盐酸克林霉素注射液处方及生产工艺的初步研究

Initial Research of Prescription and Production Technology of Clindamycin Hydrochloride Injection

利用相对含量测定和外观观察等方法对盐酸克林霉素注射液的抗氧剂和有关的生产工艺进行筛选和优化。在VC、Na2S2O3、L-半胱氨酸、EDTA-2Na、Na2S2O5五种抗氧剂当中,使用EDTA-2Na效果最好。生产工艺当中,选择pH4.0时加入0.2%活性炭进行脱色;灭菌时,选择的条件为流通蒸气115℃30min;结论:EDTA-2Na作为盐酸克林霉素注射液的抗氧剂较好。pH4.0时加入0.2%活性炭进行脱色;选择流通蒸气115℃进行灭菌30min是比较优化的生产工艺指标。

Methods such as opposite content measurement and appearance surface observation were used to select and optimize production technology and the antioxidant in clindamycin hydrochloride injection.It was found that EDTA-2Na had the most capbability of antioxidation among five kinds of antioxidant such as VC,Na2S2O3,L-cysteine,EDTA-2Na,Na2S2O5.In the production process,the optimization conditons were as follows：concentraton of activated carbon was 0.2%,pH4.0 was selected to decolour,temperature 115℃ and time 30 minutes were selected when exterminating bacterium.