加味玉屏风散煎汤外用预防乳头皲裂的安全性评估

Safety assessment of external use of augmented jade screen decoction in preventing nipple cracks

目的通过对实验动物皮肤过敏试验和急性毒性试验来评估加味玉屏风散煎汤外用预防乳头皲裂的安全性。方法皮肤致敏试验:30只豚鼠按随机数字表法分为3组(实验组、阴性对照组、阳性对照组各10只),经诱导、激发,去除含该中药煎剂敷贴纱布后1 h、24 h、48 h,观察皮肤的反应并记录;最大耐受量试验:该中药煎剂给40只ICR小鼠,随机数字表法分为2组(实验组、对照组各20只),一日2次灌胃,观察14 d动物的行为,体重增加及死亡情况并记录。结果实验组豚鼠激发后去贴1 h、24 h、48 h,均未出现红斑或水肿反应,与阴性对照组差异无统计学意义(P>0.05);实验组小鼠未见明显毒性反应及死亡情况,且体重增加与正常对照组比较差异无统计学意义(P>0.05)。结论加味玉屏风散煎剂外用涂抹预防乳头皲裂安全可行。

Objective To evaluate the safety of external use of augmented jade screen decoction through skin allergy test and acute toxicity test in animals. Methods Skin sensitization test was carried out as that 30 guinea pigs were randomly divided into three groups（ 10 in the experimental group,10 in the negative control group and 10 in the positive control group）. After induction and stimulation,to observe and record the reaction of the test parts of skin while remove the gauze with augmented jade screen decoction after 1 h,24 h and 48 h. Maximum tolerance test was carried out as that augmented jade screen decoction was given two times a day orally in 40 ICR mice which were divided into two groups（ experimental group and control group） by random number table method. Then made records after continuous observation including the daily behavior,weight gain and death of the animals for 14 days. Results There was no erythema or edema reaction in the skin test sites of experimental group in 1h,24 h and 48 h after removal of the gauze. There was no statistical significance on the difference compared with the negative control group（ P 〉 0. 05）. Meanwhile,there was no obvious toxic reaction or death in the experimental group and had no statistical significance on the difference from the control group in weight gain（ P 〉 0. 05）. Conclusion External use of augmented jade screen decoction to prevent nipple cracks is safe and feasible.