[Evaluation on safety of puerarin injection in clinical use].

Puerarin injection is commonly used in clinical treatment of coronary heart disease, angina pectoris, retinal artery, vein occlusion, sudden deafness and so on. This paper is aimed to evaluate the safety of puerarin injection in clinical use and explore the related factors that may cause its adverse reactions (ADRs), so as to find the warning signal of safety medication in time, put forward early warning, make early judgment and treatment, and ensure the safety of drug use. By strengthening surveillance, the best medication plan was established to prevent the occurrence of adverse reactions of puerarin injection and enhance people's awareness on the safety of puerarin injection. Database were searched to collect literature related to ADRs of puerarin injection. The data were extracted and analyzed by decision tree with treeage software and χ² test was used to verify the data. A total of 62 papers involving 129 cases were included. The results showed that ADRs occurred mostly in patients aged 50-79 years, with the immune system and blood system accounting for the majority (88.3%), and ADRs occurred mostly 48 h after drug administration (61.1%). The severity of ADRs was not related to the dosage of puerarin, but it was related to the choice of the infusion solvent. In puerarin injection, most of the ADRs were moderate or severe (64.3%), 13 out of 129 cases were of death. Therefore, the indications and methods of use should be strictly controlled, and the allergic history of patients should be carefully questioned before medication to strengthen the monitoring of drug use.

Quality Control of the Fuzi Lizhong Pill Through Simultaneous Determination of 16 Major Bioactive Constituents by RRLC-MS-MS.

Fuzi Lizhong pill (FLP) is used to treat gastritis, and the monarch drug of it is Aconiti Lateralis Radix Praeparata (Fuzi, aconite roots) which is a toxic herbal medicine. To better control the safety and quality of FLP, an effective method to analyze the contents of 16 toxic and bioactive components using rapid resolution liquid chromatography-tandem triple-quadrupole mass spectrometer was established. The 16 constituents included aconine, mesaconine, hypaconitine, benzoylaconine, benzoylmesaconine, benzoylhypaconine, adenosine, liquiritin, liquiritigenin, glycyrrhizic acid, isoliquiritigenin, 6-gingerol, atractylenolide III, atractylenolide I, atractylenolide II and glycyrrhetic acid. Ideal separation was performed using gradient elution in 13 min by optimized conditions. All the isomerides were isolated to baseline. The improved method with a polarity switch in contiguous time segments could analyze the five types of components, including polar and nonpolar compounds, without decreasing sensitivity. The proposed method was fully validated. The results revealed that contents of six alkaloids from Fuzi were significantly different among the samples. Using the established method and multivariate statistical method, the quality consistency of two dosage forms of FLP from different companies were analyzed. The optimized method could be used for the quality control of FLP and investigate index compound variation between two dosage forms.

[Study on HPLC fingerprint and chemical constituent difference of different species of Aurantii Fructus Immaturus].

This study is to establish an HPLC fingerprint by HPLC-DAD method and simultaneous quantitative analysis of 17 components of 18 batches of Citrus aurantium and 10 batches of C. sinensis. The separation was performed on an Agilent Poroshell 120 SB-C18 (4.6 mm×100 mm,2.7 µm) column with the gradient elution of methanol-0.1% formic acid water, the flow was 0.6 mL•min⁻¹. The detection wavelength was set at 318 nm. The column temperature was maintained at 30 ℃. The data calculation was performed with similarity evaluation system for chromatographic fingerprint of traditional Chinese medicine (Version 2004A) together with SIMCA-P 13.0 software to clarify the differential marker between these two different species of Aurantii Fructus Immaturus. This method has good precision stability and repeatability that could provide basis for quality control and evaluation of Aurantii Fructus Immaturus.

[Research on concentration of 5 different ginsenosides in Panax japonica collected from different cultivated geographic regions].

In this paper, an HPLC-QqQ-MS method for determination of 5 different ginsenosides of Panax japonica collected from different cultivated geographic regions was established. The separation was performed on a Zorbax XDB-C18 (4.6 mm×100 mm, 1.8 µm) column with the gradient elution of acetonitrile (contained 0.1% formic acid)-0.1% formic acid water. The flow rate was 0.5 mL•min⁻¹. The colunm temperature was maintained at 30 ℃. The analytes were detected using electrospray ionization (ESI) in multiple reaction monitoring (MRM) modes. Reaction selected ions were 203.2 for ginsenoside Re, 202.9 for ginsenoside Rg1, 365.0 for ginsenoside Rf, 789.1 for ginsenoside Rd, 360.9 for ginsenoside Ro. Ginsenosides Re, ginsenosides Rg1, ginsenosides Rf, ginsenosides Rd, ginsenosides Ro had good linearity in the ranges of 3.33-66.60 µg (r=0.999 1),2.83-56.54 µg (r=0.999 2), 0.32-6.51 µg (r=0.999 2), 12.55-251.00 µg (r=0.999 3), 0.85-16.90 µg (r=0.999 5), respectively. The results of recovery were among 100.8% to 104.6%, and the values of RSD were blow 3.0%. This method is simple, reliable and accurate, and can provide basis for P. japonica basic research.