1.Qualitative Analysis of Components of Glandular Hairs in Lonicera Japonica Thunb. Buds by Laser Microdissection Combined with HPLC-TOF/MS
TANG Huimin ; FU Jing ; XIONG Lewen ; ZHANG Longfei ; ZHANG Yongqing ; WANG Lingna
Chinese Journal of Modern Applied Pharmacy 2023;40(18):2499-2505
OBJECTIVE To accurately analyze the components of glandular hairs in Lonicera japonica Thunb. buds, and provide reference for quality evaluation and control of Lonicera japonica Thunb.. METHODS Laser microdissection technology was used to obtain glandular hairs of Lonicera japonica Thunb. buds, low-temperature freezing vortex method was used to removal flower buds surface hairs(glandular hairs and non glandular hairs), and the components of flower buds, flower buds removed surface hairs and glandular hairs were detected by HPLC-TOF/MS. Through comparison with standards, database retrieval and mass spectrometry fragmentation, the components were analyzed and identified. RESULTS Thirty-seven components were identified in the flower buds, 31 components were identified in the flower buds removed surface hairs, and 35 components were identified in the glandular hairs. Compared with flower buds, glandular hairs lack 2 phenolic acids, and flower buds removed surface hairs lack 6 flavonoids. CONCLUSION The glandular hair, which contains many secondary substances, is an important place for the synthesis and accumulation of secondary substances in Lonicera japonica Thunb. buds, and is closely related to the quality of Lonicera japonica Thunb..
2.Comparative study on the registration management systems of innovative medical devices in China and the United States
Qianqian ZHAO ; Keyu CHEN ; Ziyan MENG ; Runping MA ; Qiufan SUN ; Lewen FU ; Zekun LIU ; Longping YANG ; Qing LI
Chinese Journal of Medical Science Research Management 2024;37(5):434-440
Objective:This article analyzed the current situation, similarities and differences and main problems of the registration and management systems of innovative medical devices in China and the United States.Methods:This article summarized the requirements and policies for the registration management of innovative medical devices in China and the United States, as well as the development and differences of the registration of innovative medical devices in China and the United States, and the main problems in the registration management of innovative medical devices in China.Results:At present, the development level of medical device industry in China and the United States was different, facing different development problems, and there were differences in the access standards and management methods of innovative medical devices. The registration management system established for innovative medical devices in China was gradually improving, and to a certain extent, it had promoted the enthusiasm of innovative product research and development and registration applications, but there were also problems such as unclear innovation evaluation scales, insufficient early intervention of review resources, and insufficient utilization of post-marketing data.Conclusions:Drawing on the beneficial experience of breakthrough device registration management in the United States, we will improve the registration management system for innovative products and shorten the review and approval cycle by clarifying the identification criteria for innovative medical devices, promoting the placement of review resources in the R&D stage, and further strengthening the use of post-marketing data and regulatory scientific research.