中药“连蒲”透皮剂的稳定性、刺激性和安全性试验

摘要

The stability of “Lianpu”liniment was analyzed by the observation of appearance, pH, phillyrin content, microbial limit test, room temperature and accelerated test. Irritation of the liniment to damaged or health skin and acute toxicity were investigated by single and multiple doses with different dosage. The result of room temperature and accelerated test showed there was no sig-nificant change on appearance, pH and phillyrin content under normal temperature (25℃), high temperature (40℃),low temperature (4℃) after 3 months,and microbial limit test was qualified. Based on the irritation test,it was indicated that there was no significant difference on intake,tem-perature, eyes, skin and hair, mucosa, respiration, central nervous system and limbs moving in these groups,in addition,no apparent skin erythema and edema was observed with single and mul-tiple doses. Besides,there was no toxic or abnormal symptom appeared during whole experiment. The results confirmed that liniment of traditional Chinese medicine “Lianpu”for cow mastitis was stable in 3 months and had good safety but no skin acute toxicant.%为了研究中药“连蒲”乳房炎搽剂的稳定性、刺激性、安全性，笔者分别对中药“连蒲”透皮剂进行了稳定性考察，包括外观、pH值、连翘苷含量、微生物限度检查、常温留样和加速试验观察等项目；以成年健康家兔为试验动物，考察了“连蒲”乳房炎搽剂分单次和多次给药分别对完整皮肤和受损皮肤的刺激性以及不同给药剂量的急性毒性。常温留样和加速试验表明，该制剂在常温（25℃）、高温（40℃）、低温（4℃）下放置3个月后，制剂的外观性状、pH值、连翘苷的含量等检查结果与制备初期相比均无明显变化，且微生物限度检查合格；单次和多次给药对皮肤均未造成红斑和水肿现象；不同给药剂量的皮肤急性毒性试验结果显示，各组家兔的采食、体温、皮肤、毛发、眼、黏膜、呼吸、中枢神经系统及四肢活动等状况均正常，未见中毒或异常症状，表明中药“连蒲”乳房炎搽剂在3个月内稳定，无急性皮肤毒性，安全性良好。