以植物物质为基础的口腔用药技术与成分的研究进展

Q3 Pharmacology, Toxicology and Pharmaceutics
O. N. Abrosimova, N. Pivovarova, M. Burakova, T. S. Shebitchenko
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The numerical indicators of medicinal plant raw materials (grinding of raw materials and the content of impurities, total ash in medicinal plant materials and ash insoluble in hydrochloric acid, humidity, content of extractives) were determined and the good quality of the raw materials used in the subsequent stages of drug development was confirmed. Dry extracts from each type of medicinal plant raw materials have been developed and the technological properties of dry extracts have been determined. The composition and technology of effervescent granules by pressing wet masses has been developed. To improve the flowability and reduce the hygroscopicity of the granulated material, microcrystalline cellulose – 90 (EMCOCEL®90M) was used as a filler. To create an effervescent dosage form, citric acid and sodium bicarbonate were added to the granules. The mass for granulation was moistened with a 10% alcohol-water solution of Plasdone™ K-29/32. 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引用次数: 2

摘要

介绍。口腔黏膜疾病的治疗和预防是口腔医学的首要任务之一。在实践中,抗菌剂经常用于炎症和破坏性过程的复杂治疗。然而,长期不加控制地使用这些药物会导致许多并发症:药物耐受性,治疗效果减弱,口腔和胃肠道生态失调等。因此,目前寻找替代抗生素治疗的问题仍然是开放的。作为替代方案,必须考虑使用有效、安全、易消化、毒性小、实际上不会产生副作用和过敏反应、具有轻度调节和正常化作用的草药。本研究的目的是开发以植物物质为基础的泡腾剂的组成和工艺,以制备口腔冲洗液。材料和方法。从药用植物原料中提取干提取物:鼠尾草叶、金盏花、蓍草、根茎、根和黄芪。在颗粒技术中,碳酸钠、柠檬酸、无水、微晶纤维素- 90 (EMCOCEL®90M)、聚维酮(Plasdone™K-29/32)和硬脂酸钙作为辅助物质。在实验室条件下,基于植物提取物的颗粒通过压湿块获得。药用植物原料的数值指标、干提取物和颗粒的工艺性能以及颗粒的质量指标按照国家药典第十四版的方法进行测定。结果和讨论。测定了药用植物原料的数值指标(原料研磨及杂质含量、药用植物原料中总灰分和不溶于盐酸的灰分、湿度、提取物含量),确认了后续药物开发阶段使用的原料质量良好。开发了各种药用植物原料的干提取物,并测定了干提取物的工艺性能。研究了湿团压起泡颗粒的组成和工艺。为了提高颗粒材料的流动性和降低吸湿性,使用微晶纤维素- 90 (EMCOCEL®90M)作为填料。为了制造泡腾状的剂型,将柠檬酸和碳酸氢钠添加到颗粒中。用10%的Plasdone™K-29/32酒精水溶液湿润用于造粒的团块。提出了植物提取物泡腾剂质量指标规范草案。在研究过程中,确定了药用植物原料的数值指标,确定了其质量,为进一步生产干提取物提供了可能。根据国家药典第十四版的要求,对每种原料选择提取条件,开发干提取物,确定质量指标。根据干提取物的性质选择辅料,研究植物提取物泡腾剂的组成和工艺,按照国家药典十四版的要求提出泡腾剂规范草案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development of Technology and Composition of the Medicinal Product for Oral Cavity Based on Phytosubstances
Introduction. Treatment and prevention of diseases of the oral mucosa is one of the priority tasks in dentistry. In practice, antibacterial agents are often used in the complex treatment of inflammatory and destructive processes. However, long-term, uncontrolled usage of such drugs leads to numerous complications: drug tolerance, weakening of the therapeutic effect, dysbiosis of the oral cavity and gastrointestinal tract, etc. Therefore, at present, the question of search for alternative to antibiotic therapy remains open. As an alternative, it is necessary considering the usage of effective and safe herbal medicines that are easy to digest, less toxic, practically do not cause side effects and allergic reactions, and have a light regulating and normalizing effect.Aim. The aim of the present study is to develop the composition and technology of effervescent granules for the preparation of a solution for rinsing the oral cavity based on phytosubstances.Materials and methods. Dry extracts were obtained from medicinal plant materials: medicinal sage leaves, medicinal calendula flowers, yarrow herb, medicinal rhizomes and roots and astragalus woolly herb. Sodium carbonate, citric acid, anhydrous, microcrystalline cellulose – 90 (EMCOCEL®90M), povidone (Plasdone™ K-29/32) and calcium stearate were used as auxiliary substances in the granule technology. In laboratory conditions, granules based on phytoextracts were obtained by pressing wet masses. Numerical indicators of medicinal plant raw materials, technological properties of dry extracts and granules, as well as indicators of the quality of granules were determined according to the methods described in the State Pharmacopoeia XIV.Results and discussion. The numerical indicators of medicinal plant raw materials (grinding of raw materials and the content of impurities, total ash in medicinal plant materials and ash insoluble in hydrochloric acid, humidity, content of extractives) were determined and the good quality of the raw materials used in the subsequent stages of drug development was confirmed. Dry extracts from each type of medicinal plant raw materials have been developed and the technological properties of dry extracts have been determined. The composition and technology of effervescent granules by pressing wet masses has been developed. To improve the flowability and reduce the hygroscopicity of the granulated material, microcrystalline cellulose – 90 (EMCOCEL®90M) was used as a filler. To create an effervescent dosage form, citric acid and sodium bicarbonate were added to the granules. The mass for granulation was moistened with a 10% alcohol-water solution of Plasdone™ K-29/32. A draft specification of quality indicators for effervescent granules based on phytoextracts is proposed.Conclusion. In the course of the research work, the numerical indicators of medicinal plant raw materials were determined and its quality was confirmed, which made it possible to use it for further production of dry extracts. The extraction conditions were selected for each type of raw material, dry extracts were developed, and quality indicators were determined in accordance with the requirements of the State Pharmacopoeia XIV. Excipients were selected taking into account the properties of dry extracts, the composition and technology of effervescent granules based on phytoextracts was developed, a draft specification for effervescent granules was proposed in accordance with the requirements of the State Pharmacopoeia XIV.
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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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