3.Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines.
Hong-jiao LI ; Li-yun HE ; Bao-yan LIU
China Journal of Chinese Materia Medica 2015;40(12):2461-2463
The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.
Drugs, Chinese Herbal
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adverse effects
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economics
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therapeutic use
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Humans
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Medicine, Chinese Traditional
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Product Surveillance, Postmarketing
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methods
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Quality Control
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Randomized Controlled Trials as Topic
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Respiratory Tract Infections
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drug therapy
4.In vitro differentiation of umbilical cord blood-derived mononuclear cells towards osteoclast-like cells
Qinghong BAO ; Wenjia LIU ; Xiaorong WANG ; Hong ZHOU
Chinese Journal of Tissue Engineering Research 2009;13(6):1176-1180
BACKGROUND: Orthodontic tooth movement is dependent on reconstruction of periodontium. Osteoclastic bone resorption is the first step of tooth movement. The present study hotspots focus on signal transduction pathway regarding osteoclast differentiation and functional development under stress and on the relationship between periodontal ligament cells and osteoclasts. OBJECTIVE: To set up a simple method to in vitro culture human osteoclast-like cells and to observe the effects of bone resorption-stimulating factors on differentiation, proliferation, and function of osteoclast-like cells, DESIGN, TIME AND STTING: A cytological in vitro controUod observation was performed at the Central Laboratory,Stomatology Hospital, Xi'an Jiaotong University between October 2007 and May 2008. MATERIALS: Umbilical cord blood was sourced from the healthy puerperae who had not suffered from high-risk pregnancy. Freshly prepared fetal femur provided by Laboratory Animal Center, Xi'an Jiaotong University and were used for preparation of bone flaps at 100-200 μm thickness. 1α ,25-(OH)2D3, macrophage colony-stimulating factor (M-CSF), prostaglandin E2 were purchased from Sigma Company, USA.METHODS: Under aseptic condition, umbilical cord blood was collected. Following Ficoll solution separation and centrifugation, supematant was discarded. Umbilical cord blood-derived mononuclear cells were suspended with o -modified minimal essential medium (α-MEM) solution and then inoculated into a 24-well culture plate, in which, coverslips and femoral slices were pre-placed, at a density of 1×109/L, 1.0 mL per well. Five groups were set, blank control, 108 mol/L 1α ,25-(OH)2D3, 10-7 mol/L 1α ,25-(OH)2D3, macrophage colony stimulating factor (M-CSF), and 1α ,25-(OH)2D3+prostaglandin E2 (PGE2). Each group was cultured for 7 days. MAIN OUTCOME MEASURES: Cellular growth morphology was observed under an inverted microscope; osteoclast-like celt formation was examined by tartrate-resistant acid phosphatase (TRAP) staining; and osteoclastic Howship's lacuna was detected by toluidine blue staining. Any cell with TRAP-positive staining and more than two nuclei was considered osteoclast-like cell and counted. RESULTS: After 3 days of culture, cells from the blank control group did not exhibit apparent changes in morphology and quantity. In the remaining groups, mononuclear cells appeared with confluent tendency. After 7 days of culture, a small number of osteoclast- like cells with 2-3 nuclei were found in the blank control group; a great many of multinucleated osteoclast- like cells with 3-20 nuclei were present in the remaining groups. Through the use of optical microscope, osteoclast-like cells could be found for the presence of red cytoplasm, bright yellow nuclei, and TRAP-positive staining in each inducing factor-treated group, in particular in the 108 mol/L 1α ,25-(OH)2D3 group, which displayed osteoclast- like cells exhibiting 14 nuclei, strong TRAP-positive staining, and a relatively big cell body. But no osteoclastic Howship's lacuna was found in any group. Compared to the blank control group, the numbers of osteoclast-like cells were greater in each inducing factor-treated group (F = 9.78, P < 0.01). There was no significant difference in the numbers of osteoclast-like cells between the 108 mol/L 1α ,25-(OH)2D3 and the 10-7 mol/L 1 a ,25-(OH)2D3 groups (P0.05). The M-CSF group and the 1α ,25-(OH)2D3+PGE2 group exhibited significantly less numbers of osteoclast-like cells than the 108 mol/L 1α ,25-(OH)2D3 group (F= 7.46, P< 0.01). CONCLUSION: After in vitro culture of 1α ,25-(OH)2D3, M-CSF, and PGE2, umbilical cord blood-derived mononuclear cells can differentiate into TRAP-positive multinucleated osteoclast-like cells, the 10-8 mol/L 1α ,25-(OH)2D3 being the most effective.
5.History of World Federation of Acupuncture-Moxibustion Societies.
