香砂枳术凝胶贴膏的制备工艺及质量控制  

Preparation technology and quality control of Xiangsha Zhizhu gel patch

作　　者：黄思成 周云涛 赵琼 王路文 侯安国 HUANG Si-cheng;ZHOU Yu-tao;ZHAO Qiong;WANG Lu-wen;HOU An-guo(School of Chinese Materia Medica and Yunnan Key Laboratory of Southern Medicinal Utilization,Yunnan University of Chinese Medicine,Kunming 650500,China;Key Laboratory of External Drug Delivery System and Preparation Technology in University of Yunnan Province,Kunming 650500,China)

机构地区：[1]云南中医药大学中药学院暨云南省南药可持续利用研究重点实验室,云南昆明650500 [2]云南省高校外用给药系统与制剂技术研究重点实验室,云南昆明650500

出　　处：《云南民族大学学报(自然科学版)》2025年第2期184-190,共7页Journal of Yunnan Minzu University:Natural Sciences Edition

基　　金：云南省科技人才和平台计划(202105AG070012);云南省高等学校重点实验室建设计划(2019YGZ03).

摘　　要：针对儿童功能性消化不良的病理特点,将香砂枳术丸改制为凝胶贴膏,筛选最佳处方与制备工艺,并建立质量控制方法.采用正交试验设计法,以初黏力、持黏力和综合感官为评价指标筛选最佳处方.使用薄层色谱法进行定性鉴别,使用高效液相色谱法建立指标性成分橙皮苷的质量分数测定方法.结果发现,最佳处方为混合浸膏10.0 g,水16.0 g,甘油18.0 g,聚维酮K 900.2 g,聚丙烯酸钠2.4 g,羧甲基纤维素钠1.2 g,甘羟铝与柠檬酸各0.5 g,微粉硅胶1.2 g,综合评分最高;薄层斑点清晰,分离度好,阴性无干扰.建立的橙皮苷质量分数测定方法具有良好的专属性和线性关系,方法学考察结果可靠,平均每片含橙皮苷约1.44 mg.该优选的处方及制备工艺可确保该品具有较好的成型性和黏附性,载药量适宜,质量稳定,能满足临床及生产的需要.To address the pathological characteristics of functional dyspepsia in children,Xiangsha Zhizhu Pills were transformed into a gel patch.The optimal formulation and preparation process were screened,and a quality control method was established.An orthogonal experimental design was used to determine the optimal formulation,with initial adhesion,holding adhesion,and overall sensory evaluation as indicators.Thin-layer chromatography(TLC)was employed for qualitative identification,while high-performance liquid chromatography was used to establish a method for determining the mass fraction of the key component hesperidin.The results showed that the optimal formulation consisted of 10.0 g of mixed extract,16.0 g of water,18.0 g of glycerin,0.2 g of polyvinylpyrrolidone K90,2.4 g of sodium polyacrylate,1.2 g of sodium carboxymethyl cellulose,0.5 g of aluminum hydroxide with citric acid,and 1.2 g of fumed silica,achieving the highest comprehensive score.The TLC analysis displayed clear spots with good separation and no interference in the negative control.The established method for determining the mass fraction of hesperidin demonstrated good specificity and linearity,with reliable methodological validation.On average,each patch contained about 1.44 mg hesperidin.In conclusion,the optimized formulation and preparation process ensure the gel patch has good formability,adhesion,appropriate drug loading,stable quality,and the ability to meet clinical and industrial production requirements.

关 键 词：香砂枳术丸 凝胶贴膏 功能性消化不良 质量控制 

分 类 号：R283.6[医药卫生—中药学]