Shanghai Zhabei Institute for Food and Drug Control

Shanghai, China

Shanghai Zhabei Institute for Food and Drug Control

Shanghai, China
SEARCH FILTERS
Time filter
Source Type

Ye J.,Shanghai Zhabei Institute for Food and Drug Control | Chen B.,Shanghai Zhabei Institute for Food and Drug Control | Yu Y.,Shanghai Zhabei Institute for Food and Drug Control | Zhang S.,Shanghai Zhabei Institute for Food and Drug Control
Pharmaceutical Care and Research | Year: 2016

Objective: To establish a method for the determination of residual organic solvents in raw material clevidipine (RMC). Methods: Residual ethanol, acetone, isopropanol, acetonitrile, dichloromethane, isopropyl ether and ethyl acetate ether in RMC were determined by headspace gas chromatography. Results: The quantitative limits were 15.93,2.01, 15.16,5.45, 7.85,1.87 and 0.47 μg/ml, and the detection limits were 3.98,0.50,3.79,2.73,3.93,0.47 and 0.14 jig/ml for ethanol, acetone, isopropanol, acetonitrile, dichloromethane, isopropyl ether and ethyl acetate, respectively. Linearity was achieved within the ranges of 63.71-1019.4 μg/ml(r=0.999 8) for ethanol, 64.25-1028 μg/ml(r=0.999 9) for acetone, 60.63-970 pg/ml(r= 0.999 8) for isopropanol, 5.45-87.2 μg/ml(r=0.999 9) for acetonitrile, 7.85-125.6 μg/ml(r=0.999 9) for dichloromethane, 59.86-957.8 μg/ml(r=0.999 2) for isopropyl ether and 61.28-980.4 μg/ml(r=0.999 9) for ethyl acetate, respectively. The average recovery rates were 96.2%-104.5% and the precision RSD was 2.2%-3.7%. Conclusion:; The method was accurate, reliable and reproducible, and could be used for the determination of the above residual organic solvents in RMC.


Liu Y.,China Pharmaceutical University | Chen B.,Shanghai Zhabei Institute for Food and Drug Control | Le J.,Shanghai Institute for Food and Drug Control | Xu Y.,China Pharmaceutical University | And 4 more authors.
Journal of Separation Science | Year: 2014

A rapid and sensitive liquid chromatography with tandem mass spectrometry method has been developed and validated for the simultaneous quantification of 11 major compounds in Yuanhu-Bazhi herb-pair from a rat intestinal perfusion experiment, including eight alkaloids and three coumarins using diazepam as the internal standard. The analysis was performed on an Agilent Poroshell 120EC-C18 column using a gradient elution of acetonitrile/H 2O with 0.0015% formic acid and 2 mM ammonium formate buffer additive (pH 4.2). All compounds were detected by tandem mass spectrometry in positive ionization mode and quantified using multiple reaction monitoring mode. Good linearity in the related range of each compound was presented. The validation data, such as accuracy and precision, were within the required limits. The lower limit of quantification of each analyte was less than 10 ng/mL. Intra-day and inter-day precisions were less than 12.84%. The relative errors of accuracy were in the range of -13.31 to 13.19%. The recoveries of analytes were greater than 84.08%. The method has been successfully applied to an intestinal absorption study of major components following intestinal perfusion of Yuanhu-Bazhi herb-pair extract to rats. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.


Zhang S.,Shanghai Zhabei Institute for Food and Drug Control | Chen B.,Shanghai Zhabei Institute for Food and Drug Control | Ling S.,Shanghai Zhabei Institute for Food and Drug Control | Yu Y.,Shanghai Zhabei Institute for Food and Drug Control
Pharmaceutical Care and Research | Year: 2012

Objective: To establish a detection method of illegally added gout suppressants in Chinese traditional medicine and health-care food. Methods: HPLC-diode array detector (DAD) combined with electronic drug standards management system were used to screen the illegally added chemical agents of gout suppressants in complaint sample Kangtongfeng capsules, and the infrared spectrum was used for further verification. Results: The illegally added chemical agents of gout suppressants prednisone acetate and diclofenac sodium in complaint sample could be detected by this method rapidly and accurately. Conclusion: The method is simple, rapid, accurate and specific. It can be used for detection of chemical agents of gout suppressants in Chinese traditional medicine and health-care food.


