Teicoplanin preparation for injection and preparation method thereof

A technology of teicoplanin and injection preparation, applied in the field of medicine, can solve the problems of low yield, low purity, poor clarity and the like

Active Publication Date: 2021-09-14
NORTH CHINA PHARMA COMPANY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The invention discloses a teicoplanin preparation for injection and a preparation method thereof, which solves the problems of low purity, low yield, high cost, poor stability, deep color and poor clarity of existing products

Method used

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  • Teicoplanin preparation for injection and preparation method thereof
  • Teicoplanin preparation for injection and preparation method thereof
  • Teicoplanin preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] A. Adsorption: Teicoplanin fermentation filtrate totals 23.4 billion units, desorbs through macroporous adsorption resin to obtain a total of 16.97 billion units of teicoplanin raw material liquid;

[0038] B. Decolorization: Add 5.1 kilograms of 0.3% 767 injection activated carbon and 5.1 kilograms of 0.3% imported FSAC-01 activated carbon to the above-mentioned teicoplanin raw material solution for decolorization, and the total decolorization solution is 15.34 billion;

[0039] C. DAC column chromatography, the filler is polymer reversed-phase chromatography filler UniPs30-300, the teicoplanin filtrate is eluted through the column, and the total eluent collected is 8.37 billion;

[0040] D. Membrane system concentration: After the chromatographic solution is concentrated by ultrafiltration and then nanofiltration, the concentrated solution is washed with purified water to remove residual solvents, and a total of 8 billion teicoplanin concentrated solutions are obtained...

Embodiment 2

[0043] A. Adsorption: Teicoplanin fermentation filtrate has a total of 25.5 billion units, and a total of 20.87 billion units of desorption liquid is obtained by adsorption and desorption of macroporous adsorption resin;

[0044] B. Decolorization: Add 6.2 kg of 0.3% domestic activated carbon and 6.2 kg of 0.3% imported FSAC-01 activated carbon for decolorization, and the total decolorization solution is 15.9 billion;

[0045] C. DAC column chromatography, the filler is polymer reversed-phase chromatography filler UniPs30-300, and the decolorization solution is obtained by chromatography with a suitable chromatographic solution totaling 8.3 billion;

[0046]D. Membrane system concentration: After the chromatographic solution is concentrated by ultrafiltration and then nanofiltration, the molecular weight cut-off of the ultrafiltration membrane is 5000-10000 Daltons, and the molecular weight cut-off of the nanofiltration membrane is 200-300 Daltons. The concentrated solution is ...

Embodiment 3

[0049] A. Adsorption: Teicoplanin fermentation filtrate has a total of 26.6 billion units, and a total of 21.1 billion units of desorption liquid has been obtained by adsorption and desorption of macroporous adsorption resin;

[0050] B. Decolorization: Add 6.3 kg of 0.3% domestic activated carbon and 6.3 kg of 0.3% imported FSAC-01 activated carbon for decolorization, and the total decolorization solution is 15.77 billion;

[0051] C. Chromatography: the decolorized solution is obtained by chromatography with a suitable chromatographic solution totaling 7.9 billion;

[0052] D. Membrane system concentration: After the chromatographic solution is concentrated by ultrafiltration and then nanofiltration, the molecular weight cut-off of the ultrafiltration membrane is 5000-10000 Daltons, and the molecular weight cut-off of the nanofiltration membrane is 200-300 Daltons. The concentrated solution is washed with purified water Residual solvent was removed to obtain a total of 7.4 b...

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Abstract

The invention discloses a teicoplanin preparation for injection and a preparation method thereof, and belongs to the technical field of medicine, and comprises an injection preparation containing 0.2 g of teicoplanin and an injection preparation of 0.4 g of teicoplanin. The preparation includes: firstly preparing the original powder of teicoplanin, then preparing and filling the medicinal solution, and finally performing freeze-drying treatment. The clarity, color grade, purity, endotoxin qualification rate and yield index of the teicoplanin prepared by the method of the present invention are significantly improved, and the preparation product has high purity, plump appearance, no shrinkage, no bubbling, uniform color, porosity, Firm structure, fast reconstitution speed, low residual moisture, light color, greatly improved clarity and stability. At the same time, the preparation method has low production cost, short production cycle, is more conducive to industrial production, has advanced nature, and has important theoretical significance and application value for the production and clinical application of teicoplanin for injection.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a teicoplanin preparation for injection and a preparation method thereof. Background technique [0002] At present, about 700,000 people die from drug-resistant bacterial infections every year in the world, most of them in developing countries and poor areas. China's antibiotic consumption accounts for about half of the world's total, of which about half is for human use, and the rest is for the food industry. By 2050, antibiotic resistance will cause 1 million premature deaths in Chinese every year, causing a cumulative loss of 20 trillion US dollars to China. The death toll caused by antibiotic resistance worldwide will rise to 10 million, which is more than the current death toll of malignant tumors. Once Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and other similar gut-dwelling organisms develop drug resistance, the new glycopeptide antibiotics vancomyci...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/14A61K9/19A61P31/04
CPCA61K9/0019A61K9/19A61K38/14A61P31/04
Inventor 程林李彦朴张天兵张志江赵辉蒋晓声张慧明张娴栗婷婷安宁李珠陈瑞敏程启东赵建强贾灿刘超吴达
Owner NORTH CHINA PHARMA COMPANY
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