复方秦艽巴布剂质量标准研究

Study on Quality Standard of Fufang Qinjiao Cataplasm

目的建立复方秦艽巴布剂的质量标准。方法采用薄层色谱法对制剂中秦艽、川芎、延胡索、当归进行定性分析。采用高效液相色谱法对复方秦艽巴布剂中的延胡索乙素进行定量分析,Hypersil BDS-C18(250 mm×4.6 mm,5μm)色谱柱,流动相:甲醇-水-三乙胺(70∶30∶0.3,36%乙酸调pH至6.3),流速1.0 mL/min,柱温:35℃,检测波长:280 nm。结果秦艽、川芎、延胡索、当归的定性分析方法专属性强,阴性无干扰;延胡索乙素平均回收率96.01%(n=6),RSD=1.25%,进样量在6.952～69.52 ng范围内呈良好的线性关系。结论所建立的的定性、定量分析方法能有效地控制该巴布剂的质量。

Objective To establish the quality standard of Fufang Qinjiao cataplasm. Methods Radix Gentianae MacrophyUae, Rhizoma Chuanxiong, Rhizoma Corydalis, Radix Angelicae Sinensis were identified by TLC. The content of tetrahydropalmatine in Fufang Qinjiao cataplasm was determined by HPLC. Hypersil BDS-C18 （250 mm×4.6min,5μm） was used, with methanol-water-triethylamine （70 ： 30 ： 0.3, adjusting pH to 6.3 with acetic acid） as mobile phase, the flow rate was 1.0 mL/min, the column temperature was 35 ℃, the detection wavelength was 280nm. Results The TLC qualitative analysis methods for Radix Gentianae MacrophyUae, Rhizoma Chuanxiong, Rhizoma Corydalis, Radix Angelicae Sinensis were specific, and the negative sample didn＇t interfere the identification of TLC. The average recoveries （n = 6） of tetrahydropalmatine was 96.01%, RSD was 1.25%. The linear range of tetrahydropalmatine was 6.952~69.52 rig. Conclusion The established quantitative and qualitative analysis method can control the quality of Fufang Qinjiao cataplasm.