Wang R.,China Pharmaceutical University | Gu X.,China Pharmaceutical University | Dai W.,China Pharmaceutical University | Ye J.,Shanghai Zhabei Institute for Food and Drug Control | And 7 more authors.
Molecular BioSystems | Year: 2016

Celastrol is well known for its anti-inflammatory and anti-cancer effects. In this study, the efficacy of celastrol against dextran sulfate sodium (DSS)-induced inflammatory bowel disease (IBD) in mice was established and the mechanism was investigated using lipidomics. Celastrol treatment significantly alleviated DSS-induced colitis in mice, as revealed by the body weight, colon length, scores of rectal bleeding and diarrhea, serum TNF-α level, and histological analysis results. Lipidomics analysis based on UPLC/MS revealed characteristic changes in the metabolic profiles of the colitis mice, with altered levels of lipid markers associated with IBD, including LPC18:0, LPC18:1, LPC18:2, sphingomyelin (SM), and increased LPC18:0/LPC18:1 and LPC18:0/LPC18:2 ratios. For the celastrol-treated colitis mice, however, levels of the above lipid markers were restored, together with recovered saturated LPC/unsaturated LPC ratios. Accordingly, using GC-MS analysis, increased stearic acid (C18:0)/oleic acid (C18:1) and stearic acid (C18:0)/linoleic acid (C18:2) ratios were observed in colitis mice, which were later recovered after celastrol treatment. Quantitative real-time PCR analysis revealed that the liver expression of stearoyl-coenzyme A desaturase 1 (SCD1), the key enzyme controlling the desaturation of saturated fatty acid, was dramatically inhibited in IBD mice, and was obviously recovered after celastrol treatment. These results suggest that the increased saturated LPC/unsaturated LPC (and saturated fatty acid/unsaturated fatty acid) ratios associated with SCD1 down-regulation could be regarded as biomarkers of colitis, and celastrol alleviates DSS-induced colitis partially via up-regulation of SCD1, restoring the altered balance between stearic acid- and oleic acid-derived lipid species, which plays an important role in alleviating colitis. In all, this study provided the scientific basis for further development of celastrol in treating IBD. © 2016 The Royal Society of Chemistry.


Le J.,Shanghai Institute for Food and Drug Control | Li J.,Shanghai Institute for Food and Drug Control | Wen H.,Shanghai Institute for Food and Drug Control | Chen B.,Shanghai Zhabei Institute for Food and Drug Control | And 2 more authors.
Analytical Methods | Year: 2014

A procedure for the quantitative determination of ambroxol hydrochloride in its commercial injection based on the conjunction of Raman spectroscopy and chemometrics is described. The active component constitutes less than 1% (w/v) of the injection in our study. The efficiency of various spectra treatment procedures, including classical least squares (CLS), partial least squares (PLS), principal component regression (PCR) and stepwise multiple linear regression (SMLR), was compared. First, the calibration models were built using ambroxol hydrochloride standard solutions. To compare the predictive ability of the four models constructed, the performance indices were calculated. As a result, both the CLS model and the PCR model were comparably effective ones, of which the difference values were 94.9% and 94.2%, respectively, and the root mean square errors (RMSEs) were 0.07 and 0.08, respectively. Eleven commercial injections were quantified directly applying the developed models. SPSS software was used to compare the difference between the results obtained from the pharmacopoeial HPLC method and Raman analysis, and there was no significant difference between them (p > 0.05). It shows that the proposed procedure based on the chemometric treatment of Raman spectra can be a specific, fast and convenient alternative to the compendial qualitative and quantitative determination of ambroxol hydrochloride Injection. © 2014 The Royal Society of Chemistry.

Loading Shanghai Zhabei Institute for Food and Drug Control collaborators
Loading Shanghai Zhabei Institute for Food and Drug Control collaborators