鼻炎康颗粒质量标准的建立  

Quality Standard for Biyankang Granule

作　　者：蔡培培[1] 张晓丹[1] 

机构地区：[1]南京军区联勤部药品仪器检验所,南京210002

出　　处：《中国药师》2016年第9期1788-1791,共4页China Pharmacist

基　　金：军队医疗机构制剂标准提高科研专项课题(编号:14ZJZ06-3)

摘　　要：目的:建立鼻炎康颗粒的质量标准研究方法。方法:采用TLC法鉴别制剂中的黄芩和葛根;采用HPLC法测定黄芩苷的含量,色谱柱为Dubhe C18柱(250 mm×4.6 mm,5"m),以甲醇为流动相A,0.4%磷酸溶液为流动相B进行梯度洗脱,流速为1.0 ml·min^(-1),检测波长为280 nm,柱温为30℃,进样量为10"l。结果:各供试品的TLC图谱显示,在与对照品或对照药材相应的位置上显相同颜色的斑点,阴性对照无干扰;黄芩苷在15.02~300.43"g·ml-1浓度范围内与峰面积呈良好的线性关系(r=1.000 0),平均回收率为102.62%(RSD=0.72%,n=6)。结论:在鼻炎康颗粒原标准基础上建立的方法具有专属性强、准确度高、重复性好的特点,可有效控制该制剂的质量。Objective： To establish a method for the quality standard of Biyankang granule. Methods： Scutellaria baicalensis Georgi and Puerariae lobatae radix were identified by TLC. The content of baiealin was determined by HPLC with a Dubhe C18 column （250mm×4.6mm,5μm）. The mobile phase was methanol and 0.4% phosphoric acid with gradient elutiorl. The flow rate was 1.0 ml·min^-1 and the detection wavelength was 280 nm. The column temperature was 30℃ and the injection volume was 10 μl. Resuits ： The spots in TLC were clear without any interference. A good linear relationship was shown within the range of 15.02-300.43μg·ml^-1 for baicalin （ r = 1. 000 0 ）. The average recovery of baicalin was 102.62% （ RSD = 0.72%, n = 6 ）. Conclusion： The method is specific with high accuracy and good reproducibility, which can be used for the quality control of Biyankang granule.

关 键 词：鼻炎康颗粒 葛根 黄芩 黄芩苷 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]