构树叶软膏制剂的制备及其含量测定

Preparation of An Ointment Preparation of Broussonetia papyrifera Leaves and Determination of Its Content

目的:建立构树叶软膏的制备工艺及其软膏制剂中绿原酸、隐绿原酸和野黄芩苷含量的测定方法。方法:通过乳化法制备构树叶软膏制剂,并采用HPLC方法同时测定软膏制剂中绿原酸、隐绿原酸以及野黄芩苷的含量,色谱柱采用安捷伦ZORBAX SB-C18,柱温设置为40℃,以乙腈-0.4%磷酸水溶液为流动相,进行梯度洗脱,流速为0.8 mL/min,进样量为10μL;检测波长为339 nm。结果:制备所得构树叶软膏制剂易于涂抹,放置不分层,涂布无颗粒感,且所含绿原酸、隐绿原酸和野黄芩苷分别在相应浓度范围内呈现良好的线性关系(R^(2)>0.999);构树叶软膏中各目标物质的加样回收率在99.81%~103.22%,相对标准偏差(RSD)均<2%。结论:构树叶软膏制备工艺稳定可行,HPLC同时测定其绿原酸、隐绿原酸及野黄芩苷3种成分含量方法可行,具有良好的准确性和精密度,可用于构树叶软膏的质量控制。

Objective:The preparation technology of Broussonetia papyrifera leaves ointment and the determination method of the contents of chlorogenic acid,cryptochlorogenic acid,and scutellarin in the ointment preparation were established.Methods:The B.papyrifera leaves ointment preparation was prepared by emulsification method,and the contents of chlorogenic acid,cryptochlorogenic acid,and scutellarin were simultaneously determined by HPLC.The chromatographic column was Agilent ZORBAX SB-C18,and the column temperature was set to 40℃,acetonitrile-0.4%phosphoric acid aqueous solution was used as the mobile phase,gradient elution was performed,the flow rate was 0.8 mL/min,the injection volume was 10μL;the detection wavelength was 339 nm.Results:The prepared B.papyrifera leaves ointment was easy to apply,remained stable without layering,and had a smooth texture without a grainy feeling.The chlorogenic acid,cryptochlorogenic acid and scutellarin contained in the corresponding concentration range respectively showed a good linear relationship(R^(2)>0.999);the sample recovery rates of each target substance in the B.papyrifera leaves ointment ranged from 99.81%to 103.22%,and the relative standard deviations(RSD)were all<2%.Conclusion:The preparation process of B.papyrifera leaves ointment was stable and feasible.The HPLC method for the simultaneous determination of its three components:chlorogenic acid,cryptochlorogenic acid,and scutellarin was found to be feasible.It demonstrated good accuracy and precision,and could be used for the quality control of B.papyrifera ointment.