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拔脓生肌软膏的药效学及皮肤安全性评价OA北大核心CSTPCD

Pharmacological Effects and Skin Safety Evaluation of Banong Shengji Ointment

中文摘要英文摘要

目的 考察拔脓生肌软膏(BNO)治疗皮肤感染性创面的药理学作用,并初步评价其皮肤安全性,为进一步研发和安全应用提供参考.方法 采用无特定病原体(SPF)级小鼠和大鼠建立金黄色葡萄球菌诱导的细菌性感染皮肤创面模型,随机分为基质组,BNO小、中、大剂量组,龙珠组,百多邦组,给予相应药物涂抹后,考察BNO对大、小鼠细菌性皮肤感染创面的治疗作用,主要观察创面愈合率、创面病理形态、皮肤细菌逆培养细菌含量、皮肤创面组织中羟脯氨酸,以及大鼠皮肤创面组织中白细胞介素-10(IL-10)及肿瘤坏死因子-α(TNF-α)的含量;采用小鼠扭体及耳肿胀实验考察BNO的抗炎镇痛作用;采用皮肤刺激性实验和过敏性实验考察BNO对新西兰兔、豚鼠皮肤给药的安全性.结果 与基质组比较,BNO治疗后能显著促进皮肤创面愈合,改善创面组织病理形态,显著增加皮肤组织中羟脯氨酸含量,抑制创面感染部位的细菌生长,抑制炎症,降低IL-10、TNF-α的含量(P<0.05 或P<0.01);BNO大剂量能显著抑制小鼠耳肿胀(P<0.01),中、大剂量均能显著减少扭体次数(P<0.05 或P<0.01);BNO对新西兰兔、豚鼠皮肤实验结果显示没有明显的刺激性和过敏性,安全性良好.结论 BNO具有一定的抗炎镇痛及促进皮肤创面愈合作用,该制剂符合中药外用软膏的安全性要求.

Objective To investigate the pharmacological effects of Banong Shengji ointment(BNO)in treating bacte-rial skin infections and wounds,to conduct a preliminary evaluation of its skin safety,and to provide a basis for further research and safe application.Methods SPF mice and rats were used to establish a bacterial skin infection model induced by Staphylo-coccus aureus.These were randomly divided into matrix groups,low,medium,and high dose groups of BNO,Longzhu ointment group,and mupirocin ointment group.After applying the corresponding drugs,the therapeutic effects of BNO on bacterial skin in-fections in mice and rats were observed,including wound healing rate,pathological morphology,reverse culture of skin bacteria,and hydroxyproline(HYP)content in skin tissue,as well as interleukin-10(IL-10),tumor necrosis factor-α(TNF-α)levels in rat skin wound tissue.In addition,mice ear swelling and writhing experiments investigated the anti-inflammatory and analgesic effects of BNO.To evaluate the skin safety of BNO,skin irritation and allergy experiments were conducted.Results Compared with the matrix group,BNO treatment significantly promotes wound healing,improves pathological changes in wound tissue,increa-ses the content of HYP in skin tissue,inhibits bacterial growth at the infection site,suppresses inflammation,and reduces the levels of IL-10 and TNF-α(P<0.05 or P<0.01).Besides,the high-dose BNO group significantly inhibits ear swelling in mice(P<0.01),and both medium and high doses of BNO significantly reduce the number of writhes(P<0.05 or P<0.01).Moreover,BNO had no irritation to the intact and damaged skin of New Zealand rabbits and no allergic reactions in guinea pigs,it was safe in the external application.Conclusions BNO has a certain effect of anti-inflammation,analgesia and promoting skin wound healing.The preparation meets the safety requirements of traditional Chinese medicine external ointments.

范华娜;邹国发;陶曙红;郭丽冰;尹永芹;陈景胜;陈艳芬

广东药科大学中药学院,广州 510006

中医学

拔脓生肌软膏抗菌作用抗炎作用镇痛作用创面愈合安全性

Banong Shengji ointmentAntibacterial effectAnti-inflammation effectAnalgesia effectWound healingSafety

《医药导报》 2024 (005)

679-688 / 10

广东省公益研究与能力建设专项资金资助项目(2015A030302088);广东省科技厅疾病防治项目(2016A020215158);广东省科技厅-广东省中医药科学院联合项目(2014A020221095);广东省科技计划项目(2014A020212501).

10.3870/j.issn.1004-0781.2024.05.002

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