lemon 发表于 2023-10-10 11:02:00

抗体药研发问答|| 176~180 《聚山梨酯(吐温)在制剂中的作...

<div style="max-width:677px;overflow:hidden;"><section style="white-space: normal;"><span style="text-indent: 0em; font-family: &quot;Microsoft YaHei&quot;, &quot;Apple Color Emoji&quot;, &quot;Emoji Symbols Font&quot;, &quot;Segoe UI Symbol&quot;, Arial, sans-serif; color: rgb(0, 122, 170); font-size: 16px;"><strong><span style="letter-spacing: 1px;"><strong>♂</strong></span></strong></span><span style="text-indent: 0em; font-family: &quot;Microsoft YaHei&quot;, &quot;Apple Color Emoji&quot;, &quot;Emoji Symbols Font&quot;, &quot;Segoe UI Symbol&quot;, Arial, sans-serif; color: rgb(0, 122, 170);"><strong><span style="max-width: 100%; letter-spacing: 0.5px; font-size: 16px; box-sizing: border-box !important;">问题</span></strong></span><strong style="text-indent: 0em; color: rgb(0, 0, 0); font-family: &quot;Microsoft YaHei&quot;, &quot;Apple Color Emoji&quot;, &quot;Emoji Symbols Font&quot;, &quot;Segoe UI Symbol&quot;, Arial, sans-serif;"><span style="font-family: Arial, sans-serif; font-size: 15px;">176</span></strong><span style="text-indent: 0em; font-family: &quot;Microsoft YaHei&quot;, &quot;Apple Color Emoji&quot;, &quot;Emoji Symbols Font&quot;, &quot;Segoe UI Symbol&quot;, Arial, sans-serif; color: rgb(0, 122, 170);"><strong><span style="max-width: 100%; letter-spacing: 0.5px; font-size: 16px; box-sizing: border-box !important;">&nbsp;</span></strong></span><span style="text-indent: 0em; font-family: &quot;Microsoft YaHei&quot;, &quot;Apple Color Emoji&quot;, &quot;Emoji Symbols Font&quot;, &quot;Segoe UI Symbol&quot;, Arial, sans-serif; color: rgb(0, 122, 170);"><strong><span style="max-width: 100%; letter-spacing: 0.5px; font-size: 16px; box-sizing: border-box !important;"></span></strong></span><span style="text-indent: 0em; font-family: &quot;Microsoft YaHei&quot;, &quot;Apple Color Emoji&quot;, &quot;Emoji Symbols Font&quot;, &quot;Segoe UI Symbol&quot;, Arial, sans-serif; color: rgb(0, 122, 170);"><strong><span style="max-width: 100%; letter-spacing: 0.5px; font-size: 16px; box-sizing: border-box !important;">聚山梨酯(吐温)在制剂中有什么作用?</span></strong></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><section data-id="3074" style="font-variant-numeric: normal;font-variant-east-asian: normal;font-size: 14px;background-color: rgb(255, 255, 255);max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;font-family: 微软雅黑;text-align: left;"><section style="margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;"><section style="max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;align-items: center;display: flex;justify-content: center;"><section data-width="100%" style="max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;border-bottom: 1px solid rgb(88, 88, 88);border-top: 3px solid rgb(88, 88, 88);height: 6px;width: 315.047px;"><br></section><section data-width="100%" style="max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;border-bottom: 1px solid rgb(88, 88, 88);border-top: 3px solid rgb(88, 88, 88);height: 6px;width: 315.047px;"><br></section></section></section></section><p style="font-size: 16px;background-color: rgb(255, 255, 255);"><strong style="box-sizing: inherit;"></strong></p><table align="center" interlaced="enabled"><tbody><tr class="ue-table-interlace-color-single"><td width="557" valign="bottom" align="left" style="word-break: break-all;background-color: rgb(255, 255, 255);"><p style="text-indent: 0em;margin-bottom: 5px;"><span style="font-size: 16px;"><strong><span style="color: rgb(171, 25, 66);letter-spacing: 1px;">回</span></strong><strong><span style="color: rgb(171, 25, 66);letter-spacing: 1px;">答:如下</span></strong></span></p><ul class="list-paddingleft-2" style="list-style-type: disc;"><li><p style="text-indent: 0em;margin-bottom: 5px;"><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">聚山梨酯(PS)是一类两亲性,非离子表面活性剂家族,生物药物制剂中使用最广泛的表面活性剂,可防止蛋白质在融化过程中变性、聚集、表面吸附和絮凝剂制</span><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">剂。</span></p></li><li><p style="text-indent: 0em;margin-bottom: 5px;"><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;"></span><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">作为制剂中用作蛋白质稳定剂,主要是因为吐温具体生物相容性较好、低毒性、且能有效的稳定蛋白质作用。