冠心宁注射液安全性再评价研究(Ⅱ)  

Re-evaluation on security of Guanxinning Injection(Ⅱ)

作　　者：朱社敏[1] 康桦[1] 王丹[1] 李正[1] 唐登峰[1] 匡荣[1] 

机构地区：[1]浙江省食品药品检验所,浙江杭州310004

出　　处：《药物评价研究》2012年第1期18-21,共4页Drug Evaluation Research

摘　　要：目的为冠心宁注射液安全性再评价工作提供数据参考。方法采用不同药物浓度,按《中国药典》2010年版一部附录方法进行渗透压摩尔浓度测定和溶血与凝聚检查,同时采用分光光度法对样品及其稀释液进行溶血率的测定;采用显微镜法对样品及其稀释液进行血细胞凝聚检查。结果各厂家产品的渗透压摩尔浓度均为高渗,原液渗透压摩尔浓度(mOsmol/kg)A厂为400～799,F厂为400～999,B、C、D、E厂为600～1000,并可达到1000以上。用5%葡萄糖注射液对样品稀释后再进行测定,结果各厂的产品按使用说明书使用时,基本上都能达到等渗;溶血与凝聚检查结果 71批样品均符合规定;用分光光度法测定溶血率,结果各厂家样品原液均有一定的溶血(2批样品因凝聚,测定值偏低),除B厂家4批样品外,各厂家样品最小不溶血浓度均大于1∶8,B厂家3批样品的最小不溶血浓度为1∶16(相当于常规体外试管法药物浓度),1批样品的最小不溶血浓度为1∶32;红细胞凝聚检查,各厂家样品原液检查结果有58批样品未见凝聚,占总样品数的81.7%,A厂有3批样品凝聚严重,用5%葡萄糖注射液对样品稀释后,最小不凝聚浓度大于1∶8,D厂家血细胞变形、破损较严重,镜下可见大量细胞碎片。结论不同厂家生产的冠心宁注射液渗透压摩尔浓度、溶血率及红细胞凝聚存在一定的差异,建议用适当的渗透压摩尔浓度及溶血与凝聚检查方法来控制其质量,以保障临床用药的安全。Objective To provide the data for the re-evaluation on security of Guanxinning Injection. Methods According to the methods in the appendix of Chinese Pharmacopoeia 2010, the determination of osmotic pressure molar concentration （OPMC） and the inspection of hemolysis and cohesion were carried out at different concentration, while the determination of hemolysis rate for samples and their dilution was by spectrophotometry and the red blood cell pool inspection for samples and their dilution was by microscopy. Results The OPMC of the samples from different manufacturers were hypertonic and the OPMC of stock solution （mOsmol/kg） were as follows： A manufacture 400--799; B--E manufactures 600--1 000 or over 1 000; F manufacture 400--999. Using 5% glucose injection to dilute the samples, withsodium chloride injection as the reference solutionl the isotonic range is 0.9-- 1.1. In the test for hemolysis and cohesion according to Chinese Pharmacopoeia 2010, Seventy-one batches of samples were in line with the provisions; By hemolysis spectrophotometry, the sample stock solution of all the manufacturers had some hemolysis reaction （two batches of samples had low measured values due to cohesion）; In addition to four batches of B manufacture, the lowest non-hemolytic concentrations of sample from other manufactures were more than 1：8, but 1：16 was the lowest non-hemolytic concentrations for the three batches of samples from B manufacture, the same as the conventional in vitro test tube method, and 1：32 was the minimum non-hemolytic concentration for one batch of sample of B manufacture. In the red blood cell pool inspection, there were 58 batches of samples with no pool, accounting for 81.7% of the total. After dilution of the samples by 5% glucose injection, three samples from A manufacture had serious cohesion with the minimum no cohesion concentration of more than 1：8; The samples from D manufacture could be observed to have deformation, serious damage, and a large number of cell debris by microscope.

关 键 词：冠心宁注射液 安全性再评价:渗透压摩尔浓度 溶血与凝聚 

分 类 号：R965.3[医药卫生—药理学]