1.Discussions on how to elevate competency of hospital academic leaders and medical workers at large
Lihua YI ; Lei WEI ; Aimin HAO ; Yang ZHAO ; Minmin HU ; Xia LI ; Ligang BAO
Chinese Journal of Hospital Administration 2013;29(10):788-791
Talents are core competitiveness of a hospital.In view of the nature of long and slow development cycle of medical talents,Wuxi No.2 People' s Hospital has innovated aTalent-tree program.This program develops talents by categories and stages,in the model oftree root-tree trunk-tree crownto fit different stage needs of these people.The program features a categorized education mode to establish hierarchical individualized plan for the whole career.The hospital has explored a special pathway for talents development,for the purpose of providing talents to ensure sustainable and innovative growth of the hospital.
2.Method establishment for content determination of related substances in Oxcarbazepine tablets
Minmin BAO ; Beibei LYU ; Wenzhi WEI ; Minjuan ZHANG
China Pharmacy 2023;34(10):1199-1203
OBJECTIVE To establish the method for content determination of related substances in Oxcarbazepine tablets. METHODS Ultra-high performance liquid chromatography (UPLC) method was adopted and the separation was performed on ZORBAX Eclipse Plus C18 column with mobile phase consisted of acetonitrile-0.01 mol/L ammonium acetate solution (pH6.0) (gradient elution) at the flow rate of 0.5 mL/min. The detection wavelength was 230 nm and column temperature was set at 35 ℃. The sample size was 10 μL. RESULTS The linear ranges of oxcarbazepine and impurity A, B, C, D, E, I, K, L and N were 0.192-1.440, 1.019-7.639, 0.208-1.559, 0.230-1.727, 0.389-2.915, 0.182-1.364, 0.393-2.945, 0.199-1.493, 0.199-1.490 and 0.200- 1.503 μg/mL, respectively (all r>0.999). The detection limits were 0.046, 0.037, 0.049, 0.027, 0.077, 0.040, 0.114, 0.054, 0.055 and 0.039 μg/mL. The quantitation limits were 0.152, 0.122, 0.162, 0.090, 0.258, 0.132, 0.380, 0.181, 0.185 and 0.130 μg/mL. RSDs of precision, repeatability, stability (24 h) and durability tests were all lower than 5.0%. The average recoveries were 92.8%-105.6% (RSD≤3.0%, n=9). Only impurity K and unknown impurity were detected in the original preparation sample, with a total content of 0.078% to 0.083%; impurities A, B, D, I and unknown impurity were detected in the generic preparations produced by domestic enterprise Ⅰ, with a total content of 0.147% to 0.163%; impurities A, B, I and unknown impurity were detected in the generic preparations produced by domestic enterprise Ⅱ, with a total content of 0.085% to 0.161%. CONCLUSIONS The established method is rapid, sensitive, accurate, stable and durable. It can be used for the content determination of 9 known impurities in Oxcarbazepine tablets.
3.Study on Oxcarbazepine Half-tablet Preparation by Reciprocating Cylinder Method and Partial Dose Evaluation
BAO Minmin ; LYU Beibei ; WEI Wenzhi ; ZHANG Minjuan
Chinese Journal of Modern Applied Pharmacy 2023;40(15):2117-2123
OBJECTIVE To establish a reciprocating tube dissolution method to investigate the similarity of in vitro dissolution behavior of oxcarbazepine scored tablet preparations between the original and generic drugs, and to evaluate the differences in dose-specific pharmaceutical properties between the original and generic drugs. METHODS Using 250 mL of pH 1.2 hydrochloric acid solution, pH 4.5 acetate buffer, pH 6.8 phosphate buffer, and water(all 0.5% sodium dodecyl sulfate) as the dissolution medium, and reciprocating frequency of 10 dip min-1, using a reciprocating tube dissolution device to determine the dissolution curves of generic drugs and original research drugs, and combining the similarity factor(f2) method to evaluate the similarity of dissolution behavior between generic drugs and original research drugs, and compared the result with paddle method. The friability, weight variation and loss of mass of half-tablets were determined by friability tester and electronic balance through splitting by hand and by the cutting device respectively. RESULTS The f2 of generic drug A in 4 dissolution medium were higher than 50 and showed its similarity to original drug. While the generic drug B was not consistent with the dissolution behavior of original drug as its f2 factorswere all less than 50 in 4 dissolution. The post-segmentation weight variation, loss of mass and fragility of generic drug A and B were higher than those of the original drug. CONCLUSION The dissolution curve of oxcarbazepine half tablet preparation measured by the reciprocating cylinder method has good discrimination compared to the paddle method, and there is still a certain gap in the quality control of the generic drug in different doses compared to the original research drug.