千柏鼻炎胶囊质量标准研究

目的 研究修订千柏鼻炎胶囊(千里光、卷柏、决明子、麻黄、羌活等)的质量标准.方法采用薄层色谱法对制剂中千里光、决明子、麻黄和羌活进行定性鉴别,采用高效液相色谱法测定千里光中金丝桃苷和对羟基桂皮酸,色谱柱为Kromasil C18(250 mm ×4.6 mm,5 μm)；流动相为乙腈-0 2％冰醋酸(15∶85)；体积流量为1.0 mL/min;柱温35℃；检测波长310 nm (0～20 min),360nm(20～30 min)结果 薄层鉴别专属性强；对羟基桂皮酸在0.03575～0.89375μg范围内与其峰面积线性关系良好(r=1),平均回收率为99.0％,RSD为1.6％(n=6)；金丝桃苷在0.03286～0.8215μg范围内与其峰面积线性关系良好(r=0.9999),平均回收率为103.7％,RSD为1.7％(n=6).结论 所用方法简便、准确,完善了千柏鼻炎胶囊的质量标准,可作为千柏鼻炎胶囊的质量控制标准.

Quality standard for Qianbai Biyan Capsules

AIM To improve the quality standard for Qianbai Biyan Capsules(Senecionis scandentis Herba,Selaginellae Herba,Cassiae Semen,Ephedrae Herba,Notopterygii Rhizoma et Radix,etc.).METHODS Senecionis scandentis Herba,Cassiae Semen,Ephedrae Herba and Notopterygii Rhizoma et Radix were identified by TLC.Hyperoside and p-hydroxycinnamic acid were determined by HPLC.The HPLC system consisted of Kromasil C18(250 mm×4.6 mm,5 μm)with acetonitrile-0.2% glacial acetic acid as mobile phase,flow rate at 1.0 mL/min,the column temperature at 35 ℃,the detection wavelength at 310 nm(0-20 min),360 nm(20-30 min).RESULTS The quanitative identification was specific.The linear range of p-hydroxycinnamic was from 0.035 75-0.893 75 μg(r=1) with an average recovery of 99.0%(RSD was 1.6%,n=6).The linear range of hyperoside was from 0.032 86-0.821 5 μg(r=0.999 9) with an average recovery of 103.7%(RSD was 1.7%,n=6).CONCLUSION These methods are simple,accurate,and can be conducive to the improvement and control of the quality of Qianbai Biyan Capsules.