新版药典中药安全性控制标准大解读
p style=" text-align: center " strong style=" font-size: 18px text-align: center " 《中国药典》2020年版中药安全性控制标准解读 /strong /p p style=" text-align: center " span style=" font-size: 18px " strong 及岛津应对方案简介 /strong /span /p p style=" text-indent: 2em " strong span style=" font-size: 18px font-family: arial, helvetica, sans-serif color: rgb(192, 80, 77) " 导语 /span /strong br/ /p p style=" text-align: justify line-height: 1.75em " span style=" font-family: 楷体, 楷体_GB2312, SimKai " 《中国药典》2020年版书籍已于6月正式发行,国家药品监督管理局在7月2日发布的关于“国家药监局国家卫生健康委关于发布2020年版《中华人民共和国药典》的公告(2020年第78号”中,明确新版药典于2020年12月30日起实施。新版药典更具科学性和规范性,对中药安全性控制标准体系做出来进一步的完善。 /span /p p style=" text-align: justify line-height: 1.75em " span style=" font-family: 楷体, 楷体_GB2312, SimKai " 在中药标准方面,新版药典加强了对中药材(饮片)33种禁用农残和中药材(饮片)真菌毒素的控制。完善了《中药有害残留物限量制定指导原则》,指导合理制定了中药材(饮片)重金属、农残、真菌毒素等有害物质限度标准。 /span /p p style=" text-align: justify line-height: 1.75em text-indent: 2em " span style=" font-family:楷体, 楷体_GB2312, SimKai" 中药材(饮片)重金属、农残、真菌毒素等有害物质检测和限度标准有何变化?如何做好相关的检测和安全控制工作?在中药安全性控制方面,岛津公司又能提供怎样的整体应对方案呢? /span /p p style=" text-align: justify line-height: 1.75em " span style=" color: rgb(192, 80, 77) font-size: 18px " strong 禁用农残检测标准简介 /strong /span /p p style=" text-align: justify line-height: 1.75em " 2020版药典四部增订《第五法药材及饮片(植物类)中禁用农药多残留测定法》和修订《0212 药材和饮片检定通则》 strong 。首次收载禁用农药残留检测项目、限量要求、检测方法进入四部通则,形成整体检验标准,对中药安全性控制提出了更高的要求。 /strong /p table border=" 1" cellspacing=" 0" cellpadding=" 0" style=" " tbody tr class=" firstRow" td nowrap=" " style=" word-break: break-all border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " a /a a 化合物单体名称 /a /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) word-break: break-all " width=" 90" p style=" text-align:center " GC-MS/MS /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) word-break: break-all " width=" 91" p style=" text-align:center " LC-MS/MS /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) word-break: break-all " width=" 255" p style=" text-align:center " 通则定量限(mg/kg) /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " α-六六六 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td td rowspan=" 4" style=" border-color: rgb(128, 128, 128) " width=" 257" p style=" text-align:center " 四种单体含量之和,0.1 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " γ-六六六 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " β-六六六 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " δ-六六六 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 氟虫腈 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td td rowspan=" 4" style=" border-color: rgb(128, 128, 128) " width=" 259" p style=" text-align:center " 四种单体之和,以氟虫腈表示,0.02 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 氟甲腈 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 氟虫腈亚砜 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 氟虫腈砜 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 艾氏剂 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 261" p style=" text-align:center " 0.05 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 狄氏剂 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 263" p style=" text-align:center " 0.05 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " α-硫丹 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td td nowrap=" " rowspan=" 3" style=" border-color: rgb(128, 128, 128) word-break: break-all " width=" 265" p style=" text-align:center " 三种单体之和,0.05 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " β-硫丹 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 硫丹硫酸酯 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 4,4& #39 -滴滴伊 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td td rowspan=" 4" style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 四种单体之和,0.1 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 2,4& #39 -滴滴涕 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 4,4& #39 -滴滴滴 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 4,4& #39 -滴滴涕 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 特丁硫磷 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.02 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 甲基对硫磷 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.02 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 对硫磷 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.02 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 三氯杀螨醇 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " o,p`-异构体与p,p`-异构体之和,以三氯杀螨醇表示,0.2 