ABSTRACT
The present study determined five saponins in Xuesaitong Dropping Pills(XDP) by micellar electrokinetic chromatography(MEKC), and evaluated between-batch consistency by MEKC fingerprints and similarity analysis. A background buffer was composed of 20 mmol·L~(-1) sodium tetraborate-20 mmol·L~(-1) boric acid solution(pH 8.5), 55 mmol·L~(-1) sodium dodecyl sulfate(SDS), 23 mmol·L~(-1) β-cyclodextrin, and 13% isopropyl alcohol. All separations were performed at 25 ℃,20 kV and the detection wavelength was set at 203 nm. The separation channel was a fused silica capillary with a dimension of 75 μm I.D. and a total length of 50.2 cm(effective length of 40.0 cm). The contents of notoginsenoside R_1, and ginsenosides Rg_1, Re, Rb_1, Rd were determined with their quality control ranges set. The fingerprints of XDP were established and the between-batch consistency was evaluated by similarity analysis. The contents of five saponins from the 19 batches of XDP were stable in the fixed ranges. Statistical analysis was carried out on the results of multiple batches of samples, and the specific quality control ranges were recommended as follows: notoginsenoside R_1 21.92-34.16 mg·g~(-1), ginsenosides Rg_1 83.54-131.78 mg·g~(-1), ginsenosides Re 13.58-19.82 mg·g~(-1), ginsenosides Rb_1 89.40-129.90 mg·g~(-1), and ginsenosides Rd 22.34-35.67 mg·g~(-1). Eleven characteristic peaks were identified in the fingerprints. Five peaks, notoginsenoside R_1 and ginsenosides Rg_1, Re, Rb_1, Rd, were identified with reference standards. The similarities of the 19 batches of samples were all above 0.988, indicating good between-batch consistency. This method is green and simple, and can be used for the quantitative determination and quality evaluation of XDP. It can also provide references for the quality control of other Chinese medicinal dripping pills.
Subject(s)
Chromatography, Micellar Electrokinetic Capillary , Drugs, Chinese Herbal , Micelles , Quality Control , SaponinsABSTRACT
With the dropping process of Xuesaitong Dropping Pills(XDP) as the study object, critical factors affecting the quality indicators of pill pass rate, average weight of drop pills and roundness were screened out, so as to deepen the understanding of the dropping process. The critical process units, critical quality attributes and potential critical process influencing factors of XDP were determined by risk analysis and prior knowledge, and then the critical influencing factors were screened out by Plackett-Burman design. First, according to the risk assessment, the critical technique of XDP preparation process was dropping, and then the critical quality attributes of dropping process were pill pass rate, average weight of drop pills and roundness. Then, according to fishbone diagram and failure mode and effects analysis(FMEA), potential critical influencing factors were determined as flow rate, matrix ratio, solid-liquid ratio, feed-liquid temperature, top temperature of condensate, bottom temperature of condensate and dropping distance. Finally, among these seven potential factors, the critical influencing factors were determined as material liquid ratio, dropping distance, top temperature of condensate, bottom temperature of condensate. This study revealed the potential of Plackett-Burman design in screening and understanding the influence of selected factors on XDP dropping process, which could provide a reference for studying the dropping process.
Subject(s)
Drugs, Chinese Herbal , Saponins , TemperatureABSTRACT
OBJECTIVES@#This study is aimed to explore the blending process of Dahuang soda tablets. These are composed of two active pharmaceutical ingredients (APIs, emodin and emodin methyl ether) and four kinds of excipients (sodium bicarbonate, starch, sucrose, and magnesium stearate). Also, the objective is to develop a more robust model to determine the blending end-point.@*METHODS@#Qualitative and quantitative methods based on near-infrared (NIR) spectroscopy were established to monitor the homogeneity of the powder during the blending process. A calibration set consisting of samples from 15 batches was used to develop two types of calibration models with the partial least squares regression (PLSR) method to explore the influence of density on the model robustness. The principal component analysis-moving block standard deviation (PCA-MBSD) method was used for the end-point determination of the blending with the process spectra.@*RESULTS@#The model with different densities showed better prediction performance and robustness than the model with fixed powder density. In addition, the blending end-points of APIs and excipients were inconsistent because of the differences in the physical properties and chemical contents among the materials of the design batches. For the complex systems of multi-components, using the PCA-MBSD method to determine the blending end-point of each component is difficult. In these conditions, a quantitative method is a more suitable alternative.@*CONCLUSIONS@#Our results demonstrated that the effect of density plays an important role in improving the performance of the model, and a robust modeling method has been developed.
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Objective To determine the optimal electron beam energy at different field size through a Monte Carlo-based simulation of the therapy head of Varian X 6 MV linear accelerator so as to study the influence of radial intensity on depth dose.Methods Firstly,keeping the radial intensity unchanged for the field of interest while changing electron beam energy,compassion was carried out of calculated percentage depth doses between measured values.Thus,the optimal energy was identified for this field size.Then,the obtained energy was set the optimal value to study the radial intensity influence on the depth doses.Results The optimal electron energy for 4 cm ×4 cm,10 cm × 10 cm,20 cm × 20 cm and 30 cm × 30 cm field sizes was 5.9,6.0,6.3 and 6.4 MeV respectively.Changes in radial intensities resulted in negligible changes in percentage depth doses for4 cm ×4-cm and 10 cm × 10 cm fields,but led to observable discrepancy for 20 cm × 20 cm and 30 cm × 30 cm fields.Conclusions The optimal electron energies for different field sizes are slightly different.Change in radial intensity distribution has significant influence on the depth dose for large field.To improve simulation accuracy,the field size needs to be taken into consideration in determining the electron beam energy and radial intensity distribution.
ABSTRACT
<p><b>OBJECTIVE</b>To detect the serum levels of melanocyte antibodies and explore the relation between melanoma antigen recognized by T-cells (MART-1) and vitiligo in children.</p><p><b>METHODS</b>The serum samples were collected from children with vitiligo to test the autoantibodies, and divided into low- and high-titer group according to the test results. Melanocytes were incubated with the serum samples, and the changes of melanocyte surface antigen were evaluated using specific MART-1 antibody.</p><p><b>RESULTS</b>The serum melanocyte antibody levels in children with vitiligo were significantly higher than those in normal subjects. The expression level of melanocyte surface antigen MART-1 increased obviously after incubation of the melanocyte with high antibody titer serum samples, and MART-1 was found to specifically bind to specific MART-1 antibody.</p><p><b>CONCLUSION</b>Melanocytes MART-1 may correlate to the autoimmune mechanism in children with vitiligo.</p>