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化學藥品檢驗室Chemical Drugs Testing Department

發布時間:2021-03-02 文章來源: 深圳市藥品檢驗研究院
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  主要從事化學藥品、抗生素藥品、生化藥品和藥用輔料的檢驗檢測,標準研究等工作;可檢項目百余項,在上市藥物的質量評價與標準提高、進口藥品注冊復核、仿制藥質量與療效一致性評價復核、國家藥品標準物質的協作標定等方面能力突出。作為WHO-PQ實驗室,還承接部分國外藥品的檢測任務?;幨夷壳皳碛懈呒壜毞Q人員6人、博士3人、碩士9人,技術骨干多次赴國內外著名科研院所和藥檢機構交流訪問;配有AB 5500 HPLC-MS、離子色譜儀、液相色譜儀(配有二極管陣列、蒸發光散射及示差折光檢測器)、X射線衍射儀、激光粒度儀、傅立葉紅外光譜儀等一系列大型精密儀器設備?;瘜W藥品檢驗室成立至今,出色完成了各年度國家藥品專項抽驗工作,并在“國家藥品評價性抽驗”、歷版《中國藥典》起草和復核、化學藥品標準提高行動計劃等專項工作中成績卓著。

  We are mainly engaged in the analysis and testing of chemical drugs, antibiotics, biochemical drugs and pharmaceutical excipients, as well as in developments of the drug quality specifications. We have the ability to carry out hundreds of testing items and particularly strong in the quality assessments and testing method improvements for marketing drug product, validation and verification of standard specification for import drugs, quality and efficacy evaluation of generic drug, as well as in the nationally coordinating calibration of reference substance. As a WHO-PQ Laboratory, we undertake some foreign business.. In our department, 6 technicians obtained senior professional title, 3 with PhD degree and 9 with master degree. Most of our key staffs took part in the exchange program with top science institutes and drug testing institutes from domestic and worldwide. We are equipped with many advanced instruments including HPLC-TQMS (AB5500), Ion Chromatograph, HPLC with PDA, ELSD or RID detectors, X-ray Diffractometer, Laser Particle Size Analyzer, Fourier Transform Infrared spectrometer, etc. Since its establishment, we have accomplished remarkable tasks in the Annual National Special Drug Sampling & Testing Project. We have also performed extraordinally well in the program of Chinese Pharmacopoeia drafting and reviewing , the National Chemical Drug Quality Standard Improvement Plan, and so on.

  部門座右銘        務實創新,勇于擔當

  

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