裸花紫珠胶囊质量标准研究

Quality standard for Luohua Zizhu Capsules

目的建立裸花紫珠胶囊的质量标准。方法采用薄层色谱法（TLC）对胶囊中裸花紫珠进行定性鉴别;采用超高效液相色谱法（UHPLC）,Waters ACQUITY UPLCBEH C18柱（2.1 mm×100 mm,1.7μm）,同时对制剂中木犀草苷、连翘酯苷B、毛蕊花糖苷及异毛蕊花糖苷进行定量测定。结果薄层鉴别专属性强,斑点清晰,分离度好;木犀草苷、连翘酯苷B、毛蕊花糖苷及异毛蕊花糖苷分别在1.79-89.69μg/m L（r=0.999 9）、8.45-422.45μg/m L（r=0.999 9）、14.48-724.14μg/m L（r=0.999 8）、14.12-706.11μg/m L（r=0.999 9）范围内呈良好的线性关系,平均加样回收率（n=9）分别为98.1%、101.3%、98.4%、102.0%,RSD分别为1.2%、1.5%、1.3%、1.5%。结论所建立的定性、定量分析方法简便快速,准确度高,能够有效控制裸花紫珠胶囊的质量。

AIM To establish the quality standard for Luohua Zizhu Capsules. METHODS Callicarpa nudiflora Hook in capsules was identified by TLC. The contents of luteoloside,forsythoside B,acteoside and isoacteoside in capsules were determined by UHPLC. RESULTS TLC spots were clear and well-separated. Luteoloside,forsythoside B,acteoside and isoacteoside showed good linearity in the ranges of 1. 79- 89. 69 μg / m L（ r =0. 999 9）,8. 45- 422. 45 μg / m L（ r = 0. 999 9）,14. 48- 724. 14 μg / m L（ r = 0. 999 8）,14. 12- 706. 11μg /m L（ r = 0. 999 9）,respectively. The average recoveries of luteoloside,forsythoside B,acteoside and isoacteoside were 98. 1%,101. 3%,98. 4% and 102. 0%,respectively. The RSDs were 1. 2%（ n = 9）,1. 5%（ n =9）,1. 3%（ n = 9） and 1. 5%（ n = 9）,respectively. CONCLUSION The established qualitative and quantitative methods are simple and accurate,which can be used for the quality control of Luohua Zizhu Capsules.