摘要
目的:探讨说明书中含有“即配即用”字段的中药注射剂在配置完成后的输液使用时限。方法:整理某院以国药准字“Z”开头的中药注射剂说明书,共有10种中药注射剂说明书中含有“即配即用”字段,提取10种中药注射剂说明书中的信息,并通过文献调研分析即配即用中药注射剂配置后的稳定性。结果:考察各注射剂与说明书规定溶媒配置4 h内输液外观性状变化、pH变化、不溶性微粒变化、吸光度变化、主要成分相对含量变化。(1)不溶性微粒变化分析:血必净注射液与0.9%氯化钠注射液配伍,放置4 h后成品输液中的不溶性微粒数超过限定标准,使用5%葡萄糖注射液作溶媒时,药液放置1 h后微粒数已接近标准限定;舒肝宁注射液用5%葡萄糖注射液配置4 h后不溶性微粒数不再符合规定要求,建议两种注射剂使用10%葡萄糖注射液为溶媒,4 h内滴注完。(2)吸光度、主要成分相对含量变化分析:肾康注射液与0.9%氯化钠注射液配置,药液中主要成分原儿茶醛含量明显下降,建议选择10%葡萄糖注射液为溶媒,4 h内滴注完。醒脑静注射液中麝香酮、冰片在不同溶媒4~5 h含量有所降低,建议选择5%或10%葡萄糖注射液配伍后3 h内滴注完毕。银杏内酯注射液无相关试验文献。结论:中药注射液应按照说明书中规定的溶媒进行配置,建议中药注射剂说明书补充配置后输液使用时限。
Objective:This study aims to investigate the infusion time limit after preparing“ready-to-use”TCM injections according to the instructions.Methods:The instructions for TCM injections starting with“Z”in a certain hospital were reviewed,and a total of 10 TCM injection instructions containing the“ready-to-use”field were analyzed along with relevant literature.Results:The various injection solutions were examined,and it was found that the appearance of the infusion within 4 hours of being prepared with the specified solvent met the requirements as stated in the instructions,with no changes in pH or turbidity.The analysis of changes in insoluble particles showed that the Xuebijing injection solution,when mixed with 0.9%sodium chloride injection,had more than the allowable number of insoluble particles after 4 hours,while the 5%glucose injection solution had nearly reached the allowable limit after only 1 hour.It was recommended that the two injection solutions be prepared with 10%glucose injection solution and the infusion completed within 4 hours.The analysis of changes in absorbance and relative content of the main components showed that the content of the main component,protocatechuic aldehyde,in the ShengmaiJing injection solution was significantly reduced when mixed with 0.9%sodium chloride injection,and it was recommended that 10%glucose injection solution be used as the solvent and the infusion completed within 4 hours.The content of Shengxiangtong and Bingpian in the Xingnaojing injection solution decreased by 5%or 10%within 4-5 hours when mixed with different solvents,and it was recommended that the mixture be completed within 3 hours after being mixed with 5%or 10%glucose injection solution.No relevant experimental literature was found for the Yinxingneilaizhi injection solution.Conclusion:It is recommended to prepare TCM injections according to specified solvents in the instructions,and it is relatively safe to use them within 4 hours post-preparation.Clear specification of infusion time limit in TCM injection instructions is suggested.
作者
程慧
李俊灿
邓家欣
Cheng Hui;Li Junchan;Deng Jiaxin(Xiangyang Hospital of Traditional Chinese Medicine,Xiangyang 441000,China)
出处
《亚太传统医药》
2025年第8期253-256,共4页
Asia-Pacific Traditional Medicine
关键词
中药注射液
即配即用
稳定性
使用时限
Traditional Chinese Medicine Injection
Ready-To-Use
Stability
Service Life
