正骨洗剂的质量标准研究

Research on the method of controling quality in Bone setting Lotion

目的：建立正骨洗剂的质量标准。方法：用薄层色谱法定性鉴别制剂中的牡丹皮、防风、当归、续断，用高效液相色谱法测定制剂中丹皮酚的含量。结果：TLC法可鉴别制剂中的牡丹皮、防风、当归、续断；HPLC法定量测定丹皮酚在0.043～0.428μg范围内线性关系良好，相关系数为r＝0.9999，平均回收率为99.22％，RSD＝0.70％。结论：本法简便，准确，可作为本品重要的质量控制指标。

Objective To establish the standard of quality for Bone setting Lotion.Methods TLC was adopted to identify Cortex moutan Radicis,Radix sileris,Angelica and Radix Dipsaci,and HPLC was adopted to determine the content of paeonol in Bone setting Lotion.Results Cortex moutan Radicis,Radix sileris,Angelica and Radix Dipsaci could be identified by TLC.The linear range of Paeonol was 0.043～0.428 mg （r=0.999 9 ）,the average recovery was 99.22%,RSD=0.70%.Conclusion The method is simple,accurate,It is suitable for quality control of Bone setting Lotion.