清湿外洗汤质量控制研究  

Quality Control of Qingshiwaixi Decoction

作　　者：薛敏菲[1] 雷凯君[1] 吴舜芳[1] 黄建明[1] Xue Minfei Lei Kaijun Wu Shunfang Huang Jianming(Foshan Hospital of TCM, Foshan, Guangdong, China 52800)

机构地区：[1]广东省佛山市中医院,广东佛山528000

出　　处：《中国药业》2017年第11期9-12,共4页China Pharmaceuticals

基　　金：广东省佛山市医学类科技攻关项目[2016AB002051]

摘　　要：目的建立两煎常压煎药机所制清湿外洗汤的质量控制体系。方法采用薄层色谱法对清湿外洗汤中主要药味栀子、黄柏、蛇床子进行定性鉴别;采用高效液相色谱法对清湿外洗汤中主要活性成分苦参碱进行含量测定,色谱柱为XTerra Rp18柱(250 mm×4.6 mm,5μm),流动相为乙腈-乙二胺-水(45∶0.05∶55),流速为1.0 mL/min,柱温35℃,检测波长220 nm;观察室温下避光保存的汤剂,在拟订的7 d储存期内苦参碱含量的变化,同时进行微生物限度检查。结果薄层色谱中均斑点清晰,无阴性干扰,分离度好,专属性强。苦参碱质量浓度在0.029 5~0.177 0 g/L线性范围内与峰面积呈良好的线性关系(r=0.999 8);平均回收率为97.41%(n=6)。于室温下避光保存7 d苦参碱损失率为1.85%。结论该方法简单易行,灵敏度高,重复性好,专属性强,可用于清湿外洗汤的质量控制。两煎常压煎药机煎煮的清湿外洗汤于室温下避光保存7 d质量稳定。Objective To establish a quality control system of Qingshiwaixi Decoction extracted by two fried normal pressure decocting machine. Methods The main ingredients of Fructus Gardeniae, Cortex Phellodendri, Fructus Cnidii in Qingshiwaixi Decoction were identified by TLC,the content of main active ingredient matrine in Qingshiwaixi Decoction was determined by HPLC with XTerra Rp18 column（ 250 mm × 4. 6 mm,5 μm）, acetonitrile-ethylenediamine-water（ 45 ∶ 0. 05 ∶ 55） was used as mobile phase, the flow rate was 1. 0 mL/min,the column temperature was set at 35 ℃,the wavelength of the detector was set at 220 nm. The content change of matrine was observed within 7 days at room temperature and avoided light, meanwhile, microbial limit test was carried out. Results The TLC method had no negative interference,good separation and highly specificity with all the spots were clear. The linear range for matrine was 0. 029 5-0. 177 g/L（ r = 0. 999 8）. The average recovery were 97. 41%（ n = 6）. The content of matrine in Qingshiwaixi Decoction showed 1. 85% decrease in the 7th day. Conclusion The method is simple, highly sensitive, highly repeatable and specific, it can be used for quality control of Qingshiwaixi Decoction. Qingshiwaixi Decoction can be kept stably at room temperature and avoided light lasting 7 days after it was extracted by two fried normal pressure decocting machine.

关 键 词：清湿外洗汤 苦参碱 薄层色谱法 高效液相色谱法 质量控制 

分 类 号：R283.6[医药卫生—中药学] R284.1[医药卫生—中医学]