中国药师
中國藥師
중국약사
CHINA PHARMACIST
2014年
12期
2024-2026,2027
,共4页
黄开合%杜士明%田华%陈黎%彭芬芬
黃開閤%杜士明%田華%陳黎%彭芬芬
황개합%두사명%전화%진려%팽분분
甲冰缓释膜%正交试验%处方优化%质量控制
甲冰緩釋膜%正交試驗%處方優化%質量控製
갑빙완석막%정교시험%처방우화%질량공제
Metronidazole and borneol sustained-release films%Orthogonal test%Formula optimization%Quality control
目的::优化甲冰缓释膜的处方。方法:以白及多糖与聚乙烯醇124( PVA-124)的质量比、甘油和羧甲基纤维素钠(CMC-Na)的用量为考察因素,以膜剂的外观、0.5 h与4 h甲硝唑的释放度为综合评价指标,采用正交试验对成膜材料的处方进行优化。结果:白及多糖与PVA124的用量比例是影响膜剂质量的关键因素,当白及多糖与PVA124的质量比为20∶80、甘油用量为3.5 g、CMC-Na用量为0.14 g时,所制得的膜剂外观符合要求,0.5 h及4 h的释放度分别为25.17%、69.64%,8 h平均累积释放率>90%。结论:经优化的处方所制成的药膜平整光洁,柔软度适中,即能保持原处方透膜释放药物的特性,又能发挥白及的药理作用。
目的::優化甲冰緩釋膜的處方。方法:以白及多糖與聚乙烯醇124( PVA-124)的質量比、甘油和羧甲基纖維素鈉(CMC-Na)的用量為攷察因素,以膜劑的外觀、0.5 h與4 h甲硝唑的釋放度為綜閤評價指標,採用正交試驗對成膜材料的處方進行優化。結果:白及多糖與PVA124的用量比例是影響膜劑質量的關鍵因素,噹白及多糖與PVA124的質量比為20∶80、甘油用量為3.5 g、CMC-Na用量為0.14 g時,所製得的膜劑外觀符閤要求,0.5 h及4 h的釋放度分彆為25.17%、69.64%,8 h平均纍積釋放率>90%。結論:經優化的處方所製成的藥膜平整光潔,柔軟度適中,即能保持原處方透膜釋放藥物的特性,又能髮揮白及的藥理作用。
목적::우화갑빙완석막적처방。방법:이백급다당여취을희순124( PVA-124)적질량비、감유화최갑기섬유소납(CMC-Na)적용량위고찰인소,이막제적외관、0.5 h여4 h갑초서적석방도위종합평개지표,채용정교시험대성막재료적처방진행우화。결과:백급다당여PVA124적용량비례시영향막제질량적관건인소,당백급다당여PVA124적질량비위20∶80、감유용량위3.5 g、CMC-Na용량위0.14 g시,소제득적막제외관부합요구,0.5 h급4 h적석방도분별위25.17%、69.64%,8 h평균루적석방솔>90%。결론:경우화적처방소제성적약막평정광길,유연도괄중,즉능보지원처방투막석방약물적특성,우능발휘백급적약리작용。
Objective:To optimize the formula of metronidazole and borneol sustained-release films. Methods: The mass ratio of Rhizoma Bletillae polysaccharide and polyvinyl alcohol 124(PVA-124) and the dosage of glycerol and sodium carboxymethyl cellulose ( CMC-Na) as the influencing factors ,the appearance of films and the release rate of metronidazole at 0. 5h and 4h as the comprehen-sive evaluation indices, the formula of the film-forming materials was optimized by orthogonal test. Results:The mass ratio of Rhizoma Bletillae polysaccharide and PVA-124 was the key factor affecting the quality of the films. When the mass ratio of Rhizoma Bletillae pol-ysaccharide and PVA-124 was 20∶80, and the dosage of glycerol was 3. 5g and that of CMC-Na was 0. 14g, the appearance of the films was satisfied, the release rate of metronidazole at 0. 5h and 4h was 25. 17% and 69. 64%, respectively, and the average cumulative re-lease rate at 8h was over 90%. Conclusion:The films prepared by the optimized formula are flat, smooth, clean and moderately soft, which can not only remain the drug release characteristics of the films made by the original formula, but also exhibit the pharmacologi-cal effect of Rhizoma Bletillae.