六味地黄浓缩滴丸的制备工艺.docxVIP

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六味地黄浓缩滴丸的制备工艺

【摘要】目的：提取六味地黄方成分，用正交试验优化六味地黄浓缩滴丸的制备工艺，对制得滴丸的外观、理化检查、总多糖含量进行质量评价。方法：通过单因素试验来考察滴丸的含药量、复合基质比例、滴制速度、滴制距离、药液温度和冷凝液温度对六味地黄浓缩滴丸质量的影响，利用正交试验法优化六味地黄浓缩滴丸的制备工艺，对其外观、理化检查、总多糖含量进行质量评价。结果：六味地黄浓缩滴丸的最优制备工艺为药物含量为30%、且基质比例PEG6000︰PEG4000为3︰1、滴制距离为7.5cm、药液温度为81~85℃、冷凝液温度为15℃和滴制速度为25d/min。采用上述最优制备工艺，所得滴丸外观符合圆整、无气孔和拖尾现象，平均丸重变异系数稳定、溶散时限符合要求。滴丸中总多糖含量以无水葡萄糖计平均为2.933mg/g。结论：此六味地黄浓缩滴丸的制备工艺合理、稳定可靠。

【关键词】：六味地黄；正交试验；滴丸；含量测定；制备工艺

ThepreparationtechnologyofLiuweiDihuangconcentrateddroppingpill

[Abstract]:Purpose:TheingredientsofLiuweiDihuangformulawereextracted,andthepreparationprocessofLiuweiDihuangconcentrateddropswasoptimizedbyorthogonaltest,anditsqualitywasevaluatedbyitstotalpolysaccharidecontentastheevaluationindex.Method:Single-factortestswereconductedtoinvestigatetheeffectsofthedrugcontentofthedrops,theproportionofthecompoundmatrix,thedroppingspeed,thedroppingdistance,thetemperatureofthedrugsolutionandthetemperatureofthecondensateonthequalityofLiuweiDihuangconcentrateddrops,tooptimizethepreparationprocessofLiuweiDihuangconcentrateddropsusingtheorthogonaltestmethod,andtoevaluatethequalityofitsappearance,physicochemicalexaminationandtotalpolysaccharidecontent.Result:TheoptimalpreparationprocessfortheLiuweiDihuangconcentrateddropswas30%drugcontent,matrixratioPEG6000:PEG4000=3:1,droppingdistanceof7.5cm,liquidtemperatureof81-85℃,condensatetemperatureof15℃anddroppingspeedof25d/min.Withtheaboveoptimalpreparationprocess,theresultingdropshadaroundedappearance,noairholesandtrailing,andtheweightofthepillsaresustainableandthedissolutiontimewereinaccordancewiththepharmacopoeiarequirements.Thedifferenceanddissolutiontimewereinaccordancewiththepharmacopoeiarequirements.Thetotalpolysaccharidecontentofthepillswas2.933mg/gonaveragein