即使在较低浓度下,由于PS20和PS80的亲水亲脂平衡值高和临界胶束浓度低,它们也提供了足够的蛋白质稳</span><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">定性。</span></p></li></ul><p><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;"></span></p><p><span style="text-align: center;font-weight: 700;text-indent: 34px;letter-spacing: 5px;font-family: arial, helvetica, sans-serif;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;<span style="color: rgb(0, 0, 0);background-color: rgb(255, 255, 255);text-align: center;font-weight: 700;text-indent: 34px;letter-spacing: 5px;font-family: arial, helvetica, sans-serif;font-size: 15px;">&nbsp;</span><span style="font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-indent: 0em;background-color: rgb(255, 255, 255);text-align: center;color: rgb(123, 12, 0);font-size: 14px;"><span style="font-weight: 700;text-indent: 34px;letter-spacing: 5px;font-family: arial, helvetica, sans-serif;">&nbsp;</span></span></span><span style="text-align: center;color: rgb(255, 172, 170);letter-spacing: 1px;text-indent: 34px;font-family: arial, helvetica, sans-serif;"></span></p></td></tr></tbody></table><p style="margin-top: 10px;text-indent: 0em;text-align: left;margin-bottom: 5px;"><span style="color: rgb(0, 122, 170);font-size: 16px;"><strong><span style="letter-spacing: 1px;"><strong>♂</strong></span></strong></span><span style="color: rgb(0, 122, 170);"><strong><span style="max-width: 100%;letter-spacing: 0.5px;font-size: 16px;box-sizing: border-box !important;overflow-wrap: break-word !important;">问题</span></strong></span><strong><span style="font-family: Arial, sans-serif;background-color: rgb(255, 255, 255);font-size: 15px;">177&nbsp;</span></strong><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);max-width: 100%;letter-spacing: 0.5px;font-size: 16px;box-sizing: border-box !important;overflow-wrap: break-word !important;">吐温稳定蛋白的机制是什么?</span></strong></span></p><section data-id="3074" style="font-size: 14px;background-color: rgb(255, 255, 255);font-variant-numeric: normal;font-variant-east-asian: normal;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;font-family: 微软雅黑;text-align: left;"><section style="margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;"><section style="max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;align-items: center;display: flex;justify-content: center;"><section data-width="100%" style="max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;border-bottom: 1px solid rgb(88, 88, 88);border-top: 3px solid rgb(88, 88, 88);height: 6px;width: 315.047px;"><br></section><section data-width="100%" style="max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;border-bottom: 1px solid rgb(88, 88, 88);border-top: 3px solid rgb(88, 88, 88);height: 6px;width: 315.047px;"><br></section></section></section></section><p style="font-size: 16px;background-color: rgb(255, 255, 255);"><strong style="box-sizing: inherit;"></strong></p><table align="center" interlaced="enabled"><tbody><tr class="ue-table-interlace-color-single"><td width="557" valign="bottom" align="left" style="word-break: break-all;background-color: rgb(255, 255, 255);"><section style="text-indent: 0em;"><span style="font-size: 16px;"><strong><span style="color: rgb(171, 25, 66);letter-spacing: 1px;">回</span></strong><strong><span style="color: rgb(171, 25, 66);letter-spacing: 1px;">答:如下</span></strong></span></section><ul class="list-paddingleft-2" style="list-style-type: disc;"><li><p><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">通常认为PS20和PS80主要通过界面竞争来稳定蛋白质。PS20和PS80的表面活性比典型的治疗性蛋白质(例如单克隆抗体)高得多,因此,它们可以竞争性地阻断界面并抑制蛋白质吸附到气液界面。该特性可有效防止蛋白质在制造过程、样品处理和存储(包括混合、过滤、泵送、摇动、搅动和冻融)中在界面处展开。同样,它也可以防止蛋白质吸附以及随后在产品接触表面(例如过滤器、主要容器/密闭容器和静脉注射管)上的损失,在确保向患者准确递送剂量方面起着至关重要的作</span><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">用。</span></p></li><li><p><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">&nbsp;PS20和PS80还可以通过直接相互作用来稳定蛋白质,从而增加蛋白质的胶体稳定性。治疗性蛋白质可能会通过其疏水斑块合并形成聚集体。聚山梨酸酯可通过疏水相互作用与蛋白质表面上的疏水补丁相互作用,从而防止蛋白质聚集和进一步的聚集展开。但是,表面活性剂与蛋白质的直接相互作用以及随后蛋白质胶体稳定性的改善可能是蛋白质特异性的,不能广泛应用。例如,一项热力学研究表明,聚山梨酯与人血清白蛋白结合,但是,发现表面活性剂与三种被研究的免疫球蛋白的结合非常低,可以忽略</span><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">不计。