灌装温度对中药代煎包材中塑化剂迁移率的影响规律

目的研究中药代煎包材中邻苯二甲酸酯类塑化剂的迁移量随灌装温度的变化规律,为规范中药代煎流程提供一定的参考。方法检测中药代煎包材中17种常见邻苯二甲酸酯类塑化剂的含量;将蒸馏水煮沸后,在梯度温度下灌装到中药代煎包材中,采用气质联用色谱技术,定性定量各邻苯二甲酸酯类塑化剂的迁移率。结果GC-MS符合检测邻苯二甲酸酯类塑化剂的要求,标准曲线和相关系数显示,在0.05~5.00 mg/L呈良好线性关系,相关系数>0.998,检出限为0.002 mg/L。中药代煎包材检出的邻苯二甲酸酯类塑化剂及其含量为DEHP(0.122 mg/kg)、DBP(0.273 mg/kg)、DIBP(0.073 mg/kg)、DEP(0.024 mg/kg)和DMP(0.037 mg/kg),其他12种PAEs未检出。30~100℃的梯度温度灌装后,蒸馏水中检出的塑化剂及其迁移率分别为DEHP(0.14%~10.58%)、DBP(6.29%~20.76%)、DEP(ND^1.09%),其余未检出。结论GC-MS能够准确、快捷地检测中药代煎包材中邻苯二甲酸酯类塑化剂的含量;样品包材中PAEs及其迁移量符合GB96852016中相关要求;灌装温度与中药代煎包材中DEHP、DBP的迁移率呈正相关,灌装温度越高,DEHP、DBP的迁移率也越高;灌装温度对中药代煎包材中DIBP、DMP和DEP的迁移率没有显著影响。从减少塑化剂的迁移量和保证中药代煎效率的角度出发,中药代煎的灌装温度控制在60℃以下能显著降低DEHP、DBP的迁移量。

Effect of filling temperature on the rate of plasticizer migration in traditional Chinese medicine decocting package

Objective To study the migration chang of phthalate ester plasticizer in the package material of traditional Chinese medicine(TCM)decocting with the change of filling temperature,so as to provide reference for standardizing the process of TCM decocting.Methods The contents of 17 kinds of phthalate ester plasticizers in the TCM decocting package were detected.The boiling distilled water was filled into the traditional Chinese medicine package at the gradient temperature.The migration rate of phthalate plasticizers ester was qualitatively and quantitatively determined by GC-MS.Results GC-MS met the requirements for the detection of phthalate ester plasticizers.The standard curve and correlation coefficient showed a good linear relationship between 0.05 and 5.00 mg/L.The correlation coefficient was beyond 0.998 and the detection limit was 0.002 mg/L.The phthalate ester plasticizers detected and their contents were DEHP(0.122 mg/kg),DBP(0.273 mg/kg),DIBP(0.073 mg/kg),DEP(0.024 mg/kg)and DMP(0.037 mg/kg).The other 12 PAEs were not detected.The plasticizers and their nigration rates were DEHP(0.14%~10.58%),DBP(6.29%~20.76%),and DEP(ND%~1.09%)at the gradient temperature of 30~100℃,and the rest were not detected in distilled water.Conclusion GC-MS can accurately and quickly detect the content of phthalate ester plasticizer in the traditional Chinese medicine decocting package;PAEs and its migration in the sample package meet the relevant requirements of GB96852016;the filling temperature is positively related to the migration rate of DEHP and DBP in the traditional Chinese medicine decocting package:the higher the filling temperature,the higher the migration rate of DEHP and DBP;filling temperature has no significant effect on the migration rate of DIBP,DMP or DEP.In consideration of reducing the migration of plasticizer and ensuring the efficiency of TCM decocting efficienly,the filling temperature of traditional Chinese medicine can significantly reduce the migration of DEHP and DBP under 60℃.