2.Current situations of sterile and implantable medical device manufacturing in Sichuan Province:an investigation in 31 production enterprises
Jing ZHOU ; Xiang YE ; Xuehua JIANG
Chinese Journal of Tissue Engineering Research 2017;21(6):928-933
BACKGROUND:The Specification of Quality Management for Medical Device Production (for Trial Implementation) issued by the China Food and Drug Administration (CFDA) on December 16, 2009 was demanded to be initially implemented in medical device manufacturers with a higher risk in sterility and implant before January 1, 2011. The revised version was published on December 29, 2014 and came into effect on March 1, 2015. OBJECTIVE:To put forward specific suggestions through analyzing the status of 31 sterile implantable medical device manufacturers in Sichuan Province and the corresponding implementation situation of the specification for trial implementation. METHODS:The relevant data of these 31 manufacturers were collected through the quality management system assessment, supervision and inspection, flight inspection and questionnaire survey. And the data were analyzed statistically. RESULTS AND CONCLUSION:The overall size of medical device manufacturers in Sichuan Province is small. There are still some other problems, such as no advanced equipment, low quality of employees, lack of funds and inappropriate management, in these manufacturers. Considering these, we have given some guiding recommendations from the aspects of production and supervision.
3.Ultrasonographic diagnosis of hepatobiliary cystadenoma
Xiang XU ; Ling CHEN ; Zhen YE
Chinese Journal of Ultrasonography 2009;18(6):496-498
Objective To explore the characteristics of uhrasonography of hepatobiliary cystadenoma. Methods The ultrasonographic characteristics of 5 cases with hepatobiliary cystadenoma were retrospectively analysed, and compared with the operation and pathology. Results The ultrasonography of 5 cases was multilocular cystic mass,which seems to be,but not indeed communicating with the biliary tree,in which irregular septation was demonstrated in two-dimensional structure and also with perforator vessels along in color Doppler flow imagineg. And in some cases small papillary tuft and small loci of calcification was noted on the septation. Conclusions Muhilocular cystic mass,locating along the biliary tree, however not communicating with the the biliary tree, is an important diagnostic basis of biliary cystadenoma. And it should be distinguished with other cystic tumor in the liver.
4.Surgical approach of endovascular exclusion for thoracic aortic dissection.
Bo YE ; Zaiping JING ; Xiang FENG
Journal of Interventional Radiology 1994;0(04):-
Objective To evaluate the surgical approach of endovascuar exclusion for thoracic dissection.Methods Thirty-seven cases of Stanford B type thoracic aortic dissection were undergone endovascular exclusion (EVE) and had been studied retrospectively. Preoperative evaluations for delivery arteries, including common femoral artery, iliac artery, and abdominal aorta, were earried out by using duplex ultrasonography (US), computed tomographic angiography (CTA) and magnetic resonance angiography(MRA). Factors such as arterial calibers, stenosis, tortuosity, sclerotic plaque and media dissection were taken into account. Choices of surgical approach were decided after comprehensive consideration of these factors. If the common femoral artery inner diameter was wider than 8 mm, without severe iliac artery stenosis or tortuosity; the common femoral artery should be selected as the delivery artery. In case of severe arterial stenosis and tortuosities, then the common iliac arteries were exposed by retroperitonial approach and graft was delivered through this artery. Results Mural sclerotic plaques were more sensitive to be revealed by US, conversely with CTA and MRA in showing stenosis and tortuosity directly and clearly. Utilizing this preoperative evaluating system, all the grafts passed successfully and favourably through the arteries, without any delivery artery associated complications.Conclusions Using US, CTA and MRA in combination was necessary for preoperative evaluation of the delivery artery. In those with poor femoral artery condition, exposing common iliac artery decidedly is necessary to ensure the procedure favorably and to avoid delivery artery associated complications.
