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作 者:吴雪琴 孙研 王胜义[1] 王磊[1] 吴亮红 岳鹏 刘盼盼 崔东安[1] WU Xueqin;SUN Yan;WANG Shengyi;WANG Lei;WU Lianghong;YUE Peng;LIU Panpan;CUI Dongan(Engineering and Technology Research Center of Traditional Chinese Veterinary Medicine,Lanzhou Institute of Husbandry and Pharmaceutical Sciences of CAAS,Lanzhou Gansu 730050,China)
机构地区:[1]中国农业科学院兰州畜牧与兽药研究所甘肃省中兽药工程技术研究中心,甘肃兰州730050
出 处:《中兽医医药杂志》2021年第6期52-56,共5页Journal of Traditional Chinese Veterinary Medicine
基 金:农产品质量安全监管(2130109);宁夏回族自治区重点研发项目(2019BEF02003);兰州市人才创新创业项目(2018-RC-91)。
摘 要:对市售21个不同厂家的中兽药板蓝根注射液进行质量调查。采用薄层色谱法和高效液相色谱法对国内不同厂家生产的中兽药板蓝根注射液中的L-脯氨酸、精氨酸和亮氨酸色谱特征和(R,S)-告依春含量进行测定。结果表明,依据《中华人民共和国兽药典》2017年版兽药质量标准,所调查21个厂家的板蓝根注射液合格率为52.38%(11/21),定性检测合格率为71.43%(15/21);(R,S)-告依春含量测定结果为0~0.025 mg/mL,合格率为61.90%(13/21);源于21个不同厂家的中兽药板蓝根注射液质量不合格率较高,且板蓝根注射液中主要成分含量相差较大,均一性较差。因此,建议《中华人民共和国兽药典》质量标准应设定含量上限,将板蓝根其他有效成分作为衡量板蓝根注射液的指标成分并完善其质量标准,从中药材的源头控制及制剂生产环节全过程进行质量控制,以此确保中兽药板蓝根注射液质量稳定可控,有效降低不同厂家之间产品质量的差异性。In order to test the quality of Radix Isatidis injection,the samples from 21 different manufacturers were investigated.L-proline,arginine and leucine in Radix Isatidis injection,a traditional Chinese veterinary medicine,were determined by HPLC with thin layer chromatography and high-performance liquid chromatography.The results showed that the qualifie d rate of Radix Isatidis injection from 21 manufacturers was only 52.38%(11/21) according to the quality standard of 2017 edition,the qualified rate of qualitative test was 71.43%(15/21),the range of(R,S)-epigoitrin content was 0-0.025 mg·mL^(-1),and the qualified rate was 61.90%(13/21).The unqualified rate of Radix Isatidis injection from 21 factories was higher,and the content of main components in Radix Isatidis injection was different and its homogeneity was bad.Therefore,the quality standard of Pharmacopoeia should set the upper limit of the content,take other effective components of Radix Isatidis as the index to measure the content of Radix Isatidis injection,perfect the quality standard,and carry on the quality control from the source control of Chinese Materia Medica and the whole process of preparation production,in order to ensure the quality of Radix Isatidis injection of Chinese veterinary medicine stable and controllable,effectively reduce the differences between different manufacturers.
关 键 词:板蓝根注射液 薄层色谱 高效液相色谱法 (R S)-告依春
分 类 号:S853.7[农业科学—临床兽医学]
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