参茸鞭丸的质量标准提升研究  

Study on Improvement of Quality Standard for Shenrong Bianwan Pill

作　　者：谢永健 罗战彪 甘雨 余渊 粱瑞萍 XIE Yongjian;LUO Zhanbiao;GAN Yu;YU Yuan;LIANG Ruiping(School of Pharmacy,Guizhou University of Traditional Chinese Medicine,Guizhou Guiyang 550025;Guizhou Dechangxiang Pharmaceutical Company Limited,Guizhou Guiyang 550200,China)

机构地区：[1]贵州中医药大学药学院,贵州贵阳550025 [2]贵州德昌祥医药股份有限公司,贵州贵阳550200

出　　处：《广州化工》2025年第5期132-136,共5页GuangZhou Chemical Industry

摘　　要：针对参茸鞭丸现行标准(WS_(3)-B-2364-97)质控方法单一的问题,本研究通过多维度方法学体系构建其质量控制体系。显微鉴别法实现红参、鹿茸等8味药材典型组织特征识别,包括红参草酸钙簇晶、鹿茸表皮角质鳞片等特征。创新开发红参-淫羊藿“一板多鉴”TLC方法,采用三氯甲烷-甲醇-水(13∶7∶2)下层溶液为展开剂,同步分离检测人参皂苷Rg1与淫羊藿苷。补骨脂TLC鉴别以正己烷-乙酸乙酯(4∶1)为展开剂,实现补骨脂素与异补骨脂素特征斑点清晰分离。高效液相色谱-光电二极管阵列检测法(HPLC-PDA)测定金丝桃苷含量,采用C_(18)色谱柱(4.6 mm×250 mm, 5μm),以乙腈-0.1%磷酸溶液(25∶75)为流动相,360 nm波长检测,线性范围2.371 5~47.425 76μg/mL(r=0.999 8),平均加样回收率102.60%(RSD=1.43%, n=6)。方法学验证显示显微特征显著,TLC图谱无阴性干扰(RSD<2.0%),HPLC精密度RSD=1.12%,重复性RSD=1.35%,24 h稳定性RSD=1.68%。该方法体系可有效应用于参茸鞭丸的质量控制,为其生产过程监控及临床用药安全提供技术支撑。To address the issue of single-dimensional quality control in the current standard(WS 3-B-2364-97)for Shenrongbian Pills,a multi-dimensional quality control system was established.Microscopic identification was employed to characterize eight medicinal herbs in the preparation,including red ginseng,antler and cinnamon,focusing on distinct features such as calcium oxalate clusters in red ginseng and epidermal keratin scales in antler.An innovative“one-plate-multi-identification”TLC method was developed for simultaneous detection of red ginseng(ginsenoside Rg1)and Epimedium(icariin)using chloroform-methanol-water(13∶7∶2,lower layer)as the developing solvent.For Psoralea corylifolia(fructus psoraleae),TLC identification was optimized with n-hexane-ethyl acetate(4∶1)to achieve clear separation of psoralen and isopsoralen.The content of hyperoside was quantified by HPLC-PDA on a C_(18) column(4.6 mm×250 mm,5μm)with a mobile phase of acetonitrile-0.1%phosphoric acid(25∶75)at 360 nm.Microscopic features were distinct,and TLC bands showed clear separation without negative interference(RSD<2.0%).The hyperoside linearity ranged from 2.3715 to 47.42576μg/mL(r=0.9998),with an average spiked recovery of 102.60%(RSD=1.43%).Methodological validation confirmed good precision(RSD=1.12%),reproducibility(RSD=1.35%),and stability(RSD=1.68%over 24 h).This integrated method system ensured effective quality control of Shenrongbian Pills,providing technical support for production monitoring and clinical safety.

关 键 词：参茸鞭丸 一板多鉴 HPLC-PDA 质量标准提升 

分 类 号：R286.0[医药卫生—中药学]