动态显色法定量检测卡前列素氨丁三醇注射液中的细菌内毒素

目的 建立动态显色法测定卡前列素氨丁三醇注射液中细菌内毒素含量的方法.方法 建立动态显色法测定细菌内毒素的标准曲线,通过干扰预试验及干扰验证试验测定回收率以确定样品最佳稀释倍数及检测范围,并定量测定样品内毒素含量.结果 标准曲线回归方程:lgT=-0.28lgC+ 5.65,r=0.998,相关系数的绝对值(|r|) ＞0.980,细菌内毒素浓度在0.01～1.25 EU·mL-1时线性关系良好,标准曲线成立;样品稀释4 ～ 50倍时,细菌内毒素回收率在50％ ～ 200％范围内,均无干扰作用;干扰验证试验进一步证明样品稀释20倍时,其回收率均接近100％,无干扰作用,所测样品的细菌内毒素含量均小于0.01 EU·mL-1.结论 该方法专属性强、精密性和准确性良好,能快速定量检测样品中内毒素含量,可用于卡前列素氨丁三醇注射液中细菌内毒素含量的测定.

Determination of bacterial endotoxin in Carboprost Tromethamine Injection by kinetic chromogenic assay

Objective To establish a kinetic chromogenic assay (KCA) for quantitative detection of bacterial endotoxins in Carboprost Tromethamine Injection.Methods The standard curve of bacterial endotoxins by KCA was established,the recovery rates were measured by interference preliminary text and interference verification text to confirm the best dilution multiple and the concentration range of sample detection,and the bacterial endotoxins content of sample was determined quantitatively in these tests.Results The regression equation of standard curve was as follows:lgT =-0.281gC + 5.65,r =0.998,| r | ＞ 0.980.The calibration curve was linear over the concentration ranges of bacterial endotoxins from 0.01 to 1.25 EU · mL-1,which indicated the validity of standard curve.There was no interference effect when sample was diluted by 4 to 50 multiples with recovery ranged from 50％ to 200％.Interference verification test further proved that the recovery was close to 100％ when the sample was diluted 20 multiples,and there was no interference effect.The content of bacterial endotoxins in the samples was less than 0.01 EU · mL-1.Conclusions The KCA method was proved to be specific,sensitive and accurate,which can be applied to determine the endotoxin content in samples rapidly and quantitatively.It is suitable for quality control of Carboprost Tromethamine Injection.