Analysis on Work Idea of Medical Device Classification Dynamic Adjustment Mechanism in the United States / 中国医疗器械杂志

OBJECTIVE@#Discuss the working ideas of the dynamic adjustment mechanism of medical device classification in the United States, and provide reference for the construction of medical device related mechanisms in China.@*METHODS@#Collect and interpret the documents of regulatory background, procedures and orders of the dynamic adjustment mechanism of the medical device classification in the United States, and summarize the overall situation and specific cases of the medical device classification adjustment under this mechanism in recent years.@*RESULTS@#The US work idea of the medical device classification dynamic adjustment mechanism is based on the latest valid scientific evidence, conducting risk analysis and identification, and determining the corresponding measures.@*CONCLUSIONS@#During the adjustment process, industry stakeholders have repeatedly discussed and achieved final agreement. Its procedures and working ideas can be used as a reference for China's work.

Changes and Related Reflections on the European Union's in Vitro Diagnostic Medical Device Classification Supervision System / 中国医疗器械杂志

By analyzing and comparing the IVD product classification supervision system in the EU's new IVDR, old IVDD and related guidance documents, concepts of related regulatory reforms were analyzed and explored, to provide references for industrial personnel to understand and master the new EU IVD classification system, and for China's ongoing classification management reform.

Analysis of Changes in Medical Device Classification Concept of the New EU Regulations / 中国医疗器械杂志

By comparing new medical device regulations with existing directives in the European Union, the revising ideas of new EU medical device regulations, especially the changes of the classification management concepts, were analyzed to provide clues for the industry to interpret the new EU regulations, and references for the classification management innovation in our country.

Impact of 2, 3-dihydrocyclopentacoumarins to growth of transgenic hairy roots of Polygonum multiflorum and accumulation of stilbene glucosides / 中国中药杂志

<p><b>OBJECTIVE</b>To investigate the influence of 2,3-dihydrocyclopenta coumarins to the growth of transgenic hairy root of Polygonum multiflorum and the accumulation of active ingredient stilbene glucoside in the culture.</p><p><b>METHOD</b>In different culture time, 2,3-dihydrocyclopenta coumarin compounds were administrated to the hairy roots. The yield of stilbene glucoside and the growth of the hairy roots were determined after some period of co-culture. Through the investigation of the different concentrations of the 2,3-dihydrocyclopentacoumarin, and sub-culture times, the optimal experimental conditions were established.</p><p><b>RESULT</b>The optimal administration time of the 2,3-dihydrocyclopentacoumarin was on the fourth day, the optimal concentration of 2,3-dihydrocyclopentacoumarin was 0.025 g x L(-1). Under this condition, the growth of the hairy root greatly increased. Comparing with control group, the accumulation of stilbene glucoside was increased about four times.</p><p><b>CONCLUSION</b>2, 3-dihydrocyclopentacoumarins could promote the hairy hair root growth and stimulate the stilbene glucoside accumulation.</p>

Biotransformation of daphnetin by suspension transgenic hairy roots of Polygonum multiflorum / 中国中药杂志

<p><b>OBJECTIVE</b>To investigate the biotransformation of daphnetin by suspension transgenic hairy root of Polygonum multiflorum and provide a biotechnological method for large-scale production of the daphnetin-8-O-beta-D-glucoside using this new culture system.</p><p><b>METHOD</b>Daphnetin was added into the media of suspension to culture 36 h. The biotransformation product was detected with TLC and HPLC, and isolated by various chromatographic methods. The influence of co-cultured time on conversion ratio, content of degradation product and the reason for the degradation of product II were investigated using HPLC.</p><p><b>RESULT</b>One biotransformation product, daphnetin-8-O-beta-D-glucoside, was obtained, the optimal co-cultured time in suspension hairy root of P. multiflorum was 36 h with the highest biotransformation molar ratio of 32.11%, the sucrose medium (sucrose-only) can increase the biotransformation molar ratio to 72.44%. The result demonstrated that the degradation products of the product II was induced by the MS medium.</p><p><b>CONCLUSION</b>The potential application of suspension transgenic hairy root of P. multflorum in the sucrose-only medium on generating daphnetin-8-Obeta-D- glucoside could be prospective.</p>