Optimization on formulation of sinomenine hydrochloride pulsatile drug delivery tablets by central composite design-response surface method
- VernacularTitle:星点设计-效应面法优化盐酸青藤碱脉冲片处方的研究
- Author:
Yu ZHANG
;
Ying BAI
- Publication Type:Journal Article
- Keywords:
sinomenine hydrochloride;
pulsatile release systems;
central composite design-response surface method
- From:
Chinese Traditional and Herbal Drugs
1994;0(07):-
- CountryChina
- Language:Chinese
-
Abstract:
Objective To optimize the formulation of sinomenine hydrochloride pulsatile drug delivery tablets by central composite design-response surface method.Methods The tablets containing sinomenine hydrochloride were prepared by dry-compression coating technique.The influence factors included the amount of sodium carboxymethyl starch in core tablets, the ratio of HPMC/carrrageenan,and the amount of matrix materials in coating film.The evaluation parameter was lag time.Experiments were done on the central composite design,and the data were simulated using multi-linear equation and second-order polynomial equation.The possibly optimal formulation was predicted by response surface method.The lag time of the tablets prepared under the optimum condition was compared with the predicted.Results The lag time was simulated using second-order polynomial equation and the regression coefficient was 0.993 7.The lag time in vitro of the tablets prepared under the optimum conditions was about 6 h,then drug released in pulsatilerelease character.Bias between the observed and predicted values of the lag time was within ?4.43%.Conclusion The sinomenine hydrochloride pulsatile tablets could release drug quickly in vitro at the predetermined time.Central composite design-response surface method can be used to optimize the formulation and the model developed in this study proves to be highly predictable.
