1.Performance of registration regulation policies on biosimilars in Japan and its enlightenment
Yongfa CHEN ; Yunyun BIAN ; Lin WU
Chinese Journal of Health Policy 2016;9(12):50-55
Objective:This paper intends to provide reference for consummation of biosimilar registration poli-cies in China. Methods:This paper evaluates the performance of Japanese registration regulation policies on biosimi-lars by analyzing the procedure and reviewing the features of biosimilars. Results and Conclusions:According to the findings of the present investigation, the availability and affordability of biosimilars have been improved, and the bio-medicine industry has achieved great development. On the other hand, it's recommended that the guideline for the de-velopment and evaluation of biosimilars should be amended on the principle of appropriate simplification, which means to simplify the research and development procedure and exempt partial application dossier. Besides, the regis-tration procedures should be adopted continuously to ensure the stability of biosimilars' R&D and registration.
2.Antioxidant activity of different extracts from Astragalus mongholicus.
China Journal of Chinese Materia Medica 2009;34(22):2924-2927
OBJECTIVETo study the antioxidant activities of different extracts from Astragalus mongholicus.
METHODThe antioxidant activities of the total flavanoids (TFA), the total saponins (TSA) and the total polysaccharides (TPA) from A. mongholicus were measured by means of biochemiluminescence. The concentrations of these samples varied from 1.25 x 10(-3) g x L(-1) to 25 x10(-3) g x L(-1).
RESULTAll the extracts showed antioxidant activities of scavenging 3 different free radicals with obvious concentration-scavenging capacity relationship. The antioxidant activity of TFA was the strongest among them. The IC50 of scavenging superoxide anion radicals of TFA (55.48% TFA, 0.59% TFA and 0.36% TFA) were 0.654 2, 4.654 4 and 6.055 2 g x L(-1), the IC50 of scavenging hydroxyl anion were 0.060 5, 0.254 4 and 0.493 0 g x L(-1), and the IC50 of scavenging hydrogen peroxide were 0.010 4, 0.156 0 and 0.224 0 g x L(-1), respectively.
CONCLUSIONThe extracts are more sensitive to hydrogen peroxide and hydroxyl anion than to superoxide anion radicals. TFA of A. mongholicus Bunge is the main component responsible for antioxidant activity, while TSA and TPA have weaker antioxidant activity. The antioxidant activity of TFA increases with the rise of its purity. On the contrary, the antioxidant activity of TSA and TPA decreases with the rise of their purity.
Antioxidants ; analysis ; Astragalus Plant ; chemistry ; Flavonoids ; analysis ; Plant Extracts ; analysis ; Saponins ; analysis
3.Interpretation of Teacher Training Syllabus for Clinical Pharmacist Training Program (2023 edition)
Li YOU ; Zhuo WANG ; Nan DING ; Yunyun YANG ; Yangui XU ; Haixia REN ; Pinfang HUANG ; Chaohui WU ; Jing BIAN ; Jing LIU ; Jin LU ; Jiancun ZHEN
China Pharmacy 2023;34(24):2945-2950
OBJECTIVE To interpret Teacher Training Syllabus for Clinical Pharmacist Training Program (2023 edition) (hereinafter referred as to the “new syllabus”), and to provide reference and guidance for promoting the implementation of the new syllabus and realizing the quality-improving goal of the reform of the clinical pharmacist teacher training program initiated by China Hospital Association. METHODS From the perspective of the management and based on the position of the designer, the new syllabus was interpreted from four aspects: the background of its compilation and release, the process of its compilation and its characteristics, the key improvements of the program and the points for attention about its subsequent implementation. RESULTS & CONCLUSIONS The development and release of the new syllabus provide a “construction blueprint” for the reform of the clinical pharmacist teacher training program of the China Hospital Association. The whole process of compiling the new syllabus is characterized by four basic features: theory-led, goal-oriented, research-based, and synergistic. Compared with the previous syllabus, in addition to the adjustment of the text structure,the new syllabus presents more complete and clearer competence requirements for clinical teaching competence in terms of training objectives; in terms of training content, it further structures the group of task items, pays attention to the 育。E-mail:zhenjiancun@163.com sequential planning and time arrangement of items, and puts forward both quantitative and qualitative refinement requirements for each specific training task;in terms of training methods, it emphasizes the interaction of lecturing, demonstrating and guiding, and the progression of observation, operation and reflection, with the intention of guiding teacher trainees to “learn how to teach by teaching”. In the subsequent implementation of the new syllabus, it is necessary for the teacher training bases to attach great importance to the guarantee of training conditions and process quality management, and to organize the teacher training team to do a good job in the two training programs of “clinical pharmacist training” and “clinical pharmacist teacher training”. Based on further improving the connection between the two training programs, the teacher training team should continue to explore the scientific model of clinical pharmacist teacher training oriented by clinical teaching competence.