复方穿心莲片质量标准的研究

Quality standard of Compound Andrographis Paniculata tablets

目的 提高复方穿心莲片的质量标准.方法 采用TLC法对方中的穿心莲、路边青进行定性鉴别;采用RP-HPLC法测定穿心莲内酯、脱水穿心莲内酯的质量分数.结果 TLC法专属性强、简单可行.穿心莲内酯在0.024～0.24 μg范围内呈线性关系（r=0.999 5）,平均回收率为97.36％（RSD=1.56％,n=6）;脱水穿心莲内酯在0.038 4～0.384 μg范围内呈线性关系（r=0.999 8）,平均回收率为101.52％（RSD=1.55％,n=6）.结论 本法操作简单、可靠、准确,重复性好,有利于复方穿心莲片的质量控制.

Objective To improve the quality standard of Compound Andrographis Paniculata tablets.Methods Andrographis Paniculata and Herba gei were identified by TLC.The contents of andrographolide and dehydroandrographolide were determined by RP-HPLC.Results TLC identification method was simple and feasible with high specificity.Andrographolide showed good linearity in the range of 0.024-0.24 μg （r =0.999 5）,and the average recovery was 97.36% （RSD =1.56%,n =6）.Dehydroandrographolide showed good linearity in the range of 0.038 4-0.384 μg （r=0.999 8）.The average recovery was 101.52% （RSD=1.55%,n=6）.Conclusion The method is simple,reliable and accurate with good repeatability,and could be applied as the quality control method for Compound Andrographis Paniculata tablets.