中国药房2012，Vol.23Issue(1)：48-51,4.DOI:10.6039/j.issn.1001-0408.2012.01.17
甲磺酸普立地诺口腔崩解片的研制及质量评价
Preparation and Quality Control of Pridinol Mesylate Orally Disintegrating Tablets
摘要
Abstract
OBJECTIVE: To prepare orally disintegrating tablets containing pridinol mesylate and investigate its quality. METHODS : Disintegrants and correctants were selected by single-factor experiment with disintegration time and taste as index. The formulation was optimized by L9(34) orthogonal experiment with disintegration time as index using amount of PVPP, MCC, PVP K30 and correctants as factors. And validation test was conducted (content, content uniformity and dissolution). RESULTS: 4%PVPP was selected as the disintegrant and the inside-outside proportion was 1:1, 3 % correctant was aspartame/steviosin with proportion of 6:1, 15% MCC and 2% PVP K30 were used. The orally disintegrating tablets were integrated and smooth with desirable taste and feel in the mouth. The disintegration time was(21.85 ± 2.3) s and the cumulative dissolution percentage was (98.01 ± 0.83)% within 4 min. The content and content uniformity were up to specification. CONCLUSION: The prescription and technology are reasonable and the quality indexes conform to the requirement of orally disintegrating tablets.关键词
甲磺酸普立地诺/口腔崩解片/正交试验/研制/质量评价Key words
Pridinol mesylate/ Orally disintegrating tablets/ Orthogonal experiment/ Preparation/ Quality evaluation分类
医药卫生引用本文复制引用
田朋鑫,罗永煌,刘艳玲,聂延君..甲磺酸普立地诺口腔崩解片的研制及质量评价[J].中国药房,2012,23(1):48-51,4.基金项目
重庆市科技创新能力建设基金资助(CSTC,2009CB1010) （CSTC,2009CB1010）
