Analysis and structural identification of relevant substances in Breviscapine for Injection / 中国中药杂志

To define the composition of relevant substances in Breviscapine for Injection, in order to improve the quality control of impurity, and ensure the clinical safety. The analysis and structural identification of relevant substances in different specifications and batches of Breviscapine for Injection powders were carried out by HPLC and UPLC-QTOF-MS. Three primary relevant substances, namely 5,6,7,3',4'-pentahydroxyflavone-7-O-glucuronide(3), 3,5,6,7,4'-pentahydroxyflavone-3-O-glucuronide(4) and scutellarein(10), as well as three minor impurities, namely 6-hydroxyapigenin-6-O-glucosyl-7-O-glucuronide(1), methoxylscutellarin(6) and apigenin-7-O-glucuronide(7) were structurally identified by matching retention time, UV spectra, and mass spectra with authentic compounds and MS fragmentation rules. The main relevant substances(3) and(4) were separated and purified by semi-preparative HPLC, and their structures were further confirmed by NMR data. The study defined relevant substances of Breviscapine for Injection, and provided reference for improving the quality control level of single impurity in breviscapine preparation.

Determination of 13 kinds of metal elements in 10 common Chinese materia medica injections by ICP-MS / 中草药

Objective: To establish microwave digestion-inductively coupled plasma mass spectrometry (ICP-MS) method for the determination of 13 kinds of metals (Pb, Cd, Hg, As, Cu, Fe, Mn, Zn, Ba, Al, Co, Cr, and Ni) in 10 kinds of Chinese materia medica (CMM) injections which are Carthamin yellow for injection, Breviscapine for injection, Urokinase for injection, Lugua Polypeptide for injection, Xuesetong for injection, Shuanghuanglian for injection, Tanreqing Injection, Salvia miltiorrhiza Injection, Yinxing Damo Injection, and Danhong Injection). Methods: HNO3 and H2O2 are as acid digestion system; Samples were conducted pretreatment by microwave digestion instrument; Sc, In, Rh, and Re were used as internal standard elements, 13 kinds of elements were determined by ICP-MS at the same time. Results: Different kinds of the elements had a good linear relationship (r>0.999); The limit of detection was range from 0.008 to 0.069 μg/L, the average recovery rate was range from 93.61% to 100.79%; RSD values of the repeatability and precision were all less than 5%, The As and Cd in 10 kinds of CMM injections were all less than the limit of detection, Pb was ranged from 0.109 to 0.017 mg/kg, Cu was ranged from 0.016 to 0.135 mg/kg, Hg was ranged from 0.005 to 0.018 mg/kg, Fe was ranged from 0.335 to 2.081 mg/kg, Mn was ranged from 0.021 to 0.699 mg/kg, Ba was ranged from 0.009 to 0.028 mg/kg, Zn was ranged from 0.005 to 3.186 mg/kg, Al was ranged from 0.518 to 10.012 mg/kg, Co was ranged from 0.003 to 0.028 mg/kg, Cr was ranged from 0.006 to 0.179 mg/kg, Ni was ranged 0.005 to 1.187 mg/kg, five kinds of heavy metals which were needed to control were safe according to Chinese Pharmacopoeia (2010), the contents of Fe, Mn, Zn, and Al were not too high, but their safe limits were needed to be further in-depth researched and analyzed. Conclusion: This method is simple and fast, and has good accuracy and high precision, so it can be recommended for the determination of metal elements in CMM injections and provide the reference for its quality control.

Therapeutic Effect of Breviscapine for Injection on Acute Facial Neuritis / 中国药房

0.05).In 28 days before and after treatment,there was significant difference in H-B grade between two groups (P