本文關(guān)鍵詞： 氯雷他定 對(duì)乙酰氨基酚 硫酸偽麻黃堿 緩釋片 f因子　出處：《中國新藥雜志》2017年01期 　論文類型：期刊論文

【摘要】：目的:制備氯雷氨酚偽麻緩釋片,考察其含量、含量均勻度及體外溶出與釋放行為。方法:以羥丙甲纖維素(HPMC)為緩釋骨架材料,對(duì)片芯的處方、制備工藝以及包衣的工藝進(jìn)行研究,建立含量及含量均勻度、釋放度、溶出度測(cè)定方法,采用f_2因子法與原研藥進(jìn)行溶出與釋放曲線相似性評(píng)價(jià)。結(jié)果:選擇HPMC K4M作為片芯的骨架材料,HPMC K4M用量為處方量的10%,所得氯雷氨酚偽麻緩釋片的含量、含量均勻度符合要求,本制劑中各組分與原研藥各組分的f2因子均大于50。結(jié)論:本研究的處方工藝穩(wěn)定、重現(xiàn)性好,可用于制備氨酚氯雷偽麻緩釋片。
[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.
【作者單位】： 廣州白云山醫(yī)藥集團(tuán)股份有限公司白云山制藥總廠;
【分類號(hào)】：R943
【正文快照】： 氯雷氨酚偽麻緩釋片主要用于治療和緩解普通感冒以及流行性感冒有關(guān)的癥狀,包括同時(shí)伴有疼痛或者發(fā)熱的鼻塞、打噴嚏、鼻出血、瘙癢、流涕、流淚等,也可用于緩解季節(jié)性過敏性鼻炎癥狀[1]。氯雷氨酚偽麻緩釋片最早由先靈葆雅制藥公司研制,于1996年在墨西哥上市,商品名為Clarifl

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1 王菲;;硫酸偽麻黃堿凝膠骨架型緩釋片的制備與釋放度試驗(yàn)[J];中國藥業(yè);2006年20期

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本文編號(hào)：1481625