通腑脐贴膏质量标准研究

目的：建立通腑脐贴膏的质量控制方法。方法采用薄层色谱法对通腑脐贴膏中的大黄、厚朴、枳壳进行定性鉴别，采用高效液相色谱法测定制剂中大黄素、大黄酸的含量。色谱柱为SunFire C18（4.6 mm＆#215;250 mm，5μm），流动相为甲醇-0.1%磷酸溶液（85∶15），检测波长254 nm，流速1.0 ml/min,柱温30℃。结果大黄素在0.144-1.728μg范围内线性关系良好，r＝0.9996；大黄酸在0.016-0.208μg范围内线性关系良好，r＝0.9996。大黄酸和大黄素加样回收率分别为98.18%、98.75%，RSD分别为0.98%、0.91%。结论该方法重复性好，结果准确，可有效控制通腑脐贴膏的质量。

Study on quality standard of Tongfu navel plaster

Objective To establish the quality standard of Tongfu navel plaster. Methods Rhubarb, Magnolia and Citrus aurantium were identified by thin-layer chromatography（TLC）. HPLC method was established for the determination of emodin and rhein. The chromatographic column was SunFire C18 column （4.6 mm×250 mm, 5 μm） with methanol-0.1%H3PO4（85∶15） as the mobile phase. The flow rate was 1.0 ml/min, column temperature was at 30 ℃, and the detection wavelength was 254 nm. Results Within the range of 0.144-1.728μg, emodin presented a fine linear relationship, r=0.999 6. Within the range of 0.016-0.208μg, rhein presented a fine linear relationship, r=0.999 6. The recovery of rhein and emodin was 98.18%and 98.75% with RSD 0.98% and 0.91% respectively. Conclusion The methods are reliable, accurate, reproducible, and can be used for the quality control of Tongfu navel plaste.