牛黄清宫丸质量标准的研究  

Studies on Quality Standard of Niuhuang Qinggong Pills

作　　者：李方[1] 张清波[1] 曹阳 

机构地区：[1]黑龙江省药品检验所,哈尔滨150001 [2]大庆市药品检验所,大庆163316

出　　处：《中国药品标准》2011年第2期131-135,共5页Drug Standards of China

摘　　要：目的：建立牛黄清宫丸质量标准。方法：采用TLC法对处方中大黄、栀子、金银花进行了定性鉴别，并用HPLC法对处方中黄芩进行了含量测定，采用Diamonsil C18色谱柱，以甲醇-水-磷酸（46：54：0．2）为流动相，流速为1．0mL·min^-1，检测波长为280nm。结果：薄层色谱斑点清晰，易于识别，专属性强；黄芩苷线性范围为0．1175～1．175μg（r=1．0000），平均加样回收率为99．5％，RSD为1．6％。结论：本方法操作简便，快速、准确、灵敏度高，重复性好，提高后的质量标准更有效的控制该制剂的质量。Objective： To determine the quality standard of Niuhuang Qinggong Pills. Methods： Radix Et Rhizoma Rhei, Fructus Gardeniae, Flos Lonicerae Japonicae in Niuhuang Qinggong Pills were identified by TLC. The content of Baicalin was determined by HPLC. Using ODS column, Methanol-Water- Phosphoric acid （46： 54： 0. 2） as the mobile phase at flow rate of 1.0 mL ·min^-1, wavelength of the detection was 280 nm. Results：The qualitative identification with TLC were specific. The liner range of Baicalin was 0. 117 5 - 1. 175μg（r = 1. 000 0）; the recovery was 99. 5% （RSD = 1.6% ）. Conclusion： This method is simple,rapid,accurate,highly sensitive and well reproducible. This method can be used for the quality control of Niuhuang Qinggong Pills.

关 键 词：牛黄清宫丸 薄层色谱 黄芩苷 高效液相色谱 

分 类 号：R927[医药卫生—药学]