开奶茶颗粒剂质量标准的试验研究  

Quality standard for Kainaicha Granules

作　　者：黄晓文[1] 王李平[1] 范华均[1] 徐星军[1] 刘小琴[1] 朱丹[1] 

机构地区：[1]广东药学院药科学院,广东广州510006

出　　处：《中成药》2012年第10期1933-1938,共6页Chinese Traditional Patent Medicine

基　　金：广东药学院师资队伍建设基金项目(52104109)

摘　　要：目的建立开奶茶颗粒剂(灯心草、淡竹叶、钩藤等)的质量标准。方法利用反相高效液相色谱法(RP-HPLC),采用Phenomenon Gemimi C18色谱柱,分别以甲醇-0.1%乙酸溶液(梯度洗脱)、甲醇-0.1%三乙胺溶液(70∶30)和甲醇-0.1%磷酸溶液(55∶45)作为流动相分离,分别鉴别淡竹叶、钩藤和灯心草;并以甲醇-0.1%磷酸溶液为流动相梯度洗脱,在350 nm处检测同时测定开奶茶颗粒剂中的木犀草素和异牡荆素。结果 HPLC鉴别专属性强,淡竹叶、钩藤和灯心草的HPLC色谱图上分别有1～5个特征组分可用于鉴别,其相对保留值在1.05～1.25之间;木犀草素和异牡荆素的质量浓度分别在0.229～1.144 mg/L(r=0.999 9)和0.076 4～9.170 mg/L(r=0.999 6)呈良好线性关系,平均加样回收率分别为100.45%(RSD为2.6%)和94.02%(RSD为2.5%)。结论用HPLC法鉴别和同时测定木犀草素和异牡荆素,方法简便、准确、可靠、重复性好,可作为开奶茶颗粒剂的质量控制方法的依据。AIM To establish the quality standards for Kainaicha Granules（Junci Medulla,Lophatheri Herba,Uncariae Ramulus cum Uncis,etc.）.METHODS The identifications of Lophatheri Herba,Uncariae Ramulus cum Uncis and Junci Medulla were carried out on Phenomenon Gemimi C18 column with mobile phase consisting of methanol-0.1% acetic acid,methanol-0.1% triethylamine and methanol-0.1% phosphoric acid,respectively.HPLC analysis of luteolin and isovetexin in Kainaicha Granules were simultaneously completed with methanol-0.1% phosphoric acid in gradient elution at 350 nm.RESULTS The identification by HPLC was highly specific.The charecteristic peaks of Lophatheri Herba,Uncariae Ramulus cum Uncis and Junci Medulla were clearly found in chromatograms.The linear ranges of luteolin and isovetexin were in the ranges of 0.229-1.144 mg/L（r=0.999 9） and 0.076 4-9.170 mg/L（r=0.999 6）,respectively.The average recoveries were 100.45%（RSD of 2.6%）for luteolin and 94.02%（RSD of 2.5%） for isovetexin.CONCLUSION The proposed method is simple,accurate and reliable,and can be used for the quality control for Kainaicha Granules.

关 键 词：开奶茶颗粒剂 HPLC 木犀草素 异牡荆素 

分 类 号：R927.2[医药卫生—药学]