尼古丁经皮生物制剂(Nicotiana tobacum Linn)与聚合物和夹竹酸的变体的身体稳定配方和评估

Adi Nurmesa, N. Nurhabibah, A. Najihudin
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引用次数: 5

摘要

研究了烟叶尼古丁生物碱(Nicotiana toum L)透皮贴剂配方,以聚合物和油酸作为渗透促进剂,作为香烟依赖的治疗方法。本研究的目的是制备一种稳定的尼古丁生物碱烟叶透皮贴剂,并观察添加纤维素、PVP和油酸对烟碱体外释放的影响。透皮贴剂配方由烟碱生物碱烟叶、PVP、乙基纤维素、PVP、peg400、丙二醇和油酸组成。本研究以PVP: EC的浓度变化配制了3种配方,分别为F1 = 1:1, F2 = 1:1, F3 = 1:3,其中油酸形式的渗透增强变化量分别为F1: 0.10, F2: 0.15, F3: 0.20。透皮贴片制剂的评价包括感官、基质重量试验、基质厚度试验、干燥收缩率、吸湿率、基质抗折性试验、皮肤刺激试验、贴片基质表面pH值试验、延伸率试验、冻融试验、尼古丁含量试验、尼古丁释放(扩散细胞)试验。基于各相对稳定透皮贴剂配方的物理稳定性试验和透皮贴剂释放动力学服从一阶,采用方差分析(ANOVA)统计分析结果显示F1、F2和F3存在差异,基于Korsmayer Peppas检验服从非菲克定律
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FORMULASI DAN EVALUAI STABILITAS FISIK PATCH TRANSDERMAL ALKALOID NIKOTIN DAUN TEMBAKAU (Nicotiana tobacum Linn) DENGAN VARIASI POLIMER DAN ASAM OLEAT
Research on the tobacco leaves  nicotine alkaloid (Nicotiana tobacum L) transdermal patch formulation has been carried out as a cigarette dependence therapy with variations in polymers and oleic acid as a penetration enhancer. The purpose of this study is to formulate a stable transdermal patch of nicotine alkaloid tobacco leaf and to see the effect of adding cellulose, PVP and oleic acid to the release of nicotine in vitro. Transdermal patch formulation consists of nicotine alkaloid tobacco leaf, PVP, ethyl cellulose, PVP, PEG 400, propylenglycol and oleic acid. In this study, 3 formulas were made with concentration variants of PVP: EC namely F1 = 1: 1, F2 = 1: 2, and F3 = 1: 3, where the variations in penetration enhancements in the form of oleic acid were F1: 0.10, F2: 0.15, and F3: 0.20. Evaluation of transdermal patch preparations includes organoleptic, matrix weight test, matrix thickness test, drying shrinkage percentage, moisture uptake, matrix fold resistance test, skin irritation test, patch matrix surface pH test, elongation percentage, frezee and thaw test, nicotine content test, and nicotine release (diffusion cell) test, based on physical stability test of all relatively stable transdermal patch formulas and kinetics of transdermal patch release kinetics following first order and the results of statistical analysis using Variant Analysis (ANOVA) showed differences in F1, F2 and F3, and based on the Korsmayer Peppas test following the non-fick law
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