补脑丸质量标准研究

Study on quality standard for Bunao Pills

目的 :建立了HPLC测定补脑丸 (丹参、酸枣仁、朱砂等 )中丹参酮ⅡA 含量的方法 ,用TLC法对补脑丸中酸枣仁和朱砂做定性鉴别 ,以控制补脑丸的内在质量。方法 :采用超声波提取 ,用TLC法对酸枣仁和朱砂进行定性鉴别 ,应用高效液相色谱法测定丹参酮ⅡA 含量 ,色谱柱为KromasilC18柱 (2 5 0mm× 4 .6mm ,5 μm) ,流速为 1.2mL·min-1,流动相为甲醇 水 (80∶2 0 ) ,检测波长为 2 6 8nm。结果 :丹参酮ⅡA 在 0 .16～ 0 .4 8μg范围内线性良好 ,r =0 .9999,平均回收率10 0 .8% ,RSD为 2 .3% ,薄层定性实验中定性方法简便、灵敏、专属性强。结论 :此方法简便、准确 ,可有效控制补脑丸产品质量。

AIM: To establish a method to control the quality of Bunao Pill(Radix Salviae Miltiorrhize、Semen Ziziphi Spinosae, Cinnabaris, etc.). The content Tanshinone ⅡA was determined by HPLC. Semen ziziphi spinosae and Cinnabaris in pill were identified by TLC. METHODS: Tanshinone Ⅱ A was extracted by ultrasonic waves and then determined by HPLC. Kromasil C 18 column(250×4.6mm,5μm) was utilized, the mobile phase with a flow rate of 1.2mL·min -1 was methane water (80∶20), the detection wavelength was at 268nm. TLC method was used to identify Semen ziziphi spinosae and Cinnabaris. RESULTS: The good linearity of Tanshinone ⅡA was from 0.16～0.48μg, r =0.9999. The average recovery was 100.8% and RSD was 2.3%. CONCLUSION: The analyses were simple, accurate and could be used for controling the product quality of the Bunao Pill effectively.