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Method for separating and purifying high-purity sisomicin

A sisomycin, separation and purification technology, applied in chemical instruments and methods, chemical recovery, organic chemistry and other directions, can solve the problems of low purity of sisomycin collection solution, low first pass rate, and inability to increase yield, etc. Achieve the effect of saving investment in fixed assets, optimizing purity and yield, and reducing production cycle

Inactive Publication Date: 2012-11-28
WUXI FORTUNE PHARMA
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Problems solved by technology

This production process has the disadvantages of low production capacity, low output, long production cycle, huge fixed investment, and large floor area.
[0006] 2) Due to the large amount of resin used, the amount of acid and alkali required to activate the resin is also large (including water). The unit acid consumption per kg of sisomycin is 25 kg of concentrated hydrochloric acid, 10 kg of liquid alkali, and 5 kg of liquid ammonia, and the amount of wastewater discharged is large. , especially waste water containing ammonia, the environmental protection pressure is high
[0007] 3) The properties of sisomycin and the main impurity are very similar, and the separation effect is poor. In the resin desorption and absorption collection liquid, the mixture of sisomycin and impurities accounts for a large proportion; the purity of sisomycin collection liquid is low, and the first pass rate is low , needs repeated column separation, the yield is only 45%-60%

Method used

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  • Method for separating and purifying high-purity sisomicin
  • Method for separating and purifying high-purity sisomicin

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Experimental program
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Embodiment 1

[0055] Combine below figure 1 Embodiment is described in detail:

[0056] The resin selected for the separation chromatography column of the present invention is a strongly basic anion exchange resin, such as 711 resin, the resin aperture is 16-50 mesh, the resin column size is Φ600×800mm, and the actual volume of the resin column is 0.22m 3 , the filling volume of each resin column is 0.18m 3 , the actual filling ratio is 82%. The total size of the system is about 5m×5m×6m (length×width×height), and all separation chromatographic columns are integrated in a continuous chromatographic system that rotates in a forward direction in the form of a carousel.

[0057] The purification process of sisomycin continuous chromatographic separation (20 units) is divided into the following areas:

[0058] (1) Analysis area (1~6 units)

[0059] In the analysis area, the continuous elution method is used, all of which are positively fed, and 2~3N ammonia water is connected in series, and...

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Abstract

The invention discloses a method for separating and purifying high-purity sisomicin, which belongs to the technical field of membrane separation combined continuous chromatographic separation and purification of organic compounds. The high-purity sisomicin is separated from a sisomicin strippant by using a continuous chromatographic separation technology and purifying. A system combining ultra and nano-filtration membrane technologies with continuous chromatographic separation is adopted, so that a reasonable temperature condition is controlled in a membrane separation production process, the generation of degradation products is reduced, the production cost can be reduced simultaneously, the production period is shortened, the product quality is enhanced, and the discharge of waste water is reduced; and a sisomicin feed liquid can be separated and purified more effectively through a continuous chromatographic separation system. According to measurement with high performance liquid chromatography (HPLC), the sisomicin purity of a separated and purified product is more than or equal to 95 percent.

Description

technical field [0001] The present invention relates to a separation and purification method of high-purity sisomycin, which mainly uses ultra- and nanofiltration membrane technology to reduce the generation of degraded substances of sisomycin by controlling the temperature conditions in the membrane separation process; The chromatographic separation technique is a method for separating and purifying the by-product produced during the extraction process of sisomycin to obtain high-purity sisomycin. The invention belongs to the technical field of membrane separation combined with continuous chromatographic separation and purification of organic compounds. Background technique [0002] Sithomycin is an aminoglycoside antibiotic that has strong antibacterial activity against Gram-positive and Gram-negative bacteria. The clinical efficacy is similar to that of kanamycin, but the toxicity to the kidney and the eighth cranial nerve is significantly less than that of kanamycin. It...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H15/236C07H1/06
CPCY02P20/582
Inventor 徐建国葛帅卡蒋立欣甘华平宋联付静吴敏李晓明
Owner WUXI FORTUNE PHARMA
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