复方薰衣草油膏的质量标准研究

Study on Quality Standard of Compound Lavandula angustifolia Ointment

目的:建立复方薰衣草油膏的质量标准。方法:采用薄层色谱法(TLC)对制剂中黄芩提取物、薰衣草油进行定性鉴别;采用气相色谱法(GC)对制剂中薄荷素油进行定性鉴别;采用GC法测定制剂中薄荷脑的含量,色谱柱为Agilent DB-WAX毛细管柱,程序升温,进样口温度为250℃,检测器温度为250℃,进样量为1μL,分流比为5∶1,分流进样。结果:黄芩苷提取物、薰衣草油的TLC斑点清晰、分离度好、阴性对照无干扰。薄荷素油供试品色谱图中与对照品色谱峰保留时间位置处有相同的色谱峰。薄荷脑检测进样量线性范围为0.113 4~1.133 5μg(r=0.999 4);精密度、稳定性、重复性试验的RSD≤2.0%;加样回收率为95.40%~99.82%(RSD=1.61%,n=6)。结论:所建质量标准可用于复方薰衣草油膏的质量控制。

OBJECTIVE：To establish the quality standard for Compound Lavandula angustifolia ointment. METHODS：TLC was used for the qualitative identification of ethanol extract from Scutellaria baicalensis and volatile oil of L. angustifolia. GC method was used for qualitative identification of dementholized peppermint oil. GC method was used to determine the content of menthol. The determination was performed on Agilent DB-WAX capillary column,with temperature programming. The injector temperature was 250 ℃,and the temperature of detector was 250 ℃. The injection volume was 1 μL and the split ratio was 5∶1 by split sampling. RESULTS：TLC spots of ethanol extract of S. baicalensis and volatile oil of L. angustifolia were clear and wellrepeated without interference from negative control. The chromatographic peaks in TLC of test samples of dementholized peppermint oil had same retention time as that of substance control. The linear range of menthol injection amount was 0.113 4-1.133 5 μg（r=0.9994）. RSDs of precision,intra-day precision,stability and reproducibility tests were not higher than 2.0%. The recoveries were 95.40%-99.82%（RSD=1.61%,n=6）. CONCLUSIONS：Established quality standard can be used for the quality control of Compound L. angustifolia ointment.