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Method for improving total component content of colistin sulphate

A technology of colistin sulfate and component content, which is applied in the field of medicine, can solve the problems of low purity and achieve the effects of improving purity, simple operation and low cost

Active Publication Date: 2011-01-19
APELOA PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the colistin sulfate produced by the ion exchange method is not high in purity, and the total component content measured by the HPLC normalization method is generally only 70-75%, while the standard of the European Pharmacopoeia EP6.0 is that the total component content is not low at 79%

Method used

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  • Method for improving total component content of colistin sulphate
  • Method for improving total component content of colistin sulphate

Examples

Experimental program
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Effect test

Embodiment 1

[0028] Colistin sulfate dry powder (prepared according to the ion exchange method mentioned in the background technology of the present invention, commercially available product) 140g, detected by HPLC normalization method, its total component content is 72.64%, add pure water to dissolve to 550ml, then Add 350ml of acetone while stirring, and let stand to separate layers. After 1 hour, separate the supernatant and the lower layer of precipitate with a separatory funnel. Add water to the lower layer of precipitate to 680ml before it is completely dissolved. Take about 10ml of dilution and detect it by HPLC normalization method. Its total component content is 77.69%;

[0029]For the remaining 670ml, 240ml of acetone was added while stirring, and the layers were allowed to stand. After 1 hour, the supernatant was separated from the lower precipitate with a separatory funnel, and the lower precipitate was vacuum-dried at 80°C for 4 hours to obtain 106.7g of colistin sulfate dry po...

Embodiment 2

[0031] Colistin sulfate dry powder (prepared according to the ion exchange method mentioned in the background technology of the present invention, commercially available product) 150g, detected by HPLC normalization method, its total component content is 71.79%, add pure water to dissolve to 590ml, then Add 180ml of ethanol while stirring, and let stand to separate layers. After 1 hour, separate the supernatant and the lower layer of sediment with a separatory funnel. Add water to the lower layer of precipitate to 650ml before it is completely dissolved. Take about 10ml of dilution and detect it by HPLC normalization method. Its total component content is 78.13%;

[0032] For the remaining 640ml, 120ml of ethanol was added while stirring, and the layers were allowed to stand. After 1 hour, the supernatant was separated from the lower precipitate with a separatory funnel, and the lower precipitate was vacuum-dried at 80°C for 4 hours to obtain 126.7g of colistin sulfate dry powd...

Embodiment 3

[0034] Colistin sulfate dry powder (prepared according to the ion exchange method mentioned in the background technology of the present invention, commercially available product) 120g, detected by HPLC normalization method, its total component content is 72.77%, add pure water to dissolve to 550ml, then Add 270ml of isopropanol while stirring, let it stand for stratification, and separate the supernatant and the lower layer of precipitate with a separatory funnel after 1 hour, add water to the lower layer of precipitate to 630ml before completely dissolving, take about 10ml of dilution, and then normalize by HPLC Detection, its total component content is 77.36%;

[0035] For the remaining 620ml, 240ml of isopropanol was added while stirring, and the layers were allowed to stand. After 1 hour, the supernatant was separated from the lower precipitate with a separatory funnel, and the lower precipitate was vacuum-dried at 80°C for 4 hours to obtain colistin sulfate dry powder 88.3...

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Abstract

The invention belongs to the field of antibiotic medicaments and in particular discloses a method for improving the total component content of colistin sulphate. By adding an alcohol solvent or a ketone solvent with no more than six carbon atoms into aqueous solution of the colistin sulphate, the total component content of the colistin sulphate is obviously improved to reach the standard of EP6.0. Besides, a high-purity colistin sulphate sample also can be obtained by the method of the invention. The method has the advantages of low cost, convenient recovery of the solvent, simple operation, suitability for industrial amplification and capacity of efficiently improving the purity of the colistin sulphate.

Description

technical field [0001] The invention belongs to the field of medicines, in particular to a method for refining antibiotics, in particular to a method for increasing the content of the total components of colistin sulfate. Background technique [0002] Colistin sulfate is white or off-white powder with bitter taste and hygroscopicity. Insoluble in methanol or ethanol, almost insoluble in ether and chloroform. Colistin sulfate is the sulfate salt of polymyxin. Polymyxin, which was discovered in 1947 and produced by Bacillus polymyxa Macé, is a general term for a family of basic polypeptide antibiotics composed of various amino acids and fatty acids. The molecular structure of polymyxin is as follows: [0003] [0004] Note: Dab—α,γ-diaminobutyric acid; MOA—(+)-6-methyloctanoic acid; IOA—isooctanoic acid. [0005] It can be seen from the above table that each component is a 10-peptide containing a 7-membered ring. The difference between each component is D-phenylalanine...

Claims

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Application Information

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IPC IPC(8): C07K7/62C07K1/30
Inventor 周晋武
Owner APELOA PHARM CO LTD
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