城西刘姐 发表于 2022-9-17 09:23:19

紧急通告!全部停售!武安人赶紧自查!

<!----><style type="text/css">html{font-size:375%}</style><link href="https://pic.app.wuan888.com/static/publish/css/style.css?v=1605251010499" rel="stylesheet" position="1" data-qf-origin="/static/publish/css/style.css?v=1605251010499"><!--    付费贴-->    <div class="preview_article ">            <!---->    <p data-mpa-powered-by="yiban.io">全部停售、召回,暂停使用!</p><p>国家药监局近日发布通告:<strong>涉及9家企业生产的</strong><strong>藿香正气水</strong>、紫草等20批次药品,不符合规定!</p><p><img src="https://pic.app.wuan888.com/backend/20220917091903_4_FmUNOGlhQdgton07Virg4FTEqZT0.png?watermark/1/image/aHR0cHM6Ly9waWMuYXBwLnd1YW44ODguY29tL2FkbWluX0Ztb0ZBVlFDU2VmVnhoWnNYZ2J5bnFoOEkwT1cucG5n/dissolve/20/gravity/Center" width="672" height="519" data-qf-thumb="https://pic.app.wuan888.com/backend/20220917091903_4_FmUNOGlhQdgton07Virg4FTEqZT0.png?watermark/1/image/aHR0cHM6Ly9waWMuYXBwLnd1YW44ODguY29tL2FkbWluX0Ztb0ZBVlFDU2VmVnhoWnNYZ2J5bnFoOEkwT1cucG5n/dissolve/20/gravity/Center" data-qf-origin="backend/20220917091903_4_FmUNOGlhQdgton07Virg4FTEqZT0.png?watermark/1/image/aHR0cHM6Ly9waWMuYXBwLnd1YW44ODguY29tL2FkbWluX0Ztb0ZBVlFDU2VmVnhoWnNYZ2J5bnFoOEkwT1cucG5n/dissolve/20/gravity/Center" data-qf-thumb-origin="backend/20220917091903_4_FmUNOGlhQdgton07Virg4FTEqZT0.png?watermark/1/image/aHR0cHM6Ly9waWMuYXBwLnd1YW44ODguY29tL2FkbWluX0Ztb0ZBVlFDU2VmVnhoWnNYZ2J5bnFoOEkwT1cucG5n/dissolve/20/gravity/Center" /></p><p><strong>赶紧检查一下你身边有没有这些药品<br /><img src="https://pic.app.wuan888.com/backend/20220917091930_4_FigOrR1yHAkK8M1iH_IGRZPeECY_.png" width="657" height="374" /><br /></strong></p><p><strong>点击图片放大查看</strong></p><p>&nbsp;</p><p><strong>这20批次药品中</strong><strong>知名度最高的</strong><strong>莫过于&ldquo;太极藿香正气水&rdquo;!</strong><strong>这也是很多人的夏天常备药。</strong>甲醇量不符合规定,<strong>太极集团召回15677盒</strong><strong>不合格藿香正气水!</strong></p><p>&nbsp;</p><p>此次涉事的剂型为藿香正气水,<strong>该剂型含有40%-50%的酒精</strong>,为酊剂。根据国家药监局的解释,在检测中,甲醇量反映的是酒剂或酊剂等含乙醇制剂中可能由乙醇带来的甲醇的含量。《中国药典》(2020版)规定,除了另有规定外,<strong>供试液甲醇量不得过0.05%(ml/ml)。</strong><strong>甲醇</strong>,又称羟基甲烷或者&ldquo;木醇&rdquo;&ldquo;木精&rdquo;,为无色的有酒精气味的液体,具有毒性,人口服中度最低剂量约为100mg/kg体重,<strong>经口摄入0.3-1g/kg可致死。