TDDs透皮给药系统基质研究与其制备工艺设计.docVIP

TDDs透皮给药系统基质的研究及其制备工艺的设计 摘 要 本文以制备一种透皮给药系统基质为目的，重点研究该基质膜材的选择、制备工艺及改性。首先，建立本课题相关的产品质量标准；其次，通过预试验对配方及制备工艺进行正交筛选；最后，结果测定和分析。 结论：本课题研究的透皮给药系统的基质是符合国家药典要求的人工合成高分子聚合物为主体原料，由下述组分（以质量百分比计）：聚异丁烯8.6%，填料11.4%，聚乙烯醇14.3%，；聚维酮28.6%。溶剂水的用量以恰好能溶化溶胀基质为宜。首先按配比量称取各基质组份用溶剂浸泡，至全部溶胀软化、搅拌，乳化温度80℃为最佳条件，其次向基质中加入药物浸膏或制剂，制浆、涂布、干燥，得到高分子透皮给药制剂.最后检测了药物的累积释放量。 结果表明该型透皮给药制剂的基质卫生指标和理化性质优秀，但药物的释放速率较小。 关键词：质量标准，配方，制备工艺，正交，生产流程 The Research of The Transdermal Drug Delivery System TDDS`s Carrier and The Designation of The Preparation Technics Speciality：pharmaceutical engineering ABSTRACT For the purpose of producing a new kind of matrix of the transdermal drug delivery system (TDDS ), this paper mainly studied on the selection, processing and remodel of the plaster carrier. Firstly, the establishment of the topic related products quality standards; secondly, according to the pre-produced crafts and recipes for orthogonal selection, select out the best producing process. Finally, measure each of the matrixes of samples and make the conclusion and prediction. Conclusion: The research says this is in line with national pharmacopoeia using chemical called synthetic macromolecular polymers for the main raw material, which is composed of the following sub constitute (in quality %): polyisobutylene8.6%、polyvinyl alcohol14.3%、filler（calcium carbonate）11.4%、PVP28.6%. Solvents water is used to dissolve the matrixes appropriately. Firstly, meterage the compounds of the recipe, and soak them in the solvent until desolation, mixed, emulsify temperature eighty degrees is the best conditions. Secondly add the medicine or chemical agents, removal, doodle, dry, macromolecule-based patches are produced. Last measure the quantity of accumulative pervasion. The results showed that the patches accord with the health indicators and physical and chemical requirement ,but the velocity of drug relation is a little small.. KEY WORDS：Quality standard, Formula, Produced crafts, Orthogonal, Production proce