小儿化毒系列制剂中冰片投料质量分析

Determination of Borneol in Children's Detoxicating Series Preparations

目的:建立检测小儿化毒系列制剂中冰片的气相色谱法,并对冰片的投料质量进行研究,以完善和统一小儿化毒中冰片的质量标准。方法:采用气相色谱法。色谱柱为HP-INNOWax毛细管色谱柱,程序升温,检测器为氢火焰离子化检测器,检测器温度为240℃,载气为氮气,流速为2.0 m L/min,分流比为30∶1,进样量为1.0μL。结果:龙脑进样量在0.117 5～1.880μg范围内、异龙脑进样量在0.098 48～1.575 6μg范围内、冰片进样量在0.112 8～1.80 5μg范围内,峰面积积分值与进样量呈良好的线性关系(r=0.999 8、0.999 7、0.999 8);精密度、稳定性、重复性试验的RSD<3.0%;龙脑、异龙脑加样回收率分别为103.52%、97.98%。个别批次样品中樟脑检出含量接近检测限。结论:该方法简便、准确,适用于全面控制该制剂中冰片的投料质量。

Objective:To establish a gas chromatographic method for detection of Borneol in Xiao’erhuadu Series Preparations,and to study the quality of borneo to improve and unify the quality standards of borneo in that. Methods:GC method was adopted. The determination was performed on HP-INNOWax capillary column at the rate of 2.0mL/min using nitrogen gas as carrier and FID as the detector by temperature programming. The temperature of detector was set at 240℃. Carries gas was nitrogen. The split ratio was 30:1. The sample size was 1.0 μL. Results:borneol sample quantity is within the scope of 0.117 5-1.880μg, isoborneol sample quantity is within the scope of 0.098 48-1.575 6μg, borneol sample quantity in range of 0.112 8-1.805μg, the peak area of integral value and quantity of sample had good linear relationship ( r = 0.999 8, 0.999 7, 0.999 8),RSDs of precision, stability and reproducibility tests were all lower than 3.0%. The recovery rate of borneol and isoborneol is 103.52% and 97.98%. The detection of camphor in individual batches is close to the detection limit. Conclusion:The method is simple and accurate, is suitable for comprehensively controlling the feeding quality of Borneol in the preparation.