清肝解毒胶囊的质量标准研究  

Research on the quality standard for Qingganjiedu Capsules

作　　者：林兰兰[1] 黄木土[1] 谢新民[1] 陈强[1] 韩丽萍[1] 

机构地区：[1]广州军区广州总医院药剂科,广州510010

出　　处：《西北药学杂志》2016年第3期231-235,共5页Northwest Pharmaceutical Journal

基　　金：军队医疗机构制剂标准提高计划项目(编号:14ZJZ15-3);广州市科技计划项目(编号:201509010012)

摘　　要：目的建立清肝解毒胶囊的质量标准。方法对清肝解毒胶囊中的黄芪、大黄、赤芍和柴胡采用薄层色谱法定性鉴别;对清肝解毒胶囊中蒽醌类成分的含量采用高效液相色谱法测定,以大黄素、大黄酸和大黄酚进行总量计算。结果薄层鉴别项斑点清晰,分离度较好,阴性无干扰。大黄素峰面积在2.864~143.2μg·mL^(-1)范围内呈良好的线性关系(r=0.999 9,n=7);大黄酸峰面积在3.544~177.2μg·mL^(-1)范围内呈良好的线性关系(r=0.999 8,n=7);大黄酚峰面积在3.984~199.2μg·mL^(-1)范围内呈良好的线性关系(r=0.999 9,n=7)。大黄酸的平均加样回收率达99.0%,RSD为1.42%;大黄素的平均加样回收率达99.5%,RSD为0.88%;大黄酚的平均加样回收率达101.9%,RSD为1.99%。结论该方法专属性强、稳定性好、重复性好、加样回收符合含量测定要求。Objective To establish the quality standard for Qingganjiedu Capsules.Methods Radix Astragali,Rhubarb,Radix paeoniae rubra,Radix Bupleuri were identified by TLC.The contents of the constituents in the preparation were determined by HPLC,and the total amount of emodin,rhubarb and chrysophanol were calculated.Results The spots from the test solutions on the thin layer plate were clear and the negative solution had no interference.The experiment showed good linear relationship in the range of 2.864-143.2μg·mL^-1 for emodin（r=0.999 9,n=7）.The experiment showed good linear relationship in the range of3.544-177.2μg·mL^-1 for rhubarb（r=0.999 8,n=7）.The experiment showed good linear relationship in the range of 3.984-199.2μg·mL^-1 for chrysophanol（r=0.999 9,n=7）.The average recovery of rhubarb was 99.0%.RSD=1.42%.The average recovery of emodin was 99.5%,RSD=0.88%.The average recovery of chrysophanol was 101.9%,RSD=1.99%.Conclusion The established methods are highly specific,stable,and reproducible.which can be used to control the quality of Qingganjiedu Capsules.

关 键 词：大黄 清肝解毒胶囊 薄层色谱法 HPLC 

分 类 号：R284[医药卫生—中药学]