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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 explore the preparation process of compound Banlangen Spray and establish the quality control method. Methods Cross-contrast test was used to explore the preparation process of compound Banlangen Spray. The mobile phase consisted of Diamonsi TMC18 (250mm × 4.6mm, 5um), mobile phase consisted of methanol 0.1% ammonium acetate monoacetic acid (80:20:1), flow rate 1.0ml / min , Detection wavelength: 286nm for quantitative methods. The results with 65% ethanol percolation method is more efficient. The injection volume of indirubin showed a good linear relationship with the integral of peak area in the range of 0.0812 ~ 0.9745ug / ml (r2 = 0.999945, n = 7). The average recovery was 99.12% with a RSD of 1.94% (n = 6). Conclusion This method can be used as the preparation process of compound Banlangen Spray. The detection method is simple, rapid, high resolution and reproducibility. It can be used for the quality control of Banlangen.