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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。
Objective: To compare the quality of erythromycin enteric-coated tablets produced by different domestic manufacturers. Methods: The determination of release curve, the relevant substances, determination of content and other detection methods, a comprehensive evaluation of different processes of preparation products. Results: The results of the release curve showed that the quality of the erythromycin enteric-coated tablets in China was quite different at present. The quality uniformity of different batches of the same manufacturer was not good. The data also shows that there is a low limit of feed and feed with unqualified feedstocks. Conclusion: The results show that the quality of domestic erythromycin enteric-coated tablets is uneven, and should guide the enterprises to improve formulation process and improve quality.