Hong-Cai WANG ; Liang-Yue DENG ; Bao-Yan LIU
Chinese Acupuncture & Moxibustion 2014;34(12):1235-1237
The history of the World Federation of Acupuncture-Moxibustion Societies (WFAS) was reviewed through summarizing the background and process of the establishment of WFAS. The establishment background was explained in different aspects, named the recovery of acupuncture-Moxibustion in the world, the successive setup of world acupuncture-Moxibustion organizations, the divergences of International Association of Acupuncture-Moxibustion, striding forward of China reform and opening policy as well as the attention of the World Health Organization (WHO), etc. The establishment of WFAS was introduced on the proposal from eight countries, the important time of the development of acupuncture and moxibustion in China, 1984, divergences and consensus as well as the final phase. The official establishment of WFAS represents the global benefits of acupuncture-Moxibustion colleagues. It is the international organization of acupuncture and moxibustion, contributing to the promotion of acupuncture and moxibustion in the world.
Acupuncture
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history
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organization & administration
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Acupuncture Therapy
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history
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History, 20th Century
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History, 21st Century
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Humans
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Moxibustion
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history
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Societies, Medical
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history
6.Dissolution Characteristics of Trepibutone Tablets
Mingfeng XU ; Hong JIANG ; Chenxi LIU ; Shi BAO ; Chundi HU
Herald of Medicine 2016;35(4):397-400
Objective To compare the dissolution behavior between domestic trepibutone tablets and original reference product, and provide a basis for evaluating the quality consistency of generic drugs. Methods Four dissolution media recommended by Japanese Orange Book and a domestic standard dissolution media were selected to determined the dissolution profile,and f2 factor was calculated to investigate the consistency of stripping curves. Results In water,pH 4.0 and pH 1.2,the f2 of domestic formulation and reference formulation was under 50,and the dissolution profile was inconsistent.Dissolution behavior of domestic preparations of different manufacturers was dissimilar.In water,the f2 of domestic preparations of different batches of the same manufacturer was over 99.9,and the dissolution behavior was similar. Conclusion The dissolution method of existing domestic standard can not distinguish the dissolution behavior of different products,and it should be revised and completed.There is still great difference in quality between the domestic preparations and reference preparations.
7.Promotion of students'independent study by library of college and university of traditional Chinese medicine
Hong LIU ; Lijuan BAO ; Yunfeng PU ; Li ZHANG
Chinese Journal of Medical Library and Information Science 2015;(7):75-77
How to expand and deepen the educational function of library of college and university of traditional Chinese medicine by giving play to its strong points was analyzed in the new model of students'independent study , and measures to improve the information literacy and comprehensive literacy of students were elaborated, such as developing teaching reference books database, performing guidance for different readers, carrying out different activities that make entertainment a medium of education , in order to help students to acquire special knowledge outside of classroom .
8.Morphological changes of goat bone marrow mesenchymal stem cells differentiating into fibrochondrocytes
Xuelian SU ; Guangjie BAO ; Hong KANG ; Lin LIU ; Nannan KONG
Chinese Journal of Tissue Engineering Research 2014;(6):860-865
BACKGROUND:Our preliminary studies have shown that basic fibroblast growth factor can induce the differentiation of bone marrow mesenchymal stem cells into disc cells of the temporomandibular joint, and for basic fibroblast growth factor, 10μg/L is superior to 5μg/L in col agen synthesis.
OBJECTIVE:To observe ultrastructural changes of bone marrow mesenchymal stem cells after being induced by different concentrations of basic fibroblast growth factor.
METHODS:We cultured primary sheep bone marrow mesenchymal stem cells and selected passage 3 and 4 cells at good growth state. Bone marrow mesenchymal stem cells were stimulated with 5 and 10μg/L basic fibroblast growth factor and their growth state was observed under inverted phase contrast microscope. Uninduced cells served as controls. The slides with cellcrawling pieces were stained with Safranin O, picrosirius and type I col agen immunohistochemistry at days 7, 14 and 21, respectively. Simultaneously we col ected the cells at day 21 to observe the ultrastructural changes of bone marrow mesenchymal stem cells.
RESULTS AND CONCLUSION:After being induced with different concentrations of basic fibroblast growth factor, bone marrow mesenchymal stem cells were able to differentiate into disc cells of the temporomandibular joint;and after being induced with 10μg/L basic fibroblast growth factor, cells were more like fibroblast-like cells of the temporomandibular joint disc. These findings indicate that bone marrow mesenchymal stem cells have morphological basis for differentiation to the fibroblast-like cells of the temporomandibular joint disc.
9.Correlation of asthma susceptibility gene polymorphisms with API positive infantile wheezing
Hong CHEN ; Haipei LIU ; Yixiao BAO ; Li HUA
Journal of Clinical Pediatrics 2013;(6):547-550
10.3969/j.issn.1000-3606.2013.06.014
10.High IgE syndrome and its oral manifestatiom.
Li-mei GAO ; Hong-yan LIU ; Bao-hua XU
Chinese Journal of Stomatology 2011;46(12):771-773