中药注射液中聚山梨酯80含量测定方法的研究

Investigation on Determination of the Content of Polysorbate 80 in Traditional Chinese Medicine Injections

目的研究分子排阻色谱-蒸发光散射检测(SEC-ELSD)法测定中药注射液中聚山梨酯80含量中的问题并进行探讨。方法利用制备的聚山梨酯80化学组分对照品,按照分子排阻色谱-蒸发光散射检测法的色谱条件进行样品分析,研究其化学组分在分子排阻色谱上保留行为。结果测定结果表明所有组分不能在相同的时间出峰,部分组分在分子排阻色谱-蒸发光散射检测法的色谱条件下不能出峰。结论为保证分子排阻色谱-蒸发光散射检测法的合理应用,需要关注表面活性剂分子在流动相中的状态及与固定相的相互作用问题,并且实施以化学组分控制为核心的聚山梨酯80新药用辅料标准。

OBJECTIVE To point out the problems of the SEC-ELSD method for determination of polysorbate 80 in traditional Chinese medicine injections, and discuss the method. METHODS The retention behaviors of eight types of chemical compositions in polysorbate 80 in size exclusion chromatography were studied according to the chromatographic conditions of SEC-ELSD method. RESULTS Not all of the chemical compositions had same chromatographic retention time, some of them showed no chromatographic peaks in the chromatographic conditions of SEC-ELSD method. CONCLUSION In order to ensure the rational use of SEC-ELSD method, researchers must be concerned about the state of the surfactant molecules in the mobile phase and the interaction between surfactant molecules with the stationary phase. A new standard of polysorbate 80 must be implemented, the core of which is controlling the chemical compositions.