连潇嫣,任晓文,李洪起,王 博.吲达帕胺微孔渗透泵片的设计与制备[J].现代药物与临床,2011,26(5):397-402
吲达帕胺微孔渗透泵片的设计与制备
Design and preparation of indapamide micro-porous osmotic pump tablet
  
DOI:10.7501/j.issn.1674-5515.[year].[issue].[sequence]
中文关键词:  吲达帕胺微孔渗透泵片  吲达帕胺  正交试验  零级释放
英文关键词:indapamide micro-porous osmotic pump tablet  indapamide  orthogonal test  Zero order release
基金项目:国家重点基础研究发展计划项目(2010CB735602)
作者单位E-mail
连潇嫣 天津药物研究院天津 300193 lianxy@tjipr.com 
任晓文,李洪起,王 博   
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中文摘要:
      设计并制备吲达帕胺微孔渗透泵片剂。方法 通过单因素考察和正交试验设计,以释放度为指标筛选优化处方。结果 以微晶纤维素(MCC)、可压性淀粉、乳糖、氯化钠、羟丙基甲基纤维素(HPMC)K4M、十二烷基硫酸钠为片芯材料;以醋酸纤维素、聚乙二醇(PEG)400、邻苯二甲酸二乙酯(DEP)的丙酮溶液为包衣液,制备了吲达帕胺微孔渗透泵控释片。16 h累积释放率达到90%,体外释药行为符合零级释药模型,r=0.995 9。结论 该处方工艺简单、有效、重现性好,制得的吲达帕胺微孔渗透泵片可达到理想的控释效果。
英文摘要:
      Objective To design and prepare indapamide micro-porous osmotic pump tablet. Methods By single-factor and orthogonal test design with the in vitro release as the main indicator, optimal formulation modified to release drug over 16 h was obtained. Results Microcrystalline cellulose (MCC), amylum pregelatinisatum, lactose, sodium chloride, hypromellose (HPMC) and sodium dodecylsulfate (SDS) were used to make the tablet core. Cellulose acetate (CA), PEG 400, diethyl phthalate (DEP), and acetone were selected as the coating solution. Cumulative drug release of the optimal formulation at 16 h exceeded 90% with the excellent Zero-order release character in vitro(r=0.995 9). Conclusion The formulation and preparation technology of the indapamide micro-porous osmotic pump tablet are simple but effective, showing good reproducibility. The supposed indapamide porosity osmotic tablets can realize ideal controlled drug release.
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