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 甲基硫环磷 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.03 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 除草醚 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.05 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 甲胺磷 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.05 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 苯线磷砜 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td rowspan=" 2" style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 苯线磷及砜、亚砜三种单体之和,以苯线磷表示,0.02 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 苯线磷亚砜 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 地虫硫磷 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.02 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 克百威 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td rowspan=" 2" style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 两种单体之和,以克百威表示,0.05 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 3-羟基百威 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 胺苯磺隆 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.05 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 甲磺隆 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.05 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 氯磺隆 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.05 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 硫线磷 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.02 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 氯唑磷 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.01 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 甲拌磷亚砜 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td rowspan=" 2" style=" border-color: rgb(128, 128, 128) word-break: break-all " width=" 265" p style=" text-align:center " 甲拌磷、砜、亚砜三种单体之和,以甲拌磷表示,0.02 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 甲拌磷砜 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 硫环磷 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.03 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 磷胺 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 0.03 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 涕灭威 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td rowspan=" 3" style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 三种单体之和,以涕灭威表示,0.1 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 涕灭威砜 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 涕灭威亚砜 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 特丁硫磷砜 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td td rowspan=" 2" style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " 两种单体之和,0.02 /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " 特丁硫磷亚砜 /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" br/ /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " ● /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) word-break: break-all " width=" 126" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 甲基异柳磷 /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 0.02 /span /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 灭线磷 /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 0.02 /span /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 杀虫脒 /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 0.02 /span /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 甲拌磷 /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td style=" border-color: rgb(128, 128, 128) word-break: break-all " width=" 265" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 甲拌磷、砜、亚砜三种单体之和,以甲拌磷表示,0.02 /span /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 内吸磷 /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " O-异构体与S-异构体之和,以内吸磷表示,0.02 /span /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 久效磷 /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 0.03 /span /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 水胺硫磷 /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 0.05 /span /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 蝇毒磷 /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 0.05 /span /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 苯线磷 /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 苯线磷及砜、亚砜三种单体之和,以苯线磷表示,0.02 /span /p /td /tr tr td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 126" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 治螟磷 /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 98" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 91" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " ● /span /p /td td nowrap=" " style=" border-color: rgb(128, 128, 128) " width=" 265" p style=" text-align:center " span style=" color: rgb(255, 0, 0) " 0.02 /span /p /td /tr /tbody /table p style=" text-align: center line-height: 1.75em " span style=" text-align: center " 33种禁用农药残留检测方法(来源2341第五法)及项目定量限要求(来源0212通则) /span br/ /p p style=" text-align: justify line-height: 1.75em " 《0212药材和饮片检定通则》规定药材及饮片(植物类)禁用农药不得检出,检出浓度不得过定量限,两种方法检出化合物数量及定量限要求如下: /p p style=" text-align: justify line-height: 1.75em text-indent: 2em " 去除内标,两种方法共检测55个(残留物)单体 /p p style=" text-align: justify line-height: 1.75em text-indent: 2em " LC-MS/MS测定30个(残留物)单体,GC-MS/MS测定35个(残留物)单体 /p p style=" text-align: justify line-height: 1.75em " 10个残留物的测定既可使用气质联用法,也可使用液质联用法 /p p style=" text-align: justify line-height: 1.75em " 2020版药典植物类药材和饮片共收载品种数544个 /p p style=" text-align: justify line-height: 1.75em text-indent: 2em " span style=" font-size: 18px color: rgb(192, 80, 77) " strong 真菌毒素检测标准简介 /strong /span /p p style=" text-align: justify line-height: 1.75em " 2020版药典四部修订了2351通则,原《2351 黄曲霉毒素测定法》修订为《2351 真菌毒素测定法》, strong 在2015版药典收载黄曲霉毒素测定法基础上,增订了对人体危害较大的展青霉素、赭曲霉毒素A、玉米赤霉烯酮、呕吐毒素等单种毒素测定方法和10种多毒素测定法。 /strong 另外,在2015版药典基础上,2020版药典部分品种【检查】项下增订真菌毒素项目,具体品种及方法要求汇总如下: /p p style=" text-align: justify line-height: 1.5em " img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202007/uepic/5ab2e6eb-42ce-4dac-8f97-fd29a792665d.jpg" title=" 岛津2.png" alt=" 岛津2.png" / span style=" text-align: justify " 注:2351通则【附注】第二条提到:)各方法中如果采用第一法液相色谱法测定结果超出限度时,应采用收载的第二法液相色谱-串联质谱法进行确认。 /span /p p style=" text-align: justify line-height: 1.5em text-indent: 2em " span style=" color: rgb(192, 80, 77) font-size: 18px " strong 重金属及形态检测标准简介 /strong /span br/ /p p style=" text-align: justify line-height: 1.5em " strong 2322 汞、砷元素形态及价态测定法修订变化 /strong /p p style=" text-align: justify line-height: 1.5em " 相比2015版药典通则,在原有“矿物药及其制剂”检测方法基础上,增加动物类、植物类检测方法,开始被产品标准引用,成为法定检验方法。2020版药典一部“朱砂”在【检查】项下增订“二价汞”检测项目,“雄黄”在【检查】项下增订“三价砷和五价砷”检测项目。 /p p style=" text-align: justify line-height: 1.5em text-indent: 2em " strong 重金属及有害元素限量标准修订变化 /strong /p p style=" text-align: justify line-height: 1.5em " 新版药典一部植物类药材和饮片部分品种在【检查】项下增订“重金属及有害元素”项目,内容见下表。2020版药典《9302 中药有害残留物限量制定指导原则》增订“重金属及有害元素一致性限量指导值”要求,成为标准制定指导性规定。 /p p style=" text-align: justify line-height: 1.5em " 品种标准收载变化:在2015版药典一部植物类药材和饮片中,白芍、丹参、甘草等8个品种在标准中收载了【重金属及有害元素】检查项,2020版药典在15版药典基础上,白芷、当归、葛根等10个品种标准增订【重金属及有害元素】检查项。2020版药典将“镉”限量值由0.3mg/kg修订为1mg/kg,其它元素限量值保持不变。 /p p style=" text-align: center line-height: 1.5em " 品种标准(植物类药材和饮片)收载【重金属及有害元素】及限量值比较 /p p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202007/uepic/00a60dea-f1b7-4c6c-bb0c-bdf94cc61fc2.jpg" title=" 岛津3.png" alt=" 岛津3.png" / /p p style=" text-align: justify line-height: 1.5em text-indent: 2em " strong span style=" font-size: 18px color: rgb(192, 80, 77) " 岛津中药安全性控制整体应对方案及应用案例 /span /strong /p p style=" text-align: justify line-height: 1.5em " strong 植物类药材和饮片禁用农药残留全流程检测解决方案 /strong /p p style=" text-align: justify line-height: 1.5em " strong /strong /p p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202007/uepic/d078a9b5-8b2d-489c-84a5-35a83eb77464.jpg" title=" 岛津4.png" alt=" 岛津4.png" / /p p style=" text-align: left line-height: 1.5em " strong 部分植物类药材和饮片禁用农药检出禁用农药情况 /strong /p p style=" text-align: left line-height: 1.5em " strong /strong /p p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202007/uepic/370accae-ad84-4c3d-8c95-a77ebb1a8cab.jpg" title=" 岛津5.png" alt=" 岛津5.png" / /p p style=" text-align: justify line-height: 1.5em " 从汇总表可以了解 strong 氟虫腈、克百威、甲拌磷 /strong 三类残留物检出率达到50%以上,出现频率很高。麦冬、金银花、三七、石斛检出残留物数量超过4个,对于药企建议作为重点监控品种,而石斛这种不仅有多个残留物检出,而且含量基本都超过通则规定定量限,企业需要进行重点关注。 /p p style=" text-align: justify line-height: 1.5em " span style=" color: rgb(0, 0, 0) " strong 药材和饮片真菌毒素全流程检测解决方案 /strong /span /p p style=" text-align: justify line-height: 1.5em " span style=" color: rgb(0, 0, 0) " strong /strong /span /p p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202007/uepic/21ed6305-a772-4e19-bc18-fab35daed0cb.jpg" title=" 岛津6.png" alt=" 岛津6.png" / /p p style=" text-align: justify line-height: 1.5em " span style=" color: rgb(0, 0, 0) " strong /strong /span br/ /p p style=" text-align: justify line-height: 1.5em " strong 药材和饮片10种真菌毒素检测案例 /strong /p p style=" text-align: justify line-height: 1.5em " strong /strong /p