窿闭舒胶囊中补骨脂素与异补骨脂素含量分析.docVIP

窿闭舒胶囊中补骨脂素与异补骨脂素含量分析 　　【摘要】目的:建立窿闭舒胶囊中补骨脂素和异补骨脂素含量测定方法。方法:采用单因素与正交试验设计法考察最佳提取条件,薄层-紫外法分离测定补骨脂素和异补骨脂素。结果:补骨脂素在0.62～6.20?g/mL(R2=0.9995,n=6),异补骨脂素在0.50～5.00?g/mL(R2=0.9996,n=6)范围内线性关系良好。补骨脂素的平均加样回收率为100.3%,RSD=1.0%(n=6);异补骨脂素的平均加样回收率为99.3%,RSD=1.5%(n=6)。不同批号癃闭舒胶囊中补骨脂素与异补骨脂素的含量分别为:0.480mg/粒、0.462mg/粒和0.284mg/粒、0.264mg/粒。结论:方法简便可行,可有效控制癃闭舒胶囊的质量。 　　【关键词】薄层-紫外法;癃闭舒胶囊;补骨脂素;异补骨脂素 　　doi:10.3969/j.issn.1006-1959.2010.05.229 文章编号:1006-1959(2010)-05-1236-02 　　Contents Analysis of Psoralen and Isopsoralen in Longbishu Capsules ZHOU Wu-ping?1,HUANG-Qiong?1,LIANG-Dan??2*?,CEN Fei-Fe?3. 1.Guangxi University of Technology,Liuzhou,Guangxi,545006,China;2.Guangxi Traditional Chinese Medical University,Nanning,Guangxi,530001,China;3.Leshan City District Peoples Hospital,LeShan,Sichuan,614000,China 　　【Abstract】Objective:In order to establish a determination of psoralen and isopsoralen in longbishu capsules.Methods:The optimum experimental condition was set up by single-factor and orthogonal design test,and the psoralen and isopsoralen were separated and determined by TLC-UV.Results:The calibration curves were leaner in the rage of 0.62～6.20?g/mL(R2=0.9995,n=6)for psoralen and 0.50～5.00?g/mL(R2=0.9996,n=6)for isopsoralen.The average recovery of psoralen was 100.3%,RSD=1.0%(n=6);and that of isopsoralen was 99.3%,RSD=1.5%(n=6).The psoralen contents in the samples from different batch number were 0.480 mg/pill,0.462 mg/pill,and isopsoralen contents were 0.284 mg/pill,0.264 mg/pill.Conclusion:The method is simple and reliable.It can be used for quality control of longbishu capsules. 　　【Key words】TLC-UV;Longbishu;Psoralent;Isopsoralent 　　 　　癃闭舒胶囊由补骨脂、益母草、金钱草、海金沙、琥珀、山慈菇等中药加工而成的复方制剂[1],具有温肾化气,清热通淋,散结止痛等功效,用于肾气不足,湿热瘀阻之癃闭所致尿频、尿急、尿痛,小腹拘急疼痛,腰膝酸软等症;前列腺增生有以上症候者常应用[2~5]。其中补骨脂为主要原料药,主要活性成分为补骨脂素与异补骨脂素[1],《中国药典》(2005版)尚未收录癃闭舒胶囊质量控制标准[6],故采用薄层-紫外法,利用正交试验设计考察影响癃闭舒胶囊两成分提取率的因素,以补骨脂素与异补骨脂素为指标,建立一种适合基层单位的低成本检测方法。 　　1.仪器与试药 　　B2200S型超声波清洗仪(上海必能信有限公司);AL104型电子天平(梅特勒-托利多仪器有限公司);UV2100型紫外可见分光光度计(尤尼柯仪器有限公