目的: 筛选石榴提取物鞣花酸的乳膏制剂的处方工艺。方法: 以基质成型性影响最大的单硬脂酸甘油酯、白凡士林和液体石蜡的用量为因素,采用正交实验法优化石榴提取物鞣花酸乳膏剂的制备工艺。结果: 优化后的乳膏基质处方是硬脂醇0.8 g,白凡士林1.8 g,液体石蜡0.6 g,单硬脂酸甘油酯1.2 g,十二烷基硫酸钠0.1 g,丙三醇1.0 g和纯化水8.5 g;采用熔合法所制得的乳膏剂稳定性好,色泽均匀,细腻润滑,无刺激性。结论: 本乳膏剂制备工艺简便可行,质量稳定可靠,适用于石榴提取物鞣花酸乳膏剂的制备。
Objective: To screen the formulation process of the cream preparation of ellagic acid from pomegranate extract. Methods: The dosages of glyceryl monostearate, white petrolatum and liquid paraffin, which had the greatest influence on matrix formability were taken as factors, and the preparation process of pomegranate extract ellagic acid cream was optimized by the orthogonal experiment method. Results: The optimized cream base formulation was stearyl alcohol 0.8 g, white petrolatum 1.8 g, liquid paraffin 0.6 g, glycerol monostearate 1.2 g, sodium lauryl sulfate 0.1 g, glycerol 1.0g and purified water 8.5 g; the cream prepared by fusion method had good stability, uniform color, fine lubrication and no irritation. Conclusion: The preparation process of the cream is simple and feasible, the quality is stable and reliable, and it is suitable for the preparation of pomegranate extract ellagic acid cream.
[1] 蔡霞, 刘悦, 张芳芳,等.石榴的化学成分与质量控制研究进展[J].世界科学技术-中医药现代化,2014,16(1):123-129.
[2] 陈建雯, 杨剑兵, 吴双凤,等.石榴皮中化学成分及其生物学活性研究进展[J].化工设计通讯,2019,45(7):144-145.
[3] 何宇鸿, 梁敏桐, 刘璐群,等.鞣花酸药理作用综述[J].化学工程与装备,2022, (3):216-217.
[4] Saeed M, Naveed M, BiBi J, et al. The promising pharmacological effects and therapeutic/medicinal applications of Punica granatum L. (pomegranate) as a functional food in humans and animals[J]. Recent Pat Inflamm Allergy Drug Discov, 2018,12(1):24-38.
[5] 范高福, 胥振国, 刘修树,等.植物提取物鞣花酸的药理作用及制剂研究进展[J].基因组学与应用生物学,2016,35(12):3562-3568.
[6] Evtyugin DD, Magina S, Evtuguin DV. Recent advances in the production and applications of ellagic acid and its derivatives. A review[J]. Molecules, 2020,25(12):2745.
[7] 王佳鸾, 赵俸艺, 张春红,等.鞣花酸提取、纯化及其生物活性研究进展[J].食品工业科技,2022,43(13):416-424.
[8] 王恒, 赵雪芹, 刘欣欣,等.软膏剂常用优化方法的研究进展[J].中国民族民间医药,2021,30(3):54-59.
[9] 彭雪花, 张莎莎.中医外治法临证验案举隅[J].浙江中医杂志,2020,(5):386.
[10] 喻超,软膏剂制备及含量测定的研究进展[J].广东化工,2017,44(16):174-175
[11] 刘彤, 王雪萌, 刘黎瑶,等.当归提取物软膏剂的工艺处方研究[J].天津农学院学报,2019,26(1):64-68,79.
[12] 祁金玉, 李娜坤, 刘黎瑶,等.紫苏叶提取物乳膏剂的处方研究[J].天津农学院学报,2018,25(3):65-69.
[13] 曾亚. 没食子乳膏的制备、质量控制及抑菌活性的研究[D].乌鲁木齐:新疆医科大学,2020.
[14] 国家药典委员会. 中华人民共和国药典-一部:2020年版[M]. 北京:中国医药科技出版社,2020:1088.
[15] 朱朋艳, 乔妙, 刘海杨,等. 铁皮石斛多糖软膏制备工艺及其质量标准研究[J]. 中国民族民间医药,2021,30(18):26-30.