China Food and Drug Administration didn't issue any guideline on the pre-clinical study of drug-eluting coronary stent system, the basic requirement of the authorized administration was summarized to help manufacture prepare the document during the registration process.
China ; Drug Evaluation, Preclinical ; methods ; Drug-Eluting Stents ; Guidelines as Topic

During the past years transcatheter aortic valve replacement has evolved to a promising technique for the treatment of the patients who suffered from severe aortic stenosis, the progress and basic consideration on clinical study have been summarized in the article.
Aortic Valve ; physiopathology ; Aortic Valve Stenosis ; therapy ; Cardiac Catheterization ; Heart Valve Prosthesis ; Humans ; Transcatheter Aortic Valve Replacement

Ultrasound guided needle biopsy or catheterization is a rising operation in clinical diagnosis and treatment. However, poor visualization under ultrasound is the main disadvantage of this technique. This paper summarized the basic methods used to solve such problem, as well as the corresponding product technical requirements.
Catheters ; Needles ; Ultrasonics ; Ultrasonography ; Ultrasonography, Interventional

Lubrication coating is widely used to reduce the friction between the interventional devices and the blood vessels, improves the surface biocompatibility of the interventional device, and also brings the coating stability problems and related risks. This paper describes the coating-related content from the equipment description, performance verification, technical requirements, etc., to reduce the risk of the coating to an acceptable level.
Catheters ; Coated Materials, Biocompatible ; Friction ; Lubrication

Animal study plays a key role to evaluate the safety and effectivity of medical devices. This study aims to share evaluated consideration on the role, general principles, necessity, study design and quality management system of animal study, in order to improve the quality of animal study and reduce unnecessary study.
Animals ; Equipment and Supplies ; Models, Animal

Objective: Based on the information-motivation-behavioral skills (IMB) model theory, the structural equation model(SEM)was used to analyze the effect of using new media to carry out AIDS health education among young students. Methods: Stratified random cluster sampling method was used to select 2 561 students from four colleges in Yantai to conduct a questionnaire survey, and to carry out various forms of new media AIDS health education for the intervention group. Data were analyzed with structural equation model. Results: After intervention，the awareness rate of AIDS were 85.9% and 94.0% respectively(χ2=46.67，P<0.01). The structural equation model fits well, and the fitted indices were: RMSEA=0.04, GFI=0.97, AGFI=0.96, IFI=0.97, CFI=0.98. The direct effects of new media interventions on prevention information and prevention motivation were 0.30 and 0.65 respectively. The influence of information and motivation on preventive behavior was mainly reflected through the indirect effect of behavioral skills. The overall effects of standardization were 0.09 and 0.29 respectively. The overall effect of behavioral skills on preventive behavior was 0.80, which was the main factor affecting HIV prevention behavior. Conclusion The use of new media to carry out AIDS health education among young students had a significant effect. Motivation promotion should be used as a new breakthrough point for future work, and information, motivation, and behavioral skills should be used to promote the prevention of AIDS prevention among young students.

OBJECTIVETo compare the pharmcoknetic parameters of six major alkaloids in the two drug delivery system of Zuojin Wan, by LC-MS assaying the six major alkaloids plasma concentration.

METHODThe blood samples were collected at different time after transdermal administration. The plasma concentration of six major alkaloids were detected by LC-MS, then the concentration-time data are modulated by software WinNonlin.

RESULTTook the six alkaloids (berberine palmatine coptisine jateorhizine evodiamine rutecarpine) as index components, the relative bioavailability were 131%, 127%, 108%, 121%, 92%, 109%, respectively, the ratio of Ka were 10.5, 5.1, 3.7, 0.8, 1.8, 1.5, respectively.

CONCLUSIONThe LC-MS can be applied in the determination of six major alkaloids plasma concentration. The pharmcoknetic parameters indicated that Zuojin Wan microemulsion gel delivery system can accelerate the transdermal absorption rate of Zuojin Wan, compared with the hydrogel drug delivery system.

Alkaloids ; administration & dosage ; chemistry ; pharmacokinetics ; Animals ; Chromatography, Liquid ; Drug Delivery Systems ; Drugs, Chinese Herbal ; administration & dosage ; chemistry ; pharmacokinetics ; Emulsions ; Female ; Gels ; Hydrogels ; chemistry ; Male ; Mass Spectrometry ; Rats

Bacterial endotoxin is considered as one of the critical risk factors in medical devices, especially implanted devices that directly or indirectly contact with blood circulating system. In that case, endotoxin limits for implanted medical devices is important in determine the safety of medical devices. According to GB/T 14233.2-2005, the requirements of endotoxin index for intrathoracic medical devices is 2.15 EU per device. However, the definition of "intrathoracic medical devices" is vague. Specifically, "for cardiovascular system application" instead of "intrathoracic application" is more reasonable. With the deeper understanding of the risk of endotoxin in medical devices and considering the internationally accepted standards, the limits of endotoxin in medical devices for cardiovascular system application is acceptable at 20 EU per device.
Endotoxins

Tripterygium glycosides tablet(TGT),the classical commercial drug of Tripterygium wilfordii Hook.F.has been effectively used in the treatment of rheumatoid arthritis,nephrotic syndrome,leprosy,Behcet's syndrome,leprosy reaction and autoimmune hepatitis.However,due to its narrow and limited treatment window,TGT-induced organ toxicity(among which liver injury accounts for about 40％of clinical reports)has gained increasing attention.The present study aimed to clarify the cellular and molecular events underlying TGT-induced acute liver injury using single-cell RNA sequencing(scRNA-seq)technology.The TGT-induced acute liver injury mouse model was constructed through short-term TGT exposure and further verified by hematoxylin-eosin staining and liver function-related serum indicators,including alanine aminotransferase,aspartate aminotransferase,alkaline phosphatase and total bilirubin.Using the mouse model,we identified 15 specific subtypes of cells in the liver tissue,including endothelial cells,hepatocytes,cholangiocytes,and hepatic stellate cells.Further analysis indicated that TGT caused a significant inflammatory response in liver endothelial cells at different spatial locations;led to marked inflammatory response,apoptosis and fatty acid metabolism dysfunction in hepatocytes;activated he-patic stellate cells;brought about the activation,inflammation,and phagocytosis of liver capsular macrophages cells;resulted in immune dysfunction of liver lymphocytes;disturbed the intercellular crosstalk in liver microenvironment by regulating various signaling pathways.Thus,these findings elaborate the mechanism underlying TGT-induced acute liver injury,provide new insights into the safe and rational applications in the clinic,and complement the identification of new biomarkers and ther-apeutic targets for liver protection.