罂粟壳炮制前后吗啡含量的变化研究  

Study on Change of Morphine Content in Yingsuqiao(Papaveris Pericarpium)Before and After Processing

作　　者：李欣 张明童 郭晓霞 王娟弟 李冬华 马潇 LI Xin;ZHANG Mingtong;GUO Xiaoxia;WANG Juandi;LI Donghua;MA Xiao(Gansu Provincial Institute of Drug Control,Lanzhou 730070,Gansu,China;NMPA Key Laboratory for Quality Control of TCM,Lanzhou 730070,Gansu,China)

机构地区：[1]甘肃省药品检验研究院,甘肃兰州730070 [2]国家药品监督管理局中药材及饮片质量控制重点实验室,甘肃兰州730070

出　　处：《辽宁中医杂志》2023年第12期174-178,共5页Liaoning Journal of Traditional Chinese Medicine

基　　金：甘肃省药品科研项目(2022GSMPA0020,2022GSMPA0075);中药材及饮片质量控制重点实验室项目(2022GSMPA-KL12,2022GSMPA-KL10)。

摘　　要：目的建立高效液相色谱法(high performance liquid chromatography,HPLC)测定罂粟壳与蜜罂粟壳饮片中吗啡含量的方法,并对罂粟壳和蜜罂粟壳饮片及水煎煮后吗啡含量进行比较,为其质量标准提高和临床应用提供依据。方法使用Agilent-C_(18)(250 mm×4.6 mm,5μm)色谱柱,乙腈-0.1%磷酸(3∶97)为流动相,流速为1.0 mL·min^(-1),检测波长为210 nm,柱温为30℃。结果建立的吗啡含量测定方法简单、可行。吗啡在9.7156~64.7712μg·mL^(-1)的浓度范围内浓度与峰面积呈现良好的线性关系。相关系数R^(2)=1.0;重复性试验中吗啡含量的RSD为1.0%;稳定性实验中吗啡含量的RSD为0.7%;平均回收率为98.5%。罂粟壳与蜜罂粟壳吗啡含量差异有统计学意义、未水煎罂粟壳吗啡含量与罂粟壳水煎液中吗啡含量差异有统计学意义、未水煎蜜罂粟壳吗啡含量与蜜罂粟壳水煎液中吗啡含量差异有统计学意义、水煎后罂粟壳水煎液中与蜜罂粟壳水煎液中吗啡含量差异有统计学意义。结论建立的罂粟壳吗啡含量测定方法快捷、灵敏、准确、可靠,可用于罂粟壳的含量测定,《中华人民共和国药典》中蜜罂粟壳的吗啡含量限度与罂粟壳一致是不合理的,应将蜜罂粟壳中罂粟壳所占比例考虑进去。Objective To establish an HPLC(high performance liquid chromatography)method for the determination of morphine content in Yingsuqiao(Papaveris Pericarpium)and honey-processed Yingsuqiao(Papaveris Pericarpium)decoction pieces and compare the morphine content in Yingsuqiao(Papaveris Pericarpium)and honey-processed Yingsuqiao(Papaveris Pericarpium)decoction pieces before and after water decoction so as to a basis for improving their quality standards and clinical application.Methods HPLC analysis was performed on an Agilent-C_(18)(250 mm×4.6 mm,5μm)column.Acetonitrile-0.1%phos phoric acid(3∶97)was the mobile phase,the flow rate was 1.0 mL·min^(-1),the detection wavelength was 210 nm and the column temperature was 30℃.Results The HPLC determination method established for the morphine was easy and feasible.The liner area of the morphine was in the range of 9.37156-64.7712μg·mL^(-1).The correlation coefficient was R^(2)=1.0%.The RSD of morphine content in the reproducibility test was 1.0%.The RSD of morphine in stability test was 0.7%.The average recovery was 98.5%.There was a significant difference in morphine content between Yingsuqiao(Papaveris Pericarpium)and honey-processed Yingsuqiao(Papaveris Pericarpium).There was a significant difference in morphine content between Yingsuqiao(Papaveris Pericarpium)without decoction and Yingsuqiao(Papaveris Pericarpium)decoction.There was a significant difference in morphine content between Yingsuqiao(Papaveris Pericarpium)without decoction and honey-processed Yingsuqiao(Papaveris Pericarpium)decoction.There was a significant difference in morphine content between decoction of Yingsuqiao(Papaveris Pericarpium)and honey-processed Yingsuqiao(Papaveris Pericarpium).Conclusion The established method is rapid,sensitive,accurate and reliable and can be used for the determination of morphine content in Yingsuqiao(Papaveris Pericarpium).It is unreasonable that the limits of morphine content in honey-processed Yingsuqiao(Papaveris Pericarpium)in Pharmacopoeia should be the same

关 键 词：罂粟壳 蜜罂粟壳 吗啡 水煎液 炮制 

分 类 号：R282.7[医药卫生—中药学]