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OBJECTIVE To evaluate the postprandial bioequivalence of two kinds of Diacerein capsules in healthy volunteers with oral administration . METHODS A total of 24 adult healthy subjects were included and randomly divided into two groups ， with 12 subjects in each group . A randomized ，open，double-cycle cross -over trial design was adopted . Both groups took 50 mg of the test preparation （domestic Diacerein capsules ）or the reference preparation （Ambridine®）respectively at 30 min after eating the standard meal in the morning of the first day of each cycle of the trial . The cleaning period was one week . Blood samples were collected at different time points before and after taking the medicine and the protein was precipitated with methanol for sample pretreatment. The concentration of active metabolite rhein was determined by LC -MS/MS using emodin as internal standard . The pharmacokinetic parameters were calculated with DAS 3.2.9 software，and the bioequivalence of test and reference preparation were evaluated. RESULTS After the subjects took the test preparation and the reference preparation after meal ， the main pharmacokinetic parameters of rhein were as follows ：cmax were（3 517±1 121）and（3 225±755）ng/mL；AUC0－24h were （25 764±6 134）and（24 316±5 856）ng·h/mL；AUC0－∞ were（26 679±6 409）and（25 170±6 415）ng·h/mL；tmaxwere 3.50 （0.67，12.00）and 4.00（1.50，7.00）h；t1/2 were（4.26±1.12）and（4.19±1.05）h，respectively. The 90% confidence intervals of the geometric mean ratios of cmax，AUC0－24h and AUC 0－∞ were 100.8%-113.9%，103.1%-109.4% and 103.2%-109.9%，respectively. CONCLUSIONS The test preparation and reference preparation are bioequivalent in the postprandial state of healthy subjects .
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Objective To study the effect of qiangguixishu pills in the treatment with knee osteoarthritis and influence in miR of circulating and inflammatory factor index.Methods 50 patients with KOA from October 2014 to October 2015 were randomly divided into two groups,the observation group and the control group,with 25 cases in each group.The control group using Diacerein capsules for treatment,the observation group received the Qiangguixishu pills for treatment,compared the WOMAC score and clinical efficacy before and after treatment between two groups,and changes of miR and inflammatory factors circulating.Results There was no difference in WOMAC score between the two groups before treatment;pain,joint stiffness, daily activities and comprehensive scores were decreased after treatment in two groups(P<0.05),and it was lower in the observation group than in the control group(P<0.05);There was no significant difference at blood miR-146a,miR-140,miR-21,IL-6,IL-1beta,TNF-alpha contents between the two groups,miR-21 beta,IL-6,IL-1 beta,TNF-alpha were lower than that before treatment in the two groups after treatment(P<0.05),miR-140,miR-146a were higher than before treatment(P<0.05),and compared with the control group,the above indicators at the observation group were had significant difference(P<0.05).Conclusion There were the therapeutic effect in the treatment with KOA by Qiangguixishu pills and its mechanism maybe realized by regulating the miR and inflammatory factor.