莲芝消炎胶囊质量标准的研究

Quality control of Lianzhi Xiaoyan Capsule

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.