发明名称 雷贝拉唑钠化合物
摘要 本发明属于医药技术领域,具体涉及雷贝拉唑钠倍半水合物及其制备方法,本发明得到的雷贝拉唑钠倍半水合物,含有一个半结晶水,具有的优点:纯度高;稳定性好,即使在高湿度条件下吸湿增重也不明显;对胃酸分泌的抑制作用,雷贝拉唑钠倍半水合物提高近20%。本发明还涉及使用这种水合物的组合物治疗十二指肠溃疡与胃溃疡、反流性食管炎等消化系统疾病的应用。
申请公布号 CN103772355B 申请公布日期 2016.03.02
申请号 CN201210411785.2 申请日期 2012.10.25
申请人 天津汉瑞药业有限公司 发明人 严洁;李轩
分类号 C07D401/12(2006.01)I;A61K31/4439(2006.01)I;A61P1/04(2006.01)I 主分类号 C07D401/12(2006.01)I
代理机构 代理人
主权项 式I所示雷贝拉唑钠水合物晶体的制备方法,<img file="dest_path_image002.GIF" wi="359" he="165" />通过将雷贝拉唑钠在异丙醇‑哌啶‑水溶液中加热溶解,自然冷却至室温,再保温一段时间得到,所述水合物用卡尔费休法测定含有重量百分比6.50%‑6.72%的水分,用CuKa射线作为特征X射线粉末测定的图谱具有下列2θ衍射角、晶面间距d和相对强度I/I0:<tables num="0001" id="ctbl0001"><table><tgroup cols="4"><colspec colname="c001" colwidth="25%" /><colspec colname="c002" colwidth="25%" /><colspec colname="c003" colwidth="25%" /><colspec colname="c004" colwidth="25%" /><tbody><row><entry morerows="1">谱线号</entry><entry morerows="1">2θ(度)</entry><entry morerows="1">晶面间距(d)</entry><entry morerows="1">I/I0</entry></row><row><entry morerows="1">1</entry><entry morerows="1">14.120</entry><entry morerows="1">6.2671</entry><entry morerows="1">28</entry></row><row><entry morerows="1">2</entry><entry morerows="1">14.400</entry><entry morerows="1">6.1459</entry><entry morerows="1">3</entry></row><row><entry morerows="1">3</entry><entry morerows="1">15.280</entry><entry morerows="1">5.7938</entry><entry morerows="1">4</entry></row><row><entry morerows="1">4</entry><entry morerows="1">19.580</entry><entry morerows="1">4.5301</entry><entry morerows="1">38</entry></row><row><entry morerows="1">5</entry><entry morerows="1">20.060</entry><entry morerows="1">4.4227</entry><entry morerows="1">7</entry></row><row><entry morerows="1">6</entry><entry morerows="1">23.480</entry><entry morerows="1">3.7857</entry><entry morerows="1">13</entry></row><row><entry morerows="1">7</entry><entry morerows="1">24.340</entry><entry morerows="1">3.6539</entry><entry morerows="1">6</entry></row><row><entry morerows="1">8</entry><entry morerows="1">25.460</entry><entry morerows="1">3.4956</entry><entry morerows="1">7</entry></row><row><entry morerows="1">9</entry><entry morerows="1">26.140</entry><entry morerows="1">3.4062</entry><entry morerows="1">17</entry></row><row><entry morerows="1">10</entry><entry morerows="1">27.120</entry><entry morerows="1">3.2853</entry><entry morerows="1">3</entry></row><row><entry morerows="1">11</entry><entry morerows="1">27.940</entry><entry morerows="1">3.1907</entry><entry morerows="1">8</entry></row><row><entry morerows="1">12</entry><entry morerows="1">28.180</entry><entry morerows="1">3.1641</entry><entry morerows="1">4</entry></row><row><entry morerows="1">13</entry><entry morerows="1">28.940</entry><entry morerows="1">3.0827</entry><entry morerows="1">29</entry></row><row><entry morerows="1">14</entry><entry morerows="1">29.960</entry><entry morerows="1">2.9800</entry><entry morerows="1">100</entry></row><row><entry morerows="1">15</entry><entry morerows="1">30.820</entry><entry morerows="1">2.8988</entry><entry morerows="1">5</entry></row><row><entry morerows="1">16</entry><entry morerows="1">31.840</entry><entry morerows="1">2.8082</entry><entry morerows="1">6</entry></row><row><entry morerows="1">17</entry><entry morerows="1">32.440</entry><entry morerows="1">2.7576</entry><entry morerows="1">8</entry></row><row><entry morerows="1">18</entry><entry morerows="1">33.000</entry><entry morerows="1">2.7121</entry><entry morerows="1">5</entry></row><row><entry morerows="1">19</entry><entry morerows="1">33.340</entry><entry morerows="1">2.6852</entry><entry morerows="1">6</entry></row><row><entry morerows="1">20</entry><entry morerows="1">33.560</entry><entry morerows="1">2.6681</entry><entry morerows="1">9</entry></row><row><entry morerows="1">21</entry><entry morerows="1">35.320</entry><entry morerows="1">2.5391</entry><entry morerows="1">59</entry></row><row><entry morerows="1">22</entry><entry morerows="1">36.140</entry><entry morerows="1">2.4833</entry><entry morerows="1">10</entry></row><row><entry morerows="1">23</entry><entry morerows="1">37.720</entry><entry morerows="1">2.3829</entry><entry morerows="1">7</entry></row><row><entry morerows="1">24</entry><entry morerows="1">39.780</entry><entry morerows="1">2.2641</entry><entry morerows="1">8</entry></row><row><entry morerows="1">25</entry><entry morerows="1">40.280</entry><entry morerows="1">2.2371</entry><entry morerows="1">13</entry></row><row><entry morerows="1">26</entry><entry morerows="1">40.960</entry><entry morerows="1">2.2016</entry><entry morerows="1">3</entry></row><row><entry morerows="1">27</entry><entry morerows="1">41.520</entry><entry morerows="1">2.1731</entry><entry morerows="1">4</entry></row><row><entry morerows="1">28</entry><entry morerows="1">42.220</entry><entry morerows="1">2.1387</entry><entry morerows="1">12</entry></row><row><entry morerows="1">29</entry><entry morerows="1">42.520</entry><entry morerows="1">2.1243</entry><entry morerows="1">4</entry></row><row><entry morerows="1">30</entry><entry morerows="1">44.200</entry><entry morerows="1">2.0474</entry><entry morerows="1">2</entry></row><row><entry morerows="1">31</entry><entry morerows="1">45.760</entry><entry morerows="1">1.9812</entry><entry morerows="1">21</entry></row><row><entry morerows="1">32</entry><entry morerows="1">46.600</entry><entry morerows="1">1.9474</entry><entry morerows="1">2</entry></row><row><entry morerows="1">33</entry><entry morerows="1">47.180</entry><entry morerows="1">1.9248</entry><entry morerows="1">4</entry></row><row><entry morerows="1">34</entry><entry morerows="1">47.920</entry><entry morerows="1">1.8968</entry><entry morerows="1">14</entry></row><row><entry morerows="1">35</entry><entry morerows="1">48.980</entry><entry morerows="1">1.8582</entry><entry morerows="1">5</entry></row><row><entry morerows="1">36</entry><entry morerows="1">49.320</entry><entry morerows="1">1.8462</entry><entry morerows="1">5</entry></row></tbody></tgroup></table></tables>2θ 衍射角的误差为±0.2°。
地址 300409 天津市北辰区北辰科技园区华实道88号