| 主权项 |
1.一种包含式I所示化合物和/或其药学上可接受的盐的药用组合物，其特征在于，所述组合物为冻干制剂，包含糖类保护剂和中性氨基酸，所述组合物中HPLC相对保留时间为1.32-1.37的杂质的HPLC含量不超过0.10%；<img file="FDA0000396100530000011.GIF" wi="1077" he="888" />所述HPLC的条件为：高效液相色谱仪：WATERS2695-2998分析柱：YMC-Pack ODS-A柱，规格:250×4.6mm，S-5um,1.2nm柱温：35℃检测波长：220nm流动相：A:0.1%的高氯酸和0.075％的氯化钠溶液；B:乙腈；梯度条件如下表所示：<tables num="0001"><table><tgroup cols="3"><colspec colname="c001" colwidth="46%" /><colspec colname="c002" colwidth="25%" /><colspec colname="c003" colwidth="29%" /><tbody><row><entry morerows="1">时间（分钟）</entry><entry morerows="1">A％</entry><entry morerows="1">B%</entry></row><row><entry morerows="1">初始</entry><entry morerows="1">65.5</entry><entry morerows="1">34.5</entry></row><row><entry morerows="1">14.5</entry><entry morerows="1">65.5</entry><entry morerows="1">34.5</entry></row><row><entry morerows="1">35</entry><entry morerows="1">50</entry><entry morerows="1">50</entry></row><row><entry morerows="1">45</entry><entry morerows="1">35</entry><entry morerows="1">65</entry></row><row><entry morerows="1">50</entry><entry morerows="1">20</entry><entry morerows="1">80</entry></row><row><entry morerows="1">52</entry><entry morerows="1">20</entry><entry morerows="1">80</entry></row><row><entry morerows="1">53</entry><entry morerows="1">65.5</entry><entry morerows="1">34.5</entry></row><row><entry morerows="1">66</entry><entry morerows="1">655</entry><entry morerows="1">345</entry></row></tbody></tgroup></table></tables>流量为：1.45ml/min，调整色谱系统，使主峰保留时间为20min。 |
