黄芪注射剂的制备及质量控制研究

Preparation and Quality Control of Astragalus injection

目的:筛选制备黄芪注射剂的最佳工艺。方法:利用动态吸附-解吸附方法,以紫外分光光度法测定黄芪总皂苷的含量,研究D-101大孔树脂分离纯化黄芪总皂苷的条件。结果:D-101大孔树脂分离纯化黄芪总皂苷的最佳条件为:采用浓度为含生药0.06g/m L黄芪提取液,最大上样量为1BV,流速为3BV/h,解吸附时用4BV的70%乙醇解吸附,收集70%乙醇洗脱液,得黄芪总皂苷提取物。结论:该工艺简单可行,能满足大量制备的需求。

Objective： filtrate the best manufacture proeess of Astragali Radix injection. Methods： On the basis of the Dynamic adsorption-desovption method,using the UV-Vis to measure how much the total saponins of Astragalus it contains,researching the conditions of separating and purifying the total saponins of Astragalus by the means of D-101 macro resin. Results： The best conditions for using D- 101 macro resin to separate and purify the total saponins of Astragalus are as follow：the crude herbal dose of the Astragalus extract is at 0.06g/ml, the loading quantity of sample with its flow at 3BV/h is 1BV, and use 4BV 70% ethyl alcohol to do elution.Collecting the eluent, and then the total saponins of Astragulus extract is done.The rate of the total saponins of Astragulus collection can reach 86.36%. Conclusion： The manufacture process is feasible, and it can satisfy the preparation in quantity.