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Purification method of polymyxin E sulfate components

A polymyxin sulfate and purification method technology, applied in the field of medicine, can solve problems such as differences, obstacles in drug administration, and defects in effectiveness and safety, and achieve the effect of mild operating conditions and weak adsorption

Inactive Publication Date: 2016-06-29
HEBEI SHENGXUE DACHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] It is well known that the stability of multi-component pharmaceutical preparations is difficult to control, especially for injections, the physical and chemical stability, osmotic pressure, clarity, pH and other aspects of multi-component pharmaceuticals are not easy to form stable components due to the interaction between components. Due to storage, temperature, light and other factors, multi-component pharmaceutical preparations are more prone to changes such as discoloration, precipitation, and decomposition
In addition, the effectiveness and potential safety of multi-component drugs also have certain shortcomings
In addition, the difference in the chemical structure of multi-component drugs will lead to differences in their pharmacokinetic behavior in vivo, which increases the difficulty of pharmacokinetic research, and thus has a great impact on the design of safe drug doses and reasonable drug administration. ways to bring technical hurdles

Method used

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  • Purification method of polymyxin E sulfate components
  • Purification method of polymyxin E sulfate components

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] (a) Weigh an appropriate amount of polymyxin E sulfate, add water to dissolve it into a solution with a concentration of 100g / L, and load it on the G-10 gel medium according to the sample loading of 30g / L;

[0041] (b) Elute it with 35% methanol solution, the flow rate is 0.8BV / h, and start to collect when the white precipitate is titrated with 0.25% phosphotungstic acid. For HPLC analysis and chromatographic conditions, refer to the determination of the purity of polymyxin E in European Pharmacopoeia 8.0, and the eluents with a purity of polymyxin sulfate E2 of more than 90% and a purity of polymyxin sulfate E1 of more than 90% are combined ;

[0042] (c) Evaporate the eluent combined in the previous step to remove the organic solvent with a vacuum film at a temperature of 50° C., and then adjust the pH value to 4.0 with sulfuric acid;

[0043] (d) Spray drying, the inlet air temperature is 190°C, and the outlet air temperature is 110°C. As a result, 15g polymyxin su...

Embodiment 2

[0045] (a) Weigh an appropriate amount of polymyxin E sulfate, add water to dissolve it into a solution with a concentration of 100g / L, and load it on the G-25 gel medium according to the sample loading of 60g / L;

[0046] (b) Elution with 20% chloroform solution, flow rate 0.8BV / h, regularly collect a group of sample groups every 30min, use analytical HPLC analysis, chromatographic conditions refer to the purity determination of polymyxin E in European Pharmacopoeia 8.0 , combining the eluates with polymyxin sulfate E2 purity of more than 90% and polymyxin sulfate E1 purity of more than 90%;

[0047] (c) Evaporate the combined eluent in the previous step to remove the organic solvent with a vacuum film at a temperature of 40° C., and then adjust the pH value to 4.2 with sulfuric acid;

[0048](d) Spray drying, the inlet air temperature is 130°C, and the outlet air temperature is 90°C. As a result, 12 g of polymyxin sulfate E2 and 5 g of polymyxin sulfate E1 were obtained, the...

Embodiment 3

[0050] (a) Weigh an appropriate amount of polymyxin E sulfate, add water to dissolve it into a solution with a concentration of 100g / L, and load it on the G-15 gel medium according to the sample loading of 40g / L;

[0051] (b) Elution with 45% acetonitrile solution, flow rate 0.8BV / h, regularly collect a group of sample groups every 30min, use analytical HPLC analysis, chromatographic conditions refer to the purity determination of polymyxin E in European Pharmacopoeia 8.0 , combining the eluates with polymyxin sulfate E2 purity of more than 90% and polymyxin sulfate E1 purity of more than 90%;

[0052] (c) Evaporate the combined eluent in the previous step to remove the organic solvent with a vacuum film at a temperature of 60° C., and then adjust the pH value to 3.8 with sulfuric acid;

[0053] (d) Spray drying, the inlet air temperature is 180°C, and the outlet air temperature is 90°C. As a result, 18 g of polymyxin sulfate E2 and 10 g of polymyxin sulfate E1 were obtained,...

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Abstract

The invention discloses a purification method of polymyxin E sulfate components, and relates to the technical field of medicine. The purification method includes the following steps that firstly, polymyxin E sulfate is dissolved with water, and a sample is loaded to a gel medium; secondly, elution is carried out with an organic solvent after the first step is finished, and fractional collection and fusion of elution liquor containing polymyxin sulfate E1 and E2 are carried out; thirdly, the fused elution liquor obtained in the second step is taken, and the pH value is regulated with sulfuric acid after the organic solvent is removed; fourthly, spray drying is carried out after the third step is finished, and purified products of the polymyxin sulfate E2 and E1 components are obtained. According to the purification method, operation is carried out with gel which belongs to inert carriers, does not carry charges and is weak in adsorption capacity, so that the operation condition is mild, no damage is caused to the polymyxin E2 and E1 components, the polymyxin E2 and E1 components are protected to the maximum degree, and the content of the purified products of the polymyxin E2 and E1 components reaches 90%.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for purifying polymyxin sulfate E components. Background technique [0002] Polymyxin E is a polypeptide antibiotic composed of multiple components, mainly composed of E2 and E1. In the 1950s, polymyxin E was used clinically, mainly for infections caused by Gram-negative bacteria, especially the treatment of infections caused by multidrug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii. [0003] Since the 1980s, due to the high incidence of nephrotoxicity and neurotoxicity, the application of polymyxin E has been limited and almost abandoned clinically. However, in recent years, due to the emergence of Gram-negative bacterial drug-resistant strains, especially multi-drug-resistant strains, and the limited development of new drugs, polymyxin E has once again attracted the attention of the global medical community. Similarly, how to improve the antibacteria...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K7/62C07K1/16
CPCC07K7/62
Inventor 常国栋
Owner HEBEI SHENGXUE DACHENG PHARMA
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