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多级系统指纹定量法评价复方丹参片质量 被引量:4

Multiple grade systematic quantified fingerprint method for quality assessment of Fufang Dansen Pian
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摘要 目的建立多级系统指纹定量法(MSQFM)理论和技术并应用于复方丹参片(Fufang Dansen Pian,FFD-SP)280nm HPLC指纹图谱评价。方法从8个定量相似度(R、Q、M、W、P、QF、MF和C)中选取2个作平均作为宏定量目标函数,得到具有代表性的八级宏定量相似度,再与Sm及α评价中药质量等级分别构成一、二、三…八级系统指纹定量法,以均值P整合8个宏定量相似度,进而构成MSQFM,并对20批FFDSP-HPLC-FP进行评价。结果八级宏定量相似度P1,P2,…,P8都能良好地反映中药化学指纹的总体含量。用MSQFM评价S10质量(1级)极好;S9质量(2级)很好;S4、S12、S14和S19质量(3级)好;S7、S8、S11和S17质量(4级)较好;S13、S15、S16和S20质量(5级)中等;S18质量(6级)一般,其余5批为次品或劣质品。结论所建立MSQFM评价结果具有一致性,可清晰揭示FFDSPs-HPLC-FP反映的中药质量变异,是对SQFM的发展和完善。 Objective To develop the theory and technology of multiple grade systematic quantified fingerprint method (MSQFM) to evaluate the 280 nm-HPLC fingerprints of Fufang Dansen Pian (FFDSP). Methods The mean of 2 macro quantitative similarity (MSQTS) was chosen from the 8 MSQTS (R, Q, M, W, P, Qx, MF and C) as the quantitative objective functions. We obtained 8 representative grade MSQTS (P1, P2, Pa, P4, Ps, P6, P7 and Ps) and integrated the 8 MSQTS to get P presenting all 8 MSQTS. The quality of 20 batches of FFDSPs was evaluated. Results The results were consistent by MSQFM. The quality of S10 (grade 1) was excellent; that of S9 (grade 2) was very good; of S4, S12, S14 and S19 (grade 3) was good; of S7, S8, S11 and S17 (grade 4) was fairly good; of S13, S15, S16 and S20 (grade 5) was acceptable; of S18 (grade 6) was barely acceptable; and that of the other 5 batches was inferior. Conclusion The MSQFM can clearly and efficiently disclose the variance in quality reflected by FFDSPs-HPLC-FP.
出处 《中南药学》 CAS 2012年第2期140-144,共5页 Central South Pharmacy
基金 国家自然科学基金重大研究计划课题(No.90612002)
关键词 多级系统指纹定量法 系统指纹定量法 复方丹参片 八级宏定量相似度 multiple grade systematic quantified fingerprint method systematic quantified fingerprint method Fufang Dansen Pian 8 grade macro quantitative similarity
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