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目的探究地西泮—布洛芬栓制备流程及制备过程中的质量标准。方法以混合脂肪酸甘油酯为基质进行地西泮—布洛芬栓制备,按照中国药典标准(2015版)进行质量控制,探究地西泮—布洛芬栓制备流程及建立地西泮—布洛芬栓制备的质量标准。结果地西泮—布洛芬栓的制备,硬脂酸聚烃氧酯含量为6%时对地西泮—布洛芬栓的溶出有明显促进作用,对其制备质量标准进行评测。结论地西泮—布洛芬栓制备操作简便,符合中国药典标准进行质量标准评定,其评测结果可靠有效,可进一步推广应用。
Objective To investigate the preparation process and quality standards of diazepam and ibuprofen suppository. Methods The preparation of diazepam-ibuprofen suppository with mixed fatty acid glycerides as matrix was carried out according to Chinese Pharmacopoeia (2015 edition) quality control to explore the preparation of diazepam-ibuprofen plug process and the establishment of diazepam - The quality standards for the preparation of fenrants. Results The preparation of diazepam-ibuprofen suppository significantly enhanced the dissolution of diazepam-ibuprofen suppository when the content of polyoxyl ester of stearic acid was 6%. The preparation quality standard was evaluated. Conclusion The diazepam-ibuprofen suppository is simple and easy to prepare, conforms to the Chinese Pharmacopoeia standard for quality evaluation, and its evaluation results are reliable and effective, which can be further popularized and applied.