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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80~160μg·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 by activated carbon method and sterilized by autoclaving. The contents and related substances were determined by high performance liquid chromatography. Results: The bacterial endotoxin was removed with 0.05% activated carbon and autoclaved at 115 ° C for 30 min. All the tests were in accordance with Pharmacopoeia. The linear range of liguzinediol was 80 ~ 160 μg · mL-1 with the average recovery of 99.65 % (n = 6), RSD = 0.99%. The detection limit was 1.2 ng and the limit of quantification was 12 ng. Conclusion: The preparation method of Liguzinediol injection is simple and the quality is controllable. The determination method of content of Liguzinediol injection has good repeatability, specificity and accurate and reliable results, which provides a reference for the production of the pilot plant in the later period.