</strong></p><p><strong><img src="https://pic.app.wuan888.com/backend/20220917092039_4_FirqRvwrnWJ79OHdrmzWodENW-EH.png?watermark/1/image/aHR0cHM6Ly9waWMuYXBwLnd1YW44ODguY29tL2FkbWluX0Ztb0ZBVlFDU2VmVnhoWnNYZ2J5bnFoOEkwT1cucG5n/dissolve/20/gravity/Center" width="444" height="561" data-qf-thumb="https://pic.app.wuan888.com/backend/20220917092039_4_FirqRvwrnWJ79OHdrmzWodENW-EH.png?watermark/1/image/aHR0cHM6Ly9waWMuYXBwLnd1YW44ODguY29tL2FkbWluX0Ztb0ZBVlFDU2VmVnhoWnNYZ2J5bnFoOEkwT1cucG5n/dissolve/20/gravity/Center" data-qf-origin="backend/20220917092039_4_FirqRvwrnWJ79OHdrmzWodENW-EH.png?watermark/1/image/aHR0cHM6Ly9waWMuYXBwLnd1YW44ODguY29tL2FkbWluX0Ztb0ZBVlFDU2VmVnhoWnNYZ2J5bnFoOEkwT1cucG5n/dissolve/20/gravity/Center" data-qf-thumb-origin="backend/20220917092039_4_FirqRvwrnWJ79OHdrmzWodENW-EH.png?watermark/1/image/aHR0cHM6Ly9waWMuYXBwLnd1YW44ODguY29tL2FkbWluX0Ztb0ZBVlFDU2VmVnhoWnNYZ2J5bnFoOEkwT1cucG5n/dissolve/20/gravity/Center" /></strong></p><p><strong>太极藿香正气,</strong><strong>市场占有率高达58%</strong></p><p>太极集团在藿香正气市场呈<strong>一家独大之势</strong>,拥有绝对的行业话语权。中康CHIS开思系统数据显示,在2021年市场占有率高达58%,<strong>尤其是在零售渠道合剂占比更是高达92%。</strong></p><p><strong><img src="https://pic.app.wuan888.com/backend/20220917092111_4_Fr0nkhIpMXZ1cgcpNplZiE7Wdwc-.png?watermark/1/image/aHR0cHM6Ly9waWMuYXBwLnd1YW44ODguY29tL2FkbWluX0Ztb0ZBVlFDU2VmVnhoWnNYZ2J5bnFoOEkwT1cucG5n/dissolve/20/gravity/Center" width="664" height="379" data-qf-thumb="https://pic.app.wuan888.com/backend/20220917092111_4_Fr0nkhIpMXZ1cgcpNplZiE7Wdwc-.png?watermark/1/image/aHR0cHM6Ly9waWMuYXBwLnd1YW44ODguY29tL2FkbWluX0Ztb0ZBVlFDU2VmVnhoWnNYZ2J5bnFoOEkwT1cucG5n/dissolve/20/gravity/Center" data-qf-origin="backend/20220917092111_4_Fr0nkhIpMXZ1cgcpNplZiE7Wdwc-.png?watermark/1/image/aHR0cHM6Ly9waWMuYXBwLnd1YW44ODguY29tL2FkbWluX0Ztb0ZBVlFDU2VmVnhoWnNYZ2J5bnFoOEkwT1cucG5n/dissolve/20/gravity/Center" data-qf-thumb-origin="backend/20220917092111_4_Fr0nkhIpMXZ1cgcpNplZiE7Wdwc-.png?watermark/1/image/aHR0cHM6Ly9waWMuYXBwLnd1YW44ODguY29tL2FkbWluX0Ztb0ZBVlFDU2VmVnhoWnNYZ2J5bnFoOEkwT1cucG5n/dissolve/20/gravity/Center" /></strong></p><section data-tools="135编辑器" data-id="105455"><section data-tools="135编辑器" data-id="105455"><section><section><section><section><section><section><strong>20批次药品不符合规定</strong></section><section><strong>具体情况:</strong></section></section></section><section></section></section><section><section><p><strong>&nbsp;二羟丙茶碱注射液&nbsp;</strong></p></section><section data-autoskip="1"><section>标示为<strong>山西太原药业有限公司</strong>(原太原制药厂)生产的2批次二羟丙茶碱注射液不符合规定,<strong>不符合规定项目为可见异物</strong>。