骨松灵颗粒质量标准研究

The Study of the Quality Standard of Gusongling Granules

目的：建立骨松灵颗粒的质量标准。方法：采用薄层色谱法（TLC）对复方中淫羊藿、骨碎补、补骨脂、熟地黄、黄芪、当归、盐杜仲、醋龟甲进行定性鉴别;采用高效液相色谱法（HPLC）对淫羊藿中淫羊藿苷、骨碎补中柚皮苷、熟地黄中毛蕊花糖苷、黄芪中黄芪甲苷进行含量测定。结果：八味药材薄层色谱图斑点清晰,具有专属性;淫羊藿苷在0.031 5~1.712 0ug范围内线性关系良好,r=0.999 7,平均回收率为100.23%,RSD为2.23%;柚皮苷在0.056 8~1.817 5μg范围内线性关系良好,r=0.999 6,平均回收率为99.97%,RSD为1.22%;毛蕊花糖苷在0.060 8~1.945 6μg范围内线性关系良好,r=0.999 8,平均回收率为99.94%,RSD为1.24%;黄芪甲苷在0.467 6~11.220 0μg范围内线性关系良好,r=0.999 1,平均回收率为99.84%,RSD为3.35%。结论：该方法能准确可靠地进行定性、定量检测,能有效地控制骨松灵颗粒的质量。

Objective： To establish the quality standard for Gusongling Granules. Methods： TLC was performed to identify the qualification of Epimedii Folium（ Yinyanghuo）,Drynarial Rhizoma（ Gusuibu）,Psoraleae Fructus（ Buguzhi）,Rehmanniae Radix Praeparata（ Shudihuang）,Astragali Radix（ Huangqi）,Angelicae Sinensis Radix（ Danggui）,Eucommiae Cortex（ Yanduzhong）,Testudinis Carapax Et Plastrum（ Cuguijia）. Besides,a HPLC method was established for the determination of icariine,naringin,acteoside,and astragaloside. Results： The spots on TLC plates were clear with specificity. Icariin showed a good linear relationship at a range between 0. 0315 and 1. 7120 μg,r = 0. 9997,the average recovery was 100. 23%,and RSD was 2. 23%. Naringin showed a good linear relationship at a range between 0. 0568 and 1. 8175 μg,r = 0. 9996,the average recovery was 99. 97%,and RSD was 1. 22%. Acteoside showed a good linear relationship at a range between 0. 0608 and 1. 9456 μg,r = 0. 9998,the average recovery was 99. 94%,and RSD was 1. 24%. Astragaloside showed a good linear relationship at a range between 0. 4676 and11. 2200 μg,r = 0. 9998,the average recovery was 99. 84%,and RSD was 3. 35%. Conclusion： This method can be accurate and reliable in qualitative and quantitative detection,and can control the drug quality effectively.