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目的:以丹参酮ⅡA和丹酚酸B为评价指标对复方丹参片样品进行质量评价。方法:迪马公司Diamon-sil C18柱(4.6 mm×250 mm,5μm),以甲醇-水(85∶15,V/V)为流动相,检测波长为270 nm,测定丹参酮ⅡA;以乙腈-甲醇-甲酸-水(10∶31∶1∶58,V/V)为流动相,检测波长为286 nm,测定丹酚酸B。结果:同一厂家不同批次间样品丹参酮ⅡA和丹酚酸B含量差异较明显,不同厂家间的含量差异更大。结论:本含量测定方法重现性好,样品质量存在较大差异。
Objective: To evaluate the quality of compound Danshen tablet samples with tanshinone IIA and salvianolic acid B as evaluation indicators. METHODS: Dima Diamon-sil C18 column (4.6 mm×250 mm, 5 μm) with methanol-water (85:15, V/V) as the mobile phase and detection wavelength at 270 nm was used to determine tanshinone IIA; with acetonitrile- Methanol-formic acid-water (10:31:1:58, V/V) was used as the mobile phase and the detection wavelength was 286 nm. Salvianolic acid B was determined. RESULTS: There were significant differences in the contents of tanshinone IIA and salvianolic acid B between different batches of the same manufacturer, and the difference among different manufacturers was even greater. Conclusion: The determination method of this content is reproducible and the quality of the sample is quite different.