1.Primary studies on heroin abuse and injury induced by oxidation and lipoperoxidation
Junfu ZHOU ; Peiliang SI ; Zourong RUAN ; Shihong MA ; Xiaofeng YAN ; Ling SUN ; Fenying PENG ; Hong YUAN ; DONG CAI ; Deyun DING ; Sisun XU
Chinese Medical Journal 2001;114(3):297-302
Objective To further reveal serious risks of heroin abuse to human body and clarify grave injuries of oxidation, peroxidation and lipoperoxidation induced by nitric oxide and other free radicals to heroin abusers. Methods Determined and compared plasma levels of nitric oxide (P-NO), vitamin C (P-VC), vitamin E (P-VE), β-carotene (P-β-CAR), lipoperoxides (P-LPO) and erythrocyte activities of superoxide dismutase (E-SOD), catalase (E-CAT), glutathione peroxidase (E-GSH-Px) and erythrocyte level of lipoperoxides (E-LPO) in 137 cases of heroin abusers (HAs) and 100 cases of healthy volunteers (HVs), used linear regression and correlation, stepwise regression and correlation to analyze correlation among heroin-abusing-duration (HAD), daily-heroin-abusing-quantity (DHAQ) with above determination values in the HAs. Results Compared with the above average values in the HVs group, the average values of P-NO, P-LPO, E-LPO in the HAs group were significantly increased (P<0.0001), the average values of P-VC, P-VE, P-β-CAR, E-SOD, E-CAT and E-GSH-Px were significantly decreased (P<0.0001); the analysis of linear regression and correlation showed that with ascending of the HAD and DHAQ in the HAs, the values of P-NO, P-LPO, E-LPO were gradually increased (P<0.0001), the values of P-VC, P-VE, P-β-CAR, E-SOD, E-CAT, E-GSH-Px were gradually decreased (P<0.0001); the analysis of stepwise regression and correlation suggested that the correlation among the HAD, DHAQ with the values of P-NO, P-VC, P-VE was the closest. Conclusion The balance between oxidation and antioxidation in the HAs was seriously destroyed, and the injuries induced by nitric oxide and other free radicals, oxidation, peroxidation and lipoperoxidation reactions to the body of HAs gravely exacerbated. In the abstaining from heroin dependence, therefore, it should consider that sufficient quantum antioxidants such as VC, VE and β-CAR are dosed to the HAs so as to abate the injuries to their bodies.
2. Pharmacokinetics and bioequivalence evaluation of ciprofloxacin tablets in healthy Chinese subjects under fasting and fed conditions
Lu WANG ; Zourong RUAN ; Dandan YANG ; Rong SHAO ; Bo JIANG ; Kaiwen ZHANG ; Jing CHEN
Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(11):1273-1278
AIM: To evaluate the pharmacokinetic properties and bioequivalence of two ciprofloxacin tablets in healthy Chinese subjects under fasting and fed conditions. METHODS: This is a randomized, open-label, two-period crossover study. Subjects were randomized to receive a single oral dose of the ciprofloxacin test or reference formulations 250 mg under fasting and fed conditions. Human plasma concentrations were determined using a liquid chromatography tandem mass spectrometry method (LC-MS/MS). A non-compartmental method by Phoenix WinNonlin 8.0 software was used for calculating pharmacokinetic parameters and evaluating bioequivalence of the two formulations. RESULTS: A total of 26 healthy subjects were enrolled the study under fasting conditions and completed it. The pharmacokinetic parameter values of the test and reference formulation under fasting conditions were as follows: C
3. Bioequivalence of norfloxacin tablets in Chinese Healthy volunteers under Fasting and Fed Condition
Dandan YANG ; Jinliang CHEN ; Honggang LOU ; Zourong RUAN ; Bo JIANG ; Jinlian WU ; Jing CHEN
Chinese Journal of Clinical Pharmacology and Therapeutics 2020;25(12):1357-1362
AIM: To compare the bioavailability of norfloxacin tablets produced by Zhejiang Pharmaceutical Co., Ltd with the original product BACCIDAL, and to evaluate bioequivalence of two formulations, a randomized, open, two-cycle, self-crossing trial in healthy Chinese population was designed. METHODS: Under fasting and fed conditions, healthy volunteers were given a single dose of norfloxacin test or reference tablets for 100 mg. Liquid chromatography-mass spectrometry (LC-MS/MS) method were used to determine drug concentration in the plasma taken at different time points before and after dosing. Pharmacokinetic parameters and the bioequivalence of the two formulations were calculated by WinNonlin 7.0 software. RESULTS: A total of 28 healthy volunteers were enrolled and completed the fasting test. The pharmacokinetic parameters for test and reference preparations in fasting state were as follows: C
4. Application of artificial neural network model in bioequivalence study of candesartan cilexetil tablets
Yin HU ; Dandan YANG ; Yichao XU ; Rong SHAO ; Zourong RUAN ; Bo JIANG ; Jinliang CHEN ; Honggang LOU
Chinese Journal of Clinical Pharmacology and Therapeutics 2022;27(1):63-69
AIM: To evaluate the bioequivalence of two candesartan cilexetil tablet formulations in healthy Chinese subjects after administration of a single dose, and an artificial neural network model was established to predict the candesartan plasma concentration, and provide a basis for clinical rational use of drugs. METHODS: Thirty-two healthy Chinese subjects were enrolled for oral administration of a single 8 mg dose of candesartan cilexetil tablet (test or reference product) under fasting or fed conditions to conduct a bioequivalence study. The bioequivalence results were used to build a back-propagation artificial neural network model by MATLAB software, and the model was internally and externally verified to predict the plasma concentration. RESULTS: Under both fasting and fed conditions, the C