植物蜕皮甾体丝氨酸软膏成分的优化

Q3 Pharmacology, Toxicology and Pharmaceutics Drug Development and Registration Pub Date : 2021-11-25 DOI:10.33380/2305-2066-2021-10-4-89-95
E. Molokhova, Y. Sorokina, D. Lipin
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引用次数: 3

摘要

介绍植物蜕皮甾体是一组在结构和生理作用上与昆虫蜕皮激素蜕皮激素有关的天然化合物。植物蜕皮甾类化合物被发现具有抗炎作用,这表明它们具有再生特性。开发一种含有植物蜕皮甾体的软剂型是令人感兴趣的。目标通过优化基础佐剂的组成,用植物蜕皮甾体改善软膏组合物。材料和方法。Serpisten是一种活性物质,它含有大量的植物蜕皮甾体,其中主要是20羟基蜕皮甾酮,是从Serratulaeconatae的叶子中获得的。原料“Serpukhi冠叶”由俄罗斯联邦服务局(莫斯科)注册,用于生产膳食补充剂(组号77.99.23.3.U.192.3.08),物质Serpisten(组号:77.99.23.3.U.1923.3.08)。TU 9369-002-15092611-2008)。在工作中使用了允许用于医疗的赋形剂:蒸馏的单甘油酯、T-2乳化剂、吐温80、羧甲基纤维素钠、聚乙烯醇、氢氧化铝、空气力、凡士林、油性凡士林、葵花油。根据Greco Latin 4 x 4平方计划,反复观察,优化软膏辅助物质的组成。评估来自含水软膏的氢离子的浓度作为工艺参数;酸值;丝氨酸蛋白酶从软膏中释放到琼脂凝胶中,结构的热稳定性。最佳组合物软膏组合物的结构和机械性能在RV型REOTEST 2.1旋转粘度计(RHOTEST Medingen GmbH,德国)上测定。使用Bepanten软膏(GP Grenzach Produkations GmbH,德国)作为比较制剂。结果和讨论。在用serpistene优化二亲软膏的组成时,发现疏水相和亲水相的比例应为1:1,建议在软膏基质中引入乳化剂T-2、气雾剂以及凡士林和凡士林油的混合物,其比例为1:1。通过对软膏组成的优化研究,提出了以下serpisten软膏组成:serpisten-0.02;乳化剂T-2-3.0;aerosil-3.0;凡士林-23.0;凡士林油-23.0;乙醇40%-1ml;纯化水至100.0。有效粘度的比较分析表明,所提出的组合物尽可能接近Bepanten软膏。结论进行了一系列技术研究,以优化0.02°%的双亲性Serpisten软膏的成分。所开发的组合物和技术使获得具有热稳定性的组合物成为可能,使软膏的氢指数更接近人类皮肤的pH值,并实现皮肤软膏流变学最佳参数(0.34-108Pa•s)。
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Optimization of the Composition of the Ointment with Phytoecdysteroids Serpisten
Introduction. Phytoecdysteroids are a group of natural compounds related in structure and physiological effect to ecdysone - the hormone of insect molting. Phytoecdisteroids have been found to have an antiflammatory effect, which suggests that they have regenerative properties. The development of a soft dosage form containing phytoecdysteroids is of interest.Aim. Improvement of ointment compositions with phytoecdysteroids by optimizing the composition of base adjuvants.Materials and methods. As an active substance was used Serpisten, containing the sum of phytoecdysteroids, the main of which is 20-hydroxyecdysone and obtained from the leaves of Serratulaecoronatae. Raw materials "Serpukhi crowned leaves" were registered by the Federal Service Rospotrebnadzor (Moscow) for the production of dietary supplements (Gr. No. 77.99.23.3.U.1922.3.08), substance Serpisten (Gr. No. 77.99.23.3.U.1923.3.08. TU 9369-002-15092611-2008). In work were used the excipients allowed for medical use: the monoglycerides distilled, T-2 emulsifier, tween 80, sodium - carboxymethylcellulose, polyvinyl alcohol, hydroxide of aluminum, aero forces, vaseline, oil vaseline, sunflower oil. Optimization of ointment auxiliary substances composition was carried out according to the Greco-Latin 4 x 4 square plan with repeated observations. The concentration of hydrogen ions from aqueous ointments was evaluated as process parameters; acid number; release of serpistene from ointment into agar gel, thermal stability of structure. The structural and mechanical properties of the optimal composition ointment composition were determined on a RV type REOTEST 2.1 rotary viscometer (RHEOTEST Medingen GmbH, Germany). Ointment Bepanten (GP Grenzach Produktions GmbH, Germany) was used as a comparison preparation.Results and discussion. During optimization of the composition of the diphilic ointment with serpistene, was found that the ratio of hydrophobic and hydrophilic phases should be 1 : 1, it is advisable to introduce into the ointment base an emulsifier T-2, aerosil and a mixture of vaseline and vaseline oil in the proportion of 1 : 1. As a result of the carried out studies on the optimization of ointment compositions, the following serpisten ointment composition is proposed: serpisten - 0.02; emulsifier T-2 - 3.0; aerosil - 3.0; vaseline - 23.0; vaseline oil - 23.0; ethyl alcohol 40 % - 1 ml; purified water to 100.0. Comparative analysis of effective viscosity showed that the proposed composition is as close as possible to the Bepanten ointment.Conclusion. A set of technological studies was carried out to optimize the composition of the Serpisten, 0.02 °% ointment on a diphilic basis. The developed composition and technology made it possible to obtain a composition with thermal stability, bring the hydrogen index of the ointment closer to the pH of human skin and achieve the parameters included in the rheological optimum for dermatological ointments (0.34-108 Pa • s).
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来源期刊
Drug Development and Registration
Drug Development and Registration Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
1.20
自引率
0.00%
发文量
61
审稿时长
8 weeks
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