骨松宝分散片的质量标准研究

Quality standard for Gusongbao Dispersible Tablets

目的：研究骨松宝分散片（淫羊藿、续断、赤芍、川芎等）的质量标准。方法：采用TLC法对淫羊藿、赤芍、川芎、知母进行了定性鉴别;采用HPLC法测定淫羊藿苷的含量,色谱柱为C18柱（ODS,4.6 mm×200 mm,5μm）,流动相为乙腈-水（30∶70）,流速1.0 mL/m in,检测波长270 nm,柱温为室温;按中国药典溶出度测定法测定淫羊藿苷的溶出度。结果：采用TLC法可鉴别出与淫羊藿、赤芍、川芎、知母对应的斑点;采用HPLC法测定淫羊藿苷的含量,淫羊藿苷在0.13～0.78μg范围内有良好的线性关系（r=0.999 9）,平均回收率为98.90%,RSD=0.82%（n=6）;测定淫羊藿苷的溶出度符合均一性要求。结论：所建立的质量标准简便可行、重复性好,可以用来评价骨松宝分散片的质量。

AIM： To establish the quality standard of Gusongbao Dispersible Tablets （Herba Epimedii, Radix Dipsaci, Radix Pasoniae rubra, Rhizoma Chuanxiong, etc. ） METHODS： Herba Epimedii, Radix Paeoniae rubra, Rhizoma Chuanxiong, Rhizoma Anemarrhenae were identified by TLC. Icariine content was determined by HPLC. Cls column （ODS, 4.6 mm ×200 mm, 5 μm） as chromatographic column, acetonitrile-water （30： 70） as mobile phase, flow rate kept to 1.0 mL/min, detection wavelength at 270 nm, and under room temperature condition. The dissolubility test met with Chinese Pharmacopoeia for Icariine. RESULTS： The relevant spots in Herba Epimedii, Radix Paeoniae rubra, Rhizoma Chuanxiong, Rhizoma Anemarrhenae could be identified by TLC. The content of ieariine can be determined by HPLC. The linearity of ieariine was good in the range of 0. 13-0.78 μg （ r = 0.999 9）. The average recovery of ieariine was 98.90%, RSD = 0.92% （ n = 6）. Dissolubility test used for ieariine eoformed to homogeniety. CONCLUSION： The established quality standard is simple, feasible and repeatable, and can be used for quality control of Gusongbao Dispersible Tablets.