設(shè)計(jì)并制備吲達(dá)帕胺微孔滲透泵片劑。方法 通過(guò)單因素考察和正交試驗(yàn)設(shè)計(jì)，以釋放度為指標(biāo)篩選優(yōu)化處方。結(jié)果 以微晶纖維素（MCC）、可壓性淀粉、乳糖、氯化鈉、羥丙基甲基纖維素（HPMC）K4M、十二烷基硫酸鈉為片芯材料；以醋酸纖維素、聚乙二醇（PEG）400、鄰苯二甲酸二乙酯（DEP）的丙酮溶液為包衣液，制備了吲達(dá)帕胺微孔滲透泵控釋片。16 h累積釋放率達(dá)到90%，體外釋藥行為符合零級(jí)釋藥模型，r=0.995 9。結(jié)論 該處方工藝簡(jiǎn)單、有效、重現(xiàn)性好，制得的吲達(dá)帕胺微孔滲透泵片可達(dá)到理想的控釋效果。

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.

國(guó)家重點(diǎn)基礎(chǔ)研究發(fā)展計(jì)劃項(xiàng)目（2010CB735602）