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OBTAINING LATANOPROSTENE BUNOD OF REQUIRED QUALITY PRESET BY CHROMATOGRAPHY WITH GRAVITATIONAL ELUTION

机译：用重力洗脱色谱法获得所需质量的拉坦前列腺素

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FIELD: chemical or physical processes.;SUBSTANCE: present invention relates to a method of producing latanoprostene bunod of formula (I); ;consisting in that crude latanoprostene bunod of formula (I) is purified by chromatography using column chromatography on normal-phase silica gel with gravitational elution using silica gel: a.) of silica gel for normal phase with particles of irregular shape with particle size of 63–200 microns or b.) of silica gel for normal phase with particles of spherical shape with particle size of 50–150 microns, and as eluent—mixture of eluents consisting of non-polar and polar solvents, and if necessary impurities arising from eluents, which are used for purification chromatography of compound of formula (I), removed by filtration chromatography on silica gel. Produced latanoprostene bunod meets the following technical requirements for quality:; <TableGroup align="center" colSep="1" cols="2" rowSep="1"> <Colspec colName="c1" colWidth="70mm"/> <Colspec colName="c2" colWidth="30mm"/> <Tbody> <Row> <entry colSep="1" rowSep="1" valign="middle">Latanoprostene bunod</entry> <entry colSep="0" rowSep="1" valign="middle"/> </Row> <Row> <entry colSep="1" rowSep="1" valign="middle">Related impurities (HPLC)</entry> <entry colSep="0" rowSep="1" valign="middle"/> </Row> <Row> <entry colSep="1" rowSep="1" valign="middle">15S-Latanoprostene bunod</entry> <entry colSep="0" rowSep="1" valign="middle">≤ 0.5 0%</entry> </Row> <Row> <entry colSep="1" rowSep="1" valign="middle">5,6-trans-Latanoprostene bunod</entry> <entry colSep="0" rowSep="1" valign="middle">≤ 3.5 %</entry> </Row> <Row> <entry colSep="1" rowSep="1" valign="middle">Latanoprost</entry> <entry colSep="0" rowSep="1" valign="middle">≤ 0.50 %</entry> </Row> <Row> <entry colSep="1" rowSep="1" valign="middle">Latanoprost acid</entry> <entry colSep="0" rowSep="1" valign="middle">≤ 0.50 %</entry> </Row> <Row> <entry colSep="1" rowSep="1" valign="middle">Unidentified impurities separately </entry> <entry colSep="0" rowSep="1" valign="middle">≤ 0.10 %</entry> </Row> <Row> <entry colSep="1" rowSep="1" valign="middle">Unidentified admixtures, total</entry> <entry colSep="0" rowSep="1" valign="middle">≤ 0.30 %</entry> </Row> <Row> <entry colSep="1" rowSep="0" valign="middle">Sum of impurities</entry> <entry colSep="0" rowSep="0" valign="middle">≤ 5.0 %</entry> </Row> </Tbody> </TableGroup> </TableFormula> </Table> ;See the tab.;EFFECT: disclosed is production of required amount of preset quality latanoprostene bunod by chromatography with gravitational elution.;13 cl, 23 tbl, 17 ex </span> <span class="z_kbtn z_kbtnclass hoverxs" style="display: none;">展开▼</span> </div> <div class="translation abstracttxt"> <span class="zhankaihshouqi fivelineshidden" id="abstract"> <span>机译：</span>技术领域本发明涉及式（I）的拉坦前列腺素单体的制备方法。 <Image file =“ 00000009.JPG” he =“ 47” imgContent =“ undefined” imgFormat =“ JPEG” wi =“ 99” /> ;在于将式（I）的粗拉坦前列素Bunod通过在正相硅胶上通过柱色谱进行色谱法纯化，并使用硅胶进行重力洗脱：a。）正相硅胶，其粒径为不规则形状的颗粒63-200微米或b。）硅胶，用于正相，粒径为50-150微米的球形颗粒，作为洗脱液-洗脱液的混合物，由非极性和极性溶剂组成，必要时还包括用于纯化式（I）化合物的色谱法的洗脱液通过硅胶上的过滤色谱法除去。