학술논문
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
Document Type
Academic Journal
Author
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
Source
海峡药学 / Strait Pharmaceutical Journal. 35(11):30-33
Subject
Language
Chinese
ISSN
1006-3765
Abstract
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 injec-tion.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 spectrophotome-try.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 ac-cidental errors,which might lead to the erroneous in results.Thus,spectrophotometric method can be used as an ef-fective supplement to conventional methods because of its quantification,accurate detection and detailed da-ta.CONCLUSION When using Asarone Injection in clinical practice,patients should be monitored for adverse re-actions caused by hemolysis.It is recommended to add hemolysis and coagulation tests to the current standards for as-arone injection.It is suggested that the safety test items of"hemolysis and coagulation"should be added to its current standard.
OBJECTIVE The current study was performed to explore the hemolysis of asarone injec-tion.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 spectrophotome-try.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 ac-cidental errors,which might lead to the erroneous in results.Thus,spectrophotometric method can be used as an ef-fective supplement to conventional methods because of its quantification,accurate detection and detailed da-ta.CONCLUSION When using Asarone Injection in clinical practice,patients should be monitored for adverse re-actions caused by hemolysis.It is recommended to add hemolysis and coagulation tests to the current standards for as-arone injection.It is suggested that the safety test items of"hemolysis and coagulation"should be added to its current standard.