据悉,可见异物系指存在于注射剂、眼用液体制剂中,在规定的目视条件下能够观察到的不溶性物质,其粒径或长度通常大于50微米。</section><section></section></section></section><section><section><section><strong>&nbsp;沉香化滞丸&nbsp;</strong></section></section><section data-autoskip="1"><section>标示为<strong>河北扁鹊制药</strong>有限公司生产的1批次沉香化滞丸不符合规定,不符合规定项目为<strong>装量差异。</strong>据悉,装量差异系反映药物均匀性的指标,是保证准确给药的重要参数之一。</section><section></section></section></section><section><section><p>&nbsp;<strong>藿香正气水&nbsp;</strong></p></section><section data-autoskip="1"><section>标示为四川天府<strong>康达药业</strong>集团府庆制药有限公司、<strong>太极集团</strong>四川南充制药有限公司生产的3批次藿香正气水不符合规定,<strong>不符合规定项目为甲醇量。</strong>据悉,甲醇量反映的是酒剂或酊剂等含乙醇制剂中可能由乙醇带来的甲醇的含量。</section><section></section></section></section><section><section><section><strong>龙泽熊胆胶囊</strong></section></section><section data-autoskip="1"><section>标示为<strong>长春普华制药</strong>股份有限公司生产的1批次龙泽熊胆胶囊不符合规定,<strong>不符合规定项目为微生物限度。</strong>据悉,微生物限度系对非直接进入人体内环境的药物制剂的微生物控制要求。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。</section><p>&nbsp;</p></section></section><section><section><section>&nbsp;<strong>菊花</strong> 标示为盐城市中药饮片有限公司生产的3批次菊花不符合规定,不符合规定项目为<strong>禁用农药残留量。</strong></section><section></section></section><section data-autoskip="1"><section></section></section></section><section><section><section><strong>&nbsp;茜草&nbsp;</strong></section></section><section data-autoskip="1"><p>标示为云南健安堂生物科技有限公司生产的1批次茜草不符合规定,不符合规定项目包括性状、鉴别;标示为桂林中南(亳州)药业科技有限公司生产的2批次茜草不符合规定,不符合规定项目包括性状、鉴别、总灰分、酸不溶性灰分、浸出物。据悉,中药材及饮片标准中的浸出物项可以反映中药材及饮片内在成分含量。中药材及饮片的产地、生长年限、采收季节、加工方式、炮制工艺等环节不规范可能导致其浸出物不符合规定。</p><section></section></section></section><section><section><section><strong>&nbsp;紫草&nbsp;</strong></section></section><section data-autoskip="1"><p>标示为桂林中南(亳州)药业科技有限公司生产的1批次紫草不符合规定,不符合规定项目为含量测定;标示为郑州瑞龙制药股份有限公司生产的6批次紫草不符合规定,不符合规定项目为性状。据悉,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,可能涉及药材种属偏差、炮制工艺有瑕疵、储存不当等情形。</p></section></section></section></section></section><section data-role="paragraph"><section></section><section>&nbsp;停售!召回!</section><p><strong>涉现违法行为立案调查</strong></p></section></section><section data-role="paragraph"><section>对上述不符合规定药品,药品监督管理<strong>部门已要求相关企业和单位采取暂停销售使用、召回</strong>等风险控制措施,对不符合规定原因开展调查并切实进行整改。</section><section></section><section>国家药监局要求相关省级药品监督管理部门依据《中华人民共和国药品管理法》,组织对上述企业和单位<strong>存在的涉嫌违法行为立案调查,并按规定公开查处结果。</strong></section></section>    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