title: Quickly quantifying the dissolution fingerprints of compound Danshen dropping pill by HPLC.
abstract: To firstly accurately overall determine the all components of Compound Danshen Dropping Pills (CDDP) and assess how about the authentic quality is for each bath of samples through a quantified fingerprint that only can qualitatively identified which kind of a herbal or Traditional Chinese Medicine may be. The systematically quantified fingerprint method (SQFM) was employed to identify that the qualities of S4 and S6 were belong to best (grade 1), those of S3, S5, S7, S8 and S9 belong to better (grade 2), those of S2 and S10 belong to good (grade 3), and only S1 falling to fine (grade 4) where those were all with 19 fingerprint peaks. On the basis, the important HPLC dissolution fingerprints (DFPs) of CDDPs were meticulously established to investigate the dynamic process in water, 0.1 mol/L hydrogen chloride (HCl) and 0.5% sodium dodecyl sulphate (SDS), respectively, in which SQFM executed the excellently quantified analyses for the DFPs. During the evaluation, the eighth time points of DFPs were selected as the standards for all dissolving to calculate how high are the macro quantitative similarity ( P m ) of DFPs for the other different time points. Finally in terms of Weibull function, lnln [1/(1- P m )]=-0.5951 x (2)+3.8146 x -4.5195 ( r =0.9974), lnln [1/(1- P m )]=-0.5555 x (2)+3.5814 x -4.6126 ( r =0.9972) were acquired in water and in 0.1 mol/L HCl solution respectively, but without in the SDS solution. In order to specially monitor the dissolution dynamic changes of the important fingerprints to guide the preparation technology and improve their bioavailability, We investigated the four strong peaks of CDDP-DFP and calculated out the fitting equations as follows, lnln [1/(1- A i / A max )]= y , the first one (No.6, Protocatechualdehyde), y =-0.5603 x (2)+3.4516 x -3.8974 ( r =0.9988); the second one (No.19, Salvianolic acid B), y =-1.7127 x (2) +9.6655x-11.947 ( r =0.9897); the third one (No.4, Danshensu), y =-0.4239 x (2)+3.0436 x -3.6276 ( r =0.9985); the forth one (No.17, unkown), y =-0.5019 x (2)+3.3706 x -4.1053 ( r =0.9979), which indicated Salvianolic acid B with a prominent discrepancy from others. The quantified HPLC fingerprint can perfectly both quantitatively reflected the authentic quality of CDDPs and accurately overall quantitatively measure the dissolution dynamic varieties in vitro to provide the important information for bioavailability, in which water is proven to be the best dissolution medium for CDDP whose T 50 =4.1 min (released 50%) and T 90 =8.0 min (released 90%).
authors.affiliation: 1 College of Pharmacy,Shenyang Pharmaceutical University, 103, Shenyang 110016, China ; 2 GDMS, MSD R&D (China) Co., Ltd, China ; 3 Hebei chemical and pharmaceutical vocation college, Shijiazhuang 050026, China ; 4 Tasly R&D Institute, Tianjin Tasly Group Co., Ltd., Tianjin 300402, China.
authors.forename: Guoxiang
authors.initials: G
authors.lastname: Sun
authors.affiliation: 1 College of Pharmacy,Shenyang Pharmaceutical University, 103, Shenyang 110016, China ; 2 GDMS, MSD R&D (China) Co., Ltd, China ; 3 Hebei chemical and pharmaceutical vocation college, Shijiazhuang 050026, China ; 4 Tasly R&D Institute, Tianjin Tasly Group Co., Ltd., Tianjin 300402, China.
authors.forename: Yuqing
authors.initials: Y
authors.lastname: Song
authors.affiliation: 1 College of Pharmacy,Shenyang Pharmaceutical University, 103, Shenyang 110016, China ; 2 GDMS, MSD R&D (China) Co., Ltd, China ; 3 Hebei chemical and pharmaceutical vocation college, Shijiazhuang 050026, China ; 4 Tasly R&D Institute, Tianjin Tasly Group Co., Ltd., Tianjin 300402, China.
authors.forename: Lifeng
authors.initials: L
authors.lastname: Li
authors.affiliation: 1 College of Pharmacy,Shenyang Pharmaceutical University, 103, Shenyang 110016, China ; 2 GDMS, MSD R&D (China) Co., Ltd, China ; 3 Hebei chemical and pharmaceutical vocation college, Shijiazhuang 050026, China ; 4 Tasly R&D Institute, Tianjin Tasly Group Co., Ltd., Tianjin 300402, China.
authors.forename: Zhifei
authors.initials: Z
authors.lastname: Hou
authors.affiliation: 1 College of Pharmacy,Shenyang Pharmaceutical University, 103, Shenyang 110016, China ; 2 GDMS, MSD R&D (China) Co., Ltd, China ; 3 Hebei chemical and pharmaceutical vocation college, Shijiazhuang 050026, China ; 4 Tasly R&D Institute, Tianjin Tasly Group Co., Ltd., Tianjin 300402, China.
authors.forename: Ling
authors.initials: L
authors.lastname: Tong
keywords: CDDP; SQFM; dissolution fingerprints; macro qualitative similarity (Sm); macro quantitative similarity (Pm)