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Method for preparing polymyxin B sulfate for injection

A polymyxin and injection technology, applied in the field of medicine, can solve problems such as adverse reactions, unstable quality, complex components, etc., and achieve the effect of improving stability and reducing safety risks in use

Active Publication Date: 2018-07-24
湖北美林药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since polymyxin B is a composition with complex components and high viscosity, it has no fixed melting point after being frozen in an aqueous solution, and has high requirements on the freeze-drying process. The final product of the prior art has collapsed appearance and unstable quality. , and there are many insoluble particles, which can easily cause adverse drug reactions

Method used

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  • Method for preparing polymyxin B sulfate for injection
  • Method for preparing polymyxin B sulfate for injection
  • Method for preparing polymyxin B sulfate for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1 Preparation of polymyxin B sulfate for injection (specification: 500,000 units)

[0034] (1) Add 62g of polymyxin B sulfate into 600ml of water for injection and stir to dissolve, add water for injection to 1000ml, and stir evenly;

[0035] (2) Filter the solution in step 1 through a 0.22 μm filter membrane, measure the pH value and content of the filtrate, determine the filling volume (about 1ml) according to the specifications, and divide into half-stoppered filling liquid;

[0036] (3) Freeze-drying:

[0037] ① Pre-freezing: put the aliquot in a freezer that has been cooled to -28°C in advance, and keep it for 3 hours;

[0038] ②Sublimation: Turn on the vacuum device, adjust the vacuum degree to 14Pa, raise the temperature at a constant speed (1.5°C / h) to -12°C, and keep at this temperature for 10 hours;

[0039] ③Drying: heat up to 38°C at a uniform speed, dry for 7 hours, pack and store after passing the test, and obtain polymyxin B sulfate for injectio...

Embodiment 2

[0040] Example 2 Preparation of polymyxin B sulfate for injection (specification: 500,000 units)

[0041] (1) Add 62g of polymyxin B sulfate into 600ml of water for injection and stir to dissolve, add water for injection to 1000ml, and stir evenly;

[0042] (2) Filter the solution in step 1 through a 0.22 μm filter membrane, measure the pH value and content of the filtrate, determine the filling volume (about 1ml) according to the specifications, and divide into half-stoppered filling liquid;

[0043] (3) Freeze-drying:

[0044] ① Pre-freezing: put the aliquot in a freezer that has been cooled to -23°C in advance, and keep it for 4 hours;

[0045] ②Sublimation: Turn on the vacuum device, adjust the vacuum degree to 14Pa, raise the temperature at a constant speed (2.0°C / h) to -7°C, and keep at this temperature for 10 hours;

[0046] ③Drying: heat up to 38°C at a uniform speed, dry for 7 hours, pack and store after passing the test, and obtain polymyxin B sulfate for injection...

Embodiment 3

[0047] Example 3 Preparation of polymyxin B sulfate for injection (specification: 500,000 units)

[0048] (1) Add 62g of polymyxin B sulfate into 600ml of water for injection and stir to dissolve, add water for injection to 1000ml, and stir evenly;

[0049] (2) Filter the solution in step 1 through a 0.22 μm filter membrane, measure the pH value and content of the filtrate, determine the filling volume (about 1ml) according to the specifications, and divide into half-stoppered filling liquid;

[0050] (3) Freeze-drying:

[0051] ① Pre-freezing: place the aliquot in a freezer that has been cooled to -25°C in advance, and keep it for 3.5 hours;

[0052] ②Sublimation: Turn on the vacuum device, adjust the vacuum degree to 14Pa, raise the temperature at a constant speed (1.8°C / h) to -10°C, and keep at this temperature for 10 hours;

[0053] ③Drying: heat up to 38°C at a uniform speed, dry for 7 hours, pack and store after passing the test, and obtain polymyxin B sulfate for inje...

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PUM

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Abstract

The invention relates to a method for preparing polymyxin B sulfate for injection. The auxiliary material of the prepared polymyxin B sulfate for injection is injection water only, and the specification of the polymyxin B sulfate for injection is 0.5 million units. The polymyxin B sulfate for injection, prepared through the method, has significantly improved quality and stability, and has significantly reduced insoluble particle quantity.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a preparation method of polymyxin B sulfate for injection. Background technique [0002] Polymyxins are a group of polypeptide antibiotics produced by Bacillus polymyxa. Polymyxin B is used for medicinal purposes, and its sulfate salt is commonly used. Polymyxin B properties: white or light yellow powder. Soluble in water, slightly soluble in alcohol. Stable at pH=5.7-7.5, unstable in alkaline environment, polymyxin B is effective against Gram-negative bacilli, such as Escherichia coli, Pseudomonas aeruginosa, para-Escherichia coli, Klebsiella pneumoniae, acidophilus, pertussis Bacillus and Shigella have inhibitory or bactericidal effects. Clinically, it is mainly used for infection caused by sensitive bacteria and urinary system infection caused by Pseudomonas aeruginosa, as well as eye, trachea, meningitis, sepsis, burn infection, skin and mucous membrane infection, etc. P...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/12A61P31/04
CPCA61K9/0019A61K9/19A61K38/12
Inventor 不公告发明人
Owner 湖北美林药业有限公司
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