Preparation method of clindamycin phosphate injection

A technology of clindamycin phosphate and injection, which can be applied to medical preparations containing active ingredients, pharmaceutical formulations, drug delivery and other directions, can solve problems such as poor stability, increased economic burden on patients, and reduced drug efficacy, etc. Achieve the effect of improving drug stability, reducing economic burden, and solving dust pollution

Active Publication Date: 2011-08-10
辽宁格林生物药业集团股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] But existing clindamycin phosphate injection all adopts the method for high-temperature sterilization to sterilize in the preparation process, and clindamycin phosphate is not good to heat stability, adopts this method to carry out sterilization, reduces Drug efficacy
In order to solve the above-mentioned technical problems, the Chinese patent, the publication number is CN1969875A, the patent application number is 200610134458.1, and the invention name is the preparation process of clindamycin phosphate injection, which solves the above-mentioned problems, but this patented technology is only suitable for laboratories. It is not suitable for large-scale production in the production workshop because of the following reasons: the method of alternate feeding is adopted in the preparation process, and because the raw material of clindamycin phosphate is light in weight, sodium hydroxide will Exothermic, so the clindamycin p

Method used

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Examples

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Effect test

Embodiment 1

[0012] The preparation method of clindamycin phosphate injection, it is prepared by following raw materials, clindamycin phosphate 300g, sodium hydroxide 24.3g, get the sodium hydroxide that meets described parts by weight and be dissolved in In 1500g of water for injection, take the clindamycin phosphate raw material that meets the stated parts by weight and dissolve it in sodium hydroxide solution, stir evenly, add water for injection to dissolve to 2000ml, and then use a 0.65 μm microporous membrane to carry out coarse Filter, and then use a 0.22 μm microporous membrane to carry out fine filtration and sterilization, and fill to obtain clindamycin phosphate injection.

Embodiment 2

[0014] The preparation method of clindamycin phosphate injection, it is prepared by the following raw materials, content is 80% clindamycin phosphate 375g, sodium hydroxide 24.75g, get the content that meets the described parts by weight Dissolve sodium hydroxide in 1700g water for injection, take the clindamycin phosphate raw material that meets the stated parts by weight and dissolve it in the sodium hydroxide solution, stir evenly, add water for injection to dissolve to 2000ml, and then use 0.65 μm micro pore filter membrane for coarse filtration, and then 0.22 μm microporous filter membrane for fine filtration and sterilization, and filling to obtain clindamycin phosphate injection.

Embodiment 3

[0016] The preparation method of clindamycin phosphate injection, it is prepared by the following raw materials, content is 80% clindamycin phosphate 400g, sodium hydroxide 25.5g, get the content that meets described parts by weight Dissolve sodium hydroxide in 1900g water for injection, take the clindamycin phosphate raw material that meets the stated parts by weight and dissolve it in the sodium hydroxide solution, stir evenly, add water for injection to dissolve to 2000ml, and then use 0.65 μm micro pore filter membrane for coarse filtration, and then 0.22 μm microporous filter membrane for fine filtration and sterilization, and filling to obtain clindamycin phosphate injection.

[0017] The clindamycin phosphate injection that the embodiment of the present invention 1-3 makes and the patent application number are the test data of the quality research of the clindamycin phosphate injection that the 200610134458.1 patent method makes as follows:

[0018] testing sample:

[...

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Abstract

The invention discloses a chemical injection, and particularly relates to a preparation method of a clindamycin phosphate injection. The clindamycin phosphate injection is prepared from the following raw materials in grams: clindamycin phosphate 300-400 g and sodium hydroxide 24.3-25.5 g. The preparation method comprises the following steps: dissolving 24.3-25.5g of sodium hydroxide in 1500-1900 g of water for injection, dissolving 300-400 g of clindamycin phosphate in the sodium hydroxide solution, stirring uniformly, adding water for injection to a constant volume of 2,000 mL, performing coarse filtering with a 0.65 mu m microporous filter membrane, performing fine filtering with a 0.22 mu m microporous filter membrane for sterilizing, and filling to obtain the clindamycin phosphate injection. The preparation method provided by the invention has the characteristics of applicability to mass production, high product yield, stable drug quality, and good therapeutic effect of drugs.

Description

technical field [0001] The invention relates to a chemical drug injection, in particular to a preparation method of clindamycin phosphate injection. Background technique [0002] Clindamycin, also known as clindamycin, was first synthesized by Magerlein et al. in 1966. Upjohn Corporation of the United States first successfully developed it and obtained a patent right in the United States in 1969. In 1975, it was jointly developed by North China Pharmaceutical Factory and Beijing Pharmaceutical Industry Research Institute in China. [0003] At present, many companies in the world produce clindamycin, and Pharmacia Upjohn, Alter, Sumitomo, etc. are the main manufacturers. There are also many domestic manufacturers put into production. Since clindamycin was launched on the market, because of its broad antibacterial spectrum, less side effects, antibacterial activity is 4 times greater than lincomycin, the dosage is also smaller than lincomycin, clinical curative effect is uni...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7056A61K47/02A61P31/04
Inventor 李迅吴红艳王光
Owner 辽宁格林生物药业集团股份有限公司
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