谷固醇达克罗宁膜质量标准研究

Study on the Quality Standard of Compound Sitosterol Pellicles

目的：建立谷固醇达克罗宁膜的薄层鉴别、盐酸达克罗宁的含量均匀度及含量测定的方法。方法：采用薄层色谱法鉴别谷固醇及高效液相色谱法测定盐酸达克罗宁的含量及其均匀度。结果：谷固醇薄层斑点清晰；在选定的色谱条件下，盐酸达克罗宁在1.205～120.5μg·mL^-1范围内线性关系良好（r＝0.9999），平均回收率为101.3％，其RSD为0.9％（n＝9）。结论：所建方法专属性强，准确度高，可更有效地用于谷固醇达克罗宁膜的质量控制。

Objective：To develop an TLC identification method and an HPLC method for assay and uniformity of dyclonine hydrochloride＆amp;nbsp;for Compound Sitosterol Pellicles.Methods：TLC was used to identify sitosterol and HPLC to determine the content and uniformity of dy-clonine hydrochloride.Results：The TLC sports of sitosterol developed was fairly clear.A good linear relation of dyclonine hydrochloride was observed within the range of 1.205-120.5μg· mL^-1 （ r=0.999 9）.The average recovery was 101.3%with RSD of 0.9%（ n=9）.Conclusion：The method is accurate and specific which can be used to control the quality of Compound Sitosterol Pellicles.