蔡甸融媒 发表于 2021-6-15 16:00:09

紧急召回,赶紧自查!

<p style="text-align: center;"><span style="letter-spacing: 1px; text-align: center;">近日</span></p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">国家药监局官网发布了</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">关于<strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">16批次药品不符合规定</strong>的通告</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;"><strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">涉及多种常用药!</strong></p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">赶紧检查一下</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">你家的小药箱有没有中招</p><p style="margin: 0px 0.5em; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;"><br/></p><p style="margin: 0px 0.5em;text-align: center;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="image"></p><p><br/></p><section data-mpa-template="t" mpa-from-tpl="t"><section data-mpa-template="t" mpa-from-tpl="t"><section mpa-from-tpl="t" style="padding: 1px 5px;"><h2 style="margin: 5px;padding-right: 10px;padding-left: 10px;font-weight: 400;font-size: 16px;border-left: 5px solid rgb(27, 74, 134);line-height: px;color: rgb(27, 74, 134);border-top-color: rgb(27, 74, 134);border-bottom-color: rgb(27, 74, 134);border-right-color: rgb(27, 74, 134);"><p mpa-is-content="t" style="clear: both;min-height: 1em;border-color: rgb(255, 85, 35);"><strong mpa-from-tpl="t" style="font-size: 18px;"><span mpa-is-content="t" style="color: rgb(0, 0, 0);"><strong mpa-from-tpl="t" style="color: rgb(27, 74, 134);font-size: 16px;"><span mpa-is-content="t" style="font-size: 18px;">停售!召回!</span></strong></span></strong><br mpa-from-tpl="t"/></p></h2></section></section></section><p><br/></p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 1.75;" mpa-paragraph-type="image"><img data-ratio="0.537962962962963" src="http://bbs.whcdrm.com/plugin.php?id=wcn_editor:wx_img&url=https://mmbiz.qpic.cn/mmbiz_png/qgf7Xfia5CoWwgX3p8RtaRcjd3q1H3bjicicj7FxQ2Dia7PbqWJ32jUzq4wX0ek1IlJxhHjQ24Aiarke6ntDE9SY7CA/640?wx_fmt=png" data-type="png" data-w="1080" style="box-sizing:border-box;box-shadow: #d2d2d2 0em 0em 0.5em 0px;border-width: 1px;border-style: solid;border-color: #000000;overflow-wrap: break-word !important;visibility: visible !important;width: 677px !important;"/></p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 1.75;" mpa-paragraph-type="image"><img data-ratio="0.562962962962963" src="http://bbs.whcdrm.com/plugin.php?id=wcn_editor:wx_img&url=https://mmbiz.qpic.cn/sz_mmbiz_png/ia4FDiaA6IyAeIBPW9rmNIAjqdLLfgTCLHEHPvqRId6eWoAiawJlgbU4ZcibOpcyO0E8lXeqsYme6CIyHS7nLZB9oA/640?wx_fmt=png" data-type="png" data-w="1080" style="box-sizing:border-box;border-width: 1px;border-style: solid;border-color: #000000;box-shadow: #d2d2d2 0em 0em 0.5em 0px;overflow-wrap: break-word !important;visibility: visible !important;width: 677px !important;"/></p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;"><br/></p><p style="margin: 0px 0.5em; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em; text-align: center;">对上述不符合规定药品</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">药品监督管理部门</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">已要求相关企业和单位</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">采取<strong><span style="background-color: rgb(255, 0, 0);font-size: 16px;color: rgb(255, 255, 255);">暂停销售使用、召回</span></strong>等</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">风险控制措施</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">对不符合规定原因</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">开展调查并切实进行整改</p><p><br/></p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">国家药品监督管理局</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">要求相关省级药品监督管理部门</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">依据《中华人民共和国药品管理法》</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;"><strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">组织对上述企业和单位</strong></p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;"><strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">生产销售假劣药品的违法行为</strong></p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;"><strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">立案调查</strong></p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">并按规定公开查处结果</p><p style="margin: 0px 0.5em; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 1.75;" mpa-paragraph-type="body"><br/></p><p style="margin: 0px 0.5em;text-align: center;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="image"></p><p style="margin: 0px 0.5em; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 1.75;" mpa-paragraph-type="image"><br/></p><p style="margin: 0px 0.5em;text-align: center;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="image"><span