乳剂型栓剂基质的处方筛选  

Prescription screening on the emulsion base of suppository

作　　者：王淑萍[1] 张莉[2] 陈虹[3] 

机构地区：[1]武警医学院附属医院药剂科,天津300162 [2]武警医学院药剂教研室,天津300162 [3]武警医学院生药教研室,天津300162

出　　处：《武警医学院学报》2008年第4期272-274,共3页Acta Academiae Medicinae CPAPF

摘　　要：【目的】以硬度及融变时限为指标,对以聚乙二醇为主要基质制备的乳剂型栓剂进行处方筛选,并对制备的乳剂型栓剂基质类型进行鉴别。【方法】采用正交设计筛选以聚乙二醇为主体的乳剂型栓剂的处方,考察处方中各种成分对基质性状的影响。显微镜法鉴别乳剂型栓剂的基质类型。【结果】在试验设计范围内栓剂制剂工艺的影响因素大小为:聚乙二醇种类>聚乙二醇量>吐温-80>单硬脂酸甘油酯。采用直观分析和方差分析对试验数据进行综合比较,并通过直观分析图分析,确定乳剂型栓剂的最佳处方组成比例为单硬脂酸甘油酯:吐温-80:PEG4000:PEG6000:蒸馏水:甘油为30:3:22:22:21:2。在显微镜下观察在乳剂型栓剂基质溶液中,亚甲蓝均匀分散,苏丹红不能均匀分散。因此确定该栓剂为O/W型乳剂型栓剂基质。【结论】本实验制备的栓剂是以聚乙二醇为主要基质的O/W型乳剂型栓剂,其外观光滑,硬度、重量差异、融变时限均符合规定。[Objective] To the prescription of emulsion suppository was screen by determining the hardness and the limit of melting time and to identify the type of the suppository base. [Methods] The prescription of suppository with polyglycol as its main base was screened by orthogonal design and the emulsion type of the suppository base was conformed by microscope. [ Results] The influencing factor of the prescription in the range of trial design were polyglycol type 〉 polyglycol weight 〉 tween-80 〉 glyceryl monostearate. The trial data were compared by direct analysis and variance analysis. The best prescription of the emulsion suppository was selected by direct analysis figure , which was glyceryl monostearate： tween-80 ： Polyglycol 4000 ： Polyglycol 6000 ： distilled water： glycerine （ 30 ： 3 ： 22 ： 22 ： 21 ： 2） T he solution of the suppository base was observed by microscoped. The result indicated that methylene blue was well distributed in base solution, but magdala distributed badly. Therefore the type of this emulsion suppository base was O/W. [Conclusions] The suppository prepared by polyglycol as the base, is the neotype suppository. The base type of the suppositories is O/W.

关 键 词：栓剂 乳剂 基质 

分 类 号：R944.1[医药卫生—药剂学]