【摘要】 目的建立康媛颗粒的质量标准。方法采用薄层色谱法对处方中黄芪、白芍、枸杞子和干草进行鉴别;用高效液相色谱法测定制剂中芍药苷的含量,采用AichromBond-AQ-C18色谱柱( mm×150 mm,5 μm),流动相:水-乙腈(85∶15),检测波长为230 nm,柱温30 ℃,流速1 mL/min。结果薄层色谱专属性强;~ μg,r= 5,%,RSD=%(n=6)。结论该方法简便、准确,重现性好,可作为康媛颗粒的质量控制标准。
【关键词】 康媛颗粒;芍药苷;高效液相色谱法;薄层色谱法;质量标准
Abstract:Objective To establish the quality standard for Kangyuan Granula. Methods Radix Astragali, Radix Paeoniae Alba, Fructus Lycii and Radix et Rhizoma Glycyrrhizae in this prescription were identified by TLC. The content of the Paeoniflorin was determined by HPLC. The column of AichromBond-AQ-C18 ( mm×150 mm, 5 μm) was used, the mobile phase was Water-Acetonitrile (85∶15), at the flow of mL/min, the column temperature of 30 ℃, and peaks were detected at 230 nm. Results The characteristic of identification by TLC was distinct and highly specific. The linear range of Paeoniflorin was ~ μg, r= 5, the average recovery was %, RSD=% (n=6). Conclusion The method was easy to operate with accurate result and good reproducibility. It can be used effectively for the quality control of this preparation.
Key words:Kangyuan Granula;Paeoniflorin;HPLC;TLC;quality standard
康媛颗粒是本院新研制的中药6类新药,由黄芪、白芍、当归、枸杞子、茯苓、续断、柴胡、香附、白术、陈皮、甘草等组成,具有疏肝解郁、理气止痛、养血调经的功效,适用于经前期紧张综合征及原发性痛经,经前期乳房胀痛,经来小腹疼痛。为了控制该制剂的质量,笔者对黄芪、白芍、枸杞子和甘草进行了薄层色谱鉴别,同时采用高效液相色谱法测定了制剂中芍药苷的含量,
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