S. V. Gribanova, I. Udyanskaya, V. Yankova, T. Slonskaya, N. B. Epshtein, A. A. Zhukova, O. Plakhotnaya, V. N. Kuzina
{"title":"从硅胶衬垫仿真模型看生物活性物质的释放控制","authors":"S. V. Gribanova, I. Udyanskaya, V. Yankova, T. Slonskaya, N. B. Epshtein, A. A. Zhukova, O. Plakhotnaya, V. N. Kuzina","doi":"10.33380/2305-2066-2024-13-1-1468","DOIUrl":null,"url":null,"abstract":"Introduction. In modern medicine, the requirements for the quality of used materials are getting stricter. There is serious concern about bacterial and fungal contamination related to the use of silicone polymeric products, especially those that are in direct contact with human tissues and body fluids. In this regard, the issue of impregnating silicone medical products with various biologically active substances (BAS), particularly with antimicrobial properties, appears relevant.Aim. The research studies the relevance of adding BAS into silicone medical devices to improve their quality and prevent negative consequences of their use. The authors of the article aimed at proving prolonged release of the chosen BAS from silicone products during their contact with skin and the bacteriostatic effect emerging as a result of the BAS release. That required verifying the existence of BAS in the washouts from silicone disks, which, in turn, proves the fact that BAS initially distributed evenly in the volume of a silicone disk are capable of diffusing to the surface and then releasing from it under mechanical action, as well as when treating it with alcohol or alcohol-containing solutions.Materials and methods. Symdiol and bisabolol were selected as the BAS for this study due to their proved antibacterial, anti-inflammatory and moisturizing properties. Bisabolol and symdiol were used in the form of Dragosantol 100 and SymDiol 68T preparations correspondingly. Silicone disks (SDs), impregnated with BAS (0,2 % of the volume) were used as a simulation model of silicone liners. The BAS release from silicone liner models was assessed using highly sensitive chromatographic methods of thin-layer and gas-liquid chromatography.Results and discussion. The method of impregnating SDs with BAS was worked out, the optimal concentration of these substances to add them into the silicone base was selected. The release of the impregnated additives, as well as prolonged stable releasing effect, were confirmed. The data obtained during the experiment allows saying with confidence that the impregnated preparation (symdiol and bisabolol) releases from a SD even upon short and low-intensity mechanical contact with skin, which produces stable bacteriostatic effect on a wide range of microorganisms. The process of BAS release from SDs is also facilitated when treating the product periodically with alcohol-containing solutions, which is necessary according to the operating rules. The obtained results of the chromatographic research quite correlate with the data of the previous microbiological experiments regarding the studied topic. Release of the studied BAS from polymer products during their contact with the skin within the period of not less than 3 months justifies feasibility of adding these BAS into the silicone base.Conclusions. The study confirmed the release of biologically active substances from silicone medical products. Adding BAS into silicone liners undoubtedly improves the quality of these medical products, which can be applied in prosthetics and orthoses.","PeriodicalId":11259,"journal":{"name":"Drug development & registration","volume":"66 6","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Release Control of Biologically Active Substances from Simulation Model of Silicone Liners\",\"authors\":\"S. V. Gribanova, I. Udyanskaya, V. Yankova, T. Slonskaya, N. B. Epshtein, A. A. Zhukova, O. Plakhotnaya, V. N. Kuzina\",\"doi\":\"10.33380/2305-2066-2024-13-1-1468\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Introduction. In modern medicine, the requirements for the quality of used materials are getting stricter. There is serious concern about bacterial and fungal contamination related to the use of silicone polymeric products, especially those that are in direct contact with human tissues and body fluids. In this regard, the issue of impregnating silicone medical products with various biologically active substances (BAS), particularly with antimicrobial properties, appears relevant.Aim. The research studies the relevance of adding BAS into silicone medical devices to improve their quality and prevent negative consequences of their use. The authors of the article aimed at proving prolonged release of the chosen BAS from silicone products during their contact with skin and the bacteriostatic effect emerging as a result of the BAS release. That required verifying the existence of BAS in the washouts from silicone disks, which, in turn, proves the fact that BAS initially distributed evenly in the volume of a silicone disk are capable of diffusing to the surface and then releasing from it under mechanical action, as well as when treating it with alcohol or alcohol-containing solutions.Materials and methods. Symdiol and bisabolol were selected as the BAS for this study due to their proved antibacterial, anti-inflammatory and moisturizing properties. Bisabolol and symdiol were used in the form of Dragosantol 100 and SymDiol 68T preparations correspondingly. Silicone disks (SDs), impregnated with BAS (0,2 % of the volume) were used as a simulation model of silicone liners. The BAS release from silicone liner models was assessed using highly sensitive chromatographic methods of thin-layer and gas-liquid chromatography.Results and discussion. The method of impregnating SDs with BAS was worked out, the optimal concentration of these substances to add