摘要
目的完善止咳化痰合剂的质量标准。方法采用薄层色谱(TLC)法定性鉴别制剂中的桔梗、前胡、浙贝、紫菀;采用高效液相色谱(HPLC)法测定制剂中橙皮苷、黄芩苷、连翘苷的含量,色谱柱为Agilent-C18柱(250 mm×4. 6 mm,5μm),流动相为乙腈-0. 1%磷酸溶液(梯度洗脱),流速为1. 0 m L/min,柱温为30℃,检测波长为210 nm,进样量为10μL。结果 TLC图中特征斑点明显,分离度好,阴性对照无干扰。橙皮苷、黄芩苷、连翘苷质量浓度分别在5. 80~290. 00μg/m L(r=0. 999 8)、5. 66~283. 00μg/m L(r=0. 999 6)、1. 90~95. 30μg/m L(r=0. 999 2)范围内与峰面积线性关系良好;平均回收率分别为93. 28%,93. 77%,94. 68%,RSD分别为1. 45%,2. 03%,1. 67%(n=9);精密度、稳定性、重复性试验的RSD均小于2%。结论所建立的TLC法专属性强、灵敏度高,HPLC法简便快速,结果准确、重复性、稳定性均良好,可用于止咳化痰合剂的质量控制。
Objective To improve the quality control standard for Zhike Huatan Mixture. Methods The contents of Platycodonis radix,Peucedani radix,Fritilariae thunbergii and Asterris radix were identified by TLC method. The contents of hesperidin,baicalin and forsythiaside were determine by HPLC method with Agilent C18 column( 250 mm × 4. 6 mm,5 μm),the mobile phase was acetonitrile-0. 1 % phosphoric acid( gradient elution) with a flow rate of 1. 0 m L/min,the column temperature was 30 ℃,the detection wavelength was 210 nm,and the injection volume was 10 μL. Results Characteristic spots could be detected and well separated without the interference of negative samples by TLC. The mass concentrations of hesperidin,baicalin and forsythiaside showed good linear relationship with the peak area in the range of 5. 80-290. 00 μg/m L( r = 0. 999 8),5. 66-283. 00 μg/m L( r = 0. 999 6),and 1. 90-95. 30 μg/m L( r = 0. 999 2) respectively,the average recovery rates were 93. 28%,93. 77%,94. 68%,the RSDs were1. 45 %,2. 03 %,and 1. 67 % respectively( n = 9),the RSD s of precision,stability,and repeatability tests were all less than 2 %.Conclusion The established TLC method has strong specificity and high sensitivity;the HPLC method is simple and fast,and the results are accurate,repeatable and stable,which can be applied for the quality control of Zhike Huatan Mixture.
作者
徐丹洋
周谧
张金星
王素素
XU Danyang;ZHOU Mi;ZHANG Jinxing;WANG Susu(Nantong Food and Drug Control Center,Nantong,Jiangsu,China 226006)
出处
《中国药业》
CAS
2020年第1期47-50,共4页
China Pharmaceuticals
关键词
止咳化痰合剂
质量标准
薄层色谱法
高效液相色谱法
Zhike Huatan Mixture
quality control standard
Thin-Layer Chromatography
High-Performance Liquid Chromatography
