学术论文-替尼泊苷冻干粉针剂的处方及冻干工艺研究.pdf

.224.中国抗生素杂志2014年3月第39卷第3期

文章编号：1001-8689(2014)03-0224-05

替尼泊苷冻干粉针剂的处方及冻干工艺研究

杨柳1姚瑰玮1王秀玲2余邦良1,*
(1海南医学院药学院，海口571101；2海南紫杉园药业有限公司，海口570216)

摘要：目的优化替尼泊苷冻干粉针剂的处方及冻干工艺。方法采用4正交试验优选处方，以原料药的浓度、
L9(3)(A)
聚氧乙烯氢化蓖麻油的用量(B)、甘露醇的用量(C)、药液pH值(D)为考察因素，以制剂溶解性和含量为质量评价指标，确定最优
处方组合；采用4正交试验确定冻干工艺，以预冻温度和时间、升华干燥温度变化、升华干燥时间和真空压
A1B3C3D3L9(3)(E)(F)
力、解析干燥温度和真空压力为考察因素，以成品收率和残余水分为质量评价指标，确定最优冻干工艺组合。
(G)(H)E2F3G1H2
结果通过处方及冻干工艺制备批替尼泊苷冻干粉针样品，批样品的外观均为白色疏松块状，复溶性好，
A1B3C3D3E2F3G1H233
含量均在99.3%左右。结论该替尼泊苷冻干粉针处方及冻干工艺可行性好、重现性好。
关键词：替尼泊苷；冻干粉针剂；正交试验；处方优选；冻干工艺研究
中图分类号：R979.1文献标志码：A
DOI:10.13461/j.cnki.cja.005296
Studyontheprescriptionandpreparationtechniqueofteniposidefreezedried
powderinjection

YangLiu1,YaoGui-wei1,WangXiu-ling2andYuBang-liang1
(1TheDepartmentofPharmacy,HainanMedicalCollege,Haikou571101;2HainanYewPharmaceuticalCo.,Ltd.,Haikou570216)

AbstractObjectiveTooptimizetheprescriptionandfreeze-drytechniqueofteniposidefreezedriedpowder

injection.MethodsTheoptimalprescriptioncombinationA1B3C3D3wasdeterminedbyorthogonalexperimental
4
designL9(3)withtheconcentrationofpharmaceuticalproduct(A),thedosageofpoly-oxyethylenehydrogenated
castoroil(B),thedosageofmannitol(C)andphysicliquorpH(D)asconsiderationfactors.Andthesolubilityand

contentofpreparationweretakenasqualityevaluationindex;Thefreeze-driedtechniquecombinationE2F3G1H2was
4
determinedbyorthogonalexperimentaldesignL9(3)withtheforefrozentemperatureandtime(E),thesublimation
dryingtemperaturechange(F),theresolutiondryingtimeandvacuumpressure(G)andresolvedryingtemperatureand
dryingtemperature(H)asconsiderationfactors.Andtheproductyieldandremnantwatercontentweretakenasquality

evaluationindex.ResultsThreebatchsofteniposideforfreezedriedpowderinjectionwerepreparedwithA1B3C3D3

prescriptionandE2F3G1H2freeze-driedtechniqueandtheappearanceofthethreebatchsofsampleswereallwhite
porosityblock.There-dissolvabilitywasgood.Thecontentwasabout99.3%.ConclusionTheprescriptionand
preparationtechniqueofteniposideforfreezedriedpowderinjectionisbetterfeasibility