穿山龙注射液的制备工艺及质量评价研究

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1、提要目的：探索引起穿山龙注射液刺激性问题的原因，对穿山龙注射液的制剂工艺进行优化，降低其刺激性，提高其有效成分的含量，并建立穿山龙药材及制剂的指纹图谱，对制剂进行质量控制。方法：采用肌肉刺激性试验为指标，考察引起穿山龙注射液刺激性的原因；采用正交试验优选出穿山龙的水提取工艺；采用大孔树脂精制穿山龙的水溶性皂苷成分，确定工艺参数，测定了精制物中部分水溶性皂苷的含量；采用高效液相色谱法建立穿山龙水溶性皂苷含量测定方法、药材及制剂的指纹图谱。结果：穿山龙注射液中的鞣质、有效成分本身及PH对刺激性均有影响；优化了制剂工艺，确定了提取及精制工艺参数；制定了穿山龙水溶性皂苷中原薯

2、蓣皂苷和甲基原薯蓣皂苷的含量测定标准；建立了穿山龙药材及其制剂的高效液相指纹图谱。结论：经制剂工艺进行改进后得到的穿山龙水溶皂苷中原薯蓣皂苷和甲基原薯蓣皂苷的总含量达到60%以上；建立的水溶性皂苷的含量测定标准和药材及制剂的高效液相指纹图谱，方法重现性、精密度、稳定性均良好，指纹图谱相似度良好，改进了穿山龙注射液的质量控制方法。关键词穿山龙注射液；刺激性；提取工艺；精制工艺；指纹图谱ResearchonPreparationandQualityRe-evaluationofRhizomaDioscoreaeNipponicaeInjectionSpeciality:P

3、harmacyofTraditionalChineseMedicineAuthor:SuMingTutor:ProfessorTIANJing-zhenAbstractObjectiveToexplorethereasonsfortheirritationoftheDioscoreainjection,andoptimizethepreparationoftheDioscoreinjection,reducingitsirritatingandimprovethecontentofitsactiveingredients,andtoestablishthefinger

4、printofmedicinalherbsandpreparationsofDioscoreapreparationsforqualitycontrol.Methods:MuscleirritationtestwasusedasanindicatortoinvestigatethecauseofDioscoreainjectionirritating;Byorthogonaltest,thewaterextractionofDioscoreaisscreened;UsingMacroporousresinrefinedwater-solublesaponinsofDi

5、oscorea,tofindthebestpreparation,determinedbytherefinedextractpartofthewater-solublesaponins;HPLCmethodwasusedtoestablishwater-solublesaponincontentofDioscorea,fingerprintdeterminationmethodsofmedicinalherbsandpreparationsResultsThetannin,theactiveingredientitselfandPHoftheDioscoreainje

6、ctionarethereasonsforiteirritating.Theextractionandrefiningparametersofthepreparationwaeestablished.TodeveloptheCentralPlainsdiosgenin,Dioscoreawater-solublesaponinandmethylprotodioscinthedeterminationofstandardsHPLCfingerprintofmedicinalherbsandtheirpreparationoftheDioscoreawaeestablis

7、hed.-4-ConclusionAfterthepreparationprocesstoimprovewater-solubleDioscoreadiosgenin,saponinsfromtheCentralPlainsandthetotalcontentofmethylprotodioscinofmorethan60%.Theestablishmentofwater-solublesaponinsmeasuredbythestandardandmedicinalherbsandpreparationsbyhighperformanceliqui