草珊瑚马蓝口腔黏附膜的制备与质量评价  

Preparation and Quality Evaluation of Sarcandra glabra and Baphicacanthus cusia Oral Adhesion Film

作　　者：赵莹[1] 黄莉璎 聂华[1] 叶小玲[1] 黎翠英[1] ZHAO Ying;HUANG Liying;NIE Hua;YE Xiaoling;LI Cuiying;无(Jiaying University,Meizhou 514031,China;Guangzhou University of Chinese Medicine,Guangzhou 510006,China)

机构地区：[1]嘉应学院医学院,广东梅州514031 [2]广州中医药大学青蒿研究中心,广东广州510006

出　　处：《中国民族民间医药》2024年第23期40-43,共4页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：梅州市医药卫生项目(2021B61)。

摘　　要：目的:探究草珊瑚马蓝单向释药口腔溃疡黏附膜的制备工艺,并对其质量进行初步评价。方法:选定载药层和隔离层材料并确定其比例,通过改变载药层材料与药物的比例优化膜剂处方,制备草珊瑚马蓝口腔溃疡黏附膜;采用紫外分光光度法测定药物含量;以膜外观性状、重量差异、体外黏附力为检测指标对黏附膜进行质量评价。结果:单向释药黏附膜的制备工艺确定为:载药层CMC-Na与蒸馏水比例为1∶50,且CMC-Na溶液与需加入的药材提取浓缩液比例为1 mL相当于生药0.2 g;过渡层采用1∶1的PVA-1750和CMC-Na;隔离层采用PVA-1750溶液,铺在晾干的CMC-Na载药层和过渡层上,室温晾干脱膜。结论:所制得的单向释药黏附膜为浅黄褐色、表面平整光洁的(2×2)cm^(2)正方型薄膜,无肉眼可见气泡,且具有良好的柔韧性,为进一步研究与应用提供依据。Objective To investigate the preparation process of the active ingredients of Sarcandra glabra and Baphicacanthus cusia and conduct preliminary quality evaluation of the resulting dosage forms.Methods The optimal prescription of the film was optimized by determining the ratio of drug-loaded layer and barrier layer materials and changing the ratio of the drug-loaded layer materials to the drug.The drug content was determined by UV spectrophotometry.The quality of the unidirectional drug-release oral ulcer adhesion film was evaluated by using the film appearance,weight difference,and in vitro adhesion as the testing indexes.Results The preparation process of unidirectional drug-releasing adhesive film was as follows:the ratio of CMC-Na in the drug loading layer to distilled water was 1∶50,and the ratio of CMC-Na solution to the concentrated extract of medicinal herbs was 1 mL,which was equivalent to 0.2 g of raw medicine.The transition layer was formed of PVA-1750 and CMC-Na in 1∶1 ratio.The isolation layer adopted PVA-1750 solution,which was laid on the dried drug-loading layer and transition layer after the temperature of the solution dropped to room temperature.The adhesive film was prepared at room temperature to remove the film.Conclusion The produced unidirectional drug-release adhesive film is a light yellow-brown,flat and smooth surface(2×2)cm^(2) square-shaped film without bubbles visible to the naked eye and with good flexibility,which provides a basis for further research and application.

关 键 词：草珊瑚 马蓝 口腔黏附膜 质量评价 

分 类 号：R284.1[医药卫生—中药学]