瓜蒌皮注射液去热原工艺改进和质量控制  

Improvement of the process for the depyrogenation of Gualoupi injection and its quality control

作　　者：周建华 吴阿萍 刘怡婷 ZHOU Jianhua;WU Aping;LIU Yiting(SPH No.1 Biochemical ＆ Pharmaceutical Co., Ltd., Shanghai 200240, China)

机构地区：[1]上海上药第一生化药业有限公司,上海200240

出　　处：《上海医药》2018年第9期70-72,共3页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的 :降低瓜蒌皮注射液在生产过程中出现细菌内毒素二次污染的风险。方法 :使用钛合金过滤器替代板框过滤器,对去热原过程中的脱炭步骤进行工艺优化。结果 :工艺优化后所得药液中细菌内毒素的含量较工艺优化前下降超过80%,且其它各项质量指标均符合规定。结论 :使用钛合金过滤器代替板框过滤器可以显著降低在脱炭过程中造成细菌内毒素二次污染的风险,且对产品质量不存在负面影响。Objective： To reduce the risk of secondary contamination of endotoxin in the manufacturing process for Gualoupi injection. Methods： The process at the decarbonization step for depyrogenation was optimized by using a titanium flter instead of a plate and frame flter used in the original process. Results： The content of endotoxin was reduced by more than 80% and all other quality indicators were in compliance after process optimization. Conclusion： Substitution of a titanium flter for a plate and frame flter can signifcantly reduce the risk of a secondary contamination of endotoxin at the decarbonization step and there is no negative efect on the quality of Gualoupi injection.

关 键 词：瓜蒌皮注射液 板框过滤 钛合金过滤器 去热原 二次污染 

分 类 号：R927.12[医药卫生—药学] TQ460.64[化学工程—制药化工]