主办:上海医药工业研究院
   中国药学会
   中国化学制药工业协会
ISSN 1001-8255   CN 31-1243/R   ZYGZEA

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  • 2017 Volume 48 Issue 11
    Published: 10 November 2017
      

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  • SHEN Jinglin1, DING Ying2
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    An HPLC-wavelength switching method was established for the determination of allantoin (1),dehydrotumulosic acid (2), tumulosic acid (3), pachymic acid (4), catalpol (5), jionoside B1 (6), martinoside (7),ginsenoside Rg1 (8) and ginsenoside Rb1 (9) in Qinggong Changchun Jiaonang. An Agilent TC-C18 column was used,with the mobile phase of acetonitrile∶0.2% phosphoric acid by gradient elution, at the detection wavelength of 224 nm(0→19 min, 1), 210 nm (19→31 min, 2—5), 330 nm (31→37 min, 6 and 7) and 203 nm (37→55 min, 8 and 9). Their calibration curves were linear in the ranges of 8.0—160.0, 2.0—40.0, 2.5—50.0, 2.0—40.0, 5.0—100.0, 2.5—50.0,2.0—40.0, 15.0—300.0 and 8.5—170.0 μg/ml, respectively. Their average recoveries were 98.82%, 100.03%, 97.92%,98.09%, 97.64%, 98.14%, 96.91%, 97.88% and 98.39%, with RSDs less than 2%. This method can be used for the quality analysis of Qinggong Changchun Jiaonang.
  • WANG Qiwei, LAI Shuqing, GUO Wen*
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    To explore the impact of recent reform of drug registration and management system on domestic drug development, we sorted out the domestic drug registration application data during the period from 2011 to the first half of 2017 through database retrieval, analyzed the amount of drug registration application, application type, registration classification, etc. The results showed that under the guidance of encouraging innovation and curbing low-level redundant development, the number of China drug registration application dropped significantly, the situation of drug development urned rational, the innovative drug development was encouraged, and the generic drug development changed to pay attention to the clinical needs.
     
  • LI Bo1,2, SUN Lihua1*
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