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Colistin sulphate purification method

A technology of colistin sulfate and purification method, applied in the purification field of colistin sulfate, can solve the problem of low purity, and achieve the effects of simple process and stable product quality

Inactive Publication Date: 2015-06-03
JIANGSU HANBON SCI & TECH CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, from the purification results, the colistin sulfate produced by the ion exchange method is not high in purity, and the HPLC normalization method measures the total component content, generally only 70-75%, while the European Pharmacopoeia EP6.0 standard is the total Component content not less than 79%

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] The sample was dissolved in mobile phase with a concentration of 100 mg / ml, and was prepared by a semi-preparative high-performance liquid chromatography separation and purification system. 40 mg, mobile phase A is 30 mmol / L anhydrous Na 2 SO 4 Aqueous solution (pH 2.4), mobile phase B is acetonitrile, isocratic elution, the ratio of the two components in the mobile phase, A / B=80 / 20. The detection wavelength of the ultraviolet photometric detector used is 215nm. The colistin sulfate is collected, concentrated by rotary evaporation at 40°C, and then desalted by laboratory-grade nanofiltration equipment. The purity is ≥98.7% by HPLC analysis.

Embodiment 2

[0014] The sample was dissolved in mobile phase with a concentration of 100 mg / ml, and was prepared by a semi-preparative high-performance liquid chromatography separation and purification system. 50 mg, mobile phase A is 30 mmol / L anhydrous Na 2 SO 4 Aqueous solution (pH 2.4), mobile phase B is acetonitrile, isocratic elution, the ratio of the two components in the mobile phase, A / B=80 / 20. The detection wavelength of the ultraviolet photometric detector used is 215nm. The colistin sulfate is collected, concentrated by rotary evaporation at 40°C, and then desalted by laboratory-grade nanofiltration equipment. The purity is ≥98.3% by HPLC analysis.

Embodiment 3

[0016] The sample was dissolved in mobile phase with a concentration of 100 mg / ml, and was prepared by a semi-preparative high-performance liquid chromatography separation and purification system. 80 mg, mobile phase A is 30 mmol / L anhydrous Na 2 SO 4 Aqueous solution (pH 2.4), mobile phase B is acetonitrile, isocratic elution, the ratio of the two components in the mobile phase, A / B=82 / 18. The detection wavelength of the ultraviolet photometric detector used is 215nm. The colistin sulfate is collected, concentrated by rotary evaporation at 40°C, and then desalted by laboratory-grade nanofiltration equipment. The purity is ≥98.0% by HPLC analysis.

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Abstract

The invention discloses a colistin sulphate purification method. The method disclosed by the invention is implemented by using a semi-preparative HPLC (high performance liquid chromatography) separation and purification system and taking a reversed-phase C18 as packing and taking a salt solution and acetonitrile as moving phases. The preparation of colistin sulphate according to the method is simple in operation, less in experimental steps, low in cost and short in cycle, and the purity of prepared colistin sulphate can be more than or equal to 98.0%.

Description

technical field [0001] The invention relates to the field of separation and purification of medicines, in particular to a method for purifying 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. It is heat-resistant, difficult to absorb in the digestive tract, excreted quickly, has low toxicity, no side effects, and is not easy to produce drug-resistant strains. It is one of the safest livestock and poultry growth-promoting antibiotics. Colistin sulfate is a basic polypeptide antibiotic, which is mainly used to prevent and control the infection of sensitive bacteria and promote the growth of livestock and poultry. It has a strong inhibitory effect on Gram-positive bacteria (such as Staphylococcus aureus and hemolytic streptococcus). [0003] Currently, the ion exchange...

Claims

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Application Information

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IPC IPC(8): C07K7/62C07K1/20
Inventor 陈锐金新亮李胜迎
Owner JIANGSU HANBON SCI & TECH CO
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