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Tirofiban injection and preparation method thereof

A technology of tirofiban and injection, which is applied in the field of medicine and can solve problems that need to be studied

Active Publication Date: 2021-10-22
GRAND PHARM (CHINA) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Therefore, the current tirofiban hydrochloride injection remains to be studied

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] In this embodiment, hydrochloric acid is prepared according to the following method:

[0023] 1, prescription

[0024] 112.36 mg hydrochloride, 1080mg sodium citrate, 64 mg water citric acid, 280 mg mannitol, sodium hematellarin, hydraulic water to 2L.

[0025] 2, steps

[0026] Take 80% of the injection water, heating temperature rise to 80 ± 10 ° C, sequentially adds mannitol, no water citric acid, sodium citrate, sodium aspartate, stirred for 10 min; Add to regular amount of hydrochloride Class, stirring 15 min; additional 20% injection water, cool to normal temperature, then adjusting pH to 5.5-6.5, stirred for 10 min; filtered after 0.22 μm microporous filter filtration is filtered into infusion bag or infusion bottle, sealing / rolling Cover; 121 ° C Sterilization for 15 min.

Embodiment 2

[0028] In this embodiment, hydrochloric acid is prepared according to the following method:

[0029] 1, prescription

[0030] 112.36 mg hydrochloride, 1080 mg sodium citrate, 64 mg water citric acid, 290 mg mannitol, sodium hemate, sodium hematine, nourishing water to 2L.

[0031] 2, steps

[0032] In the embodiment 1.

Embodiment 3

[0034] In this embodiment, hydrochloric acid is prepared according to the following method:

[0035] 1, prescription

[0036] 112.36 mg of hydrochloride, 1080mg sodium citrate, 64 mg water citric acid, 300 mg mannitol, sodium hematine, sodium nitrogen, nourishing water to 2L.

[0037] 2, steps

[0038] In the embodiment 1.

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Abstract

The invention provides a tirofiban hydrochloride injection and a preparation method thereof. The tirofiban hydrochloride injection comprises tirofiban hydrochloride, sodium citrate, anhydrous citric acid and mannitol. The tirofiban hydrochloride injection provided by the invention has the advantages of strong stability, difficult generation of insoluble particles, good safety and few adverse reactions, and the preparation method is simple and convenient to operate and suitable for large-scale production.

Description

Technical field [0001] The present invention relates to the field of medicine. In particular, the present invention relates to the injection of t trinee and its preparation method thereof. Background technique [0002] Tido Class (English name Tirofibon) is a non-titanium platelet glycoprotein GP IIB / IIIA receptor antagonist, has an anti-platelet agglomeration, its chemical name: N- (n-butylsulfonyl) - O- [4- (4-piperidinyl) butyl] -L-tyrosine hydrochloride monohydrate. Treatted Hydrochloride for the treatment of acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) patient, also suitable for coronary angioplasty or coronary inheritance Block removal. Hydrochloride can reduce the incidence of complex endpoint incidents of death, myocardial infarction, refractory myocardial ischemia / blood reconstruction. [0003] The difficulty of the hydrochloride in the process quality is: the solution is placed, and the insoluble particles are generated at a certain ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4465A61K47/10A61K47/12A61P7/02A61P9/10
CPCA61K31/4465A61K9/0019A61K9/08A61K47/12A61K47/10A61P7/02A61P9/10
Inventor 刘孟王芝蔡一聪丁璞钟怡郑良超
Owner GRAND PHARM (CHINA) CO LTD