style="text-align: justify;"></span></p><p><br/></p><section data-mpa-template="t" mpa-from-tpl="t"><section data-mpa-template="t" mpa-from-tpl="t"><section mpa-from-tpl="t" style="padding: 1px 5px;"><h2 style="margin: 5px;padding-right: 10px;padding-left: 10px;font-weight: 400;font-size: 16px;border-left: 5px solid rgb(27, 74, 134);line-height: px;color: rgb(27, 74, 134);border-top-color: rgb(27, 74, 134);border-bottom-color: rgb(27, 74, 134);border-right-color: rgb(27, 74, 134);"><p mpa-is-content="t" style="clear: both;min-height: 1em;border-color: rgb(255, 85, 35);"><strong mpa-from-tpl="t" style="font-size: 18px;"><span mpa-is-content="t" style="color: rgb(0, 0, 0);"><strong mpa-from-tpl="t" style="color: rgb(27, 74, 134);font-size: 16px;"><span mpa-is-content="t" style="font-size: 18px;">不符合规定药品情况</span></strong></span></strong><br mpa-from-tpl="t"/></p></h2></section></section></section><p><br/></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body"><br mpa-from-tpl="t"/></p><p><br/></p><section data-mpa-template="t" mpa-from-tpl="t"><section data-mpa-template="t" mpa-from-tpl="t"><section mpa-from-tpl="t" style="color: rgb(51, 51, 51);text-align: justify;font-size: 16px;letter-spacing: 0.544px;overflow-wrap: break-word !important;"><section mpa-from-tpl="t" style="margin-top: 10px;margin-bottom: 10px;text-align: center;overflow-wrap: break-word !important;"><br mpa-from-tpl="t" style="overflow-wrap: break-word !important;"/></section></section><section mpa-from-tpl="t" style="text-align: justify;font-size: 16px;overflow-wrap: break-word !important;"><section mpa-from-tpl="t" style="margin-top: -73px;margin-bottom: 10px;text-align: center;transform: translate3d(0px, 0px, 0px);overflow-wrap: break-word !important;"><section mpa-from-tpl="t" style="margin-right: 5px;margin-left: 5px;padding: 10px 20px;border-width: 1px;border-style: solid;border-color: transparent;box-shadow: rgb(170, 170, 170) 0px 0px 5px;border-radius: 0.6em;background-color: rgb(254, 255, 255);overflow-wrap: break-word !important;"><section mpa-from-tpl="t" style="overflow-wrap: break-word !important;"><p style="color: rgb(51, 51, 51); letter-spacing: 0.544px; clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">经安徽省食品药品检验研究院检验,标示为河北九正药业有限公司生产的1批次</span><span style="letter-spacing: 1px;font-size: 16px;color: rgb(255, 255, 255);background-color: rgb(255, 0, 0);overflow-wrap: break-word !important;">复方克霉唑乳膏</span><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">不符合规定,<strong>不符合规定项目为微生物限度;</strong>标示为山东博山制药有限公司生产的1批次<strong>复方克霉唑乳膏</strong>不符合规定,<strong>不符合规定项目为装量。</strong></span></p><p style="clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="color:#494949;"><span style="letter-spacing: 1px;"><strong><br/></strong></span></span></p><p style="color: rgb(51, 51, 51); letter-spacing: 0.544px; clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">经山西省食品药品检验所检验,标示委托方为山西天致药业有限公司、受托方为重庆天致药业股份有限公司生产的1批次</span><span style="letter-spacing: 1px;font-size: 16px;background-color: rgb(255, 0, 0);color: rgb(255, 255, 255);overflow-wrap: break-word !important;">骨刺宁胶囊</span><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">不符合规定,<strong>不符合规定项目为水分。</strong></span></p><p style="color: rgb(51, 51, 51); letter-spacing: 0.544px; clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t"><strong><br/></strong></span></p><p style="color: rgb(51, 51, 51); letter-spacing: 0.544px; clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">经云南省食品药品监督检验研究院检验,标示为江苏百益制药有限公司、江西吉安三力制药有限公司生产的3批次</span><span style="letter-spacing: 1px;font-size: 16px;background-color: rgb(255, 0, 0);color: rgb(255, 255, 255);overflow-wrap: break-word !important;">关节止痛膏</span><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">不符合规定,<strong>不符合规定项目为含量测定。</strong></span></p><p style="color: rgb(51, 51, 51); letter-spacing: 0.544px; clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t"><strong><br/></strong></span></p><p style="color: rgb(51, 51, 51); letter-spacing: 0.544px; clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">经湖南省药品检验研究院(湖南药用辅料检验检测中心)检验,标示为四川琦云药业有限责任公司生产的1批次</span><strong><span style="letter-spacing: 1px;font-size: 16px;background-color: rgb(255, 0, 0);color: rgb(255, 255, 255);overflow-wrap: break-word !important;">黄连上清丸</span></strong><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">不符合规定,<strong>不符合规定项目为装量差异。</strong></span></p><p style="color: rgb(51, 51, 51); letter-spacing: 0.544px; clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t"><strong><br/></strong></span></p><p style="color: rgb(51, 51, 51); letter-spacing: 0.544px; clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">经西藏自治区食品药品检验研究院检验,标示为一力制药股份有限公司生产的1批次</span><strong><span style="letter-spacing: 1px;font-size: 16px;background-color: rgb(255, 0, 0);color: rgb(255, 255, 255);overflow-wrap: break-word !important;">咳特灵胶囊</span></strong><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">不符合规定,<strong>不符合规定项目为微生物限度。