them into the silicone base was selected. The release of the impregnated additives, as well as prolonged stable releasing effect, were confirmed. The data obtained during the experiment allows saying with confidence that the impregnated preparation (symdiol and bisabolol) releases from a SD even upon short and low-intensity mechanical contact with skin, which produces stable bacteriostatic effect on a wide range of microorganisms. The process of BAS release from SDs is also facilitated when treating the product periodically with alcohol-containing solutions, which is necessary according to the operating rules. The obtained results of the chromatographic research quite correlate with the data of the previous microbiological experiments regarding the studied topic. Release of the studied BAS from polymer products during their contact with the skin within the period of not less than 3 months justifies feasibility of adding these BAS into the silicone base.Conclusions. The study confirmed the release of biologically active substances from silicone medical products. Adding BAS into silicone liners undoubtedly improves the quality of these medical products, which can be applied in prosthetics and orthoses.\",\"PeriodicalId\":11259,\"journal\":{\"name\":\"Drug development & registration\",\"volume\":\"66 6\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-01-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug development & registration\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.33380/2305-2066-2024-13-1-1468\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug development & registration","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.33380/2305-2066-2024-13-1-1468","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
简介现代医学对所用材料的质量要求越来越严格。人们严重关注与使用硅聚合物产品有关的细菌和真菌污染问题,尤其是那些与人体组织和体液直接接触的产品。因此,在硅胶医疗产品中浸渍各种生物活性物质(BAS),特别是具有抗菌特性的物质,似乎具有现实意义。该研究探讨了在硅胶医疗器械中添加 BAS 的相关性,以提高其质量并防止其使用过程中产生负面影响。文章作者的目的是证明硅胶产品在与皮肤接触的过程中,所选 BAS 的长期释放以及 BAS 释放所产生的抑菌效果。这就需要验证硅胶盘的冲洗液中是否存在 BAS,这反过来又证明了一个事实:最初均匀分布在硅胶盘体积中的 BAS 能够扩散到表面,然后在机械作用下以及用酒精或含酒精的溶液处理硅胶盘时从表面释放出来。由于 Symdiol 和 bisabolol 具有公认的抗菌、消炎和保湿特性,因此被选为本研究的 BAS。双羟萘酸和双羟萘酸分别以 Dragosantol 100 和 SymDiol 68T 制剂的形式使用。浸渍了 BAS(占体积的 0.2%)的硅胶盘(SD)被用作硅胶衬垫的模拟模型。结果和讨论。研究了用 BAS 对 SDs 进行浸渍的方法,并选择了将这些物质添加到硅胶基材中的最佳浓度。实验证实了浸渍添加剂的释放效果以及长期稳定的释放效果。根据实验中获得的数据,我们可以肯定地说,浸渍制剂(symdiol 和 bisabolol)即使在与皮肤进行短时间和低强度的机械接触时也会从 SD 中释放出来,从而对多种微生物产生稳定的抑菌作用。根据操作规定,定期用含酒精的溶液处理 SD 产品也有助于 BAS 的释放过程。色谱研究的结果与之前有关研究主题的微生物实验数据十分吻合。在不少于 3 个月的时间内,所研究的 BAS 会在聚合物产品与皮肤接触的过程中释放出来,这证明在硅酮基料中添加这些 BAS 是可行的。研究证实了硅胶医疗产品中生物活性物质的释放。在硅胶衬里中添加 BAS 无疑会提高这些医疗产品的质量,这些产品可用于假肢和矫形器。
Release Control of Biologically Active Substances from Simulation Model of Silicone Liners
Introduction. In modern medicine, the requirements for the quality of used materials are getting stricter. There is serious concern about bacterial and fungal contamination related to the use of silicone polymeric products, especially those that are in direct contact with human tissues and body fluids. In this regard, the issue of impregnating silicone medical products with various biologically active substances (BAS), particularly with antimicrobial properties, appears relevant.Aim. The research studies the relevance of adding BAS into silicone medical devices to improve their quality and prevent negative consequences of their use. The authors of the article aimed at proving prolonged release of the chosen BAS from silicone products during their contact with skin and the bacteriostatic effect emerging as a result of the BAS release. That required verifying the existence of BAS in the washouts from silicone disks, which, in turn, proves the fact that BAS initially distributed evenly in the volume of a silicone disk are capable of diffusing to the surface and then releasing from it under mechanical action, as well as when treating it with alcohol or alcohol-containing solutions.Materials and methods. Symdiol and bisabolol were selected as the BAS for this study due to their proved antibacterial, anti-inflammatory and moisturizing properties. Bisabolol and symdiol were used in the form of Dragosantol 100 and SymDiol 68T preparations correspondingly. Silicone disks (SDs), impregnated with BAS (0,2 % of the volume) were used as a simulation model of silicone liners. The BAS release from silicone liner models was assessed using highly sensitive chromatographic methods of thin-layer and gas-liquid chromatography.Results and discussion. The method of impregnating SDs with BAS was worked out, the optimal concentration of these substances to add them into the silicone base was selected. The release of the impregnated additives, as well as prolonged stable releasing effect, were confirmed. The data obtained during the experiment allows saying with confidence that the impregnated preparation (symdiol and bisabolol) releases from a SD even upon short and low-intensity mechanical contact with skin, which produces stable bacteriostatic effect on a wide range of microorganisms. The process of BAS release from SDs is also facilitated when treating the product periodically with alcohol-containing solutions, which is necessary according to the operating rules. The obtained results of the chromatographic research quite correlate with the data of the previous microbiological experiments regarding the studied topic. Release of the studied BAS from polymer products during their contact with the skin within the period of not less than 3 months justifies feasibility of adding these BAS into the silicone base.Conclusions. The study confirmed the release of biologically active substances from silicone medical products. Adding BAS into silicone liners undoubtedly improves the quality of these medical products, which can be applied in prosthetics and orthoses.