目的建立松补力口服液的质量标准。方法根据《中国药典》中对合剂的质量要求,对松补力口服液的相对密度、PH值、重金属含量进行检查,并采用薄层色谱法对松补力口服液中阿魏酸及甘松新酮进行定性鉴别;采用高效液相色谱法对松补力口服液中阿魏酸进行含量测定。色谱柱:Hypersil ODS C18(250 mm×4.6 mm,5μm);流动相:甲醇:1%冰乙酸水(22:78),流速1 ml/min,检测波长为320 nm,柱温为35℃。结果松补力口服液的相对密度不低于1.02,PH值为3~5之间,重金属符合药典标准。阿魏酸在20~140μg/ml范围内,阿魏酸的进样量与峰面积具有良好的线性关系,r=0.9966;平均回收率为98.13%,相对标准偏差RSD为0.99%。结论所建立的定性、定量检测方法操作简便、结果准确可靠、重现性好,可用来有效控制松补力口服液质量。
Objective To establish the Songbuli Oral Solution quality standards.Methods According to the"Chinese Pharmacopoeia"mixture of quality requirements,the relative density of Songbuli Oral Solution,pH value were measured,and Songbuli Oral Solution ferulic acid were identified by thin-layer chromatography;using efficient liquid phase method to determine the content of ferulic acid in Songbuli Oral Solution.Column Hypersil ODSC18(250 mm ×4.6 mm,5 μm);mobile phase: methanol:1% aqueous acetic acid(22:78),a flow rate of 1 ml / min,detection wavelength of 320 nm,column temperature was 35℃.Results The Songbuli Oral Solution relative density was about 1.02,the pH value of between 3 ~ 5 the ferulic acid 20 μg / ml ~ 140 μg / ml with in,of ferulic acid in the amount of injection and the peak area has a good linear relationship.r = 0.9966,ferulic acid average recoveries were 98.13%,RSD 0.99%.Conclusion The method is simple,fast,and accurate,the lesson is used to control the loose-fill power oral solution quality.