</strong></span></p><p style="color: rgb(51, 51, 51); letter-spacing: 0.544px; clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t"><strong><br/></strong></span></p><p style="color: rgb(51, 51, 51); letter-spacing: 0.544px; clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">经武汉药品医疗器械检验所检验,标示为广州粤华制药有限公司生产的1批次</span><strong><span style="letter-spacing: 1px;font-size: 16px;background-color: rgb(255, 0, 0);color: rgb(255, 255, 255);overflow-wrap: break-word !important;">加味藿香正气丸</span></strong><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">不符合规定,<strong>不符合规定项目为鉴别。</strong></span></p><p style="color: rgb(51, 51, 51); letter-spacing: 0.544px; clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">经中国食品药品检定研究院检验,标示为安徽健诚中药饮片有限公司、安徽鑫泰药业有限公司、成都吉安康药业有限公司生产的3批次</span><strong><span style="letter-spacing: 1px;font-size: 16px;background-color: rgb(255, 0, 0);color: rgb(255, 255, 255);overflow-wrap: break-word !important;">青葙子</span></strong><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">不符合规定,<strong>不符合规定项目为性状。</strong></span></p><p style="color: rgb(51, 51, 51); letter-spacing: 0.544px; clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t"><strong><br/></strong></span></p><p style="color: rgb(51, 51, 51); letter-spacing: 0.544px; clear: both; min-height: 1em; text-align: justify; line-height: 2em; overflow-wrap: break-word !important;"><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">经甘肃省药品检验研究院检验,标示为重庆众妙药业有限公司生产的2批次</span><strong><span style="letter-spacing: 1px;font-size: 16px;background-color: rgb(255, 0, 0);color: rgb(255, 255, 255);overflow-wrap: break-word !important;">柴胡</span></strong><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">不符合规定,<strong>不符合规定项目为性状;</strong>标示为广西玉林泰龙中药饮片有限公司生产的1批次</span><strong><span style="letter-spacing: 1px;font-size: 16px;background-color: rgb(255, 0, 0);color: rgb(255, 255, 255);overflow-wrap: break-word !important;">柴胡(北柴胡)</span></strong><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">不符合规定,<strong>不符合规定项目为性状;</strong>标示为四川仁禾中药饮片有限公司生产的1批次</span><strong><span style="letter-spacing: 1px;font-size: 16px;background-color: rgb(255, 0, 0);color: rgb(255, 255, 255);overflow-wrap: break-word !important;">柴胡(北柴胡)</span></strong><span style="letter-spacing: 1px;color: rgb(73, 73, 73);font-size: 16px;overflow-wrap: break-word !important;" mpa-is-content="t">不符合规定,<strong>不符合规定项目为杂质。</strong></span></p></section></section></section></section></section></section><p><br/></p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;"><br/></p><p style="margin: 0px 0.5em; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em; text-align: center;">看到这,不少小伙伴是不是疑惑</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">微生物限度、含量测定...</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">这都是啥?</p><p style="margin: 0px 0.5em;text-align: center;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="image"><br/></p><p style="margin: 0px 0.5em; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 1.75; text-align: center;" mpa-paragraph-type="image"></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body"><strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;"><br mpa-from-tpl="t"/></strong></p><p><br/></p><section data-mpa-template="t" mpa-from-tpl="t"><section data-mpa-template="t" mpa-from-tpl="t"><section mpa-from-tpl="t" style="padding: 1px 5px;"><h2 style="margin: 5px;padding-right: 10px;padding-left: 10px;font-weight: 400;font-size: 16px;border-left: 5px solid rgb(27, 74, 134);line-height: px;color: rgb(27, 74, 134);border-top-color: rgb(27, 74, 134);border-bottom-color: rgb(27, 74, 134);border-right-color: rgb(27, 74, 134);"><p mpa-is-content="t" style="clear: both;min-height: 1em;border-color: rgb(255, 85, 35);"><strong mpa-from-tpl="t" style="font-size: 18px;"><span mpa-is-content="t" style="color: rgb(0, 0, 0);"><strong mpa-from-tpl="t" style="color: rgb(27, 74, 134);font-size: 16px;"><span mpa-is-content="t" style="font-size: 18px;">不符合规定项目小知识</span></strong></span></strong><br mpa-from-tpl="t"/></p></h2></section></section></section><p><br/></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body">一、微生物限度系对非直接进入人体内环境的药物制剂的<strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">微生物控制要求。</strong>由于此类药物制剂的用药风险略低,可以允许一定数量的微生物存在,但不得检出一些条件致病菌。微生物限度分为计数检查和控制菌检查两部分。</p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body"><br/></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body">二、装量系反映药品重量或容量的指标,适用于固体、半固体、液体制剂,规定应按最低装量检查法进行检查,<strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">不符合规定会导致临床给药剂量不足。