RÉSUMÉ
Objective To rapidly identify the chemical components in a traditional Chinese compound herbal preparation Babao Dan by ultra-high performance liquid chromatography-quadrupole-time of flightmass spectrometry (UHPLC-Q-TOF/ MS). Methods A formula database including 547 compounds was developed by Agilent software " Formula-Database Generator”. The total ion chromatograms of the Baboo Dan extracts were obtained by UHPLC-Q-TOF/MS, and the chemical components were identified by automatic matching method according to the exact mass-to-charge ratio of each chemical component The chemical components of Baboo Dan was further verified using the secondary fragment ion obtained by adjusting the secondary monitor voltage of Q-TOF/MS. The separation was performed on a Waters Xbridge BEH C18 column (2.1 mm X 100 mm, 2.5 μm). The mobile phase composing of acetonitrile (A) and 0.5% formic acid aqueous solution (B) was used for gradient eluting (0-5 min, 5% A; 5-25 min, 5%-95% A; 25-30 min, 95% A). The temperature of column was 25°C; the flowing rate was 0.8 mL/min; and the post-column spit ratio was 2:1. The Q-TOF/MS and electro spray ion source (ESI) were applied for qualitative analysis under positive and negative ion mode, with the mass scan range being m/z 100-1 500. The capillary voltage was 3 500 V under positive ion mode and 4 000 V under negative ion mode, and the range of collision energy of MS2 was 10-40 eV. Results UHPLC-Q-TOF-MS identified a total of 78 chemical components from Babao Dnn, including saponins, bile acids, amino acids and so on. Conclusion A rapid and efficient method for identifying the chemicaf components of Babao Dan by UHPLC-Q-TOF-MS has been established, and the chemical components of Babao Dan has been clarified, which lays a foundation for the quality control and further pharmacological study of Babao Dan.
RÉSUMÉ
Objective: To develop methods for determining the disintegration time of oral disintegrating tablets (ODTs) of Chinese herbal drug, and to select the evaluation method with good reproducibility, resolving power, and in vivo and in vitro correlation. Methods: Several placebo ODTs and Chinese herbal drug ODTs were prepared. Their in vitro disintegration time was determined by self-developed method and routine methods, and the results were compared with the oral disintegration time. The reproducibility, resolving power, and the correlation between in vivo and in vitro of those methods were evaluated. Results = Different determination methods obtained different disintegration results of the same tablet. Graduated cylinder and improved disintegration apparatus both had shortcomings and their determination results were very different from that of the oral disintegration time. Our self-developed disintegration device could better determine the disintegration ability of the ODTs, and the result was closer to the oral disintegration time, with clear end point of disintegration and better reproducibility, resolving power, and the in vivo and in vitro correlation compared with other methods. Conclusion: Our self-developed device is suitable to determine in vitro disintegration time of ODTs, and may serve as a reference for quality control of ODTs.