Chinese New Drugs Journal 

About: Chinese New Drugs Journal is an academic journal. The journal publishes majorly in the area(s): Liver injury & Pharmacokinetics. Over the lifetime, 264 publications have been published receiving 691 citations.

The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data

Abstract: Comprehensive retrospective approaches in which the abilities of several methods by which human pharmacokinetic parameters are predicted from preclinical pharmacokinetic data and/or in vitro metabolism data were reviewed.The prediction methods reviewed included those methods from scientific literatures.The prediction of main human pharmacokinetics parameters includes clearance(CL),volume of distribution(V_d),half life(t_(1/2)) and bioavailability using allometric scaling,animal-human proportionality,molecular structural parameters,physicochemical measurements,metabolism data in vitro.Such approaches should find utility in the drug discovery and development processes in the identification and selection of compounds that will possess appropriate pharmacokinetic characteristics in humans for progression to clinical trials.

Estimate of the safe starting dose in clinical trials for therapeutics in adult healthy volunteers

Abstract: A strategy was proposed to determine the maximum recommended starting dose (MRSD). Usually, no observe adverse effect level (NOAEL) from the relevant animal studies should be converted to the human equivalent dose (HED) using standard factors. Using sound scientific judgments, the MRSD is determined by dividing the HED from the most appropriate species by the safety factor. This strategy pertained to determining the MRSD of any new drug or biological therapeutic that had been studied in animals, but was not pertinent to prophylactic vaccines or endogenous proteins used at physiologic concentrations.

The anti-virus and hepatoprotective effect of bicyclol and its mechanism of action

Abstract: Bicyclol is a synthetic novel anti hepatitis drugIt has remarkable hepatoprotective and certain anti hepatitis virus actionsOral administration of 50,100,200 mg·kg -1 bicyclol protected livers of mice from damage induced by CCl 4,D galactosamine,acetoaminophen and BCGplus lipopolysacharides (LPS) expressed in decreases of ALT and AST as well as morphological damage of liver tissuesAddition of bicyclol to the cultivated 2215 cell line inhibited secretion of HBeAg and HBsAg as well as HBV DNA levelThe results of mechanistic study on bicyclol indicated that bicyclol is not an inhibitor of transaminase,but a cell membrane protector through elinmination of free radicalsMoreover,bicyclol can protect hepatocyte nuclear DNA from damage and reduce the apoptosis induced by immuno stimulating compound Con A [

The efficacy of Cordyceps militaris capsules in treatment of chronic bronchitis in comparison with Jinshuibao capsules

Abstract: Objective: To evaluate the efficacy and safety of Cordyceps militaris capsules in treatment of chronic bronchitis. Methods:The multi-centers,randomized,single blind,and positive controlled study was conducted in 425 patients with chronic bronchitis. They were divided to receive Cordyceps militaris capsules in a dose of 1g tid for 2 months ( n = 315) or Jinshuibao capsule in a dose of 1g tid for 2 months ( n = 110). Results:The symptom of cough,sputum,and wheeze as well as lung function, chest X ray syndrome and comprehensive efficacy in the active group were significantly improved compared with control group (P 0.01). No significant difference in blood routine examination, liver and renal functions, ECG and others between 2 groups were observed (P0. 1). Conclusion : Cordyceps militaris capsules are effective in treatment of chronic bronchitis.

A phase I clinical trial for recombinant human endostatin

Abstract: Objective:To determine the maximum tolerated dose (MTD) and the pharmacoki-netics of the endostatin (rh-endostatin, YH-16) injection in human. Methods: 12 healthy volunteers were equally divided into 4 groups. Each group was intravenously administrated with a single dose of YH-16 infusion at 30,60,120 and 210mg·m-2,respectively. 10 patients with advanced solid tumors were categorized into 3 groups (4,3 and 3 patients per group). Each group was intravenously given with a dose of YH-16 infusion at 7.5,15 and 30mg·m-2 once daily for 28 days, respectively. The YH-16 concentration in serum sampes from all subjects was analyzed by ELISA,so as to determine the pharmacokinetic profile. Results:The dose limiting toxicities (DLT) were measured as varieties of car-diac adverse reactions, including sinus arrhythmia, supraventricular tachycardia, ventricular premature beat and T wave changes shown in electrocardiogram. The other mild adverse events were found to be fever,rash, minor dizziness, headache, fatigue, palpitation, chest discomfort and diarrhea. One patient with malignant melanoma had a minor response and 5 patients showed stable disease.The pharmacokinetic disposition was almost linear in healthy volunteers. However,the individual difference on concentration vs. time was observed in patients with advanced solid tumors. Conclusion:The YH-16 was clini-cally tolerated well.The MTD was 120mg·m-2 in healthy volunteers with a single dose, and 15mg· m-2 in the tumor patients with a daily dose for 28 days. The efficacy of anti-tumor with YH-16 was evident.The clinical dosage of 12mg·m-2 daily for 28 days in phase Ⅱ study is recommended.