面瘫康复贴膏质量标准研究

目的：建立面瘫康复贴膏的质量标准。方法：采用薄层色谱法鉴别川芎、白芷、甘草、马钱子；采用高效液相色谱法测定士的宁和马钱子碱含量，色谱柱：（BondpackC18柱，以乙腈-0．0294mol／L磷酸二氢钾溶液（pH值=2．8）（13：87）为流动相，检测波长：260nm；流速：1．0mL·min-1。结果：薄层色谱鉴别专属性强，重复性良好。士的宁和马钱子碱的线性范围分别为0．195μg～1．172μg（r=0．9999）、0．162μg-0．970μg（r=1．0000）；平均回收率分别为96．91％（RSD=1．42％）、99．05％（RSD=3．37％），9批样品每克贴膏中士的宁和马钱子碱的平均含量分别为O．79、0．58mg。结论：建立的定性定量方法简便、可靠、准确，可作为面瘫康复贴膏的质量控制。

Studies on Quality Standards of Miantan Kangfu Patches

Objective ： To establish the quality standards for Miantan Kangfu Patches. Method ： Ligusticum chuanxiong, Angelica dahurica, Clycyrrhiza uralensis, Strychnos nux - vomica in Miantan Kangfu Patches were identified by TLC. The contents of active constituent strychnine and brucine were determined by HPLC. The analysis was carried out on C18 col- umn by HPLC. The mobile phase was CH3 CN- Potassium dihydrogen phosphate （pH = ：2.8 ）（ 13：87）. The flow rate was 1.0 mL. min -1 and it was detected at 260 nm. Result ： The method of TLC was simple with strong specificity and good reproducibility. The calibration curves of strychnine and brucine were in good linearity over the ranges of 0. 195 μg to 1.17 2μg （ r = 0. 9999） and 0. 162 μg to 0. 970 μg （r = 1. 0000） respectively, and the average recoveries were 96.91% （ RSD = 1.42% ） and 99.05% （ RSD = 3.37% ） respectively. Conclusion：This method is simple, accurate and suitable. This method can be used for the quality control of Miantan Kangfu Patches.