VitaminA VitaminD3Injectable Solution s
(30000i.u.A 5000or10000i.u.D3/ml)
1.Formulation
30000i.u.A30000i.u.A
5000i.u.D3 10000i.u.D3
VitaminApalmitate..............................1.9g1.9g 1.7Mioi.u./g(BASF)
VitaminD340Mioi.u./g...................0.013g0.026g Butylhydroxyto luene.............................0.1g0.1g Soluto lHS15[1]........................9.0–10.0g10.0g Preservative..........................................q.s.q.s.
WaterforInjectable s.....................ad100mlad100ml
2.Manufacturing Heatthemixtureofthevitaminswithbutylhydroxyto lueneandSoluto lHS
15to about65C.HeattheSolution ofthepreservativeinwaterto the
sametemperatureandadditslowlyto thewellstirredvitaminmixture.
Aftertheampouleshavebeenheat-sterilized,theyshouldbeshakenfor
ashorttime,whiletheyarestillhot,to eliminateanyseparationofthe
phasesthatmayhaveoccured.Sterilizationcanalsobeperformedby
membranefiltrationunderpressure.
3.PropertiesoftheSolution s
ClearyellowSolution swhereobtained.
4.Physicalstability(20–25C,protectedfromlight)
Nochangewasobservedduring1year.
关键字:vitamin injectable