渗透泵控释剂共性关键技术研究及帕利哌酮控释片产业化
项目来源
河(略)技(略)
项目主持人
盖(略)
项目受资助机构
河(略)药(略)公(略)
立项年度
2(略)
立项时间
未(略)
项目编号
1(略)2(略)D
项目级别
省(略)
研究期限
未(略) (略)
受资助金额
未(略)
学科
生(略)与(略)
学科代码
未(略)
基金类别
重(略)计(略)
关键词
帕(略) (略)备(略);(略)研(略) (略)i(略)i(略)e(略)P(略)a(略)i(略)p(略)e(略);(略)a(略)y(略)s(略)c(略)
参与者
未(略)
参与机构
未(略)
项目标书摘要:帕利(略)公司研发生产,是治(略)释制剂。该剂型零级(略)因素的影响,提高了(略)工艺为三层片芯双孔(略)备要求高。本课题拟(略)片,体外释放行为要(略)利哌酮是不溶于水的(略)50为22.19 (略)处方信息确定辅料的(略)性试验中,样品在高(略)外观均无明显变化,(略)好。采用湿法制粒工(略)双层包衣。通过单因(略)促渗透聚合物用量、(略)素对药物释放的影响(略)200K 92 m(略).75 mg,PV(略)g,硬脂酸(粉末)(略) 0.1 mg,黄(略)动层处方:PEO (略) mg,氯化钠(粉(略)PVP K29 7(略)末)0.75 mg(略),红氧化铁1.25(略)、PEG3350为(略)增重0.6%;采用(略)包材制备释药速度控(略)风温度30 ℃,物(略)力0.11~0.1(略)3%~4%,包衣增(略)样品进行质量检测,(略)%,杂质A含量小于(略)小于0.2%,总杂(略)点对应的释放度均满(略)f2值均大于50,(略)1.52%(小于3(略)方法的方法学验证,(略) μg/mL浓度范(略)436452.68(略)79399,R2=(略)9,专属性,精密度(略)稳定性试验研究表明(略)含量无显著变化,样(略)量小于1%,总杂小(略)需防潮、避光、密封(略)了预期目标。
Applicati(略): Paliper(略)ic pump t(略)developed(略)ed by Joh(略)n in the (略)es.It is (略)tained an(略)d release(略)n for the(略)of schizo(略) dosage f(略)o-level d(略),is not e(略)ted by va(略)ors in th(略)estinal t(略)proves th(略)ce of med(略) patients(略)al resear(略)ion is a (略) tablet c(略)-hole dru(略)he prepar(略)ss is com(略)d the equ(略)irements (略)is subjec(略)o prepare(略)ayer and (略)e drug po(略)pump tabl(略)in vitro (略)avior sho(略)istent wi(略)inal form(略) main dru(略)one,is a (略)uble,weak(略)ug,with a(略)article s(略)22.19 μm.(略)the presc(略)ormation (略)ayer osmo(略)blets,det(略) types an(略) excipien(略)arance of(略) under hi(略)ure,high (略)d light c(略)as no obv(略),the cont(略)htly redu(略) compatib(略)od.A doub(略)blet core(略)d by a we(略)on proces(略)ablet cor(略)-coated.S(略)r experim(略)onducted (略)ate the i(略) the form(略)cess fact(略) the weig(略)the coati(略) amount o(略)on enhanc(略),and the (略)on of the(略)lution on(略)elease.Dr(略)ng layer (略)n:PEO 200(略)ium chlor(略)18.75 mg,(略) mg,stear(略)der)0.75 (略)mg,yellow(略) 0.1 mg;p(略)yer presc(略) 7000K 96(略)um chlori(略)8.75 mg,P(略)mg,steari(略)er)0.75 m(略)g,red iro(略)5 mg.Usin(略)hylcellul(略)3350 as p(略)terials t(略)he inner (略)er,the we(略)f the coa(略)%;using C(略)50 as pac(略)rials to (略) drug rel(略)ontrol la(略)ting proc(略)ers:inlet(略)ature 30 (略)temperatu(略)mization (略)11~0.13 M(略)solution (略)on 3%~4%,(略)ght gain (略)atches of(略)re repeat(略) for qual(略) content (略)%,the con(略)urity A w(略)n 1%,and (略)e maximum(略) were les(略),the tota(略)s are les(略),and the (略)ree corre(略) each sam(略) meets th(略)It is req(略)the f2 va(略)release c(略)ater than(略) moisture(略) 1.48%~1.(略)an 3%).Th(略)gical ver(略)f the con(略) phase an(略)od is car(略)e results(略)t the sta(略) equation(略)centratio(略)0.3~30 μg(略)6452.6838(略)399,R2=0.(略)and the s(略)precision(略)ate are a(略) requirem(略)ity test (略)e shown t(略)earance c(略)aliperido(略)pump tabl(略)significa(略)he differ(略)n samples(略)he impuri(略)is less t(略)total imp(略) less tha(略)quality i(略)d it need(略)tected fr(略),light,an(略)e researc(略)ubject ha(略)the expec(略)
项目受资助省
河(略)
- (略)