Study on the consistency of Aspirin enteric-coated tablets process and quality in vitro
HOU Fei LUO Sihai FANG Xiaqin ZHANG Yujia ZHENG Wensheng
Beijing Key Laboratory of Drug Delivery Technology and Novel Formulation, Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100050, China
Abstract：Objective To optimize the preparation process of Aspirin enteric-coated tablets and evaluate its quality consistency in vitro. Methods Three factors including L100-55, TEC and talc powder were investigated by orthogonal experiment with in vitro dissolution as the index to screen the optimal prescription dosage. Using acetonitrile-tetrahydrofuran-glacial acetic acid-water (20∶5∶5∶70) as mobile phase, C18 column with detection wavelength of 276 nm and flow rate of 1.0 mL/min as chromatographic conditions, the similarity of dissolution behavior of self-made tablets and reference preparations in vitro was determined by direct comparison method and f2 similarity factor. Results Orthogonal test showed that the best combination of factors was A2B3C1D3. The contents of aspirin in three batches of self-made tablets were 98.9%, 100.3% and 99.9% of the labeled amount respectively, which were in accordance with the provisions of the Pharmacopoeia of the People′s Republic of China. In the solution of hydrochloric acid at pH 1.2, no release was found in the self-made tablets, and the f2 values of self-made tablets and the reference were 50%, 65%, 80% in the solution of pH 6.0, pH 6.2, pH 6.8, respectively. Conclusion The formulation of the preparation is simple, the process is feasible and the repeatability is high. It can be used to guide industrial production. The analytical method established in this study can be used for the quality control of Aspirin enteric-coated tablets.
侯飞 罗四海 方夏琴 张宇佳 郑稳生. 阿司匹林肠溶片工艺与体外质量一致性研究[J]. 中国医药导报, 2019, 16(3): 101-104.
HOU Fei LUO Sihai FANG Xiaqin ZHANG Yujia ZHENG Wensheng. Study on the consistency of Aspirin enteric-coated tablets process and quality in vitro. 中国医药导报, 2019, 16(3): 101-104.
2019, Vol. 16 
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