摘要
目的:完善速感宁胶囊质量标准。控制产品质量。方法:采用TLC法对制剂中大青叶进行了鉴别;大青叶的薄层色谱鉴别采用大青叶为对照药材,以甲苯-三氯甲烷-丙酮(5∶4∶1)为展开剂。采用HPLC法测定制剂中对乙酰氨基酚和马来酸氯苯那敏含量。流动相分别为甲醇-水-冰醋酸(20∶80∶0.5)和甲醇-0.05 mol/L,磷酸二氢钾-三乙胺(50∶50:0.02)(用磷酸调pH至5.0)。结果:对乙酰氨基酚平均回收率为99.36%,RSD为1.03%(n=6);马来酸氯苯那敏平均回收率为99.13%,RSD为1.31%(n=6)。结论:鉴别方法专属性强,定量方法准确,稳定,重现性好,可作为速感宁胶囊的质量控制标准。
Objective：To develop the quality control standards for Suganning Capsules. Methods： Folium isatidis in the capsules were identified on a thin layer plate of silice gel developed with. toluene-chloroform-acetone （5：4：1 ）with herbal reference substance. The contents of paraeetamol and chlorphenamine maleate were determined by HPLC with external standard. The mobile phases were ： methanol-water-acetic acid （20 ： 80 ： 0.5 ） and methanol-0.05 mol · L^- 1 potassium dihydrogen phosphate-triethylamine （50 ： 50 ： 0.02） （ Adjust to pH 5.0 with phosophorie acid） for the two components respectively. Resldts ： The average recovery of paracetamol was 99.36 % （RSD 1.03 %, n = 6）. The average recovery of chlorphenamine maleate was 99.13 % （RSD 1.31%, n = 6）. Conclusion： These methods are simple, accurate and specific and can be used for the quality control of Suganning Capsules.
出处
《中国实验方剂学杂志》
CAS
2007年第6期18-20,共3页
Chinese Journal of Experimental Traditional Medical Formulae
