明目十六味丸质量标准研究  

Study on the Quality Standard of Mingmu Shiliuwei Pills

作　　者：娜仁图雅 包顺茹 韩塔娜 籍学伟 王栋 Narentuya;Baoshunru;Hantana;JI Xue-wei;WANG Dong(Inner Mongolian Institute for Drug Control,Hohhot 010000,China)

机构地区：[1]内蒙古自治区药品检验研究院,内蒙古呼和浩特010000

出　　处：《中国民族医药杂志》2022年第5期55-58,共4页Journal of Medicine and Pharmacy of Chinese Minorities

摘　　要：目的:完善明目十六味丸的质量标准。方法:对其形状及显微鉴别进行修订及规范化描述;采用薄层色谱法对明目十六味丸中决明子、当归、枸杞等进行定性鉴别研究;采用高效液相法,色谱柱为PhenomenexLuna C_(18)(250 mm×4.6 mm,5μm),以甲醇-乙腈-0.7%磷酸溶液(用三乙胺调pH值为6.0)(15∶1∶84)为流动相,流速1.0 mL/min,检测波长403 nm,柱温30℃,进行红花中羟基红花黄色素A含量测定。结果:决明子、当归和枸杞的薄层色谱主斑点清晰,分离良好,阴性对照无干扰;羟基红花黄色素A在79.1~1185.9 ng(r=0.9999)范围内线性良好,平均加样回收率为98.6%,RSD为0.49%。结论:建立的TLC和HPLC专属性强、重复性好、准确可靠,能够有效评价和控制蒙成药明目十六味丸质量。Objective:To improve the quality standard of"Mingmu Liuwei Pills".Methods:The shape and microscopic identification were revised and standardized description;the qualitative identification of cassia seed,angelica and wolfberry in Mingmu Shiliuwei Pills was carried out by thin-layer chromatography;high performance liquid chromatography was used,and the chromatographic column was PhenomenexLuna C_(18)(250 mm×4.6 mm,5μm),methanol-acetonitrile-0.7%phosphoric acid solution(adjusted to pH 6.0 with triethylamine)(15∶1∶84)as mobile phase,flow rate 1.0 m L/min,detection The wavelength of 403 nm and the column temperature of 30℃were used to determine the content of hydroxysafflor yellow A in safflower.Results:The main spots of TLC of Cassia,Angelica and Lycium barbarum were clear and well separated,and the negative control had no interference;hydroxysafflor yellow A had good linearity in the range of 79.1~1185.9 ng(r=0.9999),and the average sample recovery was 98.6%with an RSD of 0.49%.Conclusion:The established TLC and HPLC methods have strong specificity,good reproducibility,accuracy and reliability,and can effectively evaluate and control the quality of Mongolian medicine Mingmu Shiliuwei Pills.

关 键 词：明目十六味丸 质量标准研究 羟基红花黄色素A 薄层色谱 高效液相色谱 

分 类 号：R291.2[医药卫生—民族医学]