红霉素肠溶片质量分析
Study on the quality of erythromycin enteric-coated tablets
分类号：
出版年·卷·期（页码）：2012,32 (4):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的: 对国内不同厂家生产的红霉素肠溶片的质量进行对比研究。 方法: 采用释放曲线测定、有关物质、含量测定等检测方法,综合评价不同工艺的制剂产品。 结果: 释放曲线测定结果显示目前国内的红霉素肠溶片厂家间质量差异较大,同一厂家不同批次的质量均一性不好。数据同时还显示存在低限投料和用不合格原料投料的情况。 结论: 结果表明国内红霉素肠溶片质量参差不齐,应引导企业进行制剂工艺改进,提高质量。
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To study the quality of different manufactures of erythromycin enteric-coated tablets. Methods: By using stripping curves of dissolution,related substances determination and determination of erythromycin,accelerated samples were analyzed. Results: The cumulative dissolutions of tablets of different manufactures were shown different dissolution process respectively.The dissolutions curves of different lots from same manufacture were different.There are low batch and unqualified raw materials in drug production. Conclusion: Studies have shown that differences among the quality of erythromycin enteric-coated tablets from different manufactures.The quality of domestic-made preparations needs to be improved.
-----参考文献：---------------------------------------------------------------------------------------
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[6] RUAN Jian(阮健),BI Jian-hua(毕建华),RUAN Xin(阮新).The application of the paradimethylaminobenzaldehyde show color method in erythromycin enteric-coated tablets dissolution assay(对二甲氨基苯甲醛显色法在红霉素肠溶片溶出度测定中的应用).J Drug Stand China(中国药品标准),2002,3(5):53
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