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Feng J.,Fudan University | Liu X.,Fudan University | Liu X.,Center for Certification and Evaluation | Li Y.,Fudan University | Duan G.,Fudan University
Talanta | Year: 2016

We developed a novel, simple and fast method for the determination of glucocorticoids residues in liver tissue by combining microwave-assisted enzymatic hydrolysis and restricted access matrix dispersive solid phase extraction (RAM-dSPE) followed with liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis. Firstly, microwave-assisted enzymatic hydrolysis was introduced in order to obtain a maximum amount of unconjugated parent drug in a short time (8 s), while the traditional method commonly needs 4-12 h. Secondly, further cleanup was carried out by RAM-dSPE based on the graphene@mSiO2-C8 nanomaterials which were synthesized by coating mesoporous silica onto hydrophilic graphene nano-sheets through a surfactant-mediated co-condensation sol-gel process. The enzymatic hydrolysis influencing factors (pH of the buffer, microwave radiation power, incubation time) and the experimental conditions of RAM-dSPE (sorbents amount, type and volume of the elution solvent, adsorption and desorption time) were optimized. Three glucocorticoids (prednisolone (PREL), betamethasone (BE) and dexamethasone (DE)) were selected as models to evaluate the feasibility of the method. According to the results, the developed method provided low detection limit (S/N=3) of 0.01-0.05 μg kg-1 and good linearity range of 0.25-800 μg kg-1 (R2>0.996) for glucocorticoids. The limit of quantification (S/N=10) range from 0.03 to 0.19 μg kg-1. Compared with other traditional methods, the developed method could provide similar or even better results in a greatly reduced analysis time. © 2016 Elsevier B.V. Source

Zhang B.-Z.,Center for Certification and Evaluation | Tian J.,Center for Drug Evaluation | Ning L.-L.,Center for Drug Evaluation
Chinese Journal of New Drugs | Year: 2013

Ophthalmic preparations are a special formulation directly acting on eye. For research and development of ophthalmic preparations, high quality requirements have been put forward. Also, change research of ophthalmic preparations has certain technical requirements and characteristics. Applicants should play attention for the requirements. In order to better regulate the research and development work and to save review resources, in this paper, we summarized common problems of ophthalmic preparations in change research, and gave rationalization recommendations for providing references for researchers and applicants. Source

Zhang B.-Z.,Center for Certification and Evaluation | Tian J.,Center for Drug Evaluation | Ning L.-L.,Center for Drug Evaluation
Chinese Journal of New Drugs | Year: 2013

Additional specifications are more common supplemental application. Due to the applicants understanding of such changes is often not deep enough, and defects exist in preliminary studies. Therefore, the supplemental applications can frequently not be approved. In order to improve efficiency of the development and evaluation, this article summarized and analyzed the frequently asked questions in supplemental application of additional specifications. Source

Du H.Y.,Center for Certification and Evaluation | Du H.Y.,PLA University of Science and Technology | Qian Y.,Jiangsu Province Medical Instrument Testing Institute | Wu C.G.,PLA University of Science and Technology | And 2 more authors.
Applied Mechanics and Materials | Year: 2013

The requirement of the accuracy of microscopic measurements becomes more and more high, and traditional methods have been unable to meet the demands. Digital image deconvolution techniques are applied in microscopic measurement. By fabricating a pointolite, the point spread function of the optical system is measured, and then the geometric blurring in traditional microscopy is removed by using the maximum likelihood estimation algorithms and iteration threshold segmentation algorithms. The technique is applied to measure the total content of perlite and spheroidal graphite in spheroidal graphite iron accurately and easily, and then to measure the area of a scratch scaled in 10 microns on a medical department of orthopedics plates. The technique makes great sense in the development of corresponding measurement. © (2013) Trans Tech Publications, Switzerland. Source

Wang F.-M.,Center for Certification and Evaluation | Zhu J.,Center for Certification and Evaluation | Zhou T.-S.,Center for Certification and Evaluation | Gao M.-J.,Center for Certification and Evaluation | And 3 more authors.
Chinese Journal of New Drugs | Year: 2013

Production site inspection for drug registration is a strong administrative means to verify the integrity and achievability of the submitted manufacturing process. However, the requirements for production site inspection released by SFDA are essentials without detailed guidance or SOP for implementation, as well as there are many difficulties in practice, therefore, the operation varies from different regions. The research has compared domestic and foreign implementation approaches of pre-approval production site inspection from different countries, and analyzed the problems existed in domestic operations. Some constructive recommendations for domestic production site inspection approach are given in aim to standardize the operation and improve the efficacy of inspection. Source

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