论文总字数：15998字

摘 要

本文首先介绍了一种新型经皮给药方式——高分子纳米微针的发明、种类、制备和应用，表明其在多种给药方式中的优越性和发展潜力。进一步介绍了近年来高分子纳米微针的研究方向和重点。本课题对两种高分子材料：玉米醇溶蛋白和聚乳酸进行深入研究。使用不同的溶剂配制不同浓度的玉米醇溶蛋白溶液和聚乳酸溶液，使用离心法制备玉米醇溶蛋白微针和聚乳酸微针并针对制备工艺中出现的问题加以改进，对不同增塑剂用量的微针进行显微镜形态观察和猪皮穿刺实验尝试。实验表明玉米醇溶蛋白微针的形态与增塑剂用量关联很大，增塑剂用量约20%能制备出良好形态的微针；聚乳酸微针因其极差的延展性使用离心法可行性不高，用热压成型的办法制备。穿刺实验表明制备的微针机械强度不够不足以穿刺猪皮肤，原因是微针的保存方法和穿刺方式有待优化。

关键词：微针 玉米醇溶蛋白 聚乳酸 制备工艺

Preliminary study on preparation of polymer nanometer microneedle

Abstract

This paper first introduces the invention, species, preparation and application of a new percutaneous dosing method, polymer nano-needle, which shows its superiority and development potential in a variety of drug delivery methods. The research direction and emphases of polymer nano-needles in recent years are further introduced. In this paper, two kinds of polymer materials: corn alcohol-soluble protein and polylactic acid were studied. Different concentrations of corn alcohol-soluble protein solution and polylactic acid solution were prepared by centrifugal method, and the problems in preparation process were improved, and the microscopic morphological observation and pig skin puncture experiment were carried out on the micro-needle with different plasticizer dosage. The results show that the morphology of corn alcohol-soluble protein microemulsion is very correlated with the dosage of plasticizer, and about 20% of the amount of plasticizer can be used to prepare a good form of micro-needle, and the method of polylactic acid microemulsion is not high because of its extremely poor ductility, and it is prepared by hot pressing molding. The puncture experiment showed that the mechanical strength of the prepared micro-needle was not enough to puncture the pig skin, because the preservation method and puncture mode of the micro needle were to be optimized.

Key words: preparation technology of microneedle； corn alcohol-soluble protein； polylactic acid

目 录

摘 要 I

Preliminary study on preparation of polymer nanometer microneedle II

Abstract II

第一章 绪论 5

1.1高分子纳米微针 5

1.1.1纳米微针简介与透皮给药 5

1.2高分子纳米微针的分类 5

1.2.1实心纳米微针 6

1.2.2涂层纳米微针 6

1.2.3空心型纳米微针 7

1.2.4可溶性聚合物微针 7

1.3纳米微针的制备 7

1.3.1 硅微针的制备 7

1.3.2 金属微针的制备 8

1.3.3 聚合物微针的制备 8

1.4纳米微针的应用和前景 10

1.5本课题研究内容 10

第二章 实验方法 12

2.1试剂 12

2.2仪器设备 12

2.3高分子纳米微针溶液制备 13

2.3.1 玉米蛋白醇溶溶液 13

2.3.2聚乳酸溶液 13

2.4高分子纳米微针制备过程 14

2.4.1玉米蛋白微针： 14

2.4.2聚乳酸微针的制备 14

第三章 结果分析与讨论 16

3.1玉米蛋白纳米微针分析 16

3.1.1玉米蛋白微针制备过程分析 16

3.1.2不同增塑剂用量的纳米微针形貌分析 17

3.1.3纳米微针猪皮穿刺尝试 21

3.2聚乳酸纳米微针分析 22

3.2.1 聚乳酸纳米微针制备过程分析 22

第四章 结论 24

参考文献： 25

致谢： 27

第一章 绪论

1.1高分子纳米微针

1.1.1纳米微针简介与透皮给药

人类的平均寿命随着药物的发展史而稳步上升，从神农尝百草开始，使用药物作为一种减轻痛苦、提高生存质量的手段而开拓了新的时代。不同种药物可以针对性的治疗不同种类的疾病，为了使药物的治疗效果达到最佳，人们创造出不同的给药方式如口服给药、注射给药和经皮给药。

经皮给药克服了口服过程中可能会出现的不适应和注射给药难以避免的恐惧心理和疼痛，成为一种更受欢迎的给药方式。经皮给药的定义是药物通过皮肤屏障进入组织液经循环系统到达靶器官的一种给药方式。经皮给药呈现很多优势：克服口服过程中可能会出现的肝脏首过效应和肠灭活等[1]。不仅如此，患者还可以自主给药或依靠家人给药，这降低了给药过程中操作的复杂性十分亲民。经皮给药虽呈现出极大潜力也有一定的实施难度，首先，药物透过皮肤屏障就会受到皮肤角质层的阻挡，药效降低。除此之外，人体的免疫系统会对一些具有皮肤刺激性的药物产生免疫反应——过敏症状。虽如此，经皮给药因其优越性还是占据了很大的市场份额，发展前景备受关注。到目前为止，经皮给药的发展历程已经更进了三代[1]。

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