盐酸川芎嗪缓释滴丸的制备工艺及质量控制

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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