片仔癀HPLC指纹图谱的总量统计矩及其相似度法分析

HPLC Fingerprint of Pien Tze Huang by Total Statistical Moment and Similarity Method

目的:对片仔癀HPLC指纹图谱总量统计矩及其相似度进行研究,进一步验证前期所创方法的关联性,并为片仔癀制剂质量控制提供依据。方法:以三七皂苷R1,人参皂苷Rg1与Rb1,牛磺胆酸钠为对照,采用RP-HPLC建立片仔癀指纹图谱,并对指纹图谱总量统计矩及其相似度法的关联性进行分析。结果:10批样品共有特征峰为14个,采用总量统计矩法计算其AUCT,相对AUCT,λT,相对λT,σT,相对σT的平均值分别为7.430×106μV·s,1.002,22.540 min,0.972,5.391 min,1.065,RSD分别为5.0%,4.3%,1.0%,1.0%,2.9%,2.9%;以生成的对照图谱为参考,采用总量统计矩相似度法分析得相似度平均值为0.943,RSD为1.9%;相关性分析得相对λT与相似度的相关系数为0.980,P<0.01,相对σT与相似度的相关系数为-0.683,P<0.05,均具有统计学意义。结论:总量统计矩及其相似度法存在关联性,该法具有加合、偶联与统计性;所建立的片仔癀HPLC指纹图谱重复性好,准确度高,可用于质量控制。

Objective： To study the fingerprints of Pien Tze Huang by total quantum statistical moment（ TQSM） and total quantum statistical moment similarity（ TQSMS） method,further verify the relevance between the previously established methods,and provide basis for the quality control of Pien Tze Huang. Method： With Notoginsenoside R1,ginsenoside Rg1,ginsenoside Rb1 and sodium taurocholic acid as the control products,RPHPLC was used to establish the chromatographic fingerprints of Pien Tze Huang,and the correlation between TQSM and TQSMS of the fingerprints was analyzed. Result： There were 14 common characteristic peaks for 10 batches of Pien Tze Huang samples. By using TQSM method,the average values of AUCT,relative AUCT,λT,relative λT,σT,relative σTwere calculated as 7. 430 × 106μV·sec,1. 002,22. 540 min,0. 972,5. 391 min,1. 065 and their RSD were 5. 0%,4. 3%,1. 0%,1. 0%,2. 9%,2. 9% respectively. The average similarity was 0. 943 and RSD was 1. 9% compared with reference fingerprint by TQSMS. The correlation coefficient of relative λTand similarity was 0. 980,P 〈 0. 01,and the correlation coefficient of relative σTand similarity was- 0. 683,P 〈0. 05,with statistically significant difference. Conclusion： There was correlation between TQSM and TQSMS and this method was additive,couplable and statistical. Besides,the established chromatographic fingerprint was highly precise and reproducible,thus can be applied in the quality control of Pien Tze Huang.