伤湿止痛膏中芸香浸膏的质量分析

Quality Analysis of Mastic Resinoid in Shangshi Zhitong Ointment

目的建立HPLC法测定伤湿止痛膏中芸香浸膏的特征成分肉桂酸的含量方法,并对10个企业48批伤湿止痛膏进行质量评价。方法色谱柱:Waters Symmetry shied C18(4.6 mm×250 mm,18.5μm);流动相:0.1%磷酸溶液(A)∶乙腈(B)(73∶27);流速:1.0 ml/min;温度:25℃;检测波长:285 nm;进样量:10μl。结果通过对48批不同企业不同批号的伤湿止痛膏进行含量测定,每平方厘米伤湿止痛膏中含芸香浸膏以肉桂酸计,应不得少于2.1μg,有15个批次不合格,不合格率为31.2%。结论此次研究所建立的伤湿止痛膏中肉桂酸的含量测定研究,方法准确,灵敏度高,能够有效提高产品的质量,为建立芸香浸膏的药用标准提供有力的支持。

Objective To establish a HPLC method for the determination of cinnamic acid,the characteristic component of mastic resinoid in Shangshi Zhitong ointment,and to evaluate the quality of 48 batches of Shangshi Zhitong ointment from 10 enterprises.Methods The chromatographic column was Waters Symmetry shied C18(4.6 mm×250 mm,18.5μm).Mobile phase was 0.1%phosphoric acid solution(A):acetonitrile(B)(73∶27).Flow rate was 1.0 ml/min.Temperature was 25℃.Detection wavelength was 285 nm.Sample size was 10μl.Results According to the content determination of 48 batches of different batches of different enterprises,each cm~2 of Rongshi Zhitong ointment contains rue extract measured by cinnamic acid,which should not be less than 2.1μg,15 batches were unqualified,and the unqualified rate was 31.2%.Conclusion The method of determination of cinnamic acid in Shangshi Zhitong ointment established in this study is accurate and sensitive,which can effectively improve the quality of the product and provide strong support for the establishment of the medicinal standard of rue extract.