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目的建立一测多评法(QAMS)同时测定3种丹参制剂(丹参片、复方丹参片和冠心丹参胶囊)中丹参酮类成分[丹参酮IIA(TIIA)、二氢丹参酮I(DTI)、隐丹参酮(CT)、丹参酮I(TI)]量,探讨QAMS技术在中药制剂质量评价中的准确性和可行性。方法采用HPLC法测定TIIA、DTI、CT和TI;以丹参片、复方丹参片和冠心丹参胶囊为研究对象,采用QAMS技术,以TIIA为内参物,建立DTI、CT、TI与TIIA之间的相对校正因子(fi/s),比较保留时间差、相对保留值和线性回归定位法对待测成分的定位效果;并用外标法对样品进行定量计算,比较实测值与QAMS计算值之间的差异,以验证其准确性。结果所建立的HPLC法测定TIIA、DTI、CT和TI准确可行;在线性范围内,DTI、CT、TI与TIIA之间的fi/s分别为0.734、0.916、0.774,在不同测试条件下待测成分的fi/s准确可靠;相对保留值法能够对待测成分进行准确定位,DTI、CT、TI与TIIA之间的相对保留值分别是0.314、0.518、0.561,外标法和QAMS测定结果无显著性差异。3种丹参制剂定量测定结果显示不同厂家即使是同一厂家不同批次,产品的内在质量存在一定差异。结论所建立的丹参酮类成分QAMS适用于多种丹参制剂的质量控制,可为其他丹参制剂的质量评价提供参考;同时,应进一步加强对以上3种中药制剂的控制与监管。
Objective To establish a multi-assessment method (QAMS) for simultaneous determination of tanshinones (Tanshinone IIA (TIIA), Dihydrotanshinone I (DTI), Cryptotanshinone (CT), tanshinone I (TI)], to discuss the accuracy and feasibility of QAMS in the quality evaluation of traditional Chinese medicine preparations. Methods TIIA, DTI, CT and TI were determined by HPLC method. The Danshen tablets, Fufang Danshen tablets and Guanxin Danshen capsules were used as the research objects. The QAMS technique and TIIA were used as the reference materials to establish the DTI, CT, TI and TIIA The relative calibration factors (fi / s), the retention time difference, the relative retention value and the linear regression method were used to determine the localization effect of the analytes. The external standard method was used to quantify the samples and the differences between the measured values and the QAMS values were compared. To verify its accuracy. Results TIIA, DTI, CT and TI were established by HPLC. The fi / s between DTI, CT, TI and TIIA were 0.734, 0.916 and 0.774 in the linear range, respectively. Under different test conditions The relative retention values of DTI, CT, TI and TIIA were 0.314, 0.518 and 0.561, respectively. There was no significant difference between external standard method and QAMS method Sex differences. The results of quantitative determination of three kinds of Salviae Miltiorrhizae preparations showed that there are some differences in the intrinsic quality of products even if different manufacturers are different batches of the same manufacturer. Conclusion The established tanshinone component QAMS is suitable for the quality control of a variety of Salvia miltiorrhiza preparations and may provide a reference for the quality evaluation of other Salvia miltiorrhiza preparations. At the same time, the control and regulation of the above three kinds of traditional Chinese medicine preparations should be further strengthened.