</strong></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body"><strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;"><br/></strong></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body">三、水分系指药品中的含水量。<strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">水分偏高通常与工艺、包装不当以及储运环境等因素有关。</strong></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body"><strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;"><br/></strong></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body">四、含量测定系指<strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">用规定的试验方法测定原料及制剂中有效成分的含量,</strong>一般可采用化学、仪器或生物测定方法。</p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body"><br/></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body">五、装量差异系反映药物均匀性的指标,是<strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">保证准确给药的重要参数之一。</strong></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body"><strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;"><br/></strong></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body">六、鉴别项主要用于<strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">区分药品特性</strong><strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">,</strong>其手段包括显微鉴别、光谱鉴别等,薄层色谱法是常用的鉴别方法。</p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body"><br/></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body">七、性状项下记载外观、臭、味、溶解度以及物理常数等,在一定程度上反映药品的质量特性。中药饮片性状项不符合规定,可能涉及<strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">药材种属偏差、炮制工艺有瑕疵、储存不当</strong>等情形。</p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body"><br/></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body">八、中药饮片中混存的杂质系指来源于<strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">规定相同但其性状或药用部位与规定不符的物质</strong>,以及来源<strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;">与规定不同的无机杂质,如砂石、泥块、尘土等。</strong></p><p style="margin: 0px 0.5em;text-align: justify;color: rgb(0, 0, 0);letter-spacing: 1px;font-size: 16px;line-height: 1.75;" mpa-paragraph-type="body"><strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;"><br/></strong></p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">药品安全,至关重要<br/></p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">容不得一丝一毫的差错</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">召回以外,还需彻查原因!</p><p style="margin: 0px 0.5em; text-align: center; color: rgb(0, 0, 0); letter-spacing: 1px; font-size: 16px; line-height: 2em;">扩散提醒身边的朋友!<strong style="margin: 0px 0em;text-align: left;color: rgb(0, 0, 0);letter-spacing: 0px;font-size: 16px;line-height: 1.75;"></strong></p><p><br/></p><section data-mpa-template="t" mpa-from-tpl="t" mpa-paragraph-type="ignored"><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; white-space: normal; overflow-wrap: break-word !important;"><section powered-by="xiumi.us" style="margin: 0.5em 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word !important;"><section style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box; overflow-wrap: break-word !important; height: 1px; background-color: rgb(160, 160, 160); line-height: 0;"><br style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important;"/></section></section></section><p><span style="color: rgb(136, 136, 136); font-size: 14px; letter-spacing: 0.544px; font-family: -apple-system-font, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif;">来源:</span><span style="color: rgb(136, 136, 136); font-size: 14px; letter-spacing: 0.544px; font-family: -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; text-align: justify; background-color: rgb(255, 255, 255);">国家药品监督管理局官网 荆楚网</span><br/></p><p style="margin: 0cm 0cm 0.0001pt; padding: 0px; max-width: 100%; clear: both; min-height: 1em; white-space: normal; font-family: -apple-system-font, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; line-height: 19.2pt; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; letter-spacing: 0.544px; color: rgb(136, 136, 136); font-size: 14px;">制作:万轶 |&nbsp;</span><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; color: rgb(136, 136, 136); letter-spacing: 0.544px; font-size: 14px;">编辑:方丹 |&nbsp;</span><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: break-word !important; letter-spacing: 0.544px; color: rgb(136, 136, 136); font-size: 14px;">责编:方军</span></p><p style="margin: 0cm 0cm 0.0001pt; padding: 0px; max-width: 100%; clear: both; min-height: 1em; white-space: normal; font-family: -apple-system-font, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; line-height: 19.2pt; box-sizing: border-box !important; overflow-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; overflow-wrap: 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