目的 建立痰热清氯化钠注射液的指纹图谱。方法 采用HPLC-ELSD法检测痰热清注射液中非挥发性成分,以黄芩苷对照品为参照,标定共有峰,计算相对保留时间和相对峰面积比值,确定10批样品之间的相似度。结果 在全面方法学研究的基础上,对10批痰热清氯化钠注射液进行检测分析,HPLC指纹图谱有16个共有峰,其相对保留时间及相对峰面积比值均符合要求。结论 建立的指纹图谱可作为痰热清氯化钠注射液质量评价的重要依据之一。

Objective To establish the fingerprint detecting standard for Tanreqing NaCl Injection. Methods Using baicalin as reference substance to calibrate the common peaks by HPLC-ELSD. According to the technical requirements on fingerprint of traditional Chinese medicine injection, their relative retention times and peak area ratios were calculated and the similarity of ten batchs of samples was determined. Results On the basis of systematic methodology, ten batches of injection samples were tested and analyzed so as to establish HPLC fingerprint for the injection. Conclusion The relative retention times and peak area ratios of 16 common peaks on HPLC fingerprint all conform to the requirement. So the established fingerprint can be used as the one of important foundations for quality control of Tanreqing NaCl Injection.