疏郁复方颗粒的质量标准  

Quality standard of compound ShuYu granule

作　　者：李淑琴[1] 马仁强 张荣华[1] 朱晓峰[3] 杨丽[1] 潘梅英 宋志娟 

机构地区：[1]暨南大学药学院中药学教研室,广东广州510632 [2]广州博济医药生物技术股份有限公司,广东广州510602 [3]暨南大学第一附属医院中医科,广东广州510630

出　　处：《暨南大学学报（自然科学与医学版）》2012年第3期289-293,共5页Journal of Jinan University(Natural Science & Medicine Edition)

摘　　要：采用薄层色谱法鉴别制剂中的首乌藤、丹参、白芍;高效液相色谱法测定制剂中芍药苷的含量.色谱柱:Hypersil ODS2-C18(4.6 mm×250 mm,5μm);流动相:乙腈-0.1%磷酸溶液(13:87);流速:1.0 mL/min;柱温:30℃;检测波长:230 nm.结果显示薄层色谱斑点清晰,阴性无干扰,重现性良好;高效液相色谱法测定芍药苷在0.023 78-0.594 44 mg.mL-1呈良好的线性关系(r=0.999 9);平均回收率为100.46%,RSD值为1.25%(n=6).此方法简便、快捷、准确,可用于疏郁复方颗粒的质量控制.To establish the quality standard of compound ShuYu granule. Thin-layer chromatography was used to identify polygoni multiflori caulix, salvia mihiorrhiza radix et rhizoma, and paeoniae radix al- ba; The content of paeoniflorin from preparation was determined by HPLC. The chromatographic conditions of paeoniflorin included the chromatographic column： hypersil ODS2 -C18 （4. 6 mm ×250 mm,5 um） ; mobile phase ： methyl cyanide-0. 1% phosphoric acid solution （ 13 ： 87 ） ; flow velocity ： 1.0 mL/ min; column temperature：30 ℃ ; detected wavelength was 230 nm. The characteristics of the TLC were accurate and reproducible ; The linear range of paeoniflorin was 0. 023 78 - 0. 594 44 mg . mL- l （ r = 0. 999 9）. The average recovery was 100. 46 % with RSD of 1.25% （n =6）. The methods are aecurate and quick in qualitative identification and quantitative assay of this preparation, which can be used for the quality control of compound ShuYu granule.

关 键 词：疏郁复方颗粒 质量标准 芍药苷 薄层色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]