双贝胶囊的质量标准
|
摘要
目的建立双贝胶囊的质量标准。方法采用薄层色谱法对双贝胶囊中土贝母、浙贝母、连翘进行定性鉴别;采用高效液相色谱法对双贝胶囊中土贝母苷甲进行定量分析。结果薄层色谱鉴别分离效果好,专属性强;土贝母苷甲含量在0.182~0.912 mg·m L-1范围内线性关系良好,r=0.9997;平均加样回收率99.31%,RSD 0.49%。结论该方法简单、准确、专属性强、重复性好,可有效控制双贝胶囊的质量。
Objective To establish a quality standard of Shuangbei Capsules. Methods Fritillaria thunbergii,Fritillaria thunbergii Miq,Forsythia in Shuangbei capsules were identified by thin-layer chromatography(TLC). The content of tubeimoside I was determined by high performance liquid chromatography(HPLC). Results The characteristic identification by TLC was distinct and specific. There was a good liner relationship with contents of tubeimoside Ⅰ in the ranges of 0. 182-0.912 mg·m L-1 with good correlation coefficient r = 0. 9997. The average recovery was 99. 31% and RSD was 0. 49%.Conclusion The established methods are simple,accurate,exclusive,reproducible and suitable for the quality control of Shuangbei capsules.
Objective To establish a quality standard of Shuangbei Capsules. Methods Fritillaria thunbergii,Fritillaria thunbergii Miq,Forsythia in Shuangbei capsules were identified by thin-layer chromatography(TLC). The content of tubeimoside I was determined by high performance liquid chromatography(HPLC). Results The characteristic identification by TLC was distinct and specific. There was a good liner relationship with contents of tubeimoside Ⅰ in the ranges of 0. 182-0.912 mg·m L-1 with good correlation coefficient r = 0. 9997. The average recovery was 99. 31% and RSD was 0. 49%.Conclusion The established methods are simple,accurate,exclusive,reproducible and suitable for the quality control of Shuangbei capsules.
引文
[1]胡军林,顾承刚,吴宁.乳癖舒片的质量标准研究[J].中国医药指南,2014,12(17):82-83.
[2]赵文静,菅原颖,王艳宏,等.仙鹿消癖胶囊中淫羊藿、浙贝母、当归的薄层鉴别研究[J].中医药信息,2011,28(4):62-63.
[3]焦玉,胡然.海藻消瘤胶囊的质量控制[J].河北医药,2014,36(14):2197-2200.
[4]石克,冉海琳.桑菊感冒冲剂中连翘、甘草的薄层色谱鉴别[J].海峡药学,2009,21(9):43-44.
[5]国家药典委员会.中华人民共和国药典(一部)[M].北京:中国医药科技出版社,2015:6,17,170,292.
[6]冯素香,郝蕊,吴兆宇,等.连翘中连翘苷和多糖的提取工艺优化及含量测定[J].医药导报,2016,35(12):1348-1351.
[7]叶玉杰,舒翔,刘敏,等.贝马喷膜剂的质量控制[J].医药导报,2013,32(7):939-941.
[8]金良,康俊琪.HPLC法测定土贝消肿汤中熊果酸和土贝母苷甲的含量[J].陕西中医学院学报,2010,33(3):87-88.
[9]崔瀚明,程慧平,刘明喜,等.HPLC法测定甲肿消及大鼠血清中土贝母苷甲的含量[J].中国中医药信息杂志,2008,15(11):37-38.
[10]黄瑾,张杰,顾正兵,等.高效液相色谱法同时测定土贝母中土贝母苷甲、乙和丙的含量[J].中国药业,2016,25(1):58-60.
[2]赵文静,菅原颖,王艳宏,等.仙鹿消癖胶囊中淫羊藿、浙贝母、当归的薄层鉴别研究[J].中医药信息,2011,28(4):62-63.
[3]焦玉,胡然.海藻消瘤胶囊的质量控制[J].河北医药,2014,36(14):2197-2200.
[4]石克,冉海琳.桑菊感冒冲剂中连翘、甘草的薄层色谱鉴别[J].海峡药学,2009,21(9):43-44.
[5]国家药典委员会.中华人民共和国药典(一部)[M].北京:中国医药科技出版社,2015:6,17,170,292.
[6]冯素香,郝蕊,吴兆宇,等.连翘中连翘苷和多糖的提取工艺优化及含量测定[J].医药导报,2016,35(12):1348-1351.
[7]叶玉杰,舒翔,刘敏,等.贝马喷膜剂的质量控制[J].医药导报,2013,32(7):939-941.
[8]金良,康俊琪.HPLC法测定土贝消肿汤中熊果酸和土贝母苷甲的含量[J].陕西中医学院学报,2010,33(3):87-88.
[9]崔瀚明,程慧平,刘明喜,等.HPLC法测定甲肿消及大鼠血清中土贝母苷甲的含量[J].中国中医药信息杂志,2008,15(11):37-38.
[10]黄瑾,张杰,顾正兵,等.高效液相色谱法同时测定土贝母中土贝母苷甲、乙和丙的含量[J].中国药业,2016,25(1):58-60.