乳腺丸的制备与质量控制

Preparation and Quality Control for Ruxian Pill

目的:制备乳腺丸及建立质量控制方法。方法:采用薄层色谱法对乳腺丸中的当归、赤芍、皂角刺等成分进行定性鉴别;采用炽灼后硫代乙酰胺法对乳腺丸进行重金属检查。结果:各主要成份分离良好,有效成分斑点清晰,阴性样品无干扰。重金属限度≤10ppm。结论:制剂稳定,所建立的鉴别方法和检查方法简便、快捷,适合制剂的质量控制。

Objective ： To establish the quality control of Ruxian Pill. Methods ： Angelica Sinensis Radix, Paeoniae Radix Rubra and Gleditsiae Spina in Ruxian Pill were identified by TLC. The limit of heavy metal in Ruxian Pill was tested with thioacetamide after ignition. Results：The TLC identification was highly specific and the spots were clear and concentrat- ed. The limit of heavy metal was less than 10ppm. Conclusion ：The quality method is simple, rapid and is able to effec- tively control the quality of Ruxian Pill.