Center for Certification and Evaluation

Shanghai, China

Center for Certification and Evaluation

Shanghai, China
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Shen Q.,East China University of Science and Technology | Shen Q.,Center for Certification and Evaluation | Gao S.-S.,East China University of Science and Technology | Xie Y.-N.,East China University of Science and Technology | And 2 more authors.
Journal of Chinese Pharmaceutical Sciences | Year: 2012

A kind of novel pitchbased activated carbon microsphere (ACM) characterized by its controlled porous structure was developed in this study, the curative effect of this ACM on diabetes mellitus in rats was investigated. ACM 0.2-0.3 mm in diameter was prepared by modified method. The optimal ACM was screened by its adsorption ability for glucose. Diabetes mellitus model was established by streptozotocin injection in male SpragueDawley rats. Two groups of rats were orally administrated with ACM twice a day for 30 d. Intestinal glucose transport was determined in vitro using everted rat intestinal sacs technique. Compared with the diabetic mellitus group, the ACM treated group showed significant lower blood glucose level and improved glucose tolerance after twoweek treatment. If ACM was applied in the mucosal side, glucose permeation clearance in the ACM treated group was significantly higher than that of the control group, especially at high glucose concentration (10 mg/mL) on the serosal side. The selected ACM possessed a BET specific surface of 1566 m 2 /g and high volume of micropores (0.478 cm 3 /g) with fine spherical morphology, and showed more significant adsorption capacity for glucose. As oral microsphere preparations, ACM presented the curative effect on streptozotocininduced diabetes mellitus in rats. © 2012 Journal of Chinese Pharmaceutical Sciences, School of Pharmaceutical Sciences, Peking University.


Li S.,University of Shanghai for Science and Technology | Zhang J.-C.,Center for Certification and Evaluation
Chinese Pharmaceutical Journal | Year: 2015

OBJECTIVE: To analyze the key problems in the management of drug production process changes during the drug life cycle, thus to improve the management of pharmaceutical production process changes. METHODS: Taking the change of injection sterilization process as an example, the issues in the study and management of process change were analyzed by employing empirical a-nalysis methods and introducing the concept of equilibrium analysis of the pharmaceutical quality system. RESULTS AND CONCLUSION: The pharmaceutical quality system is the equilibrium system of five aspects, including prescription composition, raw material control, production process, packaging and quality control. Process change research should follow the concept that quality comes from design, use process analytical technologies, and give full consideration to the quality system equilibrium. Process change management needs a systematic management of drugs. Copyright 2015 by the Chinese Pharmaceutical Association.


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.


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.


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.


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.


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.

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