氯雷氨酚伪麻缓释片的研制

发布时间：2018-02-01 10:20

本文关键词： 氯雷他定对乙酰氨基酚硫酸伪麻黄碱缓释片 f因子　出处：《中国新药杂志》2017年01期 　论文类型：期刊论文

【摘要】：目的:制备氯雷氨酚伪麻缓释片,考察其含量、含量均匀度及体外溶出与释放行为。方法:以羟丙甲纤维素(HPMC)为缓释骨架材料,对片芯的处方、制备工艺以及包衣的工艺进行研究,建立含量及含量均匀度、释放度、溶出度测定方法,采用f_2因子法与原研药进行溶出与释放曲线相似性评价。结果:选择HPMC K4M作为片芯的骨架材料,HPMC K4M用量为处方量的10%,所得氯雷氨酚伪麻缓释片的含量、含量均匀度符合要求,本制剂中各组分与原研药各组分的f2因子均大于50。结论:本研究的处方工艺稳定、重现性好,可用于制备氨酚氯雷伪麻缓释片。
[Abstract]:Objective: to prepare chloramol pseudoephedrine sustained-release tablets, and to investigate the content, content uniformity, dissolution and release behavior in vitro. Methods: HPMCs were used as sustained-release matrix materials to prepare the tablets core. The preparation process and coating technology were studied to establish a method for the determination of content and content uniformity, release and dissolution. Results: the dosage of HPMC K4M as the core skeleton material was 10% of the prescribed amount. The content and content uniformity of pseudoephedrine sustained-release tablets were consistent with the requirements, and the f2 factors of each component in this preparation and the original components were all greater than 50. Conclusion: the formulation of this study is stable and reproducible. It can be used in the preparation of paracetamol chloropramine pseudo-hemp sustained-release tablets.
【作者单位】：广州白云山医药集团股份有限公司白云山制药总厂;
【分类号】：R943
【正文快照】： 氯雷氨酚伪麻缓释片主要用于治疗和缓解普通感冒以及流行性感冒有关的症状,包括同时伴有疼痛或者发热的鼻塞、打喷嚏、鼻出血、瘙痒、流涕、流泪等,也可用于缓解季节性过敏性鼻炎症状[1]。氯雷氨酚伪麻缓释片最早由先灵葆雅制药公司研制,于1996年在墨西哥上市,商品名为Clarifl

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