中文摘要：

目的：研究适合注射用丁香苦苷冻干粉针的处方配比和制备工艺。方法：以产品外观，复水性，含量等为指标，运用正交试验法优化其处方配比；采用真空冷冻干燥法制备其样品，用高效液相色谱法检测其含量，并对制备条件如装量、共晶点、预冻温度、升华温度、解吸温度等进行研究。结果：经优化，确定丁香苦苷含量为8％（A2），赋形剂用量为5％甘露醇（B2），装量为2．5mL（C3），西林瓶规格为7mL（D1）；生产工艺为pH值为7．0，-45℃下预冻、-30℃下升华干燥和25℃时解吸干燥。结论：该工艺制备的丁香苦苷冻干粉针符合《中国药典》（2005版）冻干粉针的相关规定。

英文摘要：

Objective： To study a suitable formulation and freeze-drying process of Clove gentiopicroside for injec- tion. Methods： The formulation was optimized according to the appearance, clarity and content of the production by us- ing orthogonal analysis. The vacuum freeze-drying method was modified by changing the process conditions such as liq- uid volume in bottle, the pre-ffeezing temperature, sublimating temperature and temperature of desorption. The content of the Clove gentiopicroside was detected by HPLC. Results： The formulation consists of Clove gentiopicroside 8% （A2） and mannitol 5%（B2）, and 2.5 mL（C3） liqud was filled in 7 mL bottle（D1）. The acceptable freeze-drying process is that liquid pH value was 7.0, pre-freezing temperature was -45 ℃,sublimating temperature was -30 ℃, and desorption temperature was 25 ℃. Conelusion： The lyophilized agent prepared based on this formulation and this process meets the requirements of the Chinese Pharmacopoeia 2005.