中成药2026，Vol.48Issue(4)：1099-1106,8.DOI:10.3969/j.issn.1001-1528.2026.04.005
祛风除痹成膜凝胶制备及其抗炎镇痛作用、安全性评价
Preparation of film-forming gel for expelling wind and removing paralysis and evaluation of its anti-inflammatory and analgesic effects,safety
摘要
Abstract
AIM To prepare the film-forming gel for expelling wind and removing paralysis,and to evaluate its anti-inflammatory and analgesic effects,safety.METHODS The film-forming gel was prepared with stems and leaves of Aconitum carmichaelii Debx.as raw material.With film-forming agent(PVA1788)consumption,plasticizer(glycerol)consumption and anhydrous ethanol consumption as influencing factors,the comprehensive score for film-forming time and appearance characters as an evaluation index,the preparation process was optimized by orthogonal test on the basis of single factor test.Acetic acid-induced mouse writhing model,adjuvant-induced rat arthritis model and rabbit skin irritation test were employed to investigate anti-inflammatory effect,analgesic effect and safety,respectively.RESULTS The optimal conditions were determined to be 0.3 g for substrate(MC-400)consumption,0.1 g for film-forming agent consumption,0.5 g for plasticizer consumption,1 g for anhydrous ethanol consumption,and 0.5 g for drug consumption,and the comprehensive score was 33.69.Compared with the control group,the film-forming gel for expelling wind and removing paralysis medium-dose and high-dose groups demonstrated reduced mouse writhing frequency(P＜0.01),among with the high-dose group displayed the pain inhibitory rate of 50.94%.Compared with the model group,the film-forming gel for expelling wind and removing paralysis various dose groups demonstrated decreased rat paw swelling degree,arthritis index and serum TNF-α level(P＜0.05,P＜0.01),and decreased serum IL-6,IL-1β levels were observed in the medium-dose and high-dose groups(P＜0.05,P＜0.01).At 1,24,48,72 h after last administration,the abnormalities in rabbit unbroken,broken skins did not occur,exhibiting non-irritation.CONCLUSION This stable and reliable method can be used for the preparation of film-forming gel for expelling wind and removing paralysis with strong anti-inflammatory and analgesic effects and good safety.关键词
成膜凝胶/祛风除痹/乌头茎叶/制备工艺/正交试验/抗炎镇痛作用/安全性Key words
film-forming gel/expelling wind and removing paralysis/the stems and leaves of Aconitum carmichaelii Debx./preparation process/orthogonal test/anti-inflammatory and analgesic effects/safety分类
医药卫生引用本文复制引用
李春蓉,李政华,何茜,彭泗铭,陈胡兰,初天哲,谭玉柱..祛风除痹成膜凝胶制备及其抗炎镇痛作用、安全性评价[J].中成药,2026,48(4):1099-1106,8.基金项目
国家自然科学基金(82574371) （82574371）
国家重点研发计划(2025YFC3509100) （2025YFC3509100）
四川省科技教育联合基金(2025NSFSC2032,2025NSFSC2160) （2025NSFSC2032,2025NSFSC2160）
