以丹酚酸B为指标性成分的复方巴戟天健骨颗粒整体质量评价

Overall Quality Evaluation of Compound Morinda Jiangu Granules with Salvianolic Acid B as the Index Component

目的:通过复方巴戟天健骨颗粒中丹酚酸B质量控制研究,评价制剂质量。方法:色谱柱采用Sino Chrom ODS-BP (4.6 mm × 250 mm, 5 μm),流动相乙腈-0.1%磷酸水,等度洗脱,体积流量1.2 mL•min−1,柱温30℃,检测波长286 nm。结果:丹酚酸B在考察的浓度范围内线性关系良好(r = 1.000),线性范围为8.25~165.00 μg/mL,平均加样回收率为99.16%,RSD为1.52%。结论:该方法操作简便、准确、重复性好,可为复方巴戟天健骨颗粒质量控制提供实验依据。

Objective: To evaluate the quality of the preparation through the quality control study of salvianolic acid B in Compound Morinda Jiangu Granules. Methods: The chromatographic column adopted Sino Chrom ODS-BP (4.6 mm × 250 mm, 5 μm), and the mobile phase was acetonitrile-0.1% phosphoric acid water. Isocratic elution was used with a volume flow rate of 1.2 mL•min−1, a column tempera-ture of 30˚C, and a detection wavelength of 286 nm. Results: Salvianolic acid B had a good linear re-lationship within the investigated concentration range (r = 1.000), the linear range was 8.25~165.00 μg/mL, the average recovery rate was 99.16%, and the RSD was 1.52%. Conclusion: This method is simple to operate, accurate and reproducible, and can provide experimental basis for quality control of Compound Morinda Jiangu Granules.