</span></p></li></ul><p><span style="text-align: center;font-weight: 700;text-indent: 34px;letter-spacing: 5px;font-family: arial, helvetica, sans-serif;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span><span style="text-align: center;font-weight: 700;text-indent: 34px;letter-spacing: 5px;font-family: arial, helvetica, sans-serif;font-size: 15px;">&nbsp;</span><span style="text-indent: 0em;text-align: center;color: rgb(123, 12, 0);font-size: 14px;"><span style="font-weight: 700;text-indent: 34px;letter-spacing: 5px;font-family: arial, helvetica, sans-serif;">&nbsp;</span></span></p></td></tr></tbody></table><section style="margin-top: 20px;margin-bottom: 10px;text-indent: 0em;text-align: left;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><section style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);font-size: 16px;"><strong><span style="letter-spacing: 1px;"><strong>♂</strong></span></strong></span><span style="color: rgb(0, 122, 170);"><strong><span style="max-width: 100%;letter-spacing: 0.5px;font-size: 16px;box-sizing: border-box !important;overflow-wrap: break-word !important;">问题</span></strong></span><strong><span style="font-family: Arial, sans-serif;background-color: rgb(255, 255, 255);font-size: 15px;">178&nbsp;</span></strong><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);max-width: 100%;letter-spacing: 0.5px;font-size: 16px;box-sizing: border-box !important;overflow-wrap: break-word !important;">吐温降解的原因以及影响因素有哪些?</span></strong></span></section><p style="font-size: 16px;background-color: rgb(255, 255, 255);"><strong style="box-sizing: inherit;"></strong></p><table align="left" interlaced="enabled"><tbody><tr class="ue-table-interlace-color-single"><td width="557" valign="top" align="left" style="word-break: break-all;"><section style="text-indent: 0em;"><span style="font-size: 16px;"><strong style="text-indent: 0em;"><span style="color: rgb(171, 25, 66);letter-spacing: 1px;">回</span></strong><strong style="text-indent: 0em;"><span style="color: rgb(171, 25, 66);letter-spacing: 1px;">答:如下</span></strong></span></section><ul class="list-paddingleft-2" style="list-style-type: disc;"><li><p><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">由于聚山梨酯降解可能会无意中影响蛋白质制剂的质量、功效、安全性和稳定性,因此,药品监管部门对聚山梨酯控制策略的审查日益严格,以确保在药物产品的保质期内聚山梨酯含量保持</span><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">恒定。</span></p></li></ul><p><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;"></span></p><ul class="list-paddingleft-2" style="width: 554.434px;"><li><p><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">聚山梨酯的水解涉及脂肪酸酯键的裂解,所得释放的游离脂肪酸可形成不可见或可见的颗粒。有人提出,酶诱导的聚山梨酸酯水解是影响产品质量的可见和亚可见颗粒形成的主要原因,在典型的蛋白质制剂pH下,聚山梨酸酯水解受到限</span><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">制。</span></p></li><li><p><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">聚山梨酯也可能被温度,光或过渡痕量金属自动氧化,生成的过氧化物可能引起蛋白质氧化,而生成的酸可能导致溶液</span><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">pH降低。</span></p></li><li><p><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">通过水解降解的PS80导致表面吸附较慢。水解过程中释放的游离脂肪酸也会形成不溶性颗粒,对蛋白质质量和稳定性产生负</span><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">面影响。</span></p></li><li><p><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">组氨酸,一种常用的蛋白质制剂缓冲剂,可能对PS降解产生混杂的</span><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">影响。</span></p></li></ul><p><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;"></span></p></td></tr></tbody></table><p style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);"><strong><span style="letter-spacing: 1px;font-size: 15px;"><strong><br></strong></span></strong></span></p><p style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);"><strong><span style="letter-spacing: 1px;font-size: 15px;"><strong><br></strong></span></strong></span></p><p style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);"><strong><span style="letter-spacing: 1px;font-size: 15px;"><strong><br></strong></span></strong></span></p><p style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);"><strong><span style="letter-spacing: 1px;font-size: 15px;"><strong><br></strong></span></strong></span></p><p style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);"><strong><span