注射用丹参无菌粉末冷冻干燥工艺研究  

Study of Freezing-dry Process of Salvia miltiorrhiza Sterile Powder for Injection

作　　者：张晓茹[1] 王宝华[1] 倪健[1] 宋歌[1] 冉晓萌[1] 杨璇[1] 

机构地区：[1]北京中医药大学中药学院,北京市100102

出　　处：《中国药房》2011年第31期2902-2904,共3页China Pharmacy

基　　金：国家科技支撑计划子课题(2006BAI09B07-01)

摘　　要：目的:优化注射用丹参无菌粉末的冷冻干燥工艺,缩短冻干时间。方法:采用单因素试验,对降温方式、药液装量、浓度、预冻时间、压力、升华干燥温度、升华干燥时间、解析干燥温度等参数进行优化,确定最佳冷冻干燥工艺参数。结果:选择浓度为100mg.mL-1,装量为3.480mL,采用阶段性降温方式,预冻时间为120min,压力为5Pa,解析干燥温度为35℃,冷冻干燥总时间为36h。结论:最优参数下产品性状良好,冷冻干燥时间约缩短15h。OBJECTIVE：To optimize the freezing-dry technology of Salvia miltiorrhiza lyophilized powder to shorten the time of the freezing-dry procedure.METHODS：In single factor test,the optimal parameters was decided by optimizing cooling method,herbal liquid volume and concentration,pre-freezing time,pressure,distillation drying time and temperature,desorption-drying temperature.RESULTS：The optimal process was 3.480 mL herbal liquid with 100 mg·mL-1,phased cooling style,pre-freezing time 120 min,vacuum 5 Pa and the desorption-drying temperature 35 ℃,total freeze-drying time 36 h.CONCLUSION：The product is good under the optimal parameters.The freeze-drying time is shortened about 15 h.

关 键 词：注射用丹参无菌粉末 最优工艺 干燥温度 时间 冷冻干燥 

分 类 号：R969.1[医药卫生—药理学] R971.1[医药卫生—药学]