苦参片制备工艺研究.docxVIP

苦参片制备工艺研究

魏鹏苏州玉森新药开发

摘要：苦参片为半浸膏片，生产制备工艺存在一定难度。其中指标成分苦参碱和氧化苦参碱存在相互转化，成品中含后为两者含量之和，但两个含晟均有鉴别考察。故平衡工艺过程中的工艺参数控制尤为重要。本文对苦参片的各工艺工序进行考察，包括苦参粉的灭菌，提取，制剂等工序，以苦参碱、氧化苦参碱等指标评价苦参粉的灭菌工艺条件，以性状外观、硬度、脆碎度、片重差异、崩解时限、鉴别、含量等指标评价苦参片制剂工艺，最终确定苦参片最优的制备工艺为苦参饮片833g,加水煎煮2次，加水倍量分别为6倍量、6倍量，时间分别为3小时、2小时，保持微沸，95-100笆，煎液滤过，合并滤液，滤液浓缩至相对密度1.26.35（50°C~75°C热测）的提取物。取苦参饮片167g进行破碎，115°C灭菌5min,真空干燥2h,粉碎，过筛，混合。取苦参粉、苦参片提取物，混合均匀，制成适宜的软材，过筛，干燥。干燥后的颗粒粉碎成80目以上细粉。粉碎后的细粉加入适量乙醇，混合均匀，制成适宜的软材。过筛，制成均匀的湿颗粒，将湿颗粒干燥，整粒、过筛，筛网目数14日，加入0.说硬脂酸镁，总混，压片，即得苦参素片。

Abstract:Sophoraflavescenstabletsaresemi-extracttablets,andtherearecertaindifficultiesintheproductionandpreparationprocess.Amongthem,theindexcomponentsmatrineandoxymatrinearemutuallytransformed,andthecontentinthefinishedproductisthesumofthetwocontent,butbothcontentarcidentifiedandinvestigated.Therefore,theprocessparametercontrolinthebalanceprocessisparticularlyimportant.ThisarticleinvestigatesthevarioustechnologicalprocessesofSophoraflavescenstablets,includingthesterilization,extractionandpreparationofSophorafkivescenspowder,andevaluatesthesterilizationprocessconditionsofSophoraflavescenspowderwithindicatorssuchasmatrineandoxymatrine.,Hardness,friability,differenceintabletweight,disintegrationtimelimit,identification,contentandotherindicatorstoevaluatethepreparationprocessofKushentablets,andfinallydeterminedthattheoptimalpreparationtechnologyofKushentabletsis833gKushendecoctionpieces,decoctedtwicewithwater,andaddedwaterThedoubleamountis6timestheamountand6timestheamountrespectively.Thetimeis3hoursand2hoursrespectively.Keepslightlyboiling,95-100°C,filterthedecoction,combinethefiltrate,andconcentratethefiltratetoarelativedensityof1.26~1.35（50°C75°Cheattest）extract.Take167gofSophoraflavcscensdecoctionpiecesforcrushing,sterilizeat115°Cfor5minutes,vacuumdry