口服固体速释制剂的研究进展Research progress on the oral solid rapidly disintegrating dosage form
沈岚,林晓,徐德生,冯怡
SHEN Lan, LIN Xiao, XU De-sheng, FENG Yi(Shanghai University of Traditional Chinese Medicine, Shanghai 201203)
摘要(Abstract):
口服固体速释制剂以其服用方便、生物利用度高、吸收快、不良反应小等特点 ,日益引起人们的关注。速释机理为速崩、速溶、载体材料对药物溶出的促进作用 ;其剂型包括分散片、冻干速溶片、速释片、速液化咀嚼片、固体分散技术制得的滴丸剂和颗粒剂以及膜剂、干凝胶等。口服固体速释制剂为中药难溶性成分的口服吸收、提高生物利用度提供了一个新途径 ;为中药急症治疗开辟了新剂型 ;为新型药剂辅料的研究提供新思路。口服固体速释制剂在中药领域将有良好的发展前景
Oral solid rapidly-disintegrating dosage form has aroused general concern increasingly because of its characteristics about convenient taking, rapid absorption, high bioavailability and not serious adverse drug reaction. This article introduced its mechanism, which was rapid disintegration, fast dissolution or the promoting dissolving action of supplementary material. This dosage form included dispersible tablets, fast dissolving tablets, fast releasing tablets, droppills, granules and tablets by solid dispersible technology, quick-liquefying chewable tablets and dry elixir. It will become a new way for promoting bioavailability in traditional Chinese medicine difficultly-dissolving composition, create up a new dosage form for treating emergency case by traditional Chinese medicine and give a new thinking for studying new supplementary materials. In brief, oral solid rapidly-disintegrating dosage form will have good prospect in the field of traditional Chinese medicine.
关键词(KeyWords):
口服固体速释制剂;概念;特点;速释机理;剂型
oral solid rapidly-disintegrating dosage form; concept; characteristic; mechanism
基金项目(Foundation):
作者(Author):
沈岚,林晓,徐德生,冯怡
SHEN Lan, LIN Xiao, XU De-sheng, FENG Yi(Shanghai University of Traditional Chinese Medicine, Shanghai 201203)
参考文献(References):
- [1] 吕竹芬,刘毓文,张 蜀尼美舒利分散片的研制广东药学院学报,1999,15(2):86
- [2] 臧志和正交试验筛选西咪替丁分散片的处方华西药学杂志,2001,16(4):319
- [3] 雷同康分散片的处方和工艺中国医药工业杂志,1999,30(2):87
- [4] WatanabeY ,KoizumiK ,ZamaY ,etalNewcompresstabletrapidlydisintegratinginsalivainthemouthusingcrystallinecelluloseandadisintegrantBiolPharmBull,1995,18(9):1308
- [5] HorterD ,DressmanJB InfluenceofphysicochemicalpropertiesondissolutionofdrugsinthegastrointestinaltractAdvDrugDelivRev,1997,25(1):3
- [6] CA 1992,117:55847c
- [7] 戚海亮,张汝华药物预胶化淀粉研究混合物体外溶出及提高溶出机理的研究中国医药工业杂志,1991,22(11):493
- [8] 黄胜炎分散片进展中国药学杂志,1992,27(4):226
- [9] FererroC ,MunozN ,VelascoA ,etalDisintegratingefficiencyofcroscarmellosesodiuminadirectcompressionformulationIntPharm,1997,147(1):11
- [10] 肖学成,卢源峰,谢 云布洛芬分散片的处方设计中国医药工业杂志,1999,30(1):21
- [11] 陆锦芳,戴叶军,刘晓华,等对乙酰氨基酚分散片的研制上海医科大学学报,1999,26(1):62
- [12] 贾 燕,许伟明法莫替丁分散片的研制中国医药工业杂志,1999,30(6):251
- [13] 杜 青阿莫西林分散片的制备及性质考察河北医科大学学报,2000,21(3):135
- [14] 盛炳义,沈志群复方磺胺甲唑分散片的研究中国现代应用药学杂志,1998,15(5):28
- [15] 顾王文国产微晶纤维与Avicel性能的比较中国药学杂志,2001,36(8):532
- [16] JaccardTT ,LeyderJ Anewgalenicform:yocAnnPharmFR ,1985,43(2):123
- [17] 罗明生,高天惠药剂辅料大全成都:四川科技出版社,1995627
- [18] EurPatAppl1989,347767(CA 1990,113:158686q)
- [19] EurPatAppl1998,281200(CA 1989,110:141578w)
- [20] 雷同康硅胶型助流剂药学通报,1986,21:541
- [21] 张艳红,张茂森新型口服速溶制剂冻干速溶片国外医学·药学分册,1996,23(4):202
- [22] 苏桂兰,胡冠时速释糖衣片研究中国药学杂志,1994,29(6):343
- [23] 王中彦甲壳胺硝苯地平速释片的制备及生物利用度沈阳药科大学学报,1997,14(2):79
- [24] 张立德盐酸曲马朵双层片的研制中国药学杂志,2000,35(11):747
- [25] 张毅兰,侯惠民沙丁胺醇缓释双层片的研究中国医药工业杂志,1997,28(7):305
- [26] 方晓玲几种新型辅料在速释片剂中的应用中国医药工业杂志,2000,31(6):257
- [27] 余国瑗中国方剂的剂型改进研究概况中国中药杂志,1991,11(3):182
- [28] 吴 伟尼莫地平固体分散体的制备及体外研究中国药学杂志,1998,33(1):29
- [29] 曾德惠滴丸剂的生产与理论北京:中国医药出版社,19946,52
- [30] 陈庆华,张 炎速释硝苯地平膜剂的研究中国药学杂志,1995,30(1):20
- [31] EP 1986,192460.(PharmInd1987,49:217;CA 1986,105:158867j)
- [32] WO 1993,9304670(CA 1994,120,200433b)