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目的:建立痛宁凝胶中延胡索乙素和原阿片碱的含量测定方法。方法:采用高效液相色谱法,色谱柱为KromasilC18柱(4.6 mm×250 mm,5μm),以乙腈-磷酸盐溶液为流动相进行梯度洗脱,检测波长280 nm,柱温30℃,流速1.0 mL·min-1。结果:原阿片碱在0.100 6~5.03μg呈良好的线性关系(r=1.0),平均回收率为99.14%,RSD 1.34%(n=6);延胡索乙素在0.100 8~5.04μg呈良好的线性关系,r=1.0,平均回收率为101.1%,RSD 1.18%(n=6)。结论:方法操作简便、可靠,重现性好,专属性强,能有效控制该制剂的质量。
Objective: To establish a method for the determination of tetrahydropalmatine and protopine in Tongling Gel. Methods: High performance liquid chromatography (HPLC) was performed on a Kromasil C18 column (4.6 mm × 250 mm, 5 μm) using acetonitrile-phosphate as mobile phase. The detection wavelength was 280 nm, the column temperature was 30 ℃ and the flow rate was 1.0 mL · min-1. Results: The original opioid showed a good linearity (r = 1.0) in the range of 0.100 6 ~ 5.03 μg with an average recovery of 99.14% and a RSD of 1.34% (n = 6). Tetrahydropalmatine was good at 0.100 8 ~ 5.04 μg The linear relationship, r = 1.0, the average recovery was 101.1%, RSD 1.18% (n = 6). Conclusion: The method is simple, reliable, reproducible and specific, and can effectively control the quality of the preparation.