烧伤镇痛油膏质量控制研究

Study on quality control standards for Shaoshang Zhentong ointment

目的建立烧伤镇痛油膏(主要为其中的蒲黄、黄芩、丹参、白芷)的质量控制方法。方法采用薄层色谱法(TLC)对该复方油膏中蒲黄、黄芩、丹参、白芷进行定性鉴别,同时采用高效液相色谱法(HPLC)测定黄芩苷、黄芩素、木犀草素的含量。结果TLC鉴别分离度良好,专属性强,阴性样品无干扰;黄芩苷对照品在0.52~13.0μg(r=0.9999)范围内线性关系良好,加样回收率均值为100.3%,RSD为2.6%;木犀草素对照品在0.13~3.3μg(r=0.9999)范围内线性关系良好,加样回收率均值为103.8%,RSD为2.9%;黄芩素对照品在0.05~1.2μg(r=0.9999)范围内线性关系良好,加样回收率均值为103.6%,RSD为2.8%。结论该方法操作简便易行,专属性强,准确可靠,可用于烧伤镇痛油膏的质量控制。

Objective To establish the quality control standards for Shaoshang Zhentong ointment(Puhuang, Liujinu, Huangqin, Danshen and Baizhi). Methods Puhuang, Huangqin, Danshen and Baizhi in this compound ointment were identified qualitatively by thin layer chromatography(TLC). The content of baicalin, luteolin and baicalein were determined by high-performance liquid chromatography(HPLC). Results In identification by TLC, there was good isolation and specificity, without interference from the negative samples. Baicalin, luteolin and baicalein had a good linearity in the range of 0.52~13.0 μg(r=0.999 9), 0.13~3.3 μg(r=0.999 9) and 0.05~1.2 μg(r=0.999 9), respectively. The mean average recovery of baicalin, luteolin and baicalein was 100.3%(RSD=2.6%), 103.8%(RSD=2.9%), and 103.6%(RSD=2.8%), respectively. Conclusion This method is easy to operate, specific, accurate and reliable, and it can be used for quality control of Shaoshang Zhentong ointment.