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Refining method of clindamycin phosphate

A technology of clindamycin phosphate and refining method, which is applied in the field of medicine and chemical industry, can solve the problems of long time, about 5-6 hours, degradation of clindamycin phosphate, and short dissolution time, so as to reduce impurities content, avoid hydrolytic degradation, improve quality and purity

Inactive Publication Date: 2018-04-06
GUANGZHOU BAIYUSN TIANXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patent dissolves clindamycin directly in 0.25-5mol / L alkaline solution, and the pH of this alkaline solution is above 10; The dissolution time of ester is short, about 20-30 minutes, and the degradation is not obvious, but if it is used in large-scale production, the time from dissolution to crystallization is very long, about 5-6 hours, or even longer, long-term exposure to high-concentration alkali Aqueous aqueous solution easily degrades clindamycin phosphate seriously

Method used

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  • Refining method of clindamycin phosphate

Examples

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Effect test

Embodiment 1

[0017] Weigh 50g of clindamycin phosphate, add it to 200ml of methanol and stir evenly, add diethylamine dropwise until the solution is clear, decolorize activated carbon and sterilize and filter, add dropwise 1mol / L hydrogen chloride ethanol solution that has been sterilized and filtered to pH3 .5. Stir and grow the crystal for 1 hour, filter, wash, and vacuum dry at 50°C.

Embodiment 2

[0019] Weigh 50g of clindamycin phosphate, add it to 500ml of absolute ethanol and stir evenly, add triethylamine dropwise until the solution dissolves, decolorize the activated carbon and filter it for sterilization, add dropwise the 1mol / hydrogen chloride ethanol solution that has been sterilized and filtered to pH 4.0, stirred for 1 hour to grow crystals, filtered, washed, and vacuum dried at 50°C.

Embodiment 3

[0021] Weigh 50 g of clindamycin phosphate, add it to 450 ml of isopropanol and stir evenly, add isopropylamine dropwise until the solution dissolves, activate carbon for decolorization and sterilize and filter, add 1 mol / L hydrogen chloride ethanol solution that has been sterilized and filtered to pH 4.5, stirred for 1 hour to grow crystals, filtered, washed, and vacuum dried at 50°C.

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Abstract

The invention relates to a refining method of clindamycin phosphate and is suitable for the pharmaceutical industry. The refining method comprises the following steps: dispersing clindamycin phosphatein a low alcohol of 4-10 times; adding organic alkali till the clindamycin phosphate is fully dissolved while stirring; decoloring, degerming and filtering the mixture; adding a degermed and filteredhydrogen chloride ethanol solution till the pH is 3.5-4.5; crystallizing the mixture for 1h; and filtering, washing and drying the mixture in vacuum. The clindamycin phosphate is prepared in an anhydrous system, so that the probability of hydrolytic degradation is avoided. The refining method is operated at normal temperature, is low in energy consumption, short in production period and high in yield by adopting the low alcohol, and the yield reaches 99% or above.

Description

technical field [0001] The invention belongs to the technical field of medicine and chemical industry, and relates to a preparation method of clindamycin phosphate. technical background [0002] Clindamycin phosphate is a derivative of lincomycin, which is inactive in vitro. After being injected into the body, it is rapidly hydrolyzed into clindamycin to exert pharmacological effects. This product is mainly suitable for various infectious diseases caused by Gram-positive bacteria and anaerobic bacteria. [0003] Patents 200810080151.7, 201010165888.6, and 201510040920.0 all disclose similar refining methods of clindamycin phosphate or preparation methods of sterile raw materials, that is, dissolving clindamycin phosphate in a mixed system of ethanol and water, and then cooling down to crystallize. Filter and dry in vacuum in sections. However, the clindamycin phosphate aqueous solution is extremely unstable under high temperature conditions, and it begins to undergo obviou...

Claims

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Application Information

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IPC IPC(8): C07H15/16C07H1/06
CPCC07H1/06C07H15/16
Inventor 谭胜连文青司徒小燕郭泽彬傅锶俣许小漫
Owner GUANGZHOU BAIYUSN TIANXIN PHARMA
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