自热型熥敷中药镇痛抗炎作用评价及皮肤用药安全性观察
Analgesic and anti-inflammatory effects of a self-heating TCM package and safety for transdermal administration
徐方楚 1杨志晖 2戴博 2林阳3
作者信息
- 1. 首都医科大学药学院,北京 100069;空军军医大学空军特色医学中心药剂科,北京 100142
- 2. 空军军医大学空军特色医学中心药剂科,北京 100142
- 3. 首都医科大学附属北京安贞医院药事部,北京 100029
- 折叠
摘要
目的 考察自热型熥敷中药的有效性及安全性.方法 大鼠醋酸扭体实验:将70只SD大鼠根据体质量分为正常对照组、模型对照组、双氯芬酸二乙胺乳胶剂组(0.125 g/次,0.5 h)、传统熥敷中药组(12.42 g/kg,0.5 h)、自热型熥敷中药A(3.06 g/kg,0.5 h)、B(3.06 g/kg,3 h)、C(3.06 g/kg,6 h)组,通过注射醋酸建立大鼠疼痛模型,记录30 min内大鼠扭体的次数和潜伏期,考察自热型熥敷中药镇痛疗效以及与传统熥敷中药对比的疗效差异性;大鼠炎症模型实验:选取20只SD大鼠作为正常对照组和假手术组,60只大鼠腹股沟植入棉球建立炎症模型按体质量随机分为模型对照组、双氯芬酸二乙胺乳胶剂组、传统熥敷中药、自热型熥敷中药A、B、C组(给药剂量、时长同醋酸扭体实验),考察自热型熥敷中药抗炎疗效以及与传统熥敷中药对比的疗效差异性;实验兔皮肤刺激性实验:将8只实验兔分为皮肤完整组以及皮肤受损组,各4只,在左、右两侧分别贴上自热型熥敷中药包及去除药的自热型熥敷中药包.每次6 h,连续使用7 d,在自然光下肉眼观察并记录去除药物后1、24、48 h和72 h敷贴部位有无红斑和水肿等情况;豚鼠斑贴实验:将40只背部经去毛处理无损伤的豚鼠,分为阴性对照组(去除药的自热型熥敷中药包)、阳性对照组(1-氯-2,4-二硝基苯)、供试品组(自热型熥敷中药).致敏阶段:在第0 d、第7 d和第14 d,观察豚鼠背部左侧给药6 h后1 h、24 h是否出现皮肤刺激性反应,末次致敏14 d后,观察豚鼠右侧给药6 h后24 h、48 h是否出现皮肤刺激性反应.结果 自热型熥敷中药B、C组大鼠扭体次数与模型对照组比较,差异有统计学意义(P=0.016、=0.007);传统熥敷中药组与自热型熥敷中药A组大鼠扭体次数比较,差异有统计学意义(P=0.029);双氯芬酸二乙胺组潜伏期与模型对照组比较,差异有统计学意义(P=0.008);自热型熥敷中药C组肉芽肿重量与模型对照组比较,差异有统计学意义(P=0.016).自热型熥敷中药对皮肤无刺激、无致敏性.结论 自热型熥敷中药是具有明显镇痛抗炎作用且安全性较高的新制剂.
Abstract
Objective To investigate the efficacy and safety of a self-heating Tengfu TCM package.Methods SD rats were divided into the normal control group,model control group,self-heating Tengfu TCM(3.06 g/kg)low,medium,and high dose groups(0.5 h,3 h,6 h),traditional Tengfu TCM package group(12.42 g/kg,0.5 h),and diclofenac diethylamine emulsion group(0.125 g)according to body weight.An acetic acid-induced pain model and a cotton ball granuloma hyperplasia model in rats were used respectively,and the number of twists,latency and cotton ball granuloma hyperplasia in rats were determined to reveal the differences between the self-heating Tengfu TCM low-,medium-,and high-groups on one hand and the traditional Tengfu TCM group and the diclofenac diethylamine emulsifier group on the other hand.The skin irritation and skin sensitization of self-heating Tengfu TCM packages were investigated via skin irritation tests in experimental rabbits and patch tests in guinea pigs.Results The medium-and high-dose self-heating Tengfu TCM packages Compared with the model control group,The difference was statistically significant(P=0.016,P=0.007);traditional Tengfu TCM group Compared with low-dose self-heating Tengfu TCM packages The difference was statistically significant(P=0.029).Comparison of latency in diclofenac diethylamide group with model control group,The difference was statistically significant(P=0.008),high-dose self-heating Tengfu TCM packages Granuloma weight Compared with the model control group The difference was statistically significant(P=0.016).The self-heating Tengfu TCM package caused no irritation or sensitization to the skin.Conclusion The self-heating Tengfu TCM package has properties of analgesia and anti-inflammation,and it is safe for transdermal administration.
关键词
自热型中药/镇痛/抗炎/安全性实验Key words
Self-heating Tengfu TCM package/Analgesic effect/Anti-inflammatory effect/Safety引用本文复制引用
出版年
2024
NETL
NSTL
万方数据