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机构地区:[1]首都医科大学附属北京朝阳医院药剂科,北京100020
出 处:《中国新药杂志》2003年第1期45-46,共2页Chinese Journal of New Drugs
摘 要:目的 :建立阿司匹林粉末直接压片的新工艺。方法 :使用新型的速释直接压片辅料 ,筛选出可压性和流动性均好的稀释剂 ,建立粉末直接压片的新工艺。经影响因素试验、加速试验及室温贮存考察 ,检测制备的阿司匹林片的性状、溶出度、含量及色谱检查降解产物游离水杨酸。结果 :本工艺制备的阿司匹林片稳定性良好 ,其性状、溶出度、含量及游离水杨酸均符合 2 0 0 0版药典规定。结论Objective:To establish a new method to make aspirin tablets by directly squashing aspirin and excipients powder.Methods:Choose new excipients which can be rapidly released,directly squashed and have good fluidity,mix them with aspirin powder and directly squash the mixed powder to produce aspirin tablets.Under stress test,accelerated test,room temperature environment,the following aspirin tablets' properties were assessed:appearance,aspirin's content, dissolution speed and salicylic acid's content.Result and Conclusion:Aspirin tablets have good stability, their properties are correspondent with the requirements of Chinese Pharmcopeia 2000.The new direct powder compression method would not cause aspirin degradation.
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