style="letter-spacing: 1px;font-size: 15px;"><strong><br></strong></span></strong></span></p><p style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);"><strong><span style="letter-spacing: 1px;font-size: 15px;"><strong><br></strong></span></strong></span></p><p style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);"><strong><span style="letter-spacing: 1px;font-size: 15px;"><strong><br></strong></span></strong></span></p><p style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);"><strong><span style="letter-spacing: 1px;font-size: 15px;"><strong><br></strong></span></strong></span></p><p style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);"><strong><span style="letter-spacing: 1px;font-size: 15px;"><strong><br></strong></span></strong></span></p><p style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);"><strong><span style="letter-spacing: 1px;font-size: 15px;"><strong><br></strong></span></strong></span></p><p style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="text-indent: 0em; color: rgb(0, 122, 170);"><strong><span style="letter-spacing: 1px;font-size: 15px;"><strong>♂</strong></span></strong><strong><span style="max-width: 100%; letter-spacing: 0.5px; font-size: 16px; box-sizing: border-box !important;">问题</span></strong></span><strong style="text-indent: 0em;"><span style="font-family: Arial, sans-serif; font-size: 15px;">179</span></strong><span style="text-indent: 0em; color: rgb(0, 122, 170); font-size: 16px;"><strong><span style="letter-spacing: 1px;">&nbsp;</span></strong></span><span style="text-indent: 0em; color: rgb(0, 122, 170);"><strong><span style="max-width: 100%; letter-spacing: 0.5px; font-size: 16px; box-sizing: border-box !important;">吐温</span></strong></span><span style="text-indent: 0em; color: rgb(0, 122, 170);"><strong><span style="text-align: center;font-family: Arial, sans-serif;font-size: 16px;">80</span></strong></span><span style="text-indent: 0em; color: rgb(0, 122, 170);"><strong><span style="max-width: 100%; letter-spacing: 0.5px; font-size: 16px; box-sizing: border-box !important;">作为稳定剂的缺点有哪些?</span></strong></span></p><section data-id="3074" style="font-size: 14px;background-color: rgb(255, 255, 255);font-variant-numeric: normal;font-variant-east-asian: normal;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;font-family: 微软雅黑;"><section style="margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;"><section style="max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;align-items: center;display: flex;justify-content: center;"><section data-width="100%" style="max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;border-bottom: 1px solid rgb(88, 88, 88);border-top: 3px solid rgb(88, 88, 88);height: 6px;width: 315.047px;"><br></section><section data-width="100%" style="max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;border-bottom: 1px solid rgb(88, 88, 88);border-top: 3px solid rgb(88, 88, 88);height: 6px;width: 315.047px;"><br></section></section></section></section><p style="font-size: 16px;background-color: rgb(255, 255, 255);"><strong style="box-sizing: inherit;"></strong></p><table align="left"><tbody><tr><td width="557" valign="bottom" align="left" style="word-break: break-all;"><section style="text-indent: 0em;"><span style="font-size: 16px;"><strong style="text-indent: 0em;"><span style="color: rgb(171, 25, 66);letter-spacing: 1px;">回</span></strong><strong style="text-indent: 0em;"><span style="color: rgb(171, 25, 66);letter-spacing: 1px;">答:</span></strong></span><span style="font-size: 16px;"><strong style="text-indent: 0em;"><span style="color: rgb(171, 25, 66);letter-spacing: 1px;">如下</span></strong></span></section><ul class="list-paddingleft-2" style="width: 554.434px;"><li><p><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">吐温80作为一个聚合物本身纯度波动极大,高纯度的吐温80是无色透明的,而大多数吐温产品则是黄到棕色,含有大量杂质或降解产</span><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">品。</span></p></li><li><p><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">吐温80中亲脂成分包括不饱和脂肪酸,这些不饱和脂肪酸十分容易氧化降解而产生更多的有毒成分,由此而产生的毒副反应将会超过产品本身带来的益处。医学界证实,吐温80用于注射剂,会引起过敏反应,包括休克、呼吸困难、低血压、血管性水肿、风疹等过敏样反应症状。这些不良反应在人的临床试验可以十分严重。