5.Regulatory T lymphocytes and ischemic stroke
Xiang CHEN ; Dan YE ; Yun XUN
International Journal of Cerebrovascular Diseases 2013;21(12):933-937
Stroke is a cerebrovascular disease type with high morbidity and mortality,of which ischemic stroke accounts for about 80%.Now,it is believed that the inflammatory mechanisms play an important role in the progress of pathological physiology of ischemic stroke.Peripheral T lymphocytes infiltrate to the damaged area within 24 hours after cerebral ischemia and are involved in the advance of inflammatory process of brain tissue.As a subtype of T lymphocytes,regulatory T cells are mainly located in the ischemic penumbra; however,at present,its role in ischemic brain injury remains controversial.The research on the mechanisms of regulatory T cells in ischemic stroke may contribute to further understanding of the pathogenesis of ischemic stroke and find new therapeutic targets.
7. Characteristics of materiome release kinetics and visual evaluation of different types of Liuwei Dihuang Pills
Chinese Traditional and Herbal Drugs 2017;48(21):4425-4431
Objective To investigate the characteristics of materiome release kinetics of Liuwei Dihuang Pills (LDP), and to evaluate its visualization. Methods According to the 2015 edition of Chinese Pharmacopia, using the evaluation methods of release kinetics of Chinese material medica to determine the materiomics release kinetics and the releasecharacteristic of LDP by the paddle method. Then f2 fit factor was calculated and evaluated on other types of LDP in comparison with water-bindered pills and condensed pills as, which are two most common preparations in the market. Moreover, materiome release spectrum and release increment spectrum were used, hoping to quantify, integrate and visualise the materiome release characteristics of different types of LDP. Results The kinetic characteristics of the LDP accord with the Weibull release model, T50 and Td were calculated, and there are significant differences between different types of pills (P < 0.05) in addition to condensed pills and water pills. Also, some differences and similarities in the materiomics release characteristic by f2 fit factor were found in the study. Materiome release spectrum and release increment spectrum can be used to quantify, integrate and visualise the materiome release characteristics of LDP on different types. Conclusion The materiomics release kinetics can be applied to quantify, integrate and visualise the materiome release characteristic of LDP on different types. Basically in agreement with the saying, “water pills from the facilitation, honey pills take the slow, paste pills from the late of, wax-wrapped pills take the difficult”.
8. Correlation of powder particle size, cell wall-breaking, rate and in vitro dissolution rate of Liuwei Dihuang Pill
Chinese Traditional and Herbal Drugs 2016;47(12):2108-2112
Objective: To investigate the relationship among powder particle size, cell wall-breaking rate, and dissolution of Liuwei Dihuang Pill (LDP) in vitro. Methods: Particle size and cell wall-breaking rate of four kinds of LDP were measured by laser particle size instrument and optical microscope. The loganin and paeonol were taken as indexes, the feature of dissolution for the above four kinds of LDP was examined by grouting method. Results: There were significant differences in the distribution of particle size, wall-breaking rate, and dissolution among different crushing degrees of LDP. With the decrease of the powder particle size, the wall-breaking rate and relative cumulative dissolution of loganin and paeonol increased. The rate of characteristic cell wall-breaking in the micro powder of Corni Fructus, Alismatis Rhizoma, and Moutan Cortex could reach 100%. Conclusion: Moderately changing degree of smash could cause cell wall-breaking rate changes, so as to control effective ingredient the dissolution rate and extent of Chinese medicine.
10.Study on Susceptibility of Neisseria Gonorrhoeae Isolated from Chengdu in Different Periods
Hui XIANG ; Gang YONG ; Meijun YE
Chinese Journal of Dermatology 1995;0(03):-
Objective To study the changes of susceptibilities of Neisseria gonorrhoeae to antibiotics in Chengdu area. Methods The MIC values of 12 antibiotics to 100 strains in 1991 and 100 strains in 1996 were determined, and the MIC values to PPNG and non PPNG strains were also compared. Results and Conclusion The MIC values of 6 antibiotics (including penicillin G, tetracycline,etc.) to the isolates in different periods changed significantly (P