Preparation method of clindamycin phosphate injection

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...

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 phosphate raw material will fly in the process of alternate feeding, causing serious loss of raw materials, polluting the environment, the staff inhaled a large amount, unable to operate, and difficult to form mass production, so that the practical application is limited

This technology uses activated carbon adsorption to remove the heat source. This method has the following technical problems: the viscosity of the liquid medicine is very large, and the loss of the liquid medicine is serious during the filtration process, which makes the yield of the prepared medicine low and increases the production cost.

A 0.45μm microporous filter membrane is used in the pre-filtration process. Due to the high viscosity of the liquid medicine, the filter membrane must be replaced frequently during the filtration process, which will cause loss of the liquid medicine and increase production costs.

thereby increasing the financial burden on patients