通塞益脑口服液的质量控制研究  

Quality Control for Tongsai Yinao Oral Liquids

作　　者：任海祥[1] 贾佳[1] 方李[1] 乔立业[1] 陆崟[1] 苏华[1] 

机构地区：[1]南京军区南京总医院制剂科,南京210002

出　　处：《中国药师》2014年第9期1489-1493,共5页China Pharmacist

基　　金：全军医疗机构制剂标准提高科研专项课题面上项目(编号13ZJZ15-2)

摘　　要：目的：完善通塞益脑口服液的质量标准,为生产质量提供保障。方法：采用TLC法对制剂中的延胡索、川芎、石菖蒲三味药材进行定性鉴别;采用HPLC法对制剂中的总阿魏酸进行含量测定,色谱条件：色谱柱为Lichrospher-C18柱（250 mm×4.6 mm,5μm）,流动相为甲醇：0.1%磷酸（30∶70）,流速为1.0 ml·min-1,柱温为30℃,检测波长为321 nm,进样量20μl。结果：TLC鉴别色谱斑点清晰,阴性无干扰;阿魏酸在2.24~35.84μg·ml-1范围内有良好的线性关系,r=0.999 9,平均回收率为102.54%,RSD=0.85%（n=6）。结论：该方法准确易行,便于质量控制。Objective： To improve the quality standard of Tongsai Yinao oral liquids for the quality control. Methods： TLC was used for the qualitative identification of Rhizoma corydails,Rhizoma chuanxiong and Rhizoma acori tatarinowii. HPLC was used to simultaneously determine the content of total ferulic acid in the oral liquids. The determination was performed on a Lichrospher-C18（ 250 mm × 4. 6 mm,5 μm） column with the mobile phase of methanol-0. 1% H3PO4（ 30∶70）. The flow rate was 1.0 ml·min- 1,the column temperature was at 30℃,the detection wavelength was 321 nm and the injection volume was 20μl. Results： The spots on the TLC plates were clear without the interference of negative control. The linear range of ferulic acid was obtained between 2. 24 and 35. 84 μg·ml- 1（ r =0.999 9）,and the average recovery was 102.54%（ RSD =0.85%,n =6）. Conclusion： The improved method is accurate and feasible. It can be used very conveniently in the quality control.

关 键 词：通塞益脑口服液 薄层色谱法 总阿魏酸 高效液相色谱法 含量测定 

分 类 号：TQ450.72[化学工程—农药化工]