p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202007/uepic/b4708259-09a0-4c39-bb7d-074949489711.jpg" title=" 岛津7.png" alt=" 岛津7.png" / /p p style=" text-align: center line-height: 1.5em " strong 2351通则第六法10种真菌毒素薏苡仁基质标准溶液的MRM图谱 /strong /p p style=" line-height: 1.5em " strong br/ /strong /p p style=" text-align: center line-height: 1.5em " strong 薏苡仁样品检测结果 /strong /p p style=" line-height: 1.5em " strong /strong /p p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202007/uepic/b0d3c1d3-71ad-489f-aa0b-95f4dfd71556.jpg" title=" 岛津8.png" alt=" 岛津8.png" / /p p style=" text-align: justify line-height: 1.5em " 对“薏苡仁”样品进行检测,发现四种真菌毒素有检出,分别是DON(呕吐毒素)、FB1(伏马毒素B1)、FB2(伏马毒素B2)、ZON(玉米赤霉烯酮),其中“薏苡仁”药典正文规定需要检测黄曲霉毒素和玉米赤霉烯酮,样品检测结果满足药典要求。样品实际检测结果提示粮谷类有类似基质的中药材应注意伏马毒素、呕吐毒素和玉米赤霉烯酮的检测,如淡豆鼓、白扁豆等。 /p p style=" text-align: justify line-height: 1.5em " strong 中药重金属及形态检测整体解决方案 /strong /p p style=" text-align: justify line-height: 1.5em " strong /strong /p p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202007/uepic/1c3605df-8b4c-4aca-a8a2-9ce935174180.jpg" title=" 岛津9.png" alt=" 岛津9.png" / /p p style=" text-align: justify line-height: 1.5em " strong 朱砂中元素形态及价态分析 /strong /p p style=" text-align: justify line-height: 1.5em " 朱砂是硫化汞的天然矿石,大红色,主要成分为硫化汞,但常夹杂雄黄、磷灰石、沥青质等。考察朱砂中的不同形态汞及价态含量还是非常有意义的。2020版药典一部 “朱砂”标准在【检查】项下增订“二价汞”检测项目,要求药品中二价汞不得过0.10%。 /p p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202007/uepic/c098e443-74f2-4d90-b849-b9c91735bf86.jpg" title=" 岛津10.png" alt=" 岛津10.png" / /p p style=" text-align: center line-height: 1.5em " 形态及价态汞色谱图 /p table style=" " align=" center" tbody tr class=" firstRow" td nowrap=" " style=" word-break: break-all border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " strong 处理方式 /strong strong /strong /p /td td nowrap=" " style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " strong 测定结果 /strong /p p style=" text-align:center " strong ( /strong strong ng/mL /strong strong ) /strong strong /strong /p /td td style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " strong 样品含量 /strong strong /strong br/ & nbsp & nbsp strong (μ /strong strong g/g /strong strong ) /strong strong /strong /p /td td nowrap=" " style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " strong 加标浓度 /strong /p p style=" text-align:center " strong ( /strong strong ng/mL /strong strong ) /strong strong /strong /p /td td style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " strong 加标测定结果 /strong /p p style=" text-align:center " strong ( /strong strong ng/mL /strong strong ) /strong strong /strong /p /td td nowrap=" " style=" word-break: break-all border-width: 1px border-style: solid border-color: windowtext " width=" 78" p style=" text-align:center " strong 加标回收率( /strong strong % /strong strong ) /strong strong /strong /p p strong br/ /strong /p /td /tr tr td nowrap=" " style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " strong 人工胃液处理 /strong strong /strong /p /td td nowrap=" " style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " 2.14 /p /td td style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " 89.17 /p /td td nowrap=" " style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " 10 /p /td td style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " 12.2 /p /td td nowrap=" " style=" border-width: 1px border-style: solid border-color: windowtext " width=" 78" p style=" text-align:center " 100.8 /p /td /tr tr td nowrap=" " style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " strong 人工肠液处理 /strong strong /strong /p /td td nowrap=" " style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " ND /p /td td style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " --- /p /td td nowrap=" " style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " 10 /p /td td style=" border-width: 1px border-style: solid border-color: windowtext " p style=" text-align:center " 9.37 /p /td td nowrap=" " style=" border-width: 1px border-style: solid border-color: windowtext " width=" 78" p style=" text-align:center " 93.7 /p /td /tr /tbody /table p style=" text-align: center " 朱砂中二价汞测试结果及加标回收率(%) /p p style=" text-align: justify line-height: 1.5em " 采用岛津公司LC-20Ai系列液相色谱仪和 ICPMS-2030系列电感耦合等离子体质谱仪分析朱砂中的价态汞,样品中人工胃液和人工肠液二价汞测定总的含量为0.0089%,远低于限值要求的0.10%,满足2020版中国药典朱砂产品标准检查项二价汞含量不超过0.10% 的要求。方法检出限20.8 μg/g远低于朱砂中二价汞的限值要求1000 μg/g(即0.10%),样品二价汞加标回收率达到93.7~100.8%,岛津建立方法适用于朱砂样品中二价汞含量的测定,可为矿物药(药材、饮片)元素形态及价态检测提供参考。 /p p style=" text-align: right line-height: 1.5em " strong 供稿人:岛津企业管理(中国)有限公司 丰伟刚 /strong /p p br/ /p