增塑剂及肠溶致孔剂对醋酸纤维素游离膜性能的影响

Effects of plasticizer and pore-foaming agent on performance of cellulose acetate free film

目的研究增塑剂及肠溶致孔剂对醋酸纤维素游离膜性能的影响,以此为肠溶渗透泵制剂的包衣处方设计奠定基础。方法采用平面铸膜法制备游离膜,以膜的机械性能、透湿性、吸水率及洗脱率为评价指标,考察增塑剂及肠溶致孔剂对游离膜性能的影响。结果以聚乙二醇400(PEG400)为增塑剂时,膜的刚性及韧性均较好。柠檬酸三乙酯(TEC)、PEG400、聚乙二醇6000(PEG6000)三种增塑剂用量超过15%时,游离膜的透湿性均明显增大。其中以PEG6000为增塑剂时,吸水率及洗脱率相对较大,其用量增加到20%时,吸水率及洗脱率分别增大为184.21%、16.67%。以邻苯二甲酸羧丙甲纤维素酯HP50(HPMCP-HP50)为致孔剂时,膜的机械强度和韧性相对较好,且透湿性较大。EudragitL100、HPMCP-HP50、HPMCP-HP55三种肠溶致孔剂的吸水率及洗脱率方面差异无统计学意义。结论该研究的研究结果可为肠溶渗透泵制剂的包衣处方设计提供依据。

Objective To study the effects of plasticizer and enteric pore-foaming agent on cellulose acetate free film performance so as to lay the foundation for the performulation of enteric osmotic pump preparations. Methods Plane casting film was used to prepare free film and the mechanical properties,moisture permeability water uptake and erosion of the free film were taken as the evaluation indexes,so that we can investigate the influence of plasticizer and enteric pore-foaming agent on performance of free film. Results Membrane rigidity and toughness were better when PEG400 was used as plasticizer. When the dosages of TEC,PEG400 and PEG6000 exceeded15%,the moisture permeabilities were significantly increased. PEG6000 as plasticizer,water uptake and erosion rates were relatively higher compared with the two plasticizers. When its dosage increased to 20%,the water uptake and erosion rates increased to 184. 21%and 16. 67%,respectively. When HPMCP-HP50 was used as enteric pore-foaming agent,membrane mechanical strength and toughness were better,and the moisture permeability was higher. The rates of water uptake and erosion of Eudragit  L100,HPMCP-HP50 and HPMCP-HP55 had no significant differences. Conclusions The results of the study can provide basis for the performulation of enteric osmotic pump preparations.