麒麟丸质量标准的提高研究  

Study on the Improvement of Quality Standard for Kirin Pill

作　　者：陈小凯[1] 段启[2] 何伟[1] 李勇[1] 朱怡洁[1] 庄义修[2] 

机构地区：[1]广东药学院药物研究所/广东省药物新剂型重点实验室,广州510006 [2]广东食品药品职业学院,广州510520

出　　处：《中国药房》2013年第23期2164-2167,共4页China Pharmacy

基　　金：广东省建设中医药强省立项资助科研课题(No.20121108)

摘　　要：目的:提高麒麟丸的质量标准。方法:采用薄层色谱(TLC)法定性鉴别麒麟丸中的丹参、锁阳、枸杞子、青皮;采用高效液相色谱法测定何首乌中二苯乙烯苷的含量。色谱柱为Kromasil 100-5 C18(250mm×4.6mm,5μm),流动相为乙腈-水(15∶85,V/V),流速为1.0ml/min,柱温为25℃,检测波长为320nm。结果:TLC图谱斑点清晰、分离度好,且阴性对照无干扰。二苯乙烯苷的进样量在0.04004～0.60060μg范围内与其峰面积积分值呈良好的线性关系(r=0.9999);精密度、稳定性、重复性试验的RSD均<2%;平均加样回收率为96.40%,RSD=0.93%(n=6)。结论:提高后的质量标准能更好地控制麒麟丸的质量。OBJECTIVE： To improve the quality standard of Kirin pill. METHODS：Salvia miltiorrhiza, Citrus reticulata, Lyci-urn barbarum and Cynornorium songaricum in this prescripition were identified by TLC. The concent of stilene glucoside in Polygo-hum multiflorum was determined by HPLC. The determination was performed on Kromasil 100-5 （250mm×4.6mm,5μm） col- umn with mobile phase consisted of acotonitrile-water （15：85, V/V）at the flow rate of 1.0 ml/min. The column temperature was maintained at 25 ℃, and detection wavelength was set at 320 nm. RESULTS： TLC spots were clear and well-separated without in-terfence from negative sample. The linear range of stilene glucoside were 0.040 04-0.600 60 pg（r=0.999 9） with an average recov-ery of 96.40% （RSD = 0.93 %, n=6）. The RSDs of precision, stability and reproducibility tests were all lower than 2 %. CONCLU-SIONS：Established standard is suitable for the ouality control of Kirin pill.

关 键 词：麒麟丸 质量标准 提高 薄层色谱法 高效液相色谱法 二苯乙烯苷 锁阳 枸杞子 

分 类 号：R283.64[医药卫生—中药学] R917[医药卫生—中医学]