论文总字数：16781字

摘 要

糠酸莫米松乳膏于1986年由美国先灵葆雅公司研制开发，同年即获FDA批准上市。可用于治疗湿疹、神经性皮炎、异位性皮炎及皮肤瘙痒等症状。用法用量为：局部外用，涂于患处，每日一次。极少数患者局部会出现过敏反应，如烧灼感、瘙痒刺痛和皮肤萎缩等。长期大量使用皮质激素类药物，可造成的不良反应有：刺激反应、皮肤萎缩、多毛症、口周围皮炎、皮肤浸润、继发感染、皮肤条纹状色素沉着等。

本文研究主要内容有糠酸莫米松乳膏有关物质检查，糠酸莫米松乳膏稳定性研究。经方法验证后结果表明，糠酸莫米松在48~112μg·ml^-1的浓度范围内与峰面积呈良好的线性关系（r=0.9997）；羟苯乙酯在48~112μg·ml^-1的浓度范围内与峰面积呈良好的线性关系（r=0.9993）；糠酸莫米松的平均回收率为99.32%，RSD为0.69%；羟苯乙酯的平均回收率为99.60%，RSD为0.95%，溶液稳定，耐用性良好，且本法简单、准确、专属性强、重复性好，可用于同时测定糠酸莫米松和羟苯乙酯的含量。

关键词：糠酸莫米松 乳膏 杂质分析 耐用性

ABSTRACT

Mometasone furoate cream was researched and development in 1986 by the U.S. Schering-Plough (Schering-Plough Corporation), the same year that was approval listed on FDA. It can be used to treat eczema, neurodermatitis, atopic dermatitis, and skin itching and other symptoms. Usage and dosage is: local topical, applied to the affected area once a day. There will be a handful of patients with locally allergic reactions, such as burning, itching, tingling and skin atrophy.. Long-term heavy use of corticosteroid drugs, may cause adverse reactions such as: Long-term heavy use of corticosteroid drugs, can cause adverse reactions are: stimulus response, skin atrophy, hirsutism, dermatitis around the mouth, skin infiltration , secondary infections, stripesd pigmentation in skin and other symptoms.

The study includes two parts: Bacteriostatic agent in mometasone furoate cream; Check the related substances in mometasone furoate cream, Stability studies about mometasone furoate cream.In this paper, we establish a method for simultaneous determination of mometasone furoate and bacteriostatic agent in mometasone furoate cream, and when method validation ,the results show that mometasone furoate has a good linearity (r=0.9997) within the range of 48~112μg·ml^-1 ;ethylparaben has a good linearity (r=0.9993) within the range of 48~112μg·ml^-1 ; the mean recovery of mometasone furoate was 99.32%, and RSD=0.69% ; the mean recovery of ethyparaben was 99.60% and RSD=0.95%. the solution is stability and the durability is good. So the methods is simple, sensitive, specific and reproducible, it can be used for the simultaneous determination of mometasone furoate and ethylparaben.

Keywords: Mometasone Furoate ; Cream; Impurity analysis;Durability

目 录

摘 要 I

ABSTRACT III

第一章 文献综述 1

1.1引言...................................................................................................................1

1.2 品种基本情况 1

1.3糠酸莫米松概述 2

1.4研究背景 2

1.5 品种特点 2

1.5.1糠酸莫米松的理化性质 2

1.5.2 糠酸莫米松的作用特点 3

1.6本课题的研究目标与研究内容 3

第二章 实验部分 4

2.1 材料与仪器 4

2.1.1 仪器 4

2.1.2 材料 4

2.2 实验方法与结果 4

2.2.1 色谱条件的建立 5

2.2.2有关物质检查方法 11

2.2.3 方法验证 12

2.2.3.1 专属性试验 12

2.2.3.1.1杂质定位与分离试验 12

2.2.3.1.2强制降解试验 13

2.2.3.2系统适用性试验 15

2.2.3.3检测限、定量限试验 16

2.2.3.4线性试验 17

2.2.3.5溶液稳定性试验 18

2.2.3.6耐用性试验 18

2.3 有关物质检查 19

第三章 结论与展望 21

参考文献 22

致 谢 23

第一章 文献综述

1.1 引言

糠酸莫米松乳膏为包含0.1％糠酸莫米松的外用半固体制剂，该制剂主要针对皮肤病使用。其主成分糠酸莫米松是一种合成的具有抗炎活性糖皮质激素。 与其他外用皮质类固醇激素一样，糠酸莫米松具有消炎、止痒和血管收缩性。相较于其他半固体外用制剂，该制剂具有疗效高、不良反应小，使用方便等优点^[1]。

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