Xin-Yu-Tie-Pian, an ointment patch which is composed of Tetradium ruticarpum and Asarum sieboldii Miquel, can be used for curing recurrent oral ulcers owing to its good bioactivities. Currently, the lack of a method for its quality evaluation hinders the development and clinical application of Xin-Yu-Tie-Pian. Thus, it is necessary to perform research on quality control. The chromatographic fingerprint, as an identification method, and the simultaneous determination method for two bioactive constituents, evodiamine and rutecarpine, can be used to evaluate the quality of traditional medicine. In this study, a two-step strategy including fingerprint analysis for identification and a simultaneous determination method for two bioactive constituents was performed for Xin-Yu-Tie-Pian quality control. The fingerprint analysis was validated by stability, precision and repeatability tests and a similarity evaluation was performed with 10 selected characteristic fingerprint peaks of 10 batches of Xin-Yu-Tie-Pian patch. Meanwhile, the simultaneous determination method was evaluated by methodological experiments, including linearity, accuracy, repeatability, stability and feasibility. Finally, the results indicate that this two-step strategy, including HPLC fingerprint analysis and simultaneous determination method, can be successfully applied for the assessment of the quality and quantity of Xin-Yu-Tie-Pian.

中文翻译：

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软膏贴剂心玉贴片质量控制的两步法

心玉贴片，一种由芸香和细辛组成的软膏贴剂Miquel，由于其良好的生物活性，可用于治疗复发性口腔溃疡。目前，缺乏对其质量评价的方法，阻碍了心语贴片的开发和临床应用。因此，有必要对质量控制进行研究。色谱指纹图谱作为鉴别方法，同时测定吴茱萸碱和芸香芸香碱两种生物活性成分的方法，可用于评价中药的质量。本研究采用指纹分析鉴定和同时测定两种生物活性成分的两步策略对心玉铁片进行质量控制。指纹分析通过稳定性验证，对10批新玉贴片贴片的10个特征指纹峰进行精密度和重复性测试和相似性评价。同时，通过方法学实验对同时测定方法进行评价，包括线性、准确度、重复性、稳定性和可行性。最后，结果表明该两步法，包括高效液相色谱指纹图谱分析和同时测定法，可以成功地应用于新玉铁片的质量和数量的评估。