所生产的拉坦前列素Bunod符合以下质量技术要求： <表格> <TableFormula> <标题/> <TableGroup align =“ center” colSep =“ 1” cols =“ 2” rowSep =“ 1”> <Colspec colName =“ c1” colWidth =“ 70mm” /> <Colspec colName =“ c2” colWidth =“ 30mm” /> <身体> <行> <entry colSep =“ 1” rowSep =“ 1” valign =“ middle”>拉丁美洲前列腺素Bunod </ entry> <entry colSep =“ 0” rowSep =“ 1” valign =“ middle” /> </ Row> <行> <entry colSep =“ 1” rowSep =“ 1” valign =“ middle”>相关杂质（HPLC）</ entry> <entry colSep =“ 0” rowSep =“ 1” valign =“ middle” /> </ Row> <行> <entry colSep =“ 1” rowSep =“ 1” valign =“ middle”> 15S-拉塔诺前列腺素胶束</ entry> <entry colSep =“ 0” rowSep =“ 1” valign =“ middle”>≤0.5́0％</ entry> </ Row> <行> <entry colSep =“ 1” rowSep =“ 1” valign =“ middle”> 5,6-反-拉塔诺前列腺素混合物</ entry> <entry colSep =“ 0” rowSep =“ 1” valign =“ middle”>≤3.5％</ entry> </ Row> <行> <entry colSep =“ 1” rowSep =“ 1” valign =“ middle”>拉坦前列素</ entry> <entry colSep =“ 0” rowSep =“ 1” valign =“ middle”>≤0.50％</ entry> </ Row> <行> <entry colSep =“ 1” rowSep =“ 1” valign =“ middle”>拉坦前列素</ entry> <entry colSep =“ 0” rowSep =“ 1” valign =“ middle”>≤0.50％</ entry> </ Row> <行> <entry colSep =“ 1” rowSep =“ 1” valign =“ middle”>未识别的杂质分别</ entry> <entry colSep =“ 0” rowSep =“ 1” valign =“ middle”>≤0.10％</ entry> </ Row> <行> <entry colSep =“ 1” rowSep =“ 1” valign =“ middle”>未识别的混合物，总计</ entry> <entry colSep =“ 0” rowSep =“ 1” valign =“ middle”>≤0.30％</ entry> </ Row> <行> <entry colSep =“ 1” rowSep =“ 0” valign =“ middle”>杂质总和</ entry> <entry colSep =“ 0” rowSep =“ 0” valign =“ middle”>≤5.0％</ entry> </ Row> </ Tbody> </ TableGroup> </ TableFormula> </ Table> 效果：公开了通过重力洗脱色谱法生产所需量的预设质量的拉坦前列醇胶体的数量; 13 cl，23 tbl，17 ex </span> <span class="z_kbtn z_kbtnclass hoverxs" style="display: none;">展开▼</span> </div> </div> <div class="record"> <h2 class="all_title" id="enpatent33">著录项</h2> <div class="getdents"> <ul> <li> <p><span>公开/公告号</span><span>RU2726408C2</span></p> <p><span>专利类型</span><span></span></p> </li> <li> <p><span>公开/公告日</span><span>2020-07-14</span></p> <p><span>原文格式</span><span>PDF</span></p> </li> <li> <div class="apply"> <p><span style="width: 90px;display: inline-block;">申请/专利权人</span><span id="patentee" class="threelineshidden zhankaihshouqi"> <a href="/search.html?doctypes=12_13&sertext=CHINOIN GYOGYSZER ES VEGYESETI TERMEKEK GYARA ZRT.&option=232">CHINOIN GYOGYSZER ES VEGYESETI TERMEKEK GYARA ZRT.;</a> </span></p> <span class="designer hoverxs" style="display: none;">展开▼</span> </div> <p><span>申请/专利号</span><span style="width: 250px;">RU20180124293</span></p> </li> <li> <div class="apply"> <p><span style="width: 90px;display: inline-block;">发明设计人</span><span id="patentee" class="threelineshidden zhankaihshouqi"> <a 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</span><span style="width: 93%;">RU</span></p> </li> <li><p style="width: 100%;"> <span >入库时间</span> <span>2022-08-21 11:02:23</span></p> </li> </ul> </div> </div> </div> <div class="literature cardcommon"> <div class="similarity"> <h3 class="all_title" id="enpatent66">相似文献</h3> <div class="similaritytab clearfix"> <ul > <li >专利</li> <li >外文文献</li> <li >中文文献</li> </ul> </div> <div class="similarity_details"> <ul style="display: none;"> <li> <div> <b>1. </b><a class="enjiyixqcontent" href="/patent-detail/061204732542.html">一种拉坦前列腺素的制备方法</a> <b>[P]</b> . <span> 中国专利： CN112608294B </span> <span> . 2021.10.26</span> </div> </li> <li> <div> <b>2. </b><a class="enjiyixqcontent" href="/patent-detail/06120112573011.html">一种拉坦前列腺素的制备方法</a> <b>[P]</b> . <span> 中国专利： CN112608294A </span> <span> . 2021-04-06</span> </div> </li> <li> <div> <b>3. </b><a class="enjiyixqcontent" href="/patent-detail/06130400548259.html">OBTAINING LATANOPROSTENE BUNOD OF REQUIRED QUALITY PRESET BY CHROMATOGRAPHY WITH 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