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Volume 37 Issue 2
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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2019  >  37(2): 170-172,187

SHI Lei, YE Jun, SONG Lei. Study on the dissolution determination of Zhibitai capsules[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(2): 170-172,187. doi: 10.3969/j.issn.1006-0111.2019.02.014
Citation: SHI Lei, YE Jun, SONG Lei. Study on the dissolution determination of Zhibitai capsules[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(2): 170-172,187. doi: 10.3969/j.issn.1006-0111.2019.02.014
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Study on the dissolution determination of Zhibitai capsules

doi: 10.3969/j.issn.1006-0111.2019.02.014
  • 1.

    Shanghai Jingan Institute for Food and Drug Control, Shanghai 200435, China

  • 2.

    Tongren Hospital Affiliated to School of Medical, Shanghai Jiaotong University, Shanghai 200050, China

  • Received Date: 2018-06-02
  • Rev Recd Date: 2018-11-12
  • Objective To develop a method for the determination of the dissolution of Zhibitai capsules. Methods The chromatographic analysis was carried out on a ZABAX-C18column(250 mm×4.6 mm,5 μm)with methanol-0.05% phosphate solution(60∶40) as mobile phase.The flow rate was 1.0 ml/min and the detection wavelength was 238 nm.According to the third dissolution method (small glass-method) described in the Pharmacopoeia of the People's Republic of China (2015Edition,Volume 4),the dissolution determination conditions were established using SOTAX AT7 intelligent drug dissolution instrument,and dissolution medium,rotational speed and sampling time were selected. Results The method showed perfect specificity under the established chromatographic conditions.The linear ranges of lovastatin was 1.63-122.2 μg/ml(r=1.000 0).The dissolution rates of the samples were consistent.The 1.0% sodium dodecyl sulfate in phosphate solution (pH 7.0) was selected as release media,rotational speed was 100 r/min,the sampling time point was 45 min.The dissolution limit was not less than 80% of the labeled amount. Conclusion The established method could be used for the dissolution determination and the quality control,and provide reference for the improvement of quality standards of Zhibitai capsules.
  • [1] 叶任高,陆再英.内科学[M].6版.北京:人民卫生出版社2005:819-821.
    [2] 刘源,李东,谢静,等.高效液相色谱法测定脂必泰胶囊中洛伐他汀含量[J].中药材,2010,33(6):1002-1004.
    [3] 温中明,张法,黄毅,等.脂必泰胶囊中红曲的含量测定[J].中国药业,2011,20(13):21-23.
    [4] 罗仁才,孙开奇,谢申猛,等.红曲中洛伐他汀总量的测定方法[J].卫生研究,2003,32(2):157-158.
    [5] 宓鹤鸣,宋洪涛,陈磊,等.红曲中降血脂活性成分的研究[J].中草药,1999(3):172-174.
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Study on the dissolution determination of Zhibitai capsules

doi: 10.3969/j.issn.1006-0111.2019.02.014
  • 1. Shanghai Jingan Institute for Food and Drug Control, Shanghai 200435, China
  • 2. Tongren Hospital Affiliated to School of Medical, Shanghai Jiaotong University, Shanghai 200050, China
  • Received Date: 2018-06-02
  • Rev Recd Date: 2018-11-12

Abstract: Objective To develop a method for the determination of the dissolution of Zhibitai capsules. Methods The chromatographic analysis was carried out on a ZABAX-C18column(250 mm×4.6 mm,5 μm)with methanol-0.05% phosphate solution(60∶40) as mobile phase.The flow rate was 1.0 ml/min and the detection wavelength was 238 nm.According to the third dissolution method (small glass-method) described in the Pharmacopoeia of the People's Republic of China (2015Edition,Volume 4),the dissolution determination conditions were established using SOTAX AT7 intelligent drug dissolution instrument,and dissolution medium,rotational speed and sampling time were selected. Results The method showed perfect specificity under the established chromatographic conditions.The linear ranges of lovastatin was 1.63-122.2 μg/ml(r=1.000 0).The dissolution rates of the samples were consistent.The 1.0% sodium dodecyl sulfate in phosphate solution (pH 7.0) was selected as release media,rotational speed was 100 r/min,the sampling time point was 45 min.The dissolution limit was not less than 80% of the labeled amount. Conclusion The established method could be used for the dissolution determination and the quality control,and provide reference for the improvement of quality standards of Zhibitai capsules.

SHI Lei, YE Jun, SONG Lei. Study on the dissolution determination of Zhibitai capsules[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(2): 170-172,187. doi: 10.3969/j.issn.1006-0111.2019.02.014
Citation: SHI Lei, YE Jun, SONG Lei. Study on the dissolution determination of Zhibitai capsules[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(2): 170-172,187. doi: 10.3969/j.issn.1006-0111.2019.02.014
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