参茸三鞭丸质量标准研究

Study on Quality Standard for Shenrong SanbianPills

目的提高完善参茸三鞭丸的质量标准。方法采用TLC法对制剂中的淫羊藿、续断、木香进行定性鉴别;HPLC法测定处方中补骨脂的有效成分补骨脂素和异补骨脂素的含量,以甲醇-水(45∶55)为流动相,检测波长为246 nm。结果 TLC法可鉴别淫羊藿、续断、木香的特征斑点且空白无干扰;补骨脂素、异补骨脂素分别在0.0202～0.1212μg(r=0.9999,n=6)、0.0406～0.2436μg(r=0.9999,n=6)范围内呈良好线性关系,平均回收率分别为101.20%、101.39%,RSD分别为0.41%、0.48%。结论提高后的质量标准具有专属性强、准确、重复性好的特点,可用于参茸三鞭丸的质量控制。

Objective To improve the quality standard for Shenrong Sanbian Pills.Methods Herba Epimedii,Radix Ginseng,Radix Dipsaci,Radix Rehmanniae,Rhizoma Chuanxiong,Radix Aucklandiae were identified by TLC.The content of psoralen and isopsoralen were determined by HPLC with the mobile phase consisting of methanol-water（45∶55）.The UV detection wavelangth was at 246 nm.Results TLC could detect the corresponding chromatographic spots of Herba Epimedii,Radix Dipsaci,Rhizoma Chuanxiong,Radix Aucklandiae without the interference of negative control group.Psoralen showed a good linearity in the range of 0.0202-0.1212 μg.The average recovery was 101.20% and RSD was 0.41%.Isopsoralen showed a good linearity in the range of 0.0406-0.2436 μg.The average recovery was 101.39%.RSD was 0.41% and 0.48%,respectively.Conclusion The improved quality standard is specific and effective for quality control of this product.