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This paper evaluates a multiple and global analytical indicator of batch consistency in traditional Chinese medicine injections (TCMIs) via a chemometrics tool, which is more comprehensive to appraise quality consistency of different batches of injections than the traditional method of fingerprint similarity. A commonly used TCMI, Salviae miltiorrhizae and ligustrazine hydrochloride injection (SLI), was employed as a model. With the aid of a chemometrics tool (principal component analysis, PCA), evaluation of multiple and global analytical indicators of batch consistency, which included saccharides, phenolic acids and inorganic salts (18 indicators in total), was carried out to appraise the quality consistency of 13 batches of injection provided by the Guizhou Baite Pharmaceutical Co., Ltd. (Guizhou, China). Compared with the traditional HPLC-UV fingerprint similarity evaluation, the method proposed in the paper can more comprehensively and correctly reflect the quality consistency of different batches of injections. In this paper, the multi-index evaluation result showed poor batch consistency, which was more consistent with the determination results, while the fingerprint similarity evaluation results still showed good batch consistency. The HPLC-UV fingerprint reflects only substances with UV absorption, but it is not able to reflect substances without UV absorption or weak UV absorption, which leads to inappropriate conclusions. Therefore, quality consistency of injections can be effectively appraised by evaluation of multiple and global analytical indicators, instead of HPLC-UV fingerprint only. For visualizing the batch consistency of the multiple and global analytical indicators, a heat map was used to represent the fluctuation. Furthermore, critical indicator identification was also applied to select several indicators that should be paid more attention during the process of quality control of injection. And the analysis result showed that Na + , fructose (Fru), glucose (Glc), manninotriose (Man), danshensu (DSS) and salvianolic acid B (SAB) are the indicators that should be given more attention when controlling the quality of injections, also called critical quality control indicators. The proposed method provides a reference for the quality control of TCMIs and has broad application potential.

Aims: Pharmacokinetic Study of Salviae Miltiorrhizaeand Ligustrazine Hydrochloride injection. For the evaluation of mechanism of action, safety and clinical rational use of Salviae Miltiorrhizae and Ligustrazine Hydrochloride injection. Background: Salviae Miltiorrhizae and Ligustrazine Hydrochloride injection is a compound preparation consisted of Salvia Miltiorrhiza extract and ligustrazine hydrochloride for the treatment of cardiovascular and cerebrovascular diseases in China. Methods: Plasma samples were precipitated with methanol, which was spiked with ascorbic acid and the supernatant was separated on a Waters Cortecs C18 column, by using a gradient mobile phase system of acetonitrile-water containing 0.05% formic acid (v/v). For internal standards, puerarin was selected for the five salvianolic acids, while isofraxidin was used for ligustrazine hydrochloride. Besides, electrospray ionization in negative mode and multiple-reaction monitoring were used to identify and quantify the five salvianolic acids, whereas ligustrazine hydrochloride was quantified at 310 nm using the diode array detector. Results: Noticeably, all calibration curves showed good linearity (R2>0.99) over the concentration range, with a lower limit of quantification between 0.00411 and 0.0369μg/mL for salvianolic acids, and 1.74 μg/mL for ligustrazine hydrochloride. Next, the precision of the developed method was evaluated by intra-and inter-day assays, and the percentage of relative standard deviation was within 10%. Although the extraction efficiency of some salvianolic acids were not very satisfactory, the sensitivity of the analytical method met the analysis requirements of rat plasma samples. Moreover, the validated method was successfully applied to a pharmacokinetic study of Salviae Miltiorrhizae and Ligustrazine Hydrochloride injection in the rat model. Conclusion: Linear pharmacokinetic characteristics were observed for the six active ingredients after intravenous infusion administration in rats, within the dose range examined here. In summary, our study proposed a HPLC-DAD-MS/MS method in the simultaneous determination of multiple ingredients, and demonstrated its applicability in pharmacokinetic studies.