Tirofiban hydrochloride freeze-dried powder injecta and preparing method

A technology of tirofiban and needle injection, which is applied in the field of pharmaceutical preparations and its preparation, can solve the problems of solution-insoluble particles, inconvenient transportation, large volume, and heavy weight, and achieve easy storage and transportation, reduced transportation costs, and obvious economic benefits Effect

Active Publication Date: 2008-02-13
SHENYANG XINMA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the tirofiban hydrochloride injections listed at home and abroad all have the disadvantages of large volume and weight, inconvenient transportation and easy damage.
Moreover, the injections on the market are all liquid preparations, which need to undergo final high-temperature sterilization, which has a certain impact on the stability of the active ingredient. During storage, the active ingredient is not as stable as the solid form, and insoluble particles are easily produced in the solution. bring security risks
Freeze-dried powder injection can overcome the above defects, but so far there is no report on the listing of tirofiban hydrochloride freeze-dried powder injection

Method used

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  • Tirofiban hydrochloride freeze-dried powder injecta and preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] prescription

[0024] Tirofiban Hydrochloride Monohydrate 5.62g

[0025] Lactose 200g

[0026]

[0027] Make 1000 pieces

[0028] Get the lactose of prescription quantity, add 1600ml water for injection, stir to dissolve, add 0.1% (g / ml) active carbon for needles, stir at 50 ℃ for 30 minutes, filter and decarbonize, add tirofiban hydrochloride of prescription quantity, stir Make it dissolve, add water for injection to 2000ml, adjust the pH value of the solution to 2.5 with hydrochloric acid or sodium hydroxide, filter aseptically with a 0.22 μm microporous membrane, measure the content of the semi-finished product, quantitatively fill it in a vial, half-tamp, and freeze Dry, aseptic full press stopper, press aluminum plastic cover, and pack it.

[0029] Inspection: 1. Visible foreign matter: According to the method of Appendix IX H of the 2005 edition of the Chinese Pharmacopoeia,...

Embodiment 2

[0032] prescription

[0033] Tirofiban Hydrochloride Monohydrate 5.62g

[0034] Lactose 75g

[0035]

[0036] Make 1000 pieces

[0037] Get the prescription amount of lactose, add 1200ml water for injection, stir to dissolve, add 0.01% (g / ml) active carbon for needles, stir for 60 minutes at 25°C, filter and decarbonize, add the prescription amount of tirofiban hydrochloride, stir Make it dissolve, add water for injection to 1500ml, adjust the pH value of the solution to 2 with hydrochloric acid, aseptic fine filter with a 0.22 μm microporous membrane, measure the content of the semi-finished product, quantitatively fill it in a vial, half stopper, freeze-dry, and aseptic Fully press the plug, press the aluminum-plastic cover, and pack it.

[0038] Inspection: 1. Visible foreign matter: According to the method of Appendix IX H of the 2005 edition of the Chinese Pharmacopoeia, it meets th...

Embodiment 3

[0041] prescription

[0042] Tirofiban Hydrochloride Monohydrate 5.62g

[0043] Lactose 800g

[0044]

[0045] Make 1000 pieces

[0046] Get the prescribed amount of lactose, add 3200ml of water for injection, stir to dissolve, add 0.5% (g / ml) active carbon for needles, stir for 10 minutes at 100°C, filter and decarbonize, add the prescribed amount of tirofiban hydrochloride, stir Make it dissolve, add water for injection to 4000ml, use sodium hydroxide to adjust the pH value of the solution to 3, 0.22 μm microporous filter membrane aseptic fine filtration, measure the content of semi-finished products, quantitatively fill in vials, half stopper, freeze-dry, Sterile fully pressed stopper, pressed aluminum-plastic cap, ready to pack.

[0047] Inspection: 1. Visible foreign matter: According to the method of Appendix IX H of the 2005 edition of the Chinese Pharmacopoeia, it meets the regulations.

...

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PUM

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Abstract

The preparation method of tirofiban hydrochloride freeze-dried powder injection preparation includes the following steps: using 30-1200g of lactose, adding water for injection, dissolving, adding active carbon, stirring for 10-60 min at 25-100deg.C, filtering and removing carbon, adding 5.62g of tirofiban hydrochloride monohydrate, stirring, adding water for injection to 1500-4000ml, regulating pH value of solution to 2-3, sterile filtering, filling, freeze-drying, squeezing cap and packaging, etc.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to an anti-platelet aggregation drug tirofiban hydrochloride freeze-dried powder injection and a preparation method thereof. Background technique: [0002] Tirofiban (English name: Tirofiban) is a non-peptide platelet glycoprotein GP IIb / IIIa receptor antagonist with anti-platelet aggregation effect. Its chemical name is N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine, and its hydrochloride monohydrate is generally used in medicine. [0003] Tirofiban hydrochloride is used to treat patients with acute coronary syndrome (unstable angina or non-Q wave myocardial infarction), and is also suitable for patients with coronary ischemic syndrome undergoing coronary angioplasty or intracoronary atheroma After block resection, tirofiban hydrochloride can reduce the incidence of the composite endpoint of death, myocardial infarction, and refractory myoc...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4465A61K9/19A61P7/02A61P9/10
Inventor 闫志刚黄牧童姚俊平张曦赜
Owner SHENYANG XINMA PHARMA
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