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Huang W.,Shanghai JiaoTong University | Hou J.,Shanghai Shyndec Pharmaceutical Co. | Wang M.,Shanghai JiaoTong University | Peng C.,Shanghai JiaoTong University | And 2 more authors.
Current Pharmaceutical Analysis | Year: 2015

Aim: The purpose of this study is to explore a convenient, accurate and reliable method for quality control of Si-jun-zi Tang (SJZT) decoction. Methods: A high-performance liquid chromatography coupled with diode array and evaporative light scattering detectors (HPLC-DAD-ELSD) method and a HPLC coupled with electrospray ionization tandem mass spectrometry (HPLC-ESI-MS) method were developed for the qualitative and quantitative analysis of multiple constituents in SJZT. The chromatographic separation of multiple constituents was performed on a Boston pHlex ODS column and a C18 guard column with a gradient elution program consisting of 0.1% aqueous formic acid and acetonitrile at a flow rate of 0.7 mL/min. Results: A total of 23 constituents (7 ginsenosides, 9 licorice flavonoids, 5 licorice saponins and 2 atractylenolides) were verified based on peak retention time, ultraviolet-visible (UV) spectrum and MS data of HPLC-DAD-ELSD and HPLCESI- MS methods. The HPLC-DAD-ELSD method was successfully applied to quantify 11 major constituents (liquiritin apioside, liquiritin, Re/Rg1, isoliquiritin apioside, isoliquiritin, ononin, Rb1, Rg2, glycyrrhizic acid, and atractylenolide III) in SJZT with good linearity (R2 > 0.9990), acceptable precision (RSD < 3.0%) and high recovery (93.4%-101.7%). Conclusion: The combined methods of HPLC-DAD-ELSD and HPLC-ESI-MS proved to be convenient, accurate and reliable methods for qualitative and quantitative analysis of SJZT. © 2015 Bentham Science Publishers.

Wang Y.-F.,China Pharmaceutical University | Yuan X.-B.,Shanghai Shyndec Pharmaceutical Co. | Zhang J.,China Pharmaceutical University
Chinese Journal of New Drugs | Year: 2015

With the patent expires of biopharmaceuticals, pharmaceutical companies pay attentions to biosimilar mAbs. Many pharmaceutical companies try to research and develop biosimilar mAbs. Because of the particularity of biosimilar mAbs, general generic drug regulations and guidelines can not be applied to biosimilar mAbs. Many countries' and regions' regulatory agencies begin to actively engage in the development of biosimilar guidance and documents. As the major country of generic drug, we need to gain the opportunities to be new level. This review focuses on the outline of biosimilar mAbs' particularity and the recent development status at home and abroad of biosimilar mAbs. ©, 2015, Chinese Journal of New Drugs Co. Ltd.. All right reserved.

Nian S.,Shanghai Institute of Pharmaceutical Industry | Gan X.,Shanghai Institute of Pharmaceutical Industry | Tan X.,Guilin Medical University | Yu Z.,Shanghai Shyndec Pharmaceutical Co. | And 4 more authors.
Chemical and Pharmaceutical Bulletin | Year: 2015

Fourteen novel compounds were prepared and their antagonistic activities against liver X receptors (LXR) α/β were tested in vitro. Compound 26 had an IC50 value of 6.4 μM against LXRα and an IC50 value of 5.6 μM against LXRβ. Docking studies and the results of structure-activity relationships support the further development of this chemical series as LXRα/β antagonists. © 2015 The Pharmaceutical Society of Japan.

Li C.,Guilin Medical University | Li C.,Shanghai Institute of Pharmaceutical Industry | Sun Y.,Guilin Medical University | Sun Y.,Shanghai Shyndec Pharmaceutical Co. | And 3 more authors.
Bulletin of the Korean Chemical Society | Year: 2014

In search of new antileukopenia agents, twenty dithiolopyrrolone derivatives were synthesized and evaluated for their leukocyte-increasing activities in normal mice. Among the synthesized compounds 4-23, compounds 5 and 6 showed significant leukocyte-increasing activity ( p < 0.01), and compounds 4, 9 and 16 had a moderate effect ( p < 0.05). Compound 5 also displayed stronger leukocyte-increasing activity than that of the positive recombinant human granulocyte colony stimulating factor (rhG-CSF). Above all, compound 5 would be a potential antileukopenia agent which deserved further research.

Tan X.,Shanghai Institute of Pharmaceutical Industry | Wang P.,Shanghai Shyndec Pharmaceutical Co. | Nian S.,Shanghai Institute of Pharmaceutical Industry | Wang G.,Shanghai Institute of Pharmaceutical Industry | Wang G.,Shanghai Shyndec Pharmaceutical Co.
Chemical and Pharmaceutical Bulletin | Year: 2014

In this study, a series of amide derivatives were synthesized and evaluated for their S-adenosyl-Lhomocysteine hydrolase (SAHase) inhibitory activities. The results demonstrated that most of compounds displayed potent SAHase inhibitory activities. Interestingly, compounds 11 and 14 exhibited more potent inhibitory effects than the aristeromycin, one of the most potent SAHase inhibitors known so far. Compounds 12, 13, 15 and 17 exhibited a moderate effect (IC50<10.0 μM). The structure-activity relationship found that compounds with substituted indazole-5-yl group at Ar position and ethylamino group at the side chain showed better SAHase inhibitory activities. © 2014 The Pharmaceutical Society of Japan.

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