</span><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;"></span></p></li><li><p><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">使用吐温80是有严格限制条件的,它是一种有潜在不安全性的辅料,使用不当会对人的健康造成很</span><span style="text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">大影响。</span></p></li></ul><section style="text-indent: 0em;background-color: rgb(252, 252, 252);"><span style="font-weight: 700;text-indent: 34px;letter-spacing: 5px;font-family: arial, helvetica, sans-serif;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span><span style="font-weight: 700;text-indent: 34px;letter-spacing: 5px;font-family: arial, helvetica, sans-serif;font-size: 15px;">&nbsp;</span><span style="color: rgb(123, 12, 0);font-size: 14px;"><span style="font-weight: 700;text-indent: 34px;letter-spacing: 5px;font-family: arial, helvetica, sans-serif;">&nbsp;</span></span></section></td></tr></tbody></table><section style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);font-size: 16px;"><strong><span style="letter-spacing: 1px;"><strong><br></strong></span></strong></span></section><section style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);font-size: 16px;"><strong><span style="letter-spacing: 1px;"><strong><br></strong></span></strong></span></section><section style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);font-size: 16px;"><strong><span style="letter-spacing: 1px;"><strong><br></strong></span></strong></span></section><section style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);font-size: 16px;"><strong><span style="letter-spacing: 1px;"><strong><br></strong></span></strong></span></section><section style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);font-size: 16px;"><strong><span style="letter-spacing: 1px;"><strong><br></strong></span></strong></span></section><section style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);font-size: 16px;"><strong><span style="letter-spacing: 1px;"><strong><br></strong></span></strong></span></section><section style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);font-size: 16px;"><strong><span style="letter-spacing: 1px;"><strong><br></strong></span></strong></span></section><section style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);font-size: 16px;"><strong><span style="letter-spacing: 1px;"><strong><br></strong></span></strong></span></section><section style="margin-top: 10px;margin-bottom: 5px;text-indent: 0em;user-select: auto;max-inline-size: 100%;line-height: 1.6;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(0, 122, 170);font-size: 16px;"><strong><span style="letter-spacing: 1px;"><strong>♂</strong></span></strong></span><span style="color: rgb(0, 122, 170);"><strong><span style="max-width: 100%;letter-spacing: 0.5px;font-size: 16px;box-sizing: border-box !important;overflow-wrap: break-word !important;">问题</span></strong></span><strong><span style="font-family: Arial, sans-serif;background-color: rgb(255, 255, 255);font-size: 15px;"><strong style="font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;"><span style="font-family: Arial, sans-serif;">180&nbsp;</span></strong></span></strong><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);max-width: 100%;letter-spacing: 0.5px;font-size: 16px;box-sizing: border-box !important;overflow-wrap: break-word !important;">吐温</span></strong></span><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);text-align: center;font-family: Arial, sans-serif;font-size: 16px;">20</span></strong></span><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);max-width: 100%;letter-spacing: 0.5px;font-size: 16px;box-sizing: border-box !important;overflow-wrap: break-word !important;">和吐温</span></strong></span><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);text-align: center;font-family: Arial, sans-serif;font-size: 16px;">80</span></strong></span><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);max-width: 100%;letter-spacing: 0.5px;font-size: 16px;box-sizing: border-box !important;overflow-wrap: break-word !important;">的区别有哪些?