ABSTRACT
【Objective】 To explore the analytical methods for detecting data in the process of quality inspection of blood component samples. 【Methods】 The quality inspection data of blood component samples from 2018 to 2022 in our center were collected. Based on the principles of statistical process control, control charts were created using Minitab software to analyze key test items. 【Results】 The P control chart was used to analyze the pass rate of platelet content and revealed one out-of-control point. The normality test was performed on plasma protein content to analyze the causes of data fluctuations for further improvement. The mean and range control chart was utilized for hematocrit measurement, with abnormal data trends detected. Further analysis of the normality test and process capability analysis was conducted, resulting in a Cpk value of 0.67. 【Conclusion】 By applying statistical process control methods, the study employed P control charts to analyze count data in the quality inspection of blood component samples, conducted normality tests for measurement data, and utilized mean and range control charts to identify abnormal data trends. For data conforming to a normal distribution, the process capability index (Cpk) was calculated to explore effective monitoring methods for ensuring stability in the blood supply process.
ABSTRACT
Objective: To optimize the formulation of Haimeng Zhisuan gastric floating sustained-release tablets and to investigate its in vitro release properties. Methods: Plackett-Burman design was used to screen three most influential factors, i.e. matrices, floating material, and fillers which had significant impact on the preparation of floating sustained-release tablet by evaluating the cumulative release rate of CaCO3 at 2, 4, and 12 h; The levels of non-important factors were also determined. A 3-factor, 3-level Box-Behnken design was led to optimize the formulation, using cumulative release rate as index. The experiment result was optimized and the drug release kinetics equation was fitted by response optimizer. Results: The optimized tablet formulation was as follows: cuttlebone 225.0 mg, Montmorillonite 25.0 mg, HPMC K100M 100.0 mg, MCC 48.3 mg, EC 25.0 mg, searyl alcohol 74.7 mg, and 5% PVP-K30 ethanol solution as adhesive. The experimental data of optimized tablet were similar to the predicted values. The floating duration was over 12 h in simulated gastric fluid. Data of the in vitro release were fitted to the first-order equation. Conclusion: Formulation of Haimeng Zhisuan floating sustained-release tablet is found to be reasonable. The preparation technology is feasible. The tablet shows good in vitro release properties within 12 h.
ABSTRACT
Objective: To optimize the one-step pelletization technology of Tianshu Capsule by Minitab software. Methods: Using the qualified rates of particles as the evaluation indexes, three significant impact factors (fluid extract-dextrin ratio, infusion frequency, and atomization pressure) of one-step pelletization technology were selected and the levels of non-significant factors were identified by the Plackett-Burman experimental design. According to single factor experiments, choosing the qualified rates of particles, moisture, and angle of repose as the evaluation indexes, three levels of the three factors were selected by Box-Behnken of central composite design to establish the multiple linear regression and binomial fitting, and the experimental data were optimized by the response optimizer. Results: The best conditions were as follows: fluid extract-dextrin of 1.57:1 put in fluid-bed and heated by fan; the temperature of the bottom material in the fluidized state was increased to 50°C, fluid extract of 2% HPMC was sprayed with frequency of 32 Hz, the frequency of fan was 30 Hz, inlet air temperature was 60°C, atomization pressure was 0.21 MPa, and feed temperature was 50°C. Conclusion: Under the Minitab optimized scheme, the average experimental results are similar to the predicted values, and Minitab software could be used in the optimization of one-step pelletization for Chinese materia medica.