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目的:建立戊己丸中吴茱萸碱和吴茱萸次碱含质量的高效液相(HPLC)测定方法,并对超微戊己丸和常规戊己丸中吴茱萸碱和吴茱萸次碱的含质量进行比较。方法:采用色谱柱HypersilC18柱(4.6mm×250mm,5μm),流动相:乙腈水(48∶52),流速:1mL/min,检测波长:225nm。结果:吴茱萸碱和吴茱萸次碱的理论塔板数均大于3000,吴茱萸碱回归方程:A吴茱萸碱=107.73ρ-14.331,r=0.9999,线性范围1.02～20.4μg/mL;吴茱萸次碱回归方程:A吴茱萸次碱=15.596ρ-45.09,r=0.9998,线性范围4.4～176μg/mL。超微戊己丸中吴茱萸碱平均回收率为:99.61%,RSD为0.50%,质量分数为(0.096±0.0148)%;吴茱萸次碱平均回收率为94.85%,RSD为1.00%,质量分数为(0.343±0.0467)%。常规戊己丸中吴茱萸碱平均回收率为98.56%,RSD为1.70%,质量分数为(0.81±0.003)%;吴茱萸次碱平均回收率为99.55%,RSD为0.50%,质量分数为(0.161±0.0075)%。结论:超微戊己丸中吴茱萸碱和吴茱萸次碱的质量分数高于常规戊己丸。
OBJECTIVE: To establish a method for the determination of evodiamine and rutaecarpine in Wuji Pill by HPLC and to compare the contents of evodiamine and rutaecarpine in rhamnose and conventional. Methods: Hypersil C18 column (4.6 mm × 250 mm, 5 μm) was used. The mobile phase was acetonitrile (48:52). The flow rate was 1 mL / min. The detection wavelength was 225 nm. Results: The theoretical plate numbers of evodiamine and rutaecarpine were both higher than 3000. The evodiamine equation of evodiamine: evodiamine = 107.73ρ-14.331, r = 0.9999, linear range 1.02 ~ 20.4μg / mL; rutaecarpine regression equation: A rutaecarpine = 15.596ρ-45.09, r = 0.9998, the linear range of 4.4 ~ 176μg / mL. The average recovery rate of evodiamine in the microelement pill was 99.61%, the RSD was 0.50% and the mass fraction was 0.096 ± 0.0148%. The average recovery of rutaecarpine was 94.85% and the RSD was 1.00% 0.343 ± 0.0467)%. The average recovery of evodiamine was 98.56%, the RSD was 1.70% and the mass fraction was 0.81 ± 0.003%. The average recovery rate of rutaecarpine was 99.55%, the RSD was 0.50% and the mass fraction was 0.161 ± 0.0075)%. CONCLUSION: The mass fraction of evodiamine and rutaecarpine in the ultra-micro-amylin pills is higher than that of the conventional pentamyl pills.