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Method for purifying gentamicin sulphate

A technology of gentamicin sulfate and hydrochloric acid, which is applied in the field of medicine and chemical industry, can solve the problems of high production cost and difficulty in meeting standards, and achieve the effect of low cost, good quality and low investment

Inactive Publication Date: 2013-12-18
南阳普康药业有限公司 +1
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  • Abstract
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  • Claims
  • Application Information

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Problems solved by technology

[0003] Although various enterprises have made great efforts in the mutagenesis and selection of strains, including Micromonas spinosa, Micromonas magenta and Micromonas olivine, adjustment of fermentation formula, and regulation of process parameters in fermentation extraction. A lot of research and experimental work have been done, and the result is that it is difficult to meet the standards of the 2010 edition of the "Chinese Pharmacopoeia", or although the standards have been met, the production costs are extremely high

Method used

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Embodiment Construction

[0019] The method for purifying gentamicin sulfate of the present invention is that the gentamicin fermented liquid is statically exchanged with 732 cationic resins, washed with dilute hydrochloric acid, washed with dilute ammonia once, eluted with concentrated ammonia once, concentrated once, and then adjusted pH, resin Gentamicin sulfate is produced through fixed bed dynamic adsorption, secondary dilute ammonia washing, analysis, secondary concentration, decolorization by salt conversion, and spraying.

[0020] For this reason, the method for gentamicin sulfate purification of the present invention specifically comprises the following steps:

[0021] ①. Put or pump the fermentation hydraulic pressure into the resin exchange storage tank, according to its volume and estimated unit, cast the 732 type cationic resin with a saturation of 70000u / ml, and exchange it for more than 6 hours under the condition of stirring, Then separate the resin, remove iron, and rinse to get satura...

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Abstract

The invention discloses a method for purifying gentamicin sulphate. The method comprises the steps of: carrying out static exchange on a gentamicin fermentation broth by using 732 cation resin; washing by diluted hydrochloric acid; carrying out primary washing by dilute ammonia, primary elution by thick ammonia and primary concentration; and carrying out the technical processes such as pH adjustment, resin fixed bed dynamic adsorption, secondary washing by dilute ammonia, resolution, secondary concentration, salt conversion decoloration, and spraying to produce the gentamicin sulphate. According to the method, the quality indexes of the gentamicin sulphate bulk drug product can reach the requirements of Chinese Pharmacopoeia 2010, and the content of each related substance can conform to the quality requirements of Chinese Pharmacopoeia 2010 on bulk drugs for production of small-volume injection of gentamicin sulphate. The method has the characteristics of high yield, good quality and low cost. Meanwhile, original production equipment is combined in production, so that low investment cost is realized and the maximum economic benefit is achieved.

Description

technical field [0001] The invention belongs to the technical field of medicine and chemical industry, in particular to a method for purifying gentamicin sulfate. Background technique [0002] According to the production quality situation of each production enterprise of the national gentamicin sulfate bulk drug at present, with respect to its C 1 It is very difficult for individual production enterprises to effectively meet the component requirements of the original "Chinese Pharmacopoeia" 2005 edition gentamicin sulfate quality standard. In the 2010 edition of the "Chinese Pharmacopoeia", in addition to the requirements of the 2005 edition, the content of related substances (sisomicin, micronomycin, individual impurities and total impurities) is also included in the standards for the quality of gentamicin sulfate. included in the standard. Due to the consistency of components and related substance content of the bulk drug and small-volume injection of gentamicin sulfate ...

Claims

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Application Information

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IPC IPC(8): C07H15/236C07H1/06
Inventor 李静仁尚增强夏汉卿李彦博赵永幸田国宝张景林
Owner 南阳普康药业有限公司
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