Liguzinediol注射液的制备及质量控制

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30 min；各项检查符合药典规定；liguzinediol浓度在80~160 μg·mL^-1浓度范围内线性关系良好，平均回收率为99.65%（n=6），RSD=0.99%；检测限为1.2 ng、定量限为12 ng。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。

Objective: To prepare liguzinediol injection and establish its quality control method. Methods: Bacterial endotoxin was removed with active carbon,then the injection was sterilized by autoclaving;the contents of liguzinediol and related substances were determined by HPLC. Results: Bacterial endotoxin was removed with 0.05%active carbon,the injection was sterilized for 30 minutes at 115 ℃.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 reference for pilot scale production of liguzinediol in the later stage.

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