摘要
目的:修订莲芝消炎胶囊(穿心莲、山芝麻)的质量控制方法。方法:采用薄层色谱法对其中的山芝麻、穿心莲进行鉴别;采用HPLC法测定其中穿心莲内酯和脱水穿心莲内酯的含量,色谱柱为DiamonsilTM钻石C18(200 mm×4.6 mm,5μm);流动相为甲醇-水(60∶40),流速:1 mL/min;穿心莲内酯检测波长为225 nm,脱水穿心莲内酯检测波长为254 nm。结果:薄层色谱鉴别斑点清晰,阴性对照无干扰;穿心莲内酯在0.007 5~1.35μg(r=0.999 997),脱水穿心莲内酯在0.1~1.5μg(r=0.999 95)范围内线性关系良好。平均回收率脱水穿心莲内酯为99.1%,RSD为2.8%(n=6),穿心莲内酯为99.8%,RSD为1.9%(n=7)。结论:新修订的方法准确、简便,可有效控制莲芝消炎胶囊的质量。
AIM: To revise the method for the quality control of Lianzhi Xiaoyan Capsule(Herba Andrographis,Radix Helicteris).METHODS: Radix Helicteris and Herba Andrographis in Lianzhi Xiaoyan Capsule were identified by TLC.The contents of andrographolide and dehydroandrographolide in the capsule were determined by HPLC with DiamonsilTM C18 column(200 mm × 4.6 mm,5 μm),and methanol and water(60 ∶ 40) as the mobile phase at a flow rate of 1 mL/min.The detection wavelength for andrographo-lide was set at 225 nm and dehydroandrographolide was set at 254 nm,respectively.RESULTS: Radix Helicteris and Herba Andrographis could be identified by TLC with clear spots and without interference.Contents of andrographolide and dehydroandrographolide showed good linearity in the ranges of 0.007 5-1.35 μg(r = 0.999 997) and 0.1-1.5 μg(r = 0.999 95),respectively;The average recoveries were 99.8%(RSD = 1.9%,n = 7) and 99.1%(RSD = 2.8%,n = 6),respectively.CONCLUSION: The new method is simple,accurate,exclusive and suitable for the quality control of Lianzhi Xiaoyan Capsule.
出处
《中成药》
CAS
CSCD
北大核心
2010年第12期2096-2100,共5页
Chinese Traditional Patent Medicine
基金
<中国药典>2010年版一部标准研究课题(ZH-226)