Comprehensive Quantitative Analysis of SQ Injection Using Multiple Chromatographic Technologies.

Quality control of Chinese medicine injections remains a challenge due to our poor knowledge of their complex chemical profile. This study aims to investigate the chemical composition of one of the best-selling injections, Shenqi Fuzheng (SQ) injection (SQI), via a full component quantitative analysis. A total of 15 representative small molecular components of SQI were simultaneously determined using ultra-high performance liquid chromatography (UHPLC) coupled with quadrupole tandem time-of-flight mass spectrometry (Q-TOF-MS); saccharide composition of SQI was also quantitatively determined by high performance liquid chromatography (HPLC) with evaporative light scattering detector (ELSD) on an amino column before and after acid hydrolysis. The existence of polysaccharides was also examined on a gel permeation chromatography column. The method was well validated in terms of linearity, sensitivity, precision, accuracy and stability, and was successfully applied to analyze 13 SQI samples. The results demonstrate that up to 94.69% (w/w) of this injection product are quantitatively determined, in which small molecules and monosaccharide/sucrose account for 0.18%-0.21%, and 53.49%-58.2%, respectively. The quantitative information contributes to accumulating scientific evidence to better understand the therapy efficacy and safety of complex Chinese medicine injections.

[Simultaneous determination of six components in water extract and alcohol precipitation liquid in Astragali Radix by HPLC-UV-ELSD].

A HPLC-UV-ELSD method was established for simultaneous determination of six components in two intermediates of Shenqi Fuzheng injection (SFI) and the feasibility of establishing quantitative analysis of multi-components by single marker (QAMS) methods on different detectors was further explored. Calycosin-7-O-ß-D-glucoside and astragloside Ⅳ were selected as internal reference substances for respectively flavonoids and saponins, and relative correlation factors (RCF) of formononetin-7-O-ß-D-glucoside, 9, 10-dimethoxypterocarpan-3-O-ß-D-glucopyranoside, 2'-dihydroxy-3', 4'-dimethoxyisoflavan-7-O-ß-D-glucopyranoside and astragloside Ⅱ were calculated. Eventually, quantitative results of the 14 samples were compared between QAMS and external standard method. The sample concentrations calculated by QAMS were similar with concentrations calculated by external standard method, and the absolute values of relative deviations were generally less than 5% according to the UV detection of flavonoids. On the basis of ELSD detection for saponins, however, the absolute values of relative deviation of the two methods ranged from 0.48% to 23.17%. The QAMS method built on ultraviolet (UV) detectors was stable and can be used as a substitute method to reduce the consumption of standard compounds; meanwhile, the accuracy of QAMS method built on evaporative light scattering detector (ELSD) was inferior to that of external standard method, and the working principle of ELSD and feasible concentration range remain to be further studied.

[Design space approach to optimize first ethanol precipitation process of Dangshen].

Design space approach is applied in this study to enhance the robustness of first ethanol precipitation process of Codonopsis Radix (Dangshen) by optimizing parameters. Total flavonoid recovery, dry matter removal, and pigment removal were defined as the process critical quality attributes (CQAs). Plackett-Burman designed experiments were carried out to find the critical process parameters (CPPs). Dry matter content of concentrated extract (DMCE), mass ratio of ethanol to concentrated extract (E/C ratio) and concentration of ethanol (CEA) were identified as the CPPs. Box-Behnken designed experiments were performed to establish the quantitative models between CPPs and CQAs. Probability based design space was obtained and verified using Monte-Carlo simulation method. According to the verification results, the robustness of first ethanol precipitation process of Dangshen can be guaranteed by operating within the design space parameters. Recommended normal operation space are as follows: dry matter content of concentrated extract of 45.0% - 48.0%, E/C ratio of 2.48-2.80 g x g(-1), and the concentration of ethanol of 92.0% - 92.7%.

[Effect of Radix Polygoni Multifori praeparata by different processing on model of blood deficiency rats].

OBJECTIVE: To evaluate a proper processed method of Radix Polygoni Multiflori by pharmacodynamic action. METHODS: Model of blood deficiency rats were used in this experiment. The reagents were alcohol extracts of radix polygoni multiflori and its dreferent processing drugs made without any adjuvants in the first experiment. The reagents were alcohol extracts of te processing drugs made without any adjuvants and that made with decoction of black soybean in the second experiment. Their effecacy on model blood deficiency rats was observed. RESULTS: It was showed that some of radix polygoni multiflori praeparata could nourish the blood. The effecacy was different for alcohol extracts of variously processing drugs. Decoction of black soybean could reinforce effectiveness of radix polygoni multiflori praeparata. But it was related to the processed method. CONCLUSION: The processed method directly influences the pharmacodynamic action of radix polygoni multiflori praeparata.

Rapid quantification of multi-components in alcohol precipitation liquid of Codonopsis Radix using near infrared spectroscopy (NIRS).

A near infrared spectroscopy (NIRS) approach was established for quality control of the alcohol precipitation liquid in the manufacture of Codonopsis Radix. By applying NIRS with multivariate analysis, it was possible to build variation into the calibration sample set, and the Plackett-Burman design, Box-Behnken design, and a concentrating-diluting method were used to obtain the sample set covered with sufficient fluctuation of process parameters and extended concentration information. NIR data were calibrated to predict the four quality indicators using partial least squares regression (PLSR). In the four calibration models, the root mean squares errors of prediction (RMSEPs) were 1.22 µg/ml, 10.5 µg/ml, 1.43 µg/ml, and 0.433% for lobetyolin, total flavonoids, pigments, and total solid contents, respectively. The results indicated that multi-components quantification of the alcohol precipitation liquid of Codonopsis Radix could be achieved with an NIRS-based method, which offers a useful tool for real-time release testing (RTRT) of intermediates in the manufacture of Codonopsis Radix.