煤焦油乳膏的制备工艺及治疗寻常型银屑病的疗效观察

发布时间：2018-08-14 18:03

【摘要】：目的:探究煤焦油乳膏的制备工艺以及经过剂型改进后的煤焦油乳膏的动物皮肤刺激性实验,考察煤焦油乳膏治疗寻常型银屑病的疗效。方法:通过对煤焦油的提取以及提取液与乳膏基质的混合来制备煤焦油乳膏,并考察其稳定性;参照皮肤刺激性反应评分标准和皮肤刺激强度分级标准,进行煤焦油乳膏的皮肤刺激性实验,来测量新剂型煤焦油乳膏的皮肤毒性;通过对解放军一九五医院住院部50例寻常型银屑病患者的临床治疗观察(25例用老剂型煤焦油搽剂,25例用新剂型煤焦油乳膏),考察新剂型煤焦油乳膏的临床疗效。结果:1.经过反复多次的实验,煤焦油乳膏制备工艺稳定。经过稳定性考察下的煤焦油乳膏离心实验、耐热实验以及留样观察实验,其外观均无油水分离现象,色泽、均匀性等都不存在变化并且未出现酸败、分层、变质等现象,其他项检查也均符合《中国药典》2015年版四部通则乳膏剂项下有关的各项规定。2.煤焦油的家兔皮肤刺激性实验以及相关数据显示,实验区和对照区家兔皮肤涂药部位各只有2-3例出现轻微红斑,其他均未出现无红肿、水泡、湿疹等现象,实验区每只动物总积分为0.0536,每只动物每天积分为0.0038,而对照区分别为0.0357和0.0026,因此说明煤焦油乳膏的皮肤刺激性与煤焦油搽剂一样无明显的皮肤刺激性,其用药是安全可靠的。3.通过煤焦油搽剂组和煤焦油乳膏组治疗效果图片和数据显示,两种药物在治疗寻常性银屑病方面都有一定的疗效,治疗过程中病人的皮损状况都出现了的不同程度的消退,治疗疗程结束后,大部分患者皮损基本消退,各项指标基本恢复正常,但也存在一定的差别。从数表上显示,相对煤焦油搽剂的治疗结果,煤焦油乳膏治疗效果较好。两者治疗过程中均未出现明显的不良反应,因此可以表明煤焦油乳膏治疗寻常型银屑病疗效确切,安全有效。结论:通过对煤焦油进行剂型改进后,煤焦油乳膏制备工艺稳定;与对照组相比,煤焦油乳膏对皮肤未见明显的刺激性及其他不良反应:解放军一九五医院25例寻常型银屑病患者经煤焦油乳膏治疗后,与使用老剂型煤焦油搽剂相比,效果显著,疾病得到良好控制,并未见其他不良反应。
[Abstract]:Objective: to investigate the preparation process of coal tar cream and the animal skin irritation experiment of the modified coal tar cream, and to investigate the efficacy of coal tar cream in the treatment of psoriasis vulgaris. Methods: coal tar cream was prepared by extracting coal tar and mixing the extract with cream matrix, and its stability was investigated. The skin irritation test of coal tar cream was carried out to measure the skin toxicity of the new dosage form coal tar cream. The clinical treatment of 50 patients with psoriasis vulgaris (25 cases with old coal tar liniment and 25 cases with new coal tar emulsion) was studied. The result is 1: 1. After repeated experiments, the preparation process of coal tar emulsion is stable. After the stability investigation of coal tar emulsion centrifugation test, heat resistance test and sample observation experiment, its appearance has no oil and water separation phenomenon, the color and color, uniformity and so on do not have the change and does not appear the phenomenon such as acid, stratification, metamorphism, etc. Other tests are also in line with the 2015 edition of the four general principles of the cream under the relevant provisions. 2. The skin irritation test and related data of rabbits with coal tar showed that there were only 2 or 3 cases of mild erythema in each of the experimental and control areas, and none of the other cases appeared any erythema, blisters, eczema and so on. The total score of each animal in the experimental area was 0.0536, the score per animal per day was 0.0038, and that in the control area was 0.0357 and 0.0026, respectively. Therefore, the skin irritation of coal tar cream had no obvious skin irritation as that of coal tar liniment, and its medication was safe and reliable. According to the pictures and data of the treatment effect of the coal tar liniment group and the coal tar cream group, the two drugs have certain curative effect on the treatment of psoriasis vulgaris, and the skin lesions of the patients in the course of treatment have been subsided to varying degrees. At the end of the course of treatment, the skin lesions of most patients were basically disappeared, and the indexes returned to normal, but there were some differences. Compared with the results of coal tar liniment, the effect of coal tar cream is better than that of coal tar liniment. There were no obvious adverse reactions during the treatment, so coal tar cream was safe and effective in the treatment of psoriasis vulgaris. Conclusion: the preparation process of coal tar emulsion is stable by improving the dosage form of coal tar, and compared with the control group, Coal tar cream had no obvious irritation and other adverse reactions to the skin: 25 patients with psoriasis vulgaris in the people's Liberation Army Hospital in 1955 were treated with coal tar cream, and the effect was significant compared with that of the old dosage coal tar liniment. The disease was well controlled and no other adverse reactions were observed.
【学位授予单位】：湖北科技学院
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R943;R96

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