保儿宁颗粒质量标准研究  

Quality Standard of Bao'erning Granules

作　　者：黄玮 HUANG Wei(Xuzhou Food and Drug Administration and Inspection Center,Xuzhou,Jiangsu,China 221000)

机构地区：[1]江苏省徐州市食品药品监督检验中心,江苏徐州221000

出　　处：《中国药业》2021年第23期68-71,共4页China Pharmaceuticals

摘　　要：目的建立保儿宁颗粒的质量标准。方法采用薄层色谱(TLC)法鉴别白术;采用高效液相色谱(HPLC)法测定保儿宁颗粒中升麻素苷、毛蕊异黄酮葡萄糖苷和5-O-甲基维斯阿米醇苷的含量,色谱柱为Zobrax XDB-C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.2%磷酸水溶液(梯度洗脱),流速为1.0 m L/min,柱温为32℃,检测波长为215 nm,进样量为10μL。结果TLC图中特征斑点清晰,且阴性无干扰;升麻素苷、毛蕊异黄酮葡萄糖苷、5-O-甲基维斯阿米醇苷进样量分别在0.3422~2.0532μg,0.1513~0.9078μg,0.3041~1.8246μg范围内与峰面积线性关系良好(n=6);精密度、稳定性、重复性试验的RSD均低于2.0%(n=6);加样回收率分别为99.58%,100.19%,99.47%,RSD分别为0.87%,0.80%,1.16%(n=6)。结论该方法操作简便快捷,结果准确可靠,稳定性和重复性均良好,可用于保儿宁颗粒的质量控制。Objective To establish the quality standard of Bao'erning Granules.Methods Thin-layer chromatography(TLC)method was used for the identification of Atractylodis Macrocephalae Rhizoma.High-performance liquid chromatography(HPLC)method was used for the content determination of prim-O-glucosylcimifugin,calycosin 7-O-glucoside and 5-O-methylvisammioside in Bao'erning Granules.The chromatographic column was Zobrax XDB-C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.2%phosphoric acid solution(gradient elution),the flow rate was 1.0 m L/min,the column temperature was 32℃,the detection wavelength was 215 nm,and the injection volume was 10μL.Results The characteristic spots in the TLC chromatogram were clear and negative had no interference.The linear ranges of prim-O-glucosylcimifugin,calycosin 7-O-glucoside and 5-O-methylvisam-mioside were 0.3422-2.0532μg,0.1513-0.9078μg and 0.3041-1.8246μg(n=6),respectively.The RSDs of precision,stability and repeatability tests were lower than 2.0%(n=6).The recoveries of prim-O-glucosylcimifugin,calycosin 7-O-glucoside and 5-O-methylvisammioside were 99.58%,100.19%and 99.47%with RSDs of 0.87%,0.80%and 1.16%(n=6),respectively.Conclusion The method is simple,rapid,accurate,reliable,stable and reproducible,which can be used for the quality control of Bao'erning Granules.

关 键 词：保儿宁颗粒 升麻素苷 毛蕊异黄酮葡萄糖苷 5-O-甲基维斯阿米醇苷 高效液相色谱法 薄层色谱法 含量测定 质量标准 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学]