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总苷一氧化氮凝胶的制备、安全性评价及其对糖尿病皮肤溃疡的治疗作用

Preparation and Safety Evaluation of Total Glycosides Nitric Oxide Gel and Its Therapeutic Effect on Diabetic Cutaneous Ulcers.

作者信息

Liu Yi-Qiu, Zhang Dandan, Deng Junyu, Liu Ye, Li Wei, Nie Xuqiang

机构信息

College of Pharmacy, Zunyi Medical University, Zunyi 563006, China.

Key Laboratory of Basic Pharmacology of Ministry of Education and Joint International Research Laboratory of Ethnomedicine of Ministry of Education, Zunyi 563006, China.

出版信息

Evid Based Complement Alternat Med. 2022 Mar 25;2022:1419146. doi: 10.1155/2022/1419146. eCollection 2022.

DOI:10.1155/2022/1419146
PMID:35368764
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8975668/
Abstract

Diabetic cutaneous ulcers (DCU) are a chronic and refractory complication of diabetes mellitus, which can lead to amputation or even death in extreme cases. Promoting the early healing of DCU and reducing the disability rate and treatment cost are important research topics in treating with integrated traditional Chinese and Western medicine. total glycosides are extracted from the traditional Chinese medicine and have angiogenic, anticancer, antioxidant, and wound healing effects. Nitric oxide (NO) is a critical component of wound healing. During the development of DCU, endogenous NO secretion is insufficient. It has been reported that exogenous nitric oxide can promote wound healing, but it is difficult to adhere to the skin because of its short half-life. Therefore, in this study, we used the polymer excipient hydroxyethyl cellulose as the matrix, combined with total glycosides and NO, and developed a new type of topical gel that can promote wound healing. At the same time, we made a comprehensive research and evaluation on the preparation technology, quality standard, skin toxicity, reproductive toxicity, and pharmacodynamics against diabetic skin ulcers of the gel. According to our research results, the combination of C total glycosides and nitric oxide can accelerate the healing speed of DCU wounds, and 8% C total glycosides nitric oxide gel (CATGNOG) has the best effect in ulcer wound healing. CATGNOG has the advantages of feasible preparation method, controllable quality, good stability at low temperature, and no apparent skin toxicity and reproductive toxicity. It can effectively inhibit the growth of bacteria on the wound surface, relieve the inflammatory reaction of the wound surface, and promote the healing of ulcer wound, which provides a basis for further research of the preparation in the future.

摘要

糖尿病皮肤溃疡(DCU)是糖尿病的一种慢性难治性并发症,在极端情况下可导致截肢甚至死亡。促进DCU的早期愈合、降低致残率和治疗成本是中西医结合治疗的重要研究课题。总苷是从中药中提取的,具有血管生成、抗癌、抗氧化和伤口愈合作用。一氧化氮(NO)是伤口愈合的关键成分。在DCU发生发展过程中,内源性NO分泌不足。据报道,外源性一氧化氮可促进伤口愈合,但由于其半衰期短,难以粘附于皮肤。因此,在本研究中,我们以聚合物辅料羟乙基纤维素为基质,结合总苷和NO,研制出一种新型的能促进伤口愈合的外用凝胶。同时,我们对该凝胶的制备工艺、质量标准、皮肤毒性、生殖毒性以及对糖尿病皮肤溃疡的药效学进行了全面的研究和评价。根据我们的研究结果,总苷与一氧化氮联合应用可加快DCU伤口的愈合速度,8%总苷一氧化氮凝胶(CATGNOG)在溃疡伤口愈合方面效果最佳。CATGNOG具有制备方法可行、质量可控、低温稳定性好、无明显皮肤毒性和生殖毒性等优点。它能有效抑制创面细菌生长,减轻创面炎症反应,促进溃疡创面愈合,为该制剂今后的进一步研究提供了依据。

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