摘要
目的观察参柏祛毒袋泡剂抗炎镇痛抑菌药效学和药物安全性情况。方法(1)抗炎实验:采用小鼠耳廓肿胀法,选取昆明小鼠60只,体质量18~24 g,按体质量分层使用随机数字表分为空白组、参柏高剂量组(1.750 g生药/mL)、参柏中剂量组(0.875 g生药/mL)、参柏低剂量组(0.438 g生药/mL)、阿司匹林组(100 mg/kg)5组,每组12只。涂抹70μL二甲苯在预先给药的小鼠右耳上,处死后对比左右耳片重量,计算肿胀度。(2)镇痛实验:采用热板致痛法,选取昆明小鼠48只,雌性,体质量18~24 g,按体质量分层使用随机数字表随机分成空白组、参柏高剂量组(1.750 g生药/mL)、参柏中剂量组(0.875 g生药/mL)、参柏低剂量组(0.438 g生药/mL)4组,每组12只。测定小鼠基础痛阈,再以40℃药浴各组分别泡足20 min,测量给药后5个时间点小鼠痛阈,计算痛阈提高百分率。(3)体外抑菌实验:将观察药制备成原液、1∶1、1∶2、1∶4、1∶85个浓度梯度,分别加入5种共25菌株,培养后读取各组最低抑菌浓度值。(4)安全性实验:采用家兔皮肤刺激性实验,选取健康大耳白家兔16只,使用随机数字表随机分为单次给药正常皮肤组、破损皮肤组及多次给药正常皮肤组、破损皮肤组4组,造模破损皮肤组,一侧去毛区涂参柏祛毒袋泡剂0.5 mL,另一侧对照区涂等量蒸馏水作空白对照,单次给药(1次/d)和多次给药(1次/d,连续7 d)进行对比,观察皮肤刺激性。采用实验家兔皮肤急毒实验,选取新西兰家兔24只,使用随机数字表随机分为完整组和破损皮肤组,每组再随机分为参柏高、低剂量及空白组,共6组,药物均匀涂抹于家兔背部除毛区,于去掉受试药物后1、24、48、72 h至14 d,每日观察动物皮肤及全身情况做出评价。结果(1)抗炎实验结果提示,参柏祛毒袋泡剂对二甲苯所致小鼠耳廓肿胀有显著抑制作用,参柏高、中剂量组小鼠耳廓肿胀度低于空白组,差异有统计学意义(P<0.05,P<0.01)。(2)镇痛实验结果提示,参柏祛毒袋泡剂对热刺激所致小鼠疼痛有明显的镇痛作用,参柏高剂量组给药后0.5~4.5 h较空白组小鼠痛阈高(P<0.05,P<0.01),参柏中剂量组给药后1.5~3.5 h较空白组小鼠痛阈高(P<0.05)。(3)体外抑菌实验结果提示,参柏祛毒袋泡剂对铜绿假单胞菌、金黄色葡萄球菌、白色念珠菌、大肠埃希氏菌、肺炎克雷伯菌有不同程度的抑制作用,且对铜绿假单胞菌、金黄色葡萄球菌的抑制作用最强。(4)安全性实验结果提示,参柏祛毒袋泡剂对家兔正常皮肤和破损皮肤,单次给药和多次给药均无皮肤刺激性,与空白组比较差异无统计学意义(P>0.05);对家兔完整皮肤和破损皮肤组给药,观察至14 d,均无不良反应,参柏高、低剂量组与空白组比较差异无统计学意义(P>0.05)。结论参柏祛毒袋泡剂具有明显的抗炎、镇痛、抑菌作用,且药物外用安全。
Objective To observe the anti-inflammatory,analgesic,antibacterial and the drug safety of Shenbai Qudu Bag Foam(参柏祛毒袋泡剂).Methods(1)Anti-inflammatory experiment:Using the mouse ear swelling method,60 Kunming mice weighing 18-24 g were divided into five groups-blank control group,high-dose Shenbai group(1.750 g crude herb/mL),medium-dose Shenbai group(0.875 g crude herb/mL),low-dose Shenbai group(0.438 g crude herb/mL),and aspirin group(100 mg/kg).Each group consisted of 12 mice.70μL of xylene was applied to the right ear of the mice pre-treated with the respective substances.After euthanization,the weight difference of the ear sections was compared to calculate the degree of swelling.(2)Analgesic experiment:Using the hot plate method,48 female Kunming mice weighing 18-24 g were randomly divided into four groups-blank control group,high-dose Shenbai group(1.750 g crude herb/mL),medium-dose Shenbai group(0.875 g crude herb/mL),and low-dose Shenbai group(0.438 g crude herb/mL).Each group consisted of 12 mice.The mice's baseline pain threshold was measured,followed by soaking their feet in a 40℃ water bath containing the respective substances for 20 min.Pain thresholds were measured at five time points after administration,and the percentage of pain threshold increase was calculated.(3)In vitro antibacterial experiment:The herbal medicine was prepared as a solution and diluted to five different concentrations(1∶1,1∶2,1∶4,1∶8,and undiluted).These solutions were then tested against 25 strains of bacteria to determine the minimum inhibitory concentration for each group.