复方板蓝根喷雾剂的制备与质量控制研究  

Research of the Composite Spray of Radix Isatidis’Preparation and Quality Control

作　　者：曹智启[1] 罗宪堂[1] 杨凤琼[1] 李岩[1] 

机构地区：[1]广东岭南职业技术学院,510663

出　　处：《首都医药》2012年第2期55-56,共2页Capital Medicine

摘　　要：目的探究复方板蓝根喷雾剂的制备工艺,建立质量控制的方法。方法利用交叉对比试验探究复方板蓝根喷雾剂的制备工艺,以DiamonsiTMC18(250mm×4.6mm,5um),流动相:甲醇一0.1%乙酸铵一乙酸(80:20:1),流速:1.0ml/min,检测波长:286nm为定量方法。结果用65%乙醇渗漉法提取效率较高。靛玉红的进样量在0.0812～0.9745ug/ml(r2=0.999945,n=7)范围内与峰面积积分值呈良好的线性关系。平均加样回收率为99.12%,RSD为1.94%(n=6)。结论本法可作为复方板蓝根喷雾剂的制备工艺,检测方法简便、快捷、分离度高、重现性好,可用于复方板蓝根喷雾剂的质量控制。Objective To research of compound radix isatidis spray preparation process and to establish it＇ s quality control method Methods Using cross comparison test research of compound radix isatidis spray preparation process The determination was performed on lliamonsiTM, C18 column（ 250nm×4.6mm, 5urn ）;with mobile phase consisted of methanol- 0.1% ammonium acetat 1）at a The de e-aceti flow c acid （ 80 ： 20 rate of 1.0ml/min tection wavelength was set at 286nm. It is the quantitative method. Results Using 65% ethanol percolation extraction of effective components of radix isatidis is high efficiency. The calibration curves showed a good linear relationship in the range from 0.0812-0.9745ug/ ml（ r2 = 0.999945, n = 7 ） for the sampling amount and peak area integral values of indirubin. The average recovery rates was 99.12% （RSD =1.94% ,n= 6 ）. Conclusion This method can be used as composite spray of radix isatidis preparation process. The detection method is simple, fast, high resolution and good reproducibility, which can be used for the quality control ofcomposite spray of radix isatidis.

关 键 词：复方板蓝根喷雾剂 制备 靛玉红 质量控制 

分 类 号：R917[医药卫生—药物分析学]