Objective:To discuss and analyze the current situation of the application and approval of new Chinese medicine in China; To provide a reference for the research and development of new Chinese medicines in the future.Methods:The drug registration data were retrieved from Xanda database from January 1, 2016 to December 31, 2022, and the information of new approval and application of new Chinese medicines during this periods was systematically organized from the aspects of the number of registered varieties, registration categories, therapeutic areas, prescription sources, dosage form distribution, development cycle, clinical research and control drugs.Results:From 2016 to 2022, the total number of application for new Chinese medicines was 265. The number of registration classification 1.1 of new compound drugs was the largest. The dosage forms of new drugs were mainly granules, capsules, and tablets. Indications mainly focused on respiratory, neuropsychiatric, digestion and cardio-cerebrovascular diseases, etc. From 2016 to 2022, the total number of approval for new Chinese medicines was 29, of these, 19 from 2021 to 2022. The number of registration classification 1.1 of new Chinese medicines was the largest. The treatment fields are mainly respiratory system, gynecology and neuropsychiatric diseases, etc. The dosage forms of new drugs were mainly granules, capsules, and tablets. The number of drugs in prescriptions was 6-15. High-frequency drugs included Glycyrrhizae Radix et Rhizoma, Ephedrae Herba, Scutellariae Radix, Pinelliae Rhizoma, Poria and Gypsum Fibrosum. Phase Ⅱ and phase Ⅲ of the clinical trials had the largest number. The development period was approximately between 10-20 years. The most prescription source of new drugs was clinical experienced prescriptions and hospital pharmaceutics.Conclusion:The results show that China has been gradually building-up a relatively complete ecosystem for research and development of new Chinese medicines, helping to develop more high-quality Chinese medicines.

OBJECTIVE To prepare Lanqin extract/cyclodextrin complexes for probing its effects of different kinds of cyclodextrins on the taste-masking. METHODS Bitter compounds in the extracts were performed on ion exchange resin adsorption combined with HPLC. The formulations of complexes were screened by human taste panel method. The complexes were prepared by spray-drying and characterized through scanning electron microscope, differential scanning calorimetry, and hygroscopicty test. Moreover, the in vitro bitter taste perception of complexes was evaluated by electronic tongue and further valuation the credibility of the results was conducted on human gustatory sensation tests. RESULTS The sulfobutylether-β-cyclodextrin-based combinational formulation with multiple cyclodextrins could significantly inhibit the bitter taste of the extract which mainly caused by its alkaline constituents at a lower dosage. The results of electron scanning microscopy, differential scanning calorimetry, and hygroscopicity indicated that the Lanqin extract and cyclodextrin in the complex may form inclusion complexes rather than physical mixtures. The results of electronic tongue and human gustatory sensation tests showed that, compared with the extract suggested the taste characteristics of the optimal complexes was similar to corresponding excipient while the bitterness significantly reduced. CONCLUSION The Lanqin extract/cyclodextrin complexes prepared in this study are suitable for industrial production for its good flavour, less total amount of cyclodextrins, and simple process. The present study has important significance for the development of related taste masking products of Lanqin.