中国药业2025，Vol.34Issue(21)：43-50,8.DOI:10.3969/j.issn.1006-4931.2025.21.010
彝药斯赤列二氯甲烷提取物凝胶贴膏制备工艺优选与质量评价
Optimization of the Preparation Process and Quality Evaluation of Gel Paste Containing Dichloromethane Extract from Yi Medicine Sambucus Adnata
摘要
Abstract
Objective To prepare the gel paste containing dichloromethane extract from Yi Medicine Sambucus Adnata(SAWP),to optimize the formulation and technology,and to establish its quality evaluation method.Methods Based on the single factor test[the dosage of partially neutralized sodium polyacrylate(NP-700),carboxymethyl cellulose sodium(CMC-Na),tartaric acid,aluminum glycol,micro silica gel,and glycerol],the dosage of NP-700,CMC-Na,and micro silica gel were taken as the evaluation factors,and comprehensive scores of sensory evaluation(coating,uniformity,followability,film residue,skin residue),initial adhesion,and adhesion retention were taken as the evaluation indicators.Box-Behnken design-response surface methodology(BBD-RSM)was used to select the optimal preparation and prepare SAWP.Qualitative identification of patricide-aglucone,ursolic acid,and oleanolic acid in the preparation was performed by the thin-layer chromatography(TLC)method.Results The optimal formulation was as follows:NP700(1.35 g),CMC-Na(0.36 g),micropowder silica gel(1.5 g),glycerol(10 g),aluminium glycinate(0.09 g),and tartaric acid(0.09 g).The average comprehensive score of three batches of SAWP samples prepared by this process was 89.63 points,which was close to the predicted score of 87.86 points.The TLC chromatograms of aglucone showed clear color spots,good separation,and no interference from the negative control.The linear ranges of patrinoside-aglucone,sambulin B,betulinic acid,and ursolic acid+oleanolic acid(calculated as ursolic acid)were 21.07-630.72 µg/mL,18.17-544.00 µg/mL,26.91-805.80 µg/mL,and 154.21-4 617.00 µg/mL(r≥0.999 9,n=8),respectively.The RSDs of precision,stability,and repeatability test results were all lower than 2.0%(n=6).The average recoveries of the four components above were 97.40%,95.00%,98.69%,and 99.92%,with RSDs of 3.43%,2.52%,2.27%,and 2.08%(n=9),respectively.The average contents of the four components mentioned above in the nine batches of samples were 0.138 4,0.057 2,1.678 5,and 4.420 3 mg/g,respectively.Conclusion The optimal SAWP prescription process is stable,and the prepared SAWP has a uniform and smooth appearance,moderate viscosity,and can be used for subsequent development and utilization.The established quality evaluation method is accurate,stable,and reproducible,which can be used for its quality evaluation.关键词
斯赤列/二氯甲烷提取物/凝胶贴膏/Box-Behnken响应面法/薄层色谱法/高效液相色谱法/基质处方优化/质量评价Key words
Sambucus adnata/dichloromethane extract/gel plaster/Box-Behnken design-response surface methodology/TLC/HPLC/optimization of matrix prescription/quality evaluation分类
医药卫生引用本文复制引用
鲁昌,任炫榕,周冰洁,陶艳芬,柯瑾,王文静..彝药斯赤列二氯甲烷提取物凝胶贴膏制备工艺优选与质量评价[J].中国药业,2025,34(21):43-50,8.基金项目
云南省科技厅科技计划项目[202301AZ070001-007,202402AA310029] （）
云南省院士专家工作站项目[202305AF150030]. （）