</span></strong></span></section><section data-id="3074" style="font-size: 14px;background-color: rgb(255, 255, 255);font-variant-numeric: normal;font-variant-east-asian: normal;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;font-family: 微软雅黑;"><section style="margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;"><section style="max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;align-items: center;display: flex;justify-content: center;"><section data-width="100%" style="max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;border-bottom: 1px solid rgb(88, 88, 88);border-top: 3px solid rgb(88, 88, 88);height: 6px;width: 315.047px;"><br></section><section data-width="100%" style="max-width: 100%;box-sizing: border-box;overflow-wrap: break-word;border-bottom: 1px solid rgb(88, 88, 88);border-top: 3px solid rgb(88, 88, 88);height: 6px;width: 315.047px;"><br></section></section></section></section><p style="font-size: 16px;background-color: rgb(255, 255, 255);"><strong style="box-sizing: inherit;"></strong></p><table align="left"><tbody><tr><td width="557" valign="bottom" align="left" style="word-break: break-all;"><section style="text-indent: 0em;"><span style="font-size: 16px;"><strong style="text-indent: 0em;"><span style="color: rgb(171, 25, 66);letter-spacing: 1px;">回</span></strong><strong style="text-indent: 0em;"><span style="color: rgb(171, 25, 66);letter-spacing: 1px;">答:如下</span></strong></span></section><ul class="list-paddingleft-2" style="list-style-type: disc;"><li><p><strong><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">&nbsp;两者的合成原料不同</span></strong><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">:</span></p><p><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">1. 吐温80的合成原料:由失水山梨醇单油酸酯与环氧乙烷聚合而成;</span></p><p><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">2. 吐温20的合成原料:为聚氧乙烯去水山梨醇单月桂酸酯和一部分聚氧乙烯双去水山梨醇单月桂酸酯的混</span><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">合物。</span></p></li><li><p><strong><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">两者的用途不同:</span></strong></p><p><strong><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;"></span></strong><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">1. </span><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">吐温80的用途:吐温80属多元醇型非离子表面活性剂,是聚山梨酯类中最常用的一种。对电解质有显著的抵抗力,亲水性强,广泛应用于液体、半固体、固体制剂中,作O/W型乳化剂、增溶剂、湿润剂、分散剂和稳定剂;</span></p><p><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">2. 吐温20的用途:为司盘和环氧乙烷的缩合物,由于其分子中有较多的亲水性基团一聚氧乙烯基,故亲水性强,为一种非离子型去污剂。常作为水包油(O/W)型乳化剂;可与其他乳化剂如月桂醇硫酸钠或司盘类合用,能增加乳剂的稳定性。也可作某些药物的增溶</span><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">剂。</span></p></li><li><p><strong><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">两者的性状不同</span></strong><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">:</span></p><p><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">1. </span><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">吐温80的性状:吐温80的过氧化值不超过10,为淡黄色至橙黄色的黏稠液体;微有特臭。味微苦略涩,有温热感;</span></p><p><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">2. 吐温20的性状:吐温20为黄色或琥珀色澄明的油状液体,具有特殊的臭气和微弱</span><span style="text-indent: 0em;text-align: center;color: rgb(51, 51, 51);font-family: Arial, sans-serif;font-size: 15px;">苦味。</span><span style="font-weight: 700;text-indent: 34px;letter-spacing: 5px;font-family: arial, helvetica, sans-serif;">&nbsp;</span></p><p><span style="font-weight: 700;text-indent: 34px;letter-spacing: 5px;font-family: arial, helvetica, sans-serif;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></p></li></ul></td></tr></tbody></table><section style="margin-top: 15px;margin-bottom: 10px;text-indent: 0em;"><br></section></section></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><br></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><br></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><span style="color: rgb(51, 51, 51);font-family: Arial, sans-serif;text-align: start;background-color: rgb(255, 255, 255);font-size: 15px;"><br></span></section><section style="white-space: normal;user-select: auto;max-inline-size: 100%;line-height: 1.6;color: rgb(0, 0, 0);font-family: Microsoft YaHei, Apple Color Emoji, Emoji Symbols Font, Segoe UI Symbol, Arial, sans-serif;text-align: center;justify-content: center;box-sizing: border-box !important;"><br></section></div>
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查看完整版本: 抗体药研发问答|| 176~180 《聚山梨酯(吐温)在制剂中的作...