结肠宁灌肠剂质量标准研究

目的：建立结肠宁灌肠剂质量标准。方法：采用TLC法对蒲黄、丁香蓼进行鉴别；用HPLC法测定没食子酸的含量，色谱柱为AgilentTC-C18（250mm×4．6mm，5μm），流动相为甲醇-01％磷酸溶液（5：95），柱温：35℃，流速：0．8ml·min^-1，检测波长为273nm。结果：TLC色谱斑点清晰；没食子酸在4．985-1994．0ng范围内线性关系良好（r=0．9999），平均回收率为99．7％（RSD=2．2％，n=9）。结论：本法简便、可靠、准确，可用于该制剂的质量控制。

Study on Quality Standard for Jiechangning Enema

Objective ： To establish the quality standard for Jiechangning enema. Method ： Herbra Ludiwigiae Prostratae and Pollen Typhae in the preparation were identified by TLC. The content of gallic acid in Jiechangning enema was determined by HPLC. Agilent TC-C18（250 mm ×4.6 mm,5 μm） column was used with the mobile phase consisted of methauol-0. 1% aqueous phosphoric acid （5： 95 ） at the temperature of 35℃. The flow rate was 0. 8 ml·min^-1 and detection wavelength was 273 nm. Result： The TLC spots developed were quite clear. The linear range of gallic acid was within the range of 4. 985-1 994.0 ng （ r = 0. 9999 ）, and the average recovery was 99. 7% with RSD of 2. 2% （n = 9）. Conclusion： The method is simple, reliable, accurate, and can be used as the quality control method for Jiechangning enema.