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ID:33105376
大小:457.89 KB
页数:52页
时间:2019-02-20
《盐酸川芎嗪缓释滴丸的制备工艺及质量控制》由会员上传分享,免费在线阅读,更多相关内容在学术论文-天天文库。
1、提要目的研究盐酸川芎嗪缓释滴丸的制备工艺,并对滴丸进行了质量检查及体外释放度及长期稳定性的研究。方法对滴丸的制备成型试验中相关因素进行单因素考察,以圆整度和拖尾为指标;以料液温度,药物与基质的比例,聚乙二醇与硬脂酸的比例为考察因素,以圆整度、拖尾和累计释放度为指标,进行正交试验,对制备工艺进行优选,确定最佳制备工艺。以HPLC和薄层色谱对所制备缓释滴丸进行质量检查。并且采用转篮法,分别在盐酸缓冲液和磷酸盐缓冲液中,对缓释滴丸进行了体外释放度的考察。以盐酸川芎嗪为指标,制剂释放过程符合Higuchi方程。并对滴丸进行了初步的稳定性实验研究
2、。结果最佳工艺为:以PEG6000与硬脂酸为基质,其比例为4:1,药物与基质比-1例为1:3,料液温度为70℃。冷凝柱温度梯度为:30℃~0℃。调节滴速为45d·min,滴距为5cm。此工艺制备的盐酸川芎嗪缓释滴丸成形性良好,符合药典规定。对滴丸的体外释放度考察发现,盐酸川芎嗪缓释滴丸与普通滴丸相比释放速度缓慢且释放完全。滴丸释药重现性好。结论实验制备的缓释滴丸工艺稳定,质量可控,释放度实验中药物缓慢释放,与普通速释滴丸相比,作用时间持久,基本达到了实验预期的目标。关键词缓释滴丸;正交试验;体外释放度PreparationoftheLi
3、gustrazmeHydrochloridesustained-releasedroppingpillsandinvestigationofitsqualitySpeciality:PharmaceuticsAuthor:SunHongmeiTutor:ZhouChangzhengAbstractObjectiveTopreparetheLigustrazmeHydrochloridesustained-releasedroppingpillsandinvestitsqualityandinvitroreleasebehavior.Me
4、thodssinglefactorexperimentandorthogonaldesignwasemployedtoinvestigatethepreparation,theformerusedroundnessandtaileddegreeasindex.;Temperatureofdosageliquor,proportionofdrugsandgroundmass,proportionofPEG6000andstearicacidwereusedasinvestigationfactors,theroundness,tailed
5、degreeandthereleaserateofpillsasindexinorthogonaldesigntooptimizethepreparationtechnology.TheidentificationofLigustrazmeHydrochlorideandthemeasurementofLigustrazmeHydrochlorideinthepreparationwerebemadewiththeTLCandHPLCrespectively.Itsreleasecharacteristicswerestudiedbyr
6、otatingbasket.Resulttheoptimumtechnology:PEG6000:stearicis4:1;theproportionofdrugsandgroundmassis1:3;theTemperatureofdosageliquoris70℃;condensationTemperatureis-130℃℃~0.droppingrateis45d·min;droppingdistanceis5cm.theLigustrazmeHydrochloridesustained-releasedroppingpillsp
7、reparedbythismethodwereInlinewiththePharmacopoeia.thereleaserateisSlowing.Thepills'releaseprocessprovedtofitHiguchiequation.ConclusionTheresultofthestudyprovesthatthepreparationprocessofthesustained-releasedroppingpillsisstableandthequalityofthepillsiscontrollable.theLig
8、ustrazmeHydrochloridesustained-releasedroppingpillshastheadvantageofsustained-releaseeffect.KeywordsSus
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