[Quality control strategy of traditional Chinese medicine based on pharmaceutical product lifecycle management].

Quality control is pivotal in the research and development of traditional Chinese medicine, whose connotation is not limi-ted to the qualitative or quantitative detection of an indicator component, but extends to the establishment of a whole process quality control system from the perspective of pharmaceutical product lifecycle management. This study discussed the quality control strategy of Chinese medicine based on the concept of pharmaceutical product lifecycle management, and proposed the following suggestions:(1) to focus on the "holistic view" and "phased" characteristics of quality control and strengthen the establishment of quality control strategy based on top-level design;(2) to strengthen the research on quality control of Chinese medicine based on quality risk management, focus on the correlations of quality control indicators with the safety and effectiveness of traditional Chinese medicine, and establish a quality evaluation system consistent with the characteristics of traditional Chinese medicine;(3) to consider the characteristics of different registration classifications in the establishment of quality control strategy;(4) to highlight the quality correlation research, strengthen the quality transfer research, ensure the quality traceability, and establish a sound quality management system;(5) to strengthen the quality research on marketed drugs to achieve dynamic quality improvement.

Analysis of the fingerprint profile of bioactive constituents of traditional Chinese medicinal materials derived from animal bile using the HPLC-ELSD and chemometric methods: An application of a reference scaleplate.

Traditional Chinese medicinal materials derived from animal bile are widely applied in clinical therapy for thousands of years in several Southeast Asian countries. Although the constituents are similar, these crude drugs exhibit different pharmacological activities; bile acids are the main bioactive constituent. Depending on the source, the price of these crude drugs differs significantly.

Differentiation of Various Snake Bile Derived from Different Genus by High-Performance Thin-Layer Chromatography Coupled with Quadrupole Time-of-Flight Mass Spectrometry.

Snake bile originates from nearly 20 species from three families (Elapidae, Colubridae, and Viperidae). However, the components of various snake bile were not compared with one another. The aim of the study was to develop a TLC-MS method for differentiation of various snake bile derived from a different genus.

[Studies of pattern recognition of fingerprint profile of cattle bile powder and determination of multi-component in it].

An HPLC-ELSD method with good specificity and good accuracy was used for the studies of fingerprint and quantification of multi-components for cattle bile powder. The chromatographic analysis was carried out on a Phenomenex Gemini C₁₈ column (4.6 mm×250 mm, 5 μm) with a column temperature of 40 ℃ and a liquid flow-rate of 1.