摘要
目的通过对盐酸托烷司琼注射液不同处方及灭菌工艺的研究,选择出最佳的处方和灭菌工艺,为大生产工艺提供依据。方法采用不同的处方和不同的pH值配制药液,考察不同灭菌工艺灭菌前后样品的性状、pH值、溶液的澄清度与颜色、含量、有关物质。结果盐酸托烷司琼注射液受pH调节剂、pH值的影响较大。结论冰醋酸—醋酸钠处方的样品稳定性好,工艺条件简单,适合大规模生产操作。
Objective To research the different prescriptions of tropisetron hydrochloride injection and sterilization processes and select the best prescription and sterilization process and provide basis for the high-yield process. Methods The soup was prepared by different prescriptions and pH values, and the property, pH value, solution clarify, color, content and relevant materials of samples before and after sterilization of different sterilization processes were examined. Results The pH regulator and pH value had a big effect on the tropisetron hydroehloride injection. Conclusion The sample stability of glacial acetic acid-sodium acetate prescription is good, and the process condition is easy, which is suitable for the largescale production and operation.
出处
《中国卫生产业》
2016年第21期173-177,共5页
China Health Industry
关键词
盐酸托烷司琼
PH值
杂质
稳定性
Tropisetron hydrochloride
pH value
Impurity
Stability
