细辛脑注射液体外溶血与凝聚试验的研究  

Study on Hemolysis and Coagulation Test of Asarone Injection in vitro

作　　者：孙鹏鹏 刘枕 李惠 李强 刘京华 都宵晓 张秀婷 SUN Peng-peng;LIU Zhen;LI Hui;LI Qiang;LIU Jing-hua;DU Xiao-xiao;ZHANG Xiu-ting(Zibo Institution for Food and Drug Control,Zibo 255000,China;Qilu Medical University,Zibo 255300,China)

机构地区：[1]淄博市食品药品检验研究院,山东淄博255000 [2]齐鲁医药学院,山东淄博255300

出　　处：《海峡药学》2023年第11期30-33,共4页Strait Pharmaceutical Journal

基　　金：山东省药品质量风险监测项目[局函[2022]174号];淄博市医药卫生科研项目(No.20231906138)。

摘　　要：目的对细辛脑注射液的溶血性进行探索性研究。方法参照《中国药典》2020年版四部通则溶血凝聚检查法及注射液安全性检查法应用指导原则和《中药、天然药物刺激性和溶血性研究的技术指导原则》的要求,采用肉眼观察法和分光光度法,对市售的26批细辛脑注射液进行溶血试验研究,并比较两种方法对溶血结果判断的差异性。结果不同厂家及相同厂家不同批次的细辛脑注射液的溶血存在差异。溶血率为5%~20%时,肉眼观察法受试验者主观影响较大,可能导致漏判现象。分光光度法判定标准量化,检测准确,数据详实,可作为常规方法的有效补充。结论细辛脑注射液在临床使用时应监测患者出现溶血的不良反应,建议在细辛脑注射液现行标准中增加溶血与凝聚检查项目。OBJECTIVE The current study was performed to explore the hemolysis of asarone injection.METHODS The hemolysis and coagulation tests were conducted by following the methods as mentioned in Chinese Pharmacopoeia 2020 Volume IV.We also followed the guidelines for application of injection safety test for the study of irritation,allergic and hemolysis of drug issued by State Food and Drug Administration in 2014.asarone injection(26 batches from all manufacturers)were prepared for hemolysis test and the hemolysis was determined by eye observation and spectrophotometry.The results were compared between visual observation and spectrophotometry.RESULTS There are differences in the hemolysis rate of asarone injection which are observed among different manufacturers.When the hemolysis rate were 5%and 20%,the visual observation method showed subjective and accidental errors,which might lead to the erroneous in results.Thus,spectrophotometric method can be used as an effective supplement to conventional methods because of its quantification,accurate detection and detailed data.CONCLUSION When using Asarone Injection in clinical practice,patients should be monitored for adverse reactions caused by hemolysis.It is recommended to add hemolysis and coagulation tests to the current standards for asarone injection.It is suggested that the safety test items of“hemolysis and coagulation”should be added to its current standard.

关 键 词：细辛脑注射液 溶血试验 肉眼观察法 分光光度法 

分 类 号：R927[医药卫生—药学]