Optimization of dry granulating technique of Qibai Pingfei granule through response surface methodology / 中国中药杂志

To determine the optimum process conditions for dry granulating technique of Qibai Pingfei granule, granule excipient type, rolling wheel speed and pressure and feeding speed were studied. Taking shaping rate at a time, moisture absorption and dissolubility as index, the type and amount of granule excipient were determined. In addition, taking shaping rate at a time as index, parameters of rolling wheel speed and pressure and feeding speed were researched through single factor test and response surface methodology. The optimum parameters were as follows: lactose as excipient, dry extract powder to excipient at 1:2, rolling wheel speed and pressure at 10.9 Hz and 6.4 MPa and feeding speed at 7.2 Hz. After validation of three batches pilot-scale production, the optimum processing parameters for dry granulating technique of Qibai Pingfei granule is reasonable and feasible, which can provide reliable basis for production.

Measurement of mass fraction of Sanjie Zhentong capsules with near infrared reflectance spectroscopy / 中国中药杂志

Sanjie Zhentong capsules were scanned by using a near infrared spectra probe with different drug mass fraction and the spectral information of capsule shells and contents in it were obtained. Then partial least squares (PLS) models were developed for the prediction of mass fraction of Fritillariae Thunbergii Bulbus and Resine draconis in Sanjie Zhentong capsules. The correlation coefficient (r9c)) and root mean standard error( RMSEC) of 0.949 5, 0.958 2 and 4.742 4, 4.135 7. The models obtained correlation coefficient (r(v)) of 0.919 2, 0.936 7 and root mean square error (RMSECV) of 6.158 9, 5.037 3 respectively in the training set. The paired T test analysis of statistics showed that there were no significant difference between predictive values and measure values. The established models reflected a strong prediction performance and can meet the needs of the production.

Determination of eight components in Qibai Pingfei Granule by quantitative analysis of multi-components with a single-marker / 中草药

Objective: To establish a quantitative analysis of multi-components with a single-marker (QAMS) method for the determination of eight components in Qibai Pingfei Granule (QPG). Methods: Ginsenoside Rb1 was used as the internal reference substance. The relative correlation factors (f) of ginsenosides Rg, Re, Rf, Rc, Rb2, Rc, and astragaloside were calculated and established. The results were compared with those obtained by the external standard method in 10 batches of QPG. The results showed that the f values of ginsenosides Rg, Rf, Rc, Rb2, astragaloside, and ginsenosides Rc to ginsenoside Rb1 were 1.244, 1.075, 1.133, 1.090, 1.071, 0.967 and 1.070. Results: Ginsenosides Rg1, Re, Rf, Rb1, Rc, Rb2, Rd, and astragaloside had good relations within the ranges of 0.416 0-4.992, 0.315 4-3.785 2, 0.259 6-3.115, 0.385 2-4.622, 0.222 8-2.674, 0.193 2-2.318, 0.183 5-2.202, and 0.574 6-6.895 μg, respectively. The two methods did not show the significant difference in assay results. Conclusion: So the QAMS method is feasible and credible, and could be used to determine the multiple components in QPG.

HPLC fingerprint of liuwei dihuang soft capsule / 中国中药杂志

In order to establish HPLC fingerprint of Liuwei Dihuang soft capsule, and to provide certain reference for an quality control of it, the HPLC method was performed on an Agilent C18 (4.6 mm x 250 mm, 5 μm) column with acetonitrile-0.02% trifluoroacetic acid as mobile phase, gradient elution volume flow of 1.0 mL x min(-1), column temperature was 30 degrees C, detection wavelength: 0-60 min, 238 nm, 60-70 min, 210 nm. The software for chromatographic fingerprint was applied to analysis different batches of Liuwei Dihuang soft capsule samples. Sixteen mutual peaks were selected as the fingerprint peaks in 12 samples with loganin as the reference peak, and all of the detected peaks were separated effectively. Cluster analysis (HCA) and similarity analysis (SA) were done based on data of 12 samples clustering analysis of 12 batches of samples were divided into 2 categories. Including 7 for the first class, the rest was second, similarities calculated by SA were all above 0.92, indicating a good similarity between the reference and twelve batches of samples, also, the analysis results of HCA and SA basically the same. This method is simple with good precision, repeatability and stability, and provides the basis for Liuwei Dihuang soft capsule quality control.