RESUMO
Non-alcoholic fatty liver disease (NAFLD) is a major form of chronic liver disease in recent years. Its main clinical manifestations are insulin resistance, lipid accumulation, oxidative stress injury, inflammation, and fibrosis of the liver. The pathogenesis of NAFLD is not fully understood, and there is a lack of effective drugs in clinical treatment. Currently, the clinically recommended therapeutic regimen for NAFLD is mainly to change living habits (including diet structure, work and rest schedule, and exercise mode, etc), supplemented by drug therapy (including insulin sensitizer, antioxidant, lipid-lowering drug, and liver-protecting anti-inflammatory drug, etc). However, due to its single composition and clear target, western drugs can only improve some indicators for the complex metabolic diseases such as NAFLD, and also produce some side effects (such as elevated serum transaminase, gastrointestinal discomfort and increased liver burden). Traditional Chinese medicine has the advantages of multi-target comprehensive treatment of NAFLD. Compound traditional Chinese medicine, single Chinese medicine and its active components against NAFLD were summarized and analyzed from the aspects of lowering blood lipid, anti-oxidation, anti-inflammation, anti-fibrosis, and improving insulin resistance of the liver, so as to provide reference for clinical diagnosis and treatment of NAFLD.
RESUMO
Compound Traditional Chinese Medicine (CTCM) applying for FDA approval as botanical drug is a systemic and innovative work.Compound Danshen Dripping Pill (T89) is the first CTCM completed FDA global multi-center Phase Ⅲ clinical trial,which has become a benchmark for TCM globalization.Extensive experiences have been accumulated through the 20 years' research and development.Tasly fully considered the characteristics of CTCM while complying with FDA regulations during the entire application process.In which,product indication was clearly defined and agreed,clinical trial protocol was scientifically and innovatively designed with gold standard,phase Ⅱ study was well completed,SPA for phase Ⅲ study was obtained,and eventually the global multi-center phase Ⅲ study was successfully completed.In order to better support T89's application,Tasly conducted series of additional studies and introduced many innovations,such as drug-drug interaction study for TCM,finger printing study for CTCM,quality consistency study,biological assay study and etc.Globalization of T89 is not only a product creating history,but also a process for Tasly and the US FDA working together to continuously innovate and create history in innovating modern TCM standards,improving industrial chain GMP system for botanical drugs,making technical breakthroughs,exploring regulatory pathways and increasing product value.It represents the national power and historical progress in medicine.
RESUMO
Objective To investigate the role of compound traditional Chinese medicine Yiqilin in the regulation of immune-related genes expression in spontaneously hypertensive rats(SHR).Methods Ten SHR were randomly divided into test group(fed with Yiqilin and ordinary food at the ratio of 1:9 for 6 months,n=5)and control group(fed with ordinary food for 6 months,n=5).Total RNA was extracted from myocardial tissues of SHR after 6 months,and gene chip hybridization technique was employed to analyse the expression of immune-regulated genes of myocardial tissues in two groups.The genes with differentiation expression were screened,and were verified by Real-time PCR.Results The expression of 32 immune-related genes were up-regulated in the test group,including interleukin(IL)6 receptor,IL-6 signal transduction factor,chemotatic factor,antigen presenting molecule,antibody receptor,heat shock protein(Hsp), etc.No immune-related gene was down-regulated in test group.The results of 2 immune-related genes(Hsp 105 and Hsp 90)detected by Real-time PCR were consistent with those by gene chip hybridization.Conclusion Part of the immune-related genes in myocardial tissues in SHR may be up-regulated by Yiqiling,which indicates that Yiqiling may play a role in the regulation of expression of immune-related genes in SHR.
RESUMO
OBJECTIVE:To study the presence of the chemical compositions of Guan XinⅡ(GXEH)oral decoction in human serum.METHODS:The analysis of finger prints of the medicated serum sample obtained from the volunteers treated with GXEH decoction was conducted with3different pretreatment procedures and2different HPLC methods,and which were compared with decoction.RESULTS:The numbers of the discrepant chromatographic peaks detected from the decoction and the medicated serum were respectively less than30and10,danshensu,protocatechuic aldehyde,ligustrazine,paeoniflorin were failed to be traced in the latter.CONCLUSION:The numbers of chemical compositions of the compound preparation that can be traced in serum were limited and the active components that entered into body may be relatively limited in numbers.After oral administration of compound preparation,a part of chemical compositions of which may not presented as its original form in serum.