3种定量指纹图谱模式评价复方丹参片质量

Evaluation of Fufang Danshen tablets by 3 quantitative fingerprint modes

目的考察3种定量指纹图谱模式利用系统指纹定量法（SQFM）对复方丹参片（FFDST）进行评价时误差变动。方法采用反相高效液相色谱法,色谱柱为TEDA Chrom Kromasil C18柱（250 mm×4.6 mm,5μm）,流速1.0 mL·mi^n-1,紫外检测波长280 nm,柱温（35.0±0.15）℃,进样量10μL,采集22批FFDST的HPLC指纹图谱（NFP）,对其变换得到比率指纹图谱（ROFP）和统一化指纹图谱（UFP）,以各对照指纹图谱（RFP）为标准用SQFM计算22批FFDST超信息定量参数,阐述不同模式图谱的3个指标Sm,Pm和α间差异性。结果以丹酚酸B为参照物峰,确定46个共有指纹峰。超信息特征定量参数评价出FFDST指纹图谱指数处于中等程度。经SQFM评价结果表明NFP和ROFP图谱模式评价结果基本一致,S17-S20均为不合格品,S17-S19是由于Pm过高所致,S20则是Pm过低引起。UFP图谱模式定性评价结果与前两者基本相同,定量结果出现显著差异,但乘以最大峰校正系数fi即可消除定量误差。结论 3种定量指纹图谱模式均能对样品进行准确地定性定量评价。

Objective To compare the variance or errors in Chinese medicine-Fufang Danshen tablets（FFDST） under 3 quantitative fingerprint modes by systematically quantified fingerprint method. Methods The analyses were performed on a TEDA Chrom Kromasil C18 column（250 mm×4.6 mm, 5 μm） at 1.0 mL·min^- 1, the detection wavelength was 280 nm, the column temperature was maintained at（35.0±0.15） ℃ and the injection volume was 10 μL. Totally 22 batches of FFDSTs HPLC chromatograms were collected to establish a normal fingerprint（NFP）, the ratio of fingerprint（ROFP） and the unified fingerprint（UFP）. The super information quantitative parameters of FFDSTs were calculated, and the identification results were obtained by SQFM based on each mode, in which the distinctions within Sm, Pm and α were elucidated. Results A total of 46 co-possessing peaks were marked with salvianolic acid B as the reference peak. The FFDST fingerprint characteristic index evaluated by super information quantitative system was moderate. The 3 fingerprint modes evaluated by SQFM showed consistent results between NFP and ROFP. S17, S18, S19 and S20 were non-conforming product, due to the high Pm value of S17- S19 and the lower Pm value of S20. Evaluation of UFP mode indicated basically the same qualitative similarities of the former ones. The quantitative results were of significant difference that could be thoroughly canceled by the maximum peak correction coefficient. Conclusion The 3 fingerprint modes can all be used to accurately assess TCM quality.