(4)Safety experiment:Rabbit skin irritation experiment:16 healthy New Zealand white rabbits were randomly divided into four groups-single-dose normal skin group,single-dose damaged skin group,multiple-dose normal skin group,and multiple-dose damaged skin group.One side of the damaged skin group was treated with 0.5 mL of Shenbai Qudu Bag Foam,while the other side was treated with an equal amount of distilled water as a blank control.For single-dose experiments,substances were applied once a day,and for multiple-dose experiments,substances were applied once a day for seven consecutive days.Skin irritation was observed in all groups.Experimental rabbit skin acute toxicity experiment:24 New Zealand rabbits were randomly divided into intact and damaged skin groups using a random number table.Each group was then randomly divided into high dose,low dose,and blank groups,totaling 6 groups.The drug was evenly applied to the hair removal area on the back of the rabbits.After removing the test drug,the skin and overall condition of the animals were observed daily for evaluation from 1,24,48,72 hours to 14 days.Results(1)The results of the antiinflammatory experiment indicated that Shenbai Qudu Bag Foam significantly inhibited mouse ear swelling induced by xylene.The high and medium-dose Shenbai groups showed lower ear swelling compared to the blank group,with statistical significance(P<0.05,P<0.01).(2)The analgesic experiment revealed a significant analgesic effect against heat-induced pain in mice,with the high-dose Shenbai group showing higher pain thresholds at 0.5-4.5 h post-treatment(P<0.05,P<0.01)and the medium-dose Shenbai group showing higher pain thresholds at 1.5-3.5 h post-treatment(P<0.05)compared to the blank group.(3)The in vitro antibacterial experiment demonstrated varying degrees of inhibitory effects against Pseudomonas aeruginosa,Staphylococcus aureus,Candida albicans,Escherichia coli,and Klebsiella pneumoniae,with the strongest inhibition observed against Pseudomonas aeruginosa and Staphylococcus aureus.(4)The safety experiment showed no skin irritation in both single and multiple-dose experiments on normal and damaged rabbit skin,with no statistically significant difference compared to the blank group(P>0.05).Furthermore,no abnormal toxic reactions were observed in the rabbit skin acute toxicity test,and there was no significant difference between the high and low-dose Shenbai groups and the blank group(P>0.05)during the 14 days observation period.Conclusion Shenbai Qudu Bag Foam has significant anti-inflammatory,analgesic,and antibacterial effects when used externally,and it is safe for use on the skin.
作者
贾菲
曲牟文
李国栋
王彦云
潘健
李峨
李宇飞
JIA Fei;QU Muwen;LI Guodong;WANG Yanyun;PAN Jian;LI E;LI Yufei(Guang’anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China)
出处
《辽宁中医药大学学报》
CAS
2024年第6期15-19,共5页
Journal of Liaoning University of Traditional Chinese Medicine
基金
国家自然科学基金面上项目(82174390)
中国民族医药学会科研项目(2023ZY122-47)
中国中医科学院广安门医院新药基金项目(2005Y001)。
关键词
祛毒汤
参柏祛毒袋泡剂
药效学
安全性
Qudu Decoction(祛毒汤)
Shenbai Qudu Bag Foam(参柏祛毒袋泡剂)
pharmacodynamics
safety
