Optimization of preparation process of Zizyphi Spinosi Semen flavonoids dropping pills by central composite design-response surface methodology / 中国药学杂志

OBJECTIVE: To optimize the formulations of Zizyphi Spinosi Semen flavonoid dropping pills by central composite design-response surface methodology. METHODS: Central composite design-response surface methodology was applied to optimize the preparation process with the dropping distance, dropping temperature, and cooling temperature as independent variables, while dependent variables were the variance of weight, spherical degree, and dissolution time. SPSS software was used to fit multivariate linear equation and second-order polynomial equation for experimental data. Response surface and contour plot were delineated according to best-fit mathematic models by Origin software, and the optimum formulation was selected by response surface. RESULTS: Quadratic multinomial model was better than multivariate linear model, and the regression coefficient was 0.981. The bias between the observed and predicted values of the optimum process was negligible, indicating the high predictability of the model. CONCLUSION: The model established by central composite design-response surface methodology and SPSS software is accurate for prediction and can be used to optimize the preparation process of Zizyphi Spinosi Semen flavonoids dropping pills.

Uncertainty evaluation of determination of aflatoxin B1 in Zizyphi Spinosi Semen by HPLC / 中国药学杂志

OBJECTIVE: To establish an uncertainty analysis method for determination of aflatoxin B1 in Zizyphi Spinosi Semen by HPLC. METHODS: The uncertainty arising from various factors in the whole process of analysis was evaluated. The facilitated method of evaluation was achieved by analysis of the uncertainty sources arising from the procedure of analysis and by using the validation data of assay. All the standard uncertainties were then combined according to the appropriate rules to give a combined standard uncertainty and an expanded standard uncertainty. RESULTS: When the residue level of aflatoxin B1 in Zizyphi Spinosi Semen was 6.218 μg · kg-1, the expanded standard uncertainty for aflatoxin B1 was 0.496 μg · kg-1(P=95%). CONCLUSION: This method is applicable for the uncertainty evaluation of aflatoxin B1 residue determination. It provides an important reference for the uncertainty evaluation for the aflatoxin B1 residue determination in Zizyphi Spinosi Semen.