阿司匹林丁香酚酯栓剂的制备及质量控制

Preparation and Quality Control of AEE Suppositories

以半合成脂肪酸甘油酯为基质制备栓剂,对栓剂的外观与色泽、重量、融变时限、局部刺激性做了质量控制测定,并采用高效液相色普法测定阿司匹林丁香酚酯的含量。试验结果表明,该栓剂制备工艺可行,含量测定方法可靠;外观与色泽、重量、融变时限均符合药典规定,对兔直肠无刺激性;质量可控,稳定性好,无刺激性与不良反应,使用安全,可用于临床应用。

The aspirin eugenol ester（AEE） suppositories were prepared by semi-synthetic fatty glycoside;and its appearance,colour,weight,melting time,local stimulation were measured for quality control.HPLC（High Performance Liquid Chromatography） was used to detect the content of AEE.The results showed that the preparation technology and content measurement method of AEE suppositories was feasible and reliable.The quality test criterion for AEE suppositories conformed to the standard of Chinese Pharmacopeias.It indicated that the quality of the suppositories prepatetion could be controled.The AEE suppositories had no irritant and pessimal reaction and could be used for clinical application.