不同工艺条件对中药注射剂不溶性微粒的影响  

Influence of different process conditions on insoluble particles in Chinese medicine injection

作　　者：马志强[1] 刘彬丽[1] 刘璐[1] 蔡程科[2] 倪健[1] 

机构地区：[1]北京中医药大学中药学院,100102 [2]北京中医药大学研究生院,100029

出　　处：《国际中医中药杂志》2013年第7期616-618,共3页International Journal of Traditional Chinese Medicine

摘　　要：目的以注射用双黄连为供试品，分析中药注射液中常见的工艺步骤对药品不溶性微粒的影响。方法利用光阻法考察灭菌、超滤及不同PH值对中药注射剂不溶性微粒的影响。结果药液的灭菌、超滤及药液的pH值可引起中药注射剂不溶性微粒的变化。结论综合考虑药液灭菌、超滤及药液的PH值可降低不溶性微粒的数量，减轻临床用药风险。Objective To analyze the influence of usual processing steps on insoluble particles in Chinese medicine injection, with Shuanghuanglian injection as an example. Methods Light block method was adopted to analyze the influence of the different conditions of sterilization, ultra filtration and PH value on insoluble particles in Chinese medicine injection. Results Sterilization, ultra filtration and PH value caused the change of insoluble particles in Chinese medicine injection. Conclusion The comprehensive use of sterilization, ultra filtration, PH value can reduce the quantity of insoluble particles and clinical risk.

关 键 词：中药注射剂 不溶性微粒 影响因素 

分 类 号：R286[医药卫生—中药学]