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妇炎灵泡腾片质量标准的研究
陈建宇1, 周福军2, 李正名1
1.南开大学农药国家工程研究中心 300071;2.天津药物研究院 300193
摘要:
[目的] 建立妇炎灵泡腾片的质量控制标准。[方法] 利用薄层色谱法对妇炎灵泡腾片处方中苦参、蛇床子、冰片、樟脑等中药进行定性鉴别;采用高效液相色谱法测定妇炎灵泡腾片中苦参碱的含量。色谱条件:Dia-monsilTMC18(200mm×4.6mm)色谱柱,流动相为0.02mol/L磷酸二氢钾试液-0.2%三乙胺:乙腈(83:17),检测波长为210nm,流速为1.0mL/min,柱温为35℃,进样量为10μL。[结果] 定性鉴定出制剂中的苦参、蛇床子、冰片、樟脑。经高效液相色普法(HPLC)测定,结果显示苦参碱进样量在0.05~0.25μg范围内与峰面积有良好的线性关系,回归方程为Y=14.8212X+0.7874,相关系数r=0.9999(n=5)。平均回收率为98.92%,峰面积相对均数标准偏差(RSD)为1.89%。[结论] 该方法准确、可靠、专属性强,可用于妇炎灵泡腾片的质量控制。
关键词:  薄层色谱法  高效液相色谱法  妇炎灵泡腾片  苦参碱
DOI:10.11656/j.issn.1673-9043.2009.03.16
分类号:
基金项目:
Study on quality standard of fuyanling soaking tablet
Chen Jian-yu,Zhou Fu-jun,Li Zheng-ming
Pesticide National Engineering Research Center, Nankai University, Tianjin 300071, China
Abstract:
[Objective] To establish a quality standard of Fuyanling soaking tablet.[Methods] The prescription of traditional Chinese medicine, such as Radix Sophorae Flavescentis, Fructus Cnidii, Borneouml Syntheticum and camphor, could be identified by a series of TLC methods. The content of matrine in Fuyanling soaking tablet was determined by HPLC method. DiamonsilTM C18(200 mm×4.6 mm) column was used, the mobile phase was 0.02 mol/L potassium dihydrogen phosphate-diethlamine:acetonitrile (83:17) at the flow rate of 1.0ml/min , the detection wavelength was 210 nm, the room temperature was 35℃ and the volume of injection was 10μL.[Results] Radix Sophorae Flavescentis, Fructus Cnidii, Borneouml Syntheticum and Camphor could be detected by TLC. The linear range of matrine was within the range of 0.05~0.25 μg. The regression equation was Y=14.821 2X + 0.7874, r=0.999 9 (n=5). The average recovery was 98.92% and the RSD was 1.89%.[Conclusion] The method is accurate, reliable, specific and can be used for the quality control of Fuyanling soaking tablet.
Key words:  TLC  HPLC  Fuyanling soaking tablet  matrine
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