Tirofiban hydrochloride injection and preparation method thereof

A technology for tirofiban and injection, which is applied in the field of tirofiban hydrochloride injection and its preparation, can solve problems such as hidden safety hazards, increased substance content, unstable properties, etc., and achieves good effect, high active substance content, Simple preparation process

Active Publication Date: 2018-11-06
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] At present, tirofiban hydrochloride injection is easy to decompose when exposed to light during storage, and its properties are unstable, and the content of related substances increases, which brings certain safety hazards to clinical medication

Method used

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  • Tirofiban hydrochloride injection and preparation method thereof
  • Tirofiban hydrochloride injection and preparation method thereof
  • Tirofiban hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Embodiment 1: 10 bottles of tirofiban hydrochloride prescription and its preparation method are as follows:

[0042] prescription:

[0043] Tirofiban Hydrochloride 50mg

[0044] Sodium Alginate 500mg

[0045] Appropriate amount of PH regulator

[0046] Preparation Process:

[0047] 1) Dissolving citric acid and citric acid in 30% water to prepare a citric acid-sodium citrate buffer solution for later use;

[0048] 2) Dissolve tirofiban hydrochloride and sodium alginate in 50% water, mix with the buffer solution in step 1), set the volume to 1000ml in full, and set aside;

[0049] 3) Use dipotassium hydrogen phosphate to adjust the pH value of the mixture obtained in step 2) to 6.0, filter it through a 0.22 μm microporous membrane, and pack it into glass infusion bottles, stopper, cap, sterilize, light check, and pack. .

Embodiment 2

[0050] Embodiment 2: 10 bottles of tirofiban hydrochloride prescription and its preparation method are as follows:

[0051] prescription:

[0052] Tirofiban Hydrochloride 250mg

[0053] Sodium Alginate 1500mg

[0054] Appropriate amount of PH regulator

[0055] Preparation Process:

[0056] 1) Dissolving citric acid and citric acid in 30% water to prepare a citric acid-sodium citrate buffer solution for later use;

[0057] 2) Dissolve tirofiban hydrochloride and sodium alginate in 50% water, mix with the buffer solution in step 1), set the volume to 1000ml in full, and set aside;

[0058]3) Use dipotassium hydrogen phosphate to adjust the pH value of the mixture obtained in step 2) to 6.0, filter it through a 0.22 μm microporous membrane, and pack it into glass infusion bottles, stopper, cap, sterilize, light check, and pack. .

Embodiment 3

[0059] Embodiment 3: 10 bottles of tirofiban hydrochloride prescription and its preparation method are as follows:

[0060] prescription:

[0061] Tirofiban Hydrochloride 10mg

[0062] Sodium Alginate 50mg

[0063] Appropriate amount of PH regulator

[0064] Preparation Process:

[0065] 1) Dissolving citric acid and citric acid in 30% water to prepare a citric acid-sodium citrate buffer solution for later use;

[0066] 2) Dissolve tirofiban hydrochloride and sodium alginate in 50% water, mix with the buffer solution in step 1), set the volume to 1000ml in full, and set aside;

[0067] 3) Use dipotassium hydrogen phosphate to adjust the pH value of the mixture obtained in step 2) to 6.0, filter it through a 0.22 μm microporous membrane, and pack it into glass infusion bottles, stopper, cap, sterilize, light check, and pack. .

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Abstract

The invention relates to tirofiban hydrochloride injection and belongs to the field of pharmaceutical preparation. The injection disclosed by the invention is prepared from tirofiban hydrochloride, sodium alginate, a pH regulator and water. A preparation method comprises the steps of dissolving citric acid and sodium citrate into 10 to 50% of water to be prepared into a citric acid-sodium citratebuffer solution, then dissolving the tirofiban hydrochloride and the sodium alginate into water and mixing two solutions; adjusting a pH value and then filtering, subpackaging, disinfecting, light checking and packaging to obtain the tirofiban hydrochloride injection. According to the tirofiban hydrochloride injection disclosed by the invention, an osmotic pressure regulator is optimally chosen, acontent of active substances is high, and stability of a main drug can be kept under the conditions of high temperature, illumination and the like; a preparation technology has the advantages of simpleness, suitability for industrial production and convenience in market popularization.

Description

technical field [0001] The invention relates to a tirofiban hydrochloride injection and a preparation method thereof, belonging to the field of pharmaceutical preparations. technical background [0002] Tirofiban is a non-peptide platelet membrane glycoprotein IIb / IIIa (GP IIb / IIIa) receptor antagonist, which has the effect of blocking platelet cross-linking and platelet aggregation. Its chemical name is (S)-N-(n-butylsulfonyl-O-[4-(4-piperidinyl)butane]-L-tyrosine, and its hydrochloride monohydrate is generally used in medicine . [0003] Tirofiban hydrochloride inhibits the binding of fibrinogen to platelet membrane G P IIb / IIIa receptors, thereby blocking platelet cross-linking and platelet aggregation. It is clinically used to treat patients with acute coronary syndrome (ACS), and it is also suitable for patients with acute coronary syndrome to undergo coronary angioplasty or intracoronary plaque resection, which can reduce death, myocardial infarction, and refractory ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/36A61K31/4465A61P7/02
CPCA61K9/0019A61K9/08A61K31/4465A61K47/36A61P7/02
Inventor 张贵民王昭钦
Owner LUNAN PHARMA GROUP CORPORATION
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