参麦注射液渗透压和溶血率现状的调查Investigationofosmotic.PDF

第 33 卷 第 1 期 2010 年 2 月 - 5 - 参麦注射液渗透压和溶血率现状的调查 1 1 1 2 1＊ 朱社敏 ，匡 荣 ，王 丹 ，蔡 菲 ，倪维芳 1 浙江省食品药品检验所，浙江 杭州 310004 2 浙江大学城市学院，浙江 杭州 310015 摘 要 目的：为做好参麦注射液安全性再评价工作提供数据参考。方法：渗透压测定采用冰点测定法，对样品原液及其稀 释液进行渗透压测定，并计算与氯化钠注射液渗透压的比值；溶血率测定采用分光光度法，对样品原液及其稀释液 进行溶血率测定。结果：渗透压测定，样品原液均为低渗溶液，渗透压值在96～180 mOsmol/kg，1→4～1→8稀释 后与氯化钠注射液渗透压比可达0.9；溶血率测定，样品稀释倍数在小于1→16时，样品均存在不同程度的溶血 （溶 血率＞5％），1→32 倍稀释时，溶血率均小于等于 5％。结论：不同厂家生产的参麦注射液的渗透压和溶血率均存 在一定的差异，建议增加渗透压和溶血率测定来控制其质量。 关键词 溶血率；渗透压；安全性再评价；参麦注射液 中图分类号：R965.3 文献标志码：A 文章编号：1674–6376（2010）01–0005–04 Investigation of osmotic pressure and hemolysis ratio in Shenmai Injection 1 1 1 2 1 ZHU She-min , KUANG Rong , WANG Dan , CAI Fei , NI Wei-fang 1 Zhejiang Provincial Institute for Food and Drug Control, Hangzhou 310004, China 2 Zhejiang University City College, Hangzhou 310015, China Abstract Objective: To provide the data for re-evaluating the security of Shenmai Injection. Methods: Ice point method was used to determine the osmotic pressure of Shenmai Injection and its dilution solution. Ratio was calculated to NS. Spectrophotometry was utilized to measure the ratio of hemolysis. Results: All primary samples of Shenmai Injection were hyposmotic solution with osmotic pressure 96～180 mOsmol/kg. The ratio of the dilution(1→4 or 1→8)were up to 0.9. Different degrees of hemolysis occured when Shenmai Injection was diluted to less than 16 folds with the ratio of hemolysis more than 5%. But when Shenmai Injection was diluted to 32 folds, the ratio of hemolysis were less than 5%. Conclusion: There is obvious difference of osmotic pressure and hemolysis ratio among Shenmai Injection produced by diffe