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目的目的制备沙利度胺乳膏,建立质量控制方法。方法自乳化基质聚乙二醇-7硬脂酸酯制备沙利度胺乳膏。建立鉴别反应、粒度、微生物限度检查、含量测定等质量控制方法,采用高效液相色谱法测定沙利度胺的含量。考察其稳定性。结果沙利度胺乳膏粒度、微生物限度、含量均符合中国药典2015版的规定;沙利度胺在0.01~0.5 mg/m L浓度范围内呈良好的线性关系,r=0.999 97;平均回收率为100.83%(n=9,RSD=0.81%);乳膏无刺激性,在12个月内稳定。结论制备该乳膏工艺简单,质量稳定可控,为沙利度胺乳膏的药效学研究提供基础。
Objective To prepare thalidomide cream and establish a quality control method. Methods Self-emulsifying matrix polyethylene glycol-7 stearate was used to prepare thalidomide cream. Establish quality control methods of identification reaction, particle size, microbial limit test, content determination, and the determination of thalidomide content by high performance liquid chromatography. Examine its stability. Results The particle size, microbial limit and content of thalidomide cream all met the requirements of Chinese Pharmacopoeia 2015. Thalidomide showed good linearity in the concentration range of 0.01-0.5 mg / mL, r = 0.999 97; average recovery The rate was 100.83% (n = 9, RSD = 0.81%). The cream was non-irritating and stable within 12 months. Conclusion The preparation of the cream is simple, stable and controllable, and provides the foundation for the pharmacodynamic study of thalidomide cream.