复方氨酚烷胺片的稳定性研究

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英文篇名：Study on Stability of Comound Paracetamol and Amantadine Hydrochloride Tablets 作者：张大千 英文作者：Zhang Daqian;Heilongjiang Food and Drug Administration Cadre School; 关键词：复方氨酚烷胺片 ; 稳定性 ; 研究 英文关键词：Comound Paracetamol and Amantadine Hydrochloride Tablets;;Stability;;Study 中文刊名：HJYY 英文刊名：Heilongjiang Medicine Journal 机构：黑龙江省食品药品监督管理干部学校; 出版日期：2019-06-14 出版单位：黑龙江医药 年：2019 期：v.32;No.186 语种：中文; 页：HJYY201903014 页数：3 CN：03 ISSN：23-1383/R 分类号：41-43

摘要

目的:复方氨酚烷胺片的稳定决定着疗效。为研究复方氨酚烷胺片在温度,湿度,光线等不同因素和环境中的药物特性规律,为保障药品质量提供科学依据,本研究对该药物稳定性和影响因素测试。结果:复方氨酚烷胺片高湿不稳定,应在密封、防潮的环境下保存。通过对加速试验与长期试验考察,到12个月为止,各项检测指标与0天数据无显著性差异。结论:通过稳定性研究考察,暂定药品有效期为12个月。
        Objective: The stability of Comound Paracetamol and Amantadine Hydrochloride Tablets determines the curative effect.For the study of Comound Paracetamol and Amantadine Hydrochloride Tablets in the temperature,humidity,light and other factors in different environment and drug characteristics,and provide scientific basis for the protection of the quality of drugs,the study of the stability factors and the impact of the drug test. Methods: Comound Paracetamol and Amantadine Hydrochloride Tablets high moisture unstable,should be sealed,moisture-proof preservation. Results: By means of accelerated test and long-term test,there was no significant difference between the test indexes and the 0 day data up to 12 months. Conclusion: Through the stability study,the temporary drug is valid for 12 months.

引文

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