ABSTRACT
Objective:To confirm the efficacy and safety of Tiankui antihypertension tablets combined with chemical drugs in the treatment of patients with hypertension whose blood pressure can 't reach the standard after the treatment only with chemical drugs. Methods:Randomized, double-blind, placebo control and multicenter clinical trials were performed on 240 subjects (160 in the ex-periment group and 80 in the control group) in 6 clinical trial centers. Tiankui antihypertension tablets and the placebo were respec-tively given with 4 tablets per time and 3 times a day. The efficacy and safety were observed. Results:For the blood pressure control, the significant efficiency of the experimental group was 63. 23%, while that of the control group was 31. 65%. The significant efficien-cy and effective rate of the traditional Chinese medicine (TCM) syndrome of the experimental group was 48. 39% and 20. 25%, re-spectively, while that of the control group was 20. 25% and 36. 71%, respectively. All of the studied clinical indicators showed signifi-cant differences between the two groups (P<0. 05). No severe adverse reaction was shown in the two groups. Conclusion:Tiankui an-tihypertension tablets combined with chemical drugs exhibits better curative effect and safety in the treatment of hypertension patients whose blood pressure can’ t reach the standard after the treatment only with chemical drugs.
ABSTRACT
Objective:To establish a method for the determination of 4-methyl-N-(4-(pyridin-3-yl) pyrimidin-2-yl) benzene-1,3-diamine as an impurity in the preparation of imatinib mesylate. Methods: An LC-MS/MS method was used with ESI ion source con-trolled by a positive-ion mode. The MRM mode was performed with 278. 1/106. 1 as the scanning and ion-pair. Acetonitrile solution containing ammonium formate and formic acid was used with gradient elution. Results:The linear range was 1. 572~47. 160 ng/ml(r=0. 999 7). The detection limit was 0. 002 1ng and the limit of quantitation was 0. 006 8ng. The average recovery was 100. 9% with RSD of 2. 88. The results of specificity, solution stability, repeatability and durability all met the specification. Conclusion:The meth-od is sensitive, accurate and special in the determination of 4-methyl-N-(4-(pyridin-3-yl) pyrimidin-2-yl) benzene-1,3-diamine in imatinib mesylate.
ABSTRACT
Objective:To evaluate the tolerance and safety of Zhengbiguanjie tablets in healthy volunteers to provide the safe dose range for phase II clinical trial. Methods:Totally 36 healthy volunteers were randomly divided into five single dose groups at different doses ranging from 400 mg to 3200 mg per day and two multiple dose groups with 1600 mg and 2400 mg for continuous 7 days. The tol-erance and safety of the tablets were observed. Results: All vital signs were normal in all the volunteers in both single and multiple dose tests. Although some indicators turned into abnormal after the administration, it was not significant for clinical judgment. Neither drug combination nor serious adverse reactions were shown during the trial. However, two mild adverse events occurred and disap-peared later without any treatment. Conclusion:All the volunteers have good tolerance to Zhengbiguanjie tablets. The study proved the safety of Zhengbiguanjie tablets at single and multiple dose.