动态显色法检测4种清热解毒类中药注射液中细菌内毒素含量
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篇名: 动态显色法检测4种清热解毒类中药注射液中细菌内毒素含量
TITLE:
摘要: 目的:建立定量检测4种清热解毒类中药注射液中细菌内毒素的试验方法。方法:采用动态显色法,测定温度为(37±0.5) ℃,检测波长为405 nm,预设吸光度(A)值为0.1,反应时间为3 600 s。依据2015年版《中国药典》(四部)通则细菌内毒素检查法中的光度测定法及其指导原则,进行标准曲线可靠性试验和干扰试验,确定4个品种(清开灵注射液、复方半边莲注射液、茵栀黄注射液、双黄连注射液)的最大不干扰浓度并进行细菌内毒素定量检测。结果:可靠性试验中标准曲线的相关系数r为0.999;清开灵注射液、复方半边莲注射液、茵栀黄注射液、双黄连注射液分别在原液200、125、75、12.5倍及以下稀释倍数时对鲎试剂检测无干扰作用;干扰试验中回收率均在50%~200%;样品中细菌内毒素含量分别小于1.66、1.04、0.62、0.104 EU/mL,均低于各样品规定的限值。结论:采用动态显色法可检测这4种中药注射液的细菌内毒素,且方法简单快捷,结果稳定可靠。
ABSTRACT: OBJECTIVE: To set up the method for quantitative determination of bacterial endotoxin in 4 kinds of heat-clearing and detoxifying TCM injections. METHODS: The kinetic chromogenic assay (KCA) method was used. The determination conditions included detection temperature (37±0.5) ℃, detection wavelength 405 nm, preset absorbance (A) 0.1, and reaction time 3 600 s. According to photometry method and guidance principle general rule of bacterial endotoxin test in 2015 edition of Chinese Pharmacopoeia (part Ⅳ), reliability test and interference test of standard curve were conducted. The non-interference concentration of 4 type (Qingkailing injection, Compound Banbianlian injection, Yinzhihuang injection and Shuanghuanglian injection) was determined and quantitative determination of bacterial endotoxin was also conducted. RESULTS: The correlation coefficient r of standard curve was 0.999. Qingkailing injection, Compound Banbianlian injection, Yinzhihuang injection and Shuanghuanglian injection didn’t interfere with the detection of tachypleus amebocyte lysate in 200, 125, 75 and 12.5 times and below dilution times respectively. The recoveries were 50%-200%, and the contents of bacterial endotoxin in samples were 1.66, 1.04, 0.62, 0.104 EU/mL, which were all lower than the limits of samples. CONCLUSIONS: KCA is suitable for the detection of bacterial endotoxin in 4 kinds of TCM injections. The method is simple, convenient, stable and reliable.
期刊: 2018年第29卷第13期
作者: 张军霞,郭姣梅,周继春,李振国,陈炜,张振中
AUTHORS: ZHANG Junxia,GUO Jiaomei,ZHOU Jichun,LI Zhenguo,CHEN Wei,ZHANG Zhenzhong
关键字: 动态显色法;清热解毒类;中药注射液;细菌内毒素;干扰试验
KEYWORDS: Kinetic chromogenic assay; Heat-clearing and detoxifying; TCM injection; Bacterial endotoxin; Interference test
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