论文部分内容阅读
目的:研究胡矾口腔膜的安全性为临床安全用药提供科学依据。方法:急性毒性试验:12只家兔分为给药组和对照组,每组6只。给药组将用于制备胡矾口腔膜的浸膏(含苦矾0.14g/ml)每次10ml涂于兔下唇与齿龈之间,面积为5cm×5cm,每天6次。对照组同法给予相同剂量的赋型剂。给药24h后观察与记录家兔体重、皮肤、皮毛和黏膜变化,共7d。口腔黏膜刺激试验:12只家兔分为给药组和对照组,每组6只。给药组家兔口腔黏膜每次涂抹胡矾浸膏(含苦矾0.07g/ml)0.5ml,4h内涂药8次,共7d,对照组同法给予同体积的赋型剂。观察口腔黏膜涂药部位的局部反应,并对呼吸道黏膜组织进行病理检查。皮肤刺激试验:16只家兔分为4组——完整皮肤组与对照组,破损皮肤组与对照组,每组4只家兔。2个给药组均于家兔背部去毛皮肤处每次贴胡矾口腔膜7片,2个对照组贴无药的赋型剂膜7片,均1次/d,连续给药7d。末次给药24h后,用温水去除残留物,然后于1、24、48、72h观察皮肤反应。结果:给药组和对照组比较,家兔体重、皮肤、皮毛、黏膜均无异常变化。口腔黏膜涂药第7天,给药组有1只家兔口腔黏膜轻度充血,其余家兔口腔黏膜未见局部反应。组织病理检查示:给药组仅1只家兔鳞状上皮有少量炎性细胞浸润。完整皮肤组和破损皮肤组各有1只家兔于涂药后1h出现红斑,24h红斑减轻,48h消退。结论:胡矾口腔膜是一种较为安全的治疗口腔溃疡的中药制剂。
OBJECTIVE: To study the safety of oral membranes of Poria aurantium in order to provide scientific basis for clinical safe medication. Methods: Acute toxicity test: 12 rabbits were divided into administration group and control group, 6 in each group. In the administration group, 10 ml of the extract (containing buckwheat 0.14 g/ml) used to prepare the oral cavity film of Hupi was applied between the lower lip of the rabbit and the gum, and the area was 5 cm×5 cm, 6 times per day. The control group received the same dose of excipients. After 24 hours of administration, changes in body weight, skin, coat, and mucous membranes were observed and recorded for 7 days. Oral mucosal irritation test: 12 rabbits were divided into administration group and control group, 6 in each group. The oral mucosa of the rabbits in the administration group was applied with 0.5 ml of Huqi extract (containing 0.07 g/ml of tartary buckwheat), and applied 8 times within 4 hours for 7 days. The control group received the same volume of excipients. Observed the local reaction of oral mucosal drug application site, and pathological examination of respiratory mucosa tissue. Skin irritation test: 16 rabbits were divided into 4 groups - intact skin group and control group, damaged skin group and control group, 4 rabbits in each group. In the two administration groups, seven oral films were applied to the depilated skin on the back of the rabbits, and two control groups were given seven non-medicated vehicle films, one time per day and continuous administration for 7 days. Twenty-four hours after the last administration, the residue was removed with warm water, and the skin reaction was observed at 1, 24, 48, and 72 hours. RESULTS: There was no abnormal change in body weight, skin, coat, and mucous membranes in the treated group compared with the control group. On the 7th day after oral mucosal application, one rabbit had mild oral congestion in the drug-administered group and no local reaction was observed in the other oral mucosa. Histopathological examination showed that only a small amount of inflammatory cells infiltrated in the squamous epithelium of the rabbits in the administration group. One rabbit in the intact skin group and the damaged skin group had erythema 1 hour after the application of the drug, 24 hours erythema reduced, and 48 hours subsided. Conclusion: Hujing oral membrane is a safe Chinese medicine preparation for treating oral ulcers.