论文部分内容阅读
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 standards of Tongseiyanyao oral liquid to provide guarantee for the quality of production. Methods: The contents of total ferulic acid in the preparations were determined by TLC method. The chromatographic conditions were as follows: Lichrospher-C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol: 0.1% phosphoric acid (30:70), the flow rate was 1.0 ml · min-1, the column temperature was 30 ℃, the detection wavelength was 321 nm and the injection volume was 20μl. Results: TLC spots were clear and negative without interference. Ferulic acid had a good linear relationship in the range of 2.24-35.84 μg · ml-1, r = 0.999 9, the average recovery was 102.54% and RSD was 0.85% (n = 6). Conclusion: The method is accurate and easy to facilitate quality control.