【摘要】：目的:探究煤焦油乳膏的制備工藝以及經(jīng)過劑型改進(jìn)后的煤焦油乳膏的動物皮膚刺激性實驗,考察煤焦油乳膏治療尋常型銀屑病的療效。方法:通過對煤焦油的提取以及提取液與乳膏基質(zhì)的混合來制備煤焦油乳膏,并考察其穩(wěn)定性;參照皮膚刺激性反應(yīng)評分標(biāo)準(zhǔn)和皮膚刺激強(qiáng)度分級標(biāo)準(zhǔn),進(jìn)行煤焦油乳膏的皮膚刺激性實驗,來測量新劑型煤焦油乳膏的皮膚毒性;通過對解放軍一九五醫(yī)院住院部50例尋常型銀屑病患者的臨床治療觀察(25例用老劑型煤焦油搽劑,25例用新劑型煤焦油乳膏),考察新劑型煤焦油乳膏的臨床療效。結(jié)果:1.經(jīng)過反復(fù)多次的實驗,煤焦油乳膏制備工藝穩(wěn)定。經(jīng)過穩(wěn)定性考察下的煤焦油乳膏離心實驗、耐熱實驗以及留樣觀察實驗,其外觀均無油水分離現(xiàn)象,色澤、均勻性等都不存在變化并且未出現(xiàn)酸敗、分層、變質(zhì)等現(xiàn)象,其他項檢查也均符合《中國藥典》2015年版四部通則乳膏劑項下有關(guān)的各項規(guī)定。2.煤焦油的家兔皮膚刺激性實驗以及相關(guān)數(shù)據(jù)顯示,實驗區(qū)和對照區(qū)家兔皮膚涂藥部位各只有2-3例出現(xiàn)輕微紅斑,其他均未出現(xiàn)無紅腫、水泡、濕疹等現(xiàn)象,實驗區(qū)每只動物總積分為0.0536,每只動物每天積分為0.0038,而對照區(qū)分別為0.0357和0.0026,因此說明煤焦油乳膏的皮膚刺激性與煤焦油搽劑一樣無明顯的皮膚刺激性,其用藥是安全可靠的。3.通過煤焦油搽劑組和煤焦油乳膏組治療效果圖片和數(shù)據(jù)顯示,兩種藥物在治療尋常性銀屑病方面都有一定的療效,治療過程中病人的皮損狀況都出現(xiàn)了的不同程度的消退,治療療程結(jié)束后,大部分患者皮損基本消退,各項指標(biāo)基本恢復(fù)正常,但也存在一定的差別。從數(shù)表上顯示,相對煤焦油搽劑的治療結(jié)果,煤焦油乳膏治療效果較好。兩者治療過程中均未出現(xiàn)明顯的不良反應(yīng),因此可以表明煤焦油乳膏治療尋常型銀屑病療效確切,安全有效。結(jié)論:通過對煤焦油進(jìn)行劑型改進(jìn)后,煤焦油乳膏制備工藝穩(wěn)定;與對照組相比,煤焦油乳膏對皮膚未見明顯的刺激性及其他不良反應(yīng):解放軍一九五醫(yī)院25例尋常型銀屑病患者經(jīng)煤焦油乳膏治療后,與使用老劑型煤焦油搽劑相比,效果顯著,疾病得到良好控制,并未見其他不良反應(yīng)。
[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.
【學(xué)位授予單位】：湖北科技學(xué)院
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R943;R96

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