ABSTRACT
OBJECTIVE： To establish the method for the content determination of related substance in Terazosin hydrochloride tablets. METHODS： HPLC and principal component self-control with correction factor were adopted. The determination was performed on Agilent Zorbax Eclipse XDB C18 column with mobile phase consisted of acetonitrile-perchloric acid solution （20 ∶ 80， V/V） at the flow rate of 1.0 mL/min. The detection wavelength was set at 246 nm， and sample size was 20 μL. The column temperature was 50 ℃. The linear equations of terazosin hydrochloride， impurity A， B， C were drawn. The correction factors of each impurity related to terazosin hydrochloride were calculated by slope， and relative retention time was used to determine the position of impurities. The contents of impurity A， B and C in 3 batches of Terazosin hydrochloride tablets were determined and compared with the results of impurity control method. RESULTS： The relative retention time of impurity A， B， C was 0.39， 0.74， 2.77， respectively； the linear range of them were 0.25-3.0 μg/mL， respectively. The correction factors were 0.75， 1.09， 0.84， respectively. The detection limits were 0.35， 0.51， 0.43 ng， and the limits of quantification were 0.70， 1.02， 0.86 ng， respectively. The contents of impurity A， B and C in 3 batches of Terazosin hydrochloride tablets were 0.11％-0.13％， 0.03％ and 0.09％-0.12％； impurity B did not detected. The results are consistent with the determination of impurity control method. CONCLUSIONS： The method is simple， rapid and accurate for the content determination of related substances A， B， C in Terazosin hydrochloride tablets.
ABSTRACT
Objective To explore the effect of terazosin hydrochloride combined with finasteride on serum TNF-αand PSA in old patients with benign prostatic hyperplasia.Methods 64 elderly patients of benign prostatic hyperplasia were randomly divided into 2 groups, 32 cases in each group.2 groups were given routine treatment and symptomatic treatment, the control group was given finasteride; the experimental group were treated with terazosin hydrochloride combined with finasteride.A cycle of 2 groups were 28 d, a total of 1 cycle of treatment.Clinical efficacy, maximum urinary flow rate, prostate volume, residual urine volume, international prostate symptom score(IPSS), serum tumor necrosis factor alpha, prostate specific antigen level and adverse reactions were compared after the end of treatment.Results Compared with before treatment, maximum urinary flow rate (Qmax) level of 2 groups increased, prostate volume, residual urine volume, international prostate symptom score(IPSS)decreased (P<0.05), compared with the control group, maximum urinary flow rate of the experimental group was higher (P<0.05), prostate volume, residual urine volume, IPSS were lower (P<0.05), 2 groups of TNF-αand PSA levels decreased after treatment (P<0.05), compared with the control group, TNF-αand PSA levels were lower(P<0.05).There was no significant difference in adverse reactions in 2 groups.Conclusion Terazosin hydrochloride combined with finasteride had a clinical efficacy of elderly patients with benign prostatic hyperplasia, can reduce serum TNF-αand PSA levels.
ABSTRACT
Objective:To compare the dissolution of domestic terazosin hydrochloride tablets and capsules to provide reference for clinical use. Methods:The dissolution of the products from different manufacturers was investigated respectively in 4 kinds of media:pH 1. 0 hydrochloric acid solution,pH 4. 5 phosphate buffer solution,pH 6. 8 phosphate buffer solution and water. The dissolution tests were carried out by a paddle method at the stirring speed of 50 r·min-1 and an HPLC method was used to determine the dissolution rate. The dissolution behavior of the samples from different manufacturers was compared by a similar factor method. Results:The do-mestic tablets showed higher similarity with the reference formula, and the dissolution behavior of the capsules had significant differ-ence. Conclusion:The calculation method for the specification in some manufacturers is different from that of the reference prepara-tion, which leads to the difference between the testing preparation and the reference preparation, and should be paid attention in clini-cal use.
ABSTRACT
Objective To evaluate the bioequivalence of domestic and imported terazosin hydrochloride tablets after single oral dose .Methods It was a single center ,randomized ,open ,cross-over trail design ,21 subjects were fasting oral adminis-tered of 2 mg domestic and imported terazosin hydrochloride tablets in different periods ,venous blood 4 ml were collected in different time points before and 60 h after administration ,plasma concentration of terazosin was determined by LC-MS/MS . Results The main pharmacokinetic parameters of domestic and imported terazosin hydrochloride tablets were as follows :t1/2 :(13.2± 2.39)hvs(12.5±1.93)h,tmax :(1.01±0.83)hvs(1.08±0.69)h,Cmax :(40.1±10.6)ng/mlvs(37.3± 9 .57) ng/ml;AUC0- ∞ :(428 ± 82 .1) ng · h/ml vs (426 ± 85 .2) ng · h/ml .The relative bioavailability of domestic terazosin hydrochloride tablets was (101 .2 ± 14 .7)% .90% CI of domestic and imported terazosin hydrochloride tablets AUC0-t and Cmax geometric mean ratio fell between 80% -125% .Conclusion The domestic tablets are bioequivalent to the imported tablets .