| 张婷婷,高珊,矫建,杜鹃,刘进朋.香丹注射液溶血性实验及药物安全性检测问题探讨[J].中国药事,2018,32(4):529-532 |
| 香丹注射液溶血性实验及药物安全性检测问题探讨 |
| Study on Hemolytic Properties of Xiangdan Injection |
| 投稿时间：2017-09-28 |
| DOI：10.16153/j.1002-7777.2018.04.017 |
| 中文关键词: 药物安全性 香丹注射液 溶血试验 分光光度法 |
| 英文关键词: drug safety xiangdan Injection,hemolysis test,uv-visible spectrophotometric method |
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| 中文摘要: |
| 目的：建立体外溶血试验方法，评价香丹注射液的体外溶血作用，为药物安全性检测提供参考。方法：用常规体外试管法、分光光度法和氰化高铁血红蛋白法3种方法探讨3批香丹注射液对兔红细胞的溶血作用。结果：香丹注射液按常规体外试管法有部分溶血发生，与其他两种方法结果不一致，说明肉眼观察影响结果判断，分光光度法更准确可靠。结论：香丹注射液可能有溶血作用，故需要对药品进行溶血性检测；采用抗凝兔血紫外分光光度法更能准确检查该制剂的潜在溶血倾向，保证临床用药安全。 |
| 英文摘要: |
| Objective: To establish a test method for the hemolysis of Xiangdan injection. To evaluate the invitro hemolytic effect of Xiangdan injection and provide reference for drug safety testing. Methods: The methods of usual in-vitro test tube, UV-visible spectrophotometry and the Cyanide methemoglobin were used to explore the hemolytic effect of three batches of Xiangdan injection on rabbit erythrocyte. Results: Partial hemolysis was observed with the method of in-vitro test tube, inconsistent with the other two methods. Visual inspection affects the result judgment and UV-Visible spectrophotometric method is more accurate and reliable. Conclusion: Xiangdan injection may cause hemolysis. It is necessary to carry out hemolytic detection of drugs. The UV-visible spectrophotometry is more accurate to check the potential hemolytic tendency of the injection so as to ensure the clinical drug safety. |
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