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Method for preparing clindamycin phosphate powder injection raw medicine

A technology of clindamycin phosphate and powder injection, which is used in pharmaceutical formulations, medical preparations containing active ingredients, and powder transportation, etc., can solve the problems of low crystal bulk density, poor water solubility of finished products, serious electrostatic adsorption, etc. Large crystal bulk density, good fluidity, and the effect of increasing yield

Active Publication Date: 2010-07-14
华北制药华胜有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantages of this process are that the finished product has poor water solubility, small crystal bulk density, large specific volume, serious electrostatic adsorption, poor fluidity, high solvent residue, cumbersome process, and low output.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The crude clindamycin phosphate, absolute ethanol, and purified water are put into a dissolution tank at a weight ratio of 1:4:1.5, and the temperature is raised to 65-70°C until it is completely dissolved, decolorized by activated carbon, and crystallized after aseptic filtration. Before crystallization, pre-cool the crystallization tank at -15-0°C, and feed at a stirring speed of 20-40hz. After the feeding is completed, slowly lower the temperature until the temperature of the feed liquid is lower than 20°C, allowing the crystals to slowly precipitate from the feed liquid. Adjust the stirring speed to 15-35hz, keep the crystallization temperature at -10-5°C, centrifuge after growing the crystal for 10-12 hours, and wash according to the weight ratio of crude product and absolute ethanol at 1:1.5. Pour the clindamycin phosphate wet product after centrifugation into the desiccator, open the valve of the vacuum pipeline, control the vacuum gauge pressure at ≤-0.098MPa, co...

Embodiment 2

[0025] Put the crude clindamycin phosphate, absolute ethanol, and purified water into a dissolution tank at a weight ratio of 1:5:2.1, raise the temperature to 75-82°C until completely dissolved, decolorize with activated carbon, and crystallize after aseptic filtration. Before crystallization, pre-cool the crystallization tank at -15-0°C, and feed at a stirring speed of 20-40hz. After the feeding is completed, slowly lower the temperature until the temperature of the feed liquid is lower than 20°C, allowing the crystals to slowly precipitate from the feed liquid. Adjust the stirring speed to 15-35hz, keep the crystallization temperature at -10-5°C, centrifuge after growing the crystal for 10-12 hours, and wash according to the ratio of crude product to absolute ethanol 1:2.0. Pour the clindamycin phosphate wet product after centrifugation into the desiccator, open the valve of the vacuum pipeline, control the vacuum gauge pressure at ≤-0.098MPa, cold pump for 1-3 hours, heat u...

Embodiment 3

[0027] Put the crude clindamycin phosphate, absolute ethanol, and purified water into a dissolution tank at a weight ratio of 1:7:2.5, raise the temperature to 82°C until completely dissolved, decolorize with activated carbon, and crystallize after aseptic filtration. Before crystallization, pre-cool the crystallization tank at -15-0°C, and feed at a stirring speed of 20-40hz. After the feeding is completed, slowly lower the temperature until the temperature of the feed liquid is lower than 20°C, allowing the crystals to slowly precipitate from the feed liquid. Adjust the stirring speed to 15-35hz, keep the crystallization temperature at -10-5°C, centrifuge after growing the crystal for 10-12 hours, and wash according to the ratio of crude product to absolute ethanol 1:2.0. Pour the clindamycin phosphate wet product after centrifugation into the desiccator, open the valve of the vacuum pipeline, control the vacuum gauge pressure at ≤-0.098MPa, cold pump for 1 to 3 hours, heat u...

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Abstract

The invention discloses a preparation method for a clindamycin phosphate powder injection raw medicine which comprises the steps: (a) purification is carried out on a crude product of clindamycin phosphate; (b) crystallization and crystal growth are carried out on filter liquor after the filter liquor is arranged in a crystallization tank; (c) centrifugal separation and washing are carred on crystallization liquor; (d) fast temperature raising and drying are carried out on a clindamycin phosphate wet finished product. The preparation method for the clindamycin phosphate powder injection raw medicine has the advantages of favorable water solubility, uniform crystal form particles, small specific volume, big bulk density, low solvent residue, and the like. The method also simplifies the process operation, and dramatically enhances the product yield.

Description

technical field [0001] The invention relates to a preparation method of chemically synthesized medicine, in particular to a preparation method of clindamycin phosphate bulk medicine. Background technique [0002] Clindamycin phosphate is a derivative of clindamycin, which is widely used in the treatment of various infectious diseases caused by Gram-positive bacteria and anaerobic bacteria. Currently clinically used clindamycin phosphate has oral preparations and injections. Clindamycin phosphate injection is more popular in clinic because of its strong penetrating power, high bioavailability, and wide distribution into tissues and body fluids. However, the aqueous solution of clindamycin phosphate has poor stability, and the heating and sterilization of the injection during the preparation process also resulted in high drug degradation rate and increased impurity content. There are also many adverse reactions in clinical application. Therefore, the state has banned the cl...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7056A61K9/19A61P31/04
Inventor 孙国伟刘学文吴春虎杨燕平牛宾华
Owner 华北制药华胜有限公司
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