宁神颗粒质量控制研究

Study on Quality Standards of Ningshen Granule

目的建立宁神颗粒(女贞子、丹参、首乌藤、香橼)的质量控制方法。方法采用薄层色谱法对该复方颗粒中女贞子、丹参、首乌藤、香橼进行定性鉴别,同时采用高效液相色谱法测定丹酚酸B、2,3,5,4’-四羟基二苯乙烯苷-2-O-β-D-葡萄糖苷(以下简称二苯乙烯苷)及柚皮苷的含量。结果 TLC鉴别分离度良好,专属性强,阴性样品无干扰;丹酚酸B对照品在0. 45~5. 63μg(r=0. 9999)范围内线性关系良好,加样回收率均值为94. 63%,RSD为0. 43%;二苯乙烯苷对照品在0. 25~5μg(r=0. 9996)范围内线性关系良好,加样回收率均值为102. 51%,RSD为0. 35%;柚皮苷对照品在0. 6~7. 50μg(r=0. 9995)范围内线性关系良好,加样回收率均值为102. 75%,RSD为0. 38%。结论该方法操作简便易行,专属性强,准确可靠,可用于宁神颗粒的质量控制。

Objective To establish the quality control standard of Ningshen Granule. Methods Ningshen( Ligustrum lucidum Ait),Danshen( Salvia miltiorrhiza Bge),Shouwuteng( Polygonum multiflorum Thunb) and Xiangyuan( Citrus medic L) in this preparation were identified by TLC. The contents of salvianolic acid B,2,3,5,4’-tetrahydroxyl diphenylethylene-2-O-glucoside and naringin were determined by HPLC. Results The identification by TLC was distinct and highly specific,and the negative sample did not interfere the identification of TLC. The salvianolic acid B,stilbene glucoside and naringin had a good linearity in the range of 0. 45-5. 63 μg( r = 0. 9999),0. 15-1. 88 μg( r = 0. 9996) and 0. 6-7. 5 μg( r = 0. 9995). The average recovery of salvianolic acid B,stilbene glucoside and naringin was 94. 63%,102. 75% and 102. 51% and the RSD values( n = 9) were 0.43%,0. 38% and 0. 35%,respectively. Conclusion This method with strong specificity is simple,accurateand reproducible,and it could provide a reference for the quality standard of Ningshen Granule.