelet inhibitor. Tirofiban hydrochloride inhibits the binding of fibrinogen to platelets and inhibits platelet aggregation through the binding of fibrinogen receptor antagonists to glycoprotein (GP) IIb / IIIa fibrinogen receptor sites. The Chinese Patent Publication No. 1200676A of U.S. Mike Company has described the pharmaceutical composition of this compound, and this patent has described using citrate buffer to be superior to phosphate buffer, the citrate composition stability that contains tirofiban hydrochloride For more than 18 months, particles with a particle size greater than 50um can be seen in the solution after ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4465A61K9/08A61P7/02
Inventor 耿海明谢国范穆惠芳周建明
Owner GRAND PHARM (CHINA) CO LTD
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