Method for removing impurities from gentamicin

A technology of gentamicin and concentrated liquid, which is applied in chemical instruments and methods, preparation of sugar derivatives, sugar derivatives, etc., can solve the problems of low yield and the product does not meet the requirements of the new pharmacopoeia, and improve product quality. , the effect of alleviating the pressure of short supply

Inactive Publication Date: 2012-08-15
南阳普康药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The 2010 edition of the Pharmacopoeia of the People's Republic of China has more stringent requirements for its C component and the content of various impurities. However, the existing conventional impurity removal methods often fail to meet the requirements of the new Pharmacopoeia, or the yield is very low

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] A kind of gentamicin impurity removal method of the present invention adopts following steps to carry out impurity removal:

[0014] Take 200,000 u / ml of gentamicin concentrate (from Nanyang Pukang Pharmaceutical Co., Ltd.), and dilute it to 60,000-80,000 u / ml with purified water, so that the volume of the sample will not be too large for subsequent concentration The treatment brings more pressure, and it will not cause uneven adsorption and slow adsorption speed due to high sample concentration, then adjust the pH to 6.0-8.0 with commercially available concentrated hydrochloric acid, and slowly adsorb on the weak acidic cation exchange resin HZD -2 (purchased from Shanghai Huazhen Technology Co., Ltd., East China University of Science and Technology), the adsorption flow rate is 0.5-0.8 BV / h. After the adsorption is completed, wash with about 2BV of purified water until impurities such as chloride ions are removed, and then wash with 0.05-0.15 mol / L dilute ammonia wate...

Embodiment 2

[0017] A kind of gentamicin impurity removal method of the present invention adopts following steps to carry out impurity removal:

[0018] Take 200,000 u / ml of gentamicin concentrate (from Nanyang Pukang Pharmaceutical Co., Ltd.), dilute it to 60,000-80,000 u / ml with purified water, and then adjust the pH to 6.0-8.0 with commercially available concentrated hydrochloric acid. Slowly adsorbed on the weakly acidic cation exchange resin HZD-2 (purchased from Shanghai Huazhen Technology Co., Ltd., East China University of Science and Technology), and the adsorption flow rate was 0.5-0.8 BV / h. After the adsorption is completed, wash with 3.0BV purified water to remove impurities such as chloride ions, and then wash with 0.05-0.15 mol / L dilute ammonia water, with an amount of about 10-15 BV and a flow rate of 1.0-1.5 BV / h to remove most of the Small components with poor adsorption to resin. When the effluent unit is 1700 u / ml, stop washing. Continue to wash with 0.3-0.6 mol / L ammo...

Embodiment 3

[0021] A kind of gentamicin impurity removal method of the present invention adopts following steps to carry out impurity removal:

[0022] Take 200,000 u / ml of gentamicin concentrate (from Nanyang Pukang Pharmaceutical Co., Ltd.), dilute it to 60,000-80,000 u / ml with purified water, and then adjust the pH to between 6.0-8.0 with commercially available concentrated hydrochloric acid. Slowly adsorbed on the weakly acidic cation exchange resin HZD-2 (purchased from Shanghai Huazhen Technology Co., Ltd., East China University of Science and Technology), and the adsorption flow rate was 0.5-0.8 BV / h. After the adsorption is completed, wash with 3.0BV purified water to remove impurities such as chloride ions, and then wash with 0.05-0.15 mol / L dilute ammonia water, with an amount of about 10-15 BV and a flow rate of 1.0-1.5 BV / h to remove most of the Small components with poor adsorption to resin. When the effluent unit is 1800 u / ml, stop washing. Continue to wash with 0.3-0.6 mo...

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PUM

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Abstract

The invention belongs to the technical field of pharmaceutical preparation, and provides a method for removing impurities from gentamicin. The method is characterized by comprising the following steps of: diluting a gentamicin concentrated solution, adjusting the pH value, slowly adsorbing the gentamicin concentrated solution to a weak-acidity cation exchange resin column, then adding ammonia water for washing and removing the impurities, slowly desorbing the gentamicin by the ammonia water, and performing vacuum concentration, sulfuric acidification, activated carbon decoloration and spray drying on the desorbed solution. According to the method, the yield is up to 65% or so, and the quality of a product is improved; the product which meets the quality requirement of a new pharmacopeia is obtained; and the pressure of short supply of high-quality gentamicin in the existing market is relieved to a certain extent.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation and relates to a method for removing impurities of gentamicin. Background technique [0002] Gentamicin is a broad-spectrum aminoglycoside antibiotic whose active ingredient is mainly C 1 、C 2 、C 1a , C 2a etc., and also includes various small components such as sisomicin and micronomycin. The 2010 edition of the Pharmacopoeia of the People's Republic of China has stricter requirements on the C component and the content of various impurities. However, the existing conventional impurity removal methods often fail to meet the requirements of the new Pharmacopoeia, or the yield is very low. Therefore, a new impurity removal method must be adopted in order to produce gentamicin with better quality and meet the requirements of the new pharmacopoeia for impurity content. Contents of the invention [0003] The technical problem to be solved by the present invention is to provide...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H15/236C07H1/06
Inventor 简朝星习羽袁旭耀王香红李红德周海晓朱波张小贝张景林杜旭举
Owner 南阳普康药业有限公司
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