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目的:探讨制备硫酸沙丁胺醇延迟释放片的方法。方法:用湿法制粒制备片芯,PEG6000/EudragitS100聚合物的分散物做外层释药控制层,采用干压包衣技术制备延迟释放片,用DSC,X-ray衍射及傅立叶红外对PEG6000/EudragitS100共熔物进行鉴定,并进行延迟释放片体外释放度测定。结果:PEG6000和EudragitS100完全混合生成一种新的固体分散物聚合物,延迟释放片的体外迟滞时间为4h。结论:硫酸沙丁胺醇延迟释放片处方设计和工艺方法可行,达到预期的设计目的。
Objective: To investigate the preparation of salbutamol sulfate delayed release tablets. Methods: The core of PEG6000 / Eudragit S100 was prepared by wet granulation, and the release layer of PEG6000 / Eudragit S100 polymer was used as the control layer for drug release. The delayed release tablets were prepared by dry-pressure coating. The delayed release tablets were prepared by DSC, XRD and Fourier transform infrared EudragitS100 eutectic were identified, and delayed release tablets in vitro release determination. Results: PEG6000 and Eudragit S100 were completely mixed to form a new solid dispersion polymer. Delayed release tablets were delayed in vitro for 4 h. Conclusion: The prescription and process of salbutamol sulfate delayed release tablets are feasible and reach the expected design goals.