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Jin Y.,Shenzhen Institute for Drug Control
Chinese Journal of New Drugs | Year: 2016

In 2013, China Food and Drug Administration (CFDA) released “technical guidelines for chemical substances irritation, sensitization and hemolytic study (2005)” for public consideration. Nine of the suggestions were put forward by Prof. Yuan Bo-jun and me, according to the author's papers of irritation test standardization published in “Chinese Journal of New Drugs” and other journals. In 2014, CFDA released a new version of “technical guidelines of drug irritation, sensitization and hemolytic study”. Interpretation and suggestions on the new guidelines were given after nearly 1-year practice. © 2016, Chinese Journal of New Drugs Co. Ltd. All right reserved.

Zhu K.Y.,Chinese University of Hong Kong | Leung K.W.,Chinese University of Hong Kong | Ting A.K.L.,Chinese University of Hong Kong | Wong Z.C.F.,Chinese University of Hong Kong | And 7 more authors.
Analytical and Bioanalytical Chemistry | Year: 2012

A microfluidic chip based nano-HPLC coupled to tandem mass spectrometry (nano-HPLC-Chip-MS/MS) has been developed for simultaneous measurement of abused drugs and metabolites: cocaine, benzoylecgonine, cocaethylene, norcocaine, morphine, codeine, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, MDMA, MDA, MDEA, and methadone in the hair of drug abusers. The microfluidic chip was fabricated by laminating polyimide films and it integrated an enrichment column, an analytical column and a nanospray tip. Drugs were extracted from hairs by sonication, and the chromatographic separation was achieved in 15 min. The drug identification and quantification criteria were fulfilled by the triple quardropule tandem mass spectrometry. The linear regression analysis was calibrated by deuterated internal standards with all of the R 2 at least over 0.993. The limit of detection (LOD) and the limit of quantification (LOQ) were from 0.1 to 0.75 and 0.2 to 1.25 pg/mg, respectively. The validation parameters including selectivity, accuracy, precision, stability, and matrix effect were also evaluated here. In conclusion, the developed sample preparation method coupled with the nano-HPLC-Chip-MS/MS method was able to reveal the presence of drugs in hairs from the drug abusers, with the enhanced sensitivity, compared with the conventional HPLC-MS/MS. © 2012 Springer-Verlag.

Jin Y.,Shenzhen Institute for Drug Control
Chinese Journal of New Drugs | Year: 2014

Toxicologic pathology report is an indispensable content in drug safety evaluation of new drug research and application. The value of pathological diagnosis is limited because of problems in dyeing methods, equipments and other experimental conditions, and the diagnosis is affected by pathologist's personnel knowledge and experience that unavoidably possess subjectivity. Therefore, peer review based on unified, standardized and scientific terminology is an essential element. Due to the toxicologic pathology in China is still in the developing stage, diagnostic terms among pathologists are quite different, so that sometimes the same pathological change might be given many similar terms but have completely different pathogenesis. In this article, the definition, pathogenesis, light microscopic observation and confirming methods of hepatocellular vacuolation and necrosis were discussed mainly combined with current situation of the diagnose based on hematoxylin-eosin stained sections, and unifying the nomenclature for rat and mouse hepatocellular vacuolation and necrosis was suggested. ©, 2014, Chinese Journal of New Drugs Co. Ltd. All right reserved.

Yu H.,Shenzhen Polytechnic | Xu L.,Shenzhen Institute for Drug Control | Chen S.,Shenzhen University
Ultrasonics Sonochemistry | Year: 2014

Ultrasound is a very promising technology to mediated drug/gene transferring into cells. However the relations between cell experimental conditions and results have been still unknown. It seriously impeded the development of the technology. In the article, a transfer efficiency model for ultrasound mediated drug/gene transferring into cells in stable cavitation was constructed. To testify the model, the numerical results were compared with the cell experimental data from six literatures in the entirely different experimental conditions. The numerical results fit the cell experimental data well. Despite simplifications and limitations, the model for the first time established the relationship between the cell experimental results about transfer efficiency and the conditions including ultrasound, microbubble and cells in stable cavitation. © 2013 Elsevier B.V. All rights reserved.

Zhao J.,Southern Medical University | Su C.,Shenzhen Institute for Drug Control | Yang C.,Sun Yat Sen University | Liu M.,Sun Yat Sen University | And 3 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2012

A sensitive rapid resolution liquid chromatography-tandem mass spectrometry method was developed to determine the pharmacokinetics of ginsenoside Rb 1, Rb 2, and Rb 3 in rats, after oral administration (50mg/kg) and intravenous administration (10mg/kg) of Rb 1, Rb 2, and Rb 3, respectively. The plasma samples were extracted by saturated N-butanol with Rg 2 as internal standard. Chromatographic separation was performed on a Zorbax SB-C18 column (50mm×4.6mm, 1.8μm) with a mobile phase consisting of methanol and 1mM ammonium formate (74:26, v/v). Multiple reaction monitoring mode was performed using the fragmentation transitions of m/z 1107.7→m/z 178.9, m/z 1077.7→m/z 148.6, and m/z 1077.7→m/z 783.4 for Rb 1, Rb 2, and Rb 3, respectively. Calibration curves were recovered over a concentration range of 20-1000ng/ml for Rb 1 and Rb 2, and 50-2500ng/ml for Rb 3. The limits of detection were 3.0ng/ml, 4.0ng/ml, and 6.5ng/ml. Both intra-day and inter-day variances were less than 15% and the accuracy was within 86-114% for the three ginsenosides. All three ginsenosides had poor oral bioavailability (0.78%, 0.08%, and 0.52% for Rb 1, Rb 2, and Rb 3, respectively). The value of Rb 1 is higher than that of Rb 2 or Rb 3, indicating that ginsenosides with hexose and hydroxyl groups (Rb 1) could present better pharmacokinetic behaviors than those with pentose groups in the same glycosylation site by oral administration. © 2012 Elsevier B.V.

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