本文選題：阿達帕林 + 過氧苯甲酰��； 參考：《湖北中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：痤瘡(acne)作為青少年人患病率極高的皮膚病,多發(fā)生在面部、胸部、背部以及頸部,其具體的發(fā)病機理尚不明確。目前有一個觀點影響了人們對痤瘡發(fā)病機理的認知:除開丙酸痤瘡桿菌引發(fā)的原因外,自然免疫介導(dǎo)也能產(chǎn)生炎癥引發(fā)痤瘡。國外學(xué)者Del和Kircik通過基因技術(shù)在亞臨床皮損中檢測到IL-1α和整合素的基因表達,因此我們有理由認為非炎性痤瘡(開放性或閉合性粉刺)也有炎癥反應(yīng)的參與。據(jù)相關(guān)研究顯示痤瘡系一種原發(fā)性的伴隨炎癥癥狀的皮膚性疾病,炎癥反應(yīng)貫穿了痤瘡的發(fā)病過程。基于炎癥反應(yīng)貫穿了痤瘡的整個病程,因此除抗感染治療外,抗炎治療將左右痤瘡治療效果的好壞,也將成為痤瘡治療新方向。痤瘡這種皮膚病雖然對人體正常的生理功能干擾較輕,但外貌上的缺陷常伴隨著精神壓力以及心理負擔。所以,用于治療痤瘡的藥物研發(fā)一直以來備受重視。本課題以抗炎效果顯著的阿達帕林與具有強效殺菌能力的過氧苯甲酰為主藥,以甘油、依地酸二鈉、丙二醇、多庫酯鈉、SIMUGEL 600PHA、泊洛沙姆124、氫氧化鈉為輔料研制出一種新型的復(fù)方制劑—阿達帕林過氧苯甲酰凝膠。并對其進行了以下研究:首先我們對其進行處方工藝研究:篩選出最為合適的防腐劑、潤濕劑等,并對甘油、Simugel 600PHA、丙二醇的用量進行篩選。通過研究凝膠劑各項指標來決定最優(yōu)的處方工藝。其次在質(zhì)量研究方面,參考國家食品藥品監(jiān)督管理局發(fā)布的阿達帕林凝膠標準,2013版美國藥典記載的過氧苯甲酰凝膠標準,我們對自制凝膠進了相關(guān)質(zhì)量考察。試驗過程中我們采用兩種不同的色譜條件分別測定阿達帕林的有關(guān)物質(zhì)與含量以及過氧苯甲酰的有關(guān)物質(zhì),采用碘量法對過氧化苯甲酰進行含量測定,并對有關(guān)物質(zhì)及含量測定進行了方法學(xué)研究并建立了一系列質(zhì)量檢測標準。為質(zhì)量控制提供了試驗依據(jù)。同時,質(zhì)量控制中穩(wěn)定性考察不可或缺的一個部分,我們通過研究自制樣品隨溫濕度與光強度的改變趨勢來設(shè)計實驗,分別從影響因素、加速試驗和長期試驗三個方面對阿達帕林過氧苯甲酰凝膠劑進行初步考察,實驗結(jié)果顯示,自制樣品凝膠穩(wěn)定性良好,在避光,陰涼處貯藏。最后,我們對自制樣品進行了體外透皮吸收實驗。結(jié)果表明:主藥的滲透性能良好,且自制與市售樣品的滲透性能相似。通過方差分析,判斷二者的治療效果相當。
[Abstract]:Acne acnes (Acne), as a highly prevalent skin disease in adolescents, occurs mostly on the face, chest, back and neck. The specific mechanism of acne acnes is still unclear. At present, there is a view to affect the understanding of the pathogenesis of acne: in addition to the causes caused by Acne propionate, natural immune mediated acne can also produce inflammation. Foreign scholars Del and Kircik detected the gene expression of IL-1 偽 and integrin in subclinical skin lesions by gene technique. Therefore, we can conclude that non-inflammatory acne (open or closed acne) is also involved in inflammatory reaction. According to related studies, acne is a primary skin disease with inflammatory symptoms, and inflammatory reaction is involved in the development of acne. Based on the inflammatory reaction throughout the whole course of acne, in addition to anti-infection treatment, anti-inflammatory treatment will affect the effectiveness of acne treatment, but also will become a new direction of acne treatment. Although acne, a skin disease, interferes slightly with normal physiological function, the defects in appearance are often accompanied by mental stress and psychological burden. Therefore, the research and development of the drug used to treat acne has been paid more attention. In this study, the anti-inflammatory effect of Adaphalin and strong bactericidal ability of peroxobenzoyl drug, glycerol, disodium etate, propylene glycol, A new compound preparation, adalepalin peroxy benzoyl gel, was developed by using polycuryl sodium (SIMUGEL 600 PHA, Poloxamer 124, sodium hydroxide as excipient). And the following studies were carried out: first, we studied the formulation technology: the most suitable preservatives, wetting agents, and the amount of glycerol Simugel 600PHA, propylene glycol were screened. The optimum prescription technology was determined by studying the indexes of gel. Secondly, in terms of quality research, we investigated the quality of self-made gel by referring to the Adaphalin Gel Standard published by the State Food and Drug Administration (SFDA) and the peroxobenzoyl gel standard recorded in the US Pharmacopoeia in 2013. In the course of the experiment, we used two different chromatographic conditions to determine the related substances and contents of adalpine and peroxybenzoyl, and determined the content of benzoyl peroxide by iodimetry. The methods for the determination of related substances and their contents were studied and a series of quality standards were established. It provides experimental basis for quality control. At the same time, an indispensable part of stability investigation in quality control, we design experiments by studying the changing trend of self-made samples with temperature, humidity and light intensity. The results showed that the gel prepared by ourselves was stable and stored in shade and shade. Finally, in vitro transdermal absorption experiments were carried out on the self-made samples. The results showed that the permeability of the main drug was good, and the permeability of the self-made samples was similar to that of the commercial samples. According to the analysis of variance, it was judged that the therapeutic effect of the two was equal.
【學(xué)位授予單位】：湖北中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R943

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本文編號：2007341