中文摘要：

目的：制备liguzinediol注射液，建立其质量控制方法。方法：采用活性炭法去除细菌内毒素，热压灭菌法进行灭菌；采用高效液相色谱法测定其含量及有关物质。结果：用0．05％的活性炭除细菌内毒素，115℃热压灭菌30min；各项检查符合药典规定；liguzinediol浓度在80～160μg·mL^-1浓度范同内线性关系良好，平均回收率为99．65％（n=6），RSD=0．99％；检测限为1．2ng、定量限为12ng。结论：Liguzinediol注射液制备工艺简便，质量可控；所建立的含量测定方法重复性好，专属性强，结果准确可靠，为后期中试生产提供参考依据。

英文摘要：

Objective： To prepare liguzinediol injection and establish its quality control method. Methods： Bacteri- al endotoxin was removed with active carbon, then the injection was sterilized by autoclaving ; the contents of liguzin- ediol and related substances were determined by HPLC. Results： Bacterial endotoxin was removed with O. 05% ac- tive carbon,the injection was sterilized for 30 minutes at 115 ~C. Each detection was in accordance with Chinese Pharmacopoeia. The linear range was 80 - 160 μg·mL^-1（r = 0. 9995）for liguzinediol. The average recovery was 99.5% （n = 6 ）. The limits of detection and quantitation were 1.2 ng and 12 ng, respectively. Conclusion： The preparation is controllable and convenient and the method is reliable, reproducible and specific and can provide ref- erence for pilot scale production of liguzinediol in the later stage.