雪上一枝蒿总生物碱微乳凝胶的制备及质量评价  

Preparation and Quality Evaluation of Shortstalk Monkshood Root Total Alkaloids in Microemulsion Gel

作　　者：吴玉梅[1] 陈晓兰[1] 唐红艳[1] 戴雅洁 林亚平[2] 刘文[1] WU Yu-mei CHEN Xiao-lan TANG Hong-yan DAI Ya-jie LIN Ya-ping LIU Wen(School of Pharmacy, Guiyang University of Traditional Chinese Medicine, Guiyang 550002, China Food and Drug Administration of Guizhou Province, Guiyang 550003, China)

机构地区：[1]贵阳中医学院药学院,贵阳550002 [2]贵州省食品药品监督管理局,贵阳550003

出　　处：《中国实验方剂学杂志》2016年第20期10-13,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金地区基金项目(81260646);贵州省贵阳中医学院院士工作站项目[黔科合院士站(2014)4013];贵阳中医学院博士基金项目(ZYY2011005)

摘　　要：目的:优选雪上一枝蒿总生物碱微乳凝胶的处方与制备工艺,并对其质量与稳定性进行评价。方法:制备雪上一枝蒿总碱微乳,利用凝胶基质加入法制备雪上一枝蒿总生物碱微乳凝胶,考察该制剂中指标成分含量和p H等,通过离心试验、耐寒试验及耐热试验考察其稳定性。采用HPLC测定雪上一枝蒿甲素的含量,流动相乙腈-p H 7.3磷酸盐缓冲液(18∶82),检测波长199 nm。结果:雪上一枝蒿总生物碱微乳86 g,黄原胶4.0 g,甘油10 g,制成100 g。平均粒径18.72 nm,多分散指数0.663,p H 6.4,微乳凝胶离心后无分层现象,放入-4℃和40℃条件下24 h后外观、性状、延展性等与放入前无明显差异,雪上一枝蒿甲素质量分数1.79 mg·g^(-1)。结论:雪上一枝蒿总生物碱微乳凝胶的制备工艺简单,符合凝胶局部外用制剂主要指标要求,为该有效部位的研究与开发提供参考。Objective： To optimize prescription and preparation technology of shortstalk monkshood root total alkaloids microemulsion gel,and investigation of its quality and stability. Method： Shortstalk monkshood root total alkaloids microemulsion was prepared,then shortstalk monkshood root total alkaloids microemulsion gel was prepared by gel matrix addition,the concentration of index components and p H value were evaluated, its stability was investigated by centrifugation test,cold and heat test. HPLC was adopted to determine the content of bullatine A with mobile phase consisted of acetonitrile-phosphate buffer with p H of 7. 3（ 18 ∶ 82） and detection wavelength at 199 nm. Result： Shortstalk monkshood root total alkaloids microemulsion gel（ 100 g） were consisted of 86 g of microemulsion,4 g of Xanthan gum and 10 g of glycerin. Its average particle size was 18. 72 nm and polydispersity index was 0. 663 with p H of 6. 4. There was no stratification after centrifugation,and after storaged at- 4 ℃ and 40 ℃ conditions for 24 h,there were no significant difference in appearance,character,ductility by comparing with before. The content of bullatine A was 1. 79 mg·g^-1. Conclusion： The preparation process of shortstalk monkshood root total alkaloids microemulsion gel is simple,which is in line with requirements of gel topical preparation.

关 键 词：雪上一枝蒿 总生物碱 微乳凝胶 雪上一枝蒿甲素 稳定性试验 粒径 

分 类 号：R283.6[医药卫生—中药学] R284.1[医药卫生—中医学]