中药口服缓控释制剂的研究进展

目的：通过对中药口服缓控释制剂进行综合论述,为我国中药缓控释制剂的研究与发展提供参考经验。方法：全面收集掌握近十年以来世界范围内中药口服缓控释制剂的研究资料与结果,从中药缓控释制剂的类型、体内释放评价、体外释放评价以及体内外相关性等方面进行研究。结论：目前,世界范围内的中药口服缓控释制剂的研究主要侧重点在于制剂加工生产工艺和体外释药性等方面,中药口服缓控释制剂的生物利用度、体内释药特性和药动学过程等生物药剂学方面的研究涉及比较少,中药口服缓控释制剂的设计原理和质量评价体系方面的研究基本上还没有起步。因此,需要全面扩充中药口服缓控释制剂的研究内容,加大研究力度,持续拓展研究空间,以提升我国中药口服缓控释制剂的研究与发展水平。     

中药新型给药系统研究进展

目的：介绍中药新型给药系统的研究进展情况。方法：广泛查阅有关资料，综述新型给药系统在天然药物和中药制刑中的应用。结果：目前中药新型给药系统研究主要集中在口服缓控释、靶向、透皮给药系统3个方面。结论：应加强对中药新型给药系统的应用研究。     

中药缓控释微丸研究进展

微丸作为一种多单元释药系统,有着普通制剂难以比拟的优越性而倍受瞩目。查阅近年中药缓控释微丸制剂研究的有关文献资料,本文对中药缓控释微丸的特点、种类、辅料、制备新方法、存在的问题及思考几个方面的研究进行了综述,旨在为研究开发中药口服缓控释制剂提供思路和方法。     

口服缓控释制剂研究概况

本文综述了口服缓控释制剂研究概况。缓控释制剂有三种释药类型：定时、定速、定位释药。有多种剂型：包括骨架缓控释制剂、薄膜包衣缓控释制剂、渗透泵型缓控释制剂、胃内漂浮缓控释制剂、缓控释微丸、缓控释液体制剂等。口服缓控释释放系统的迅猛发展，为新药物的研制、老药新用途的开发提供了更为广阔的前景。     

口服液体缓控释制剂技术的研究进展

目的 针对各类口服液体缓控释技术的释药机理、应用特点及局限性进行综述,为此类制剂的开发提供参考。方法 查阅国内外相关文献,对口服液体缓控释技术进行整理归纳。结果 目前已有基于离子交换树脂和微囊技术的口服液体缓控释制剂上市,此外,微球、固体脂质纳米粒、原位凝胶等技术也应用于口服液体缓控释制剂领域。结论 口服液体缓控释给药系统相比于传统固体缓控释制剂,因其口服可接受性良好,剂量调整灵活,给药依从性优势明显,具有良好的开发应用前景。     

药用高分子在缓控释制剂中的应用现状

<正>缓控释制剂的发展除与制药设备的不断发展、革新有关外,药用高分子在该类制剂中也是不可分割的重要组成部分。近年来,一些新型高分子材料的研究和应用使缓控释制剂步入了定时、定向、定位、速效、高效、长效的精密化给药阶段,出现了口服渗透泵控释制剂、脉冲式释药系统、环境敏感型定位释药系统、结肠定位给药系统等新型缓控释制剂。辅料的成分、组成与结构对药物的释放性能有很大的影响,因此在缓控释制剂中合理应用新型高分子材料,就具有重要的意义。1药用高分子作为药物载体药用高分子的广泛研究和应用,促进了缓控释制剂的快     

口服缓控释系统的研究进展

目的:综述口服缓控释系统的研究进展。方法:以"骨架片""渗透泵片""纳米技术""缓控释制剂"等为关键词,在Elsevier期刊、清华大学镜像、中国期刊全文数据库等检索源检索相关文献,筛选2009-2014年口服缓控释系统的释药机制、剂型及制备技术等研究进行综述。结果:共检索到相关文献651 055篇,其中有效文献237篇。口服缓控释制剂的释药机制主要有扩散、溶蚀、溶出、渗透泵和离子交换等,常用剂型有骨架片、渗透泵片、胃滞留制剂、结肠定位制剂、定时脉冲胶囊等,最新的制备技术有纳米制剂技术、靶向制剂技术、固体分散技术和半固体制剂技术等。结论:口服缓控释系统的研究与开发已经成为缓控释制剂发展的一个重要方向,但作为一种新型给药系统仍需进一步研究。     

口服脉冲控释给药系统的释药机制及其应用

口服脉冲控释给药系统因具有定时或定位释放的特点而成为当前药剂研究领域的热点.本文介绍了其释药机制,包括有机酸诱导、渗透压调节、pH依赖、时间依赖、酶依赖、pH-时间依赖及各释药机制应用实例.提出了该给药系统在应用中,尤其是对中药复方制剂所存在的一些问题,期望为口服中药脉冲控释给药系统的研究提供思路.     

中药口服缓控释制剂研究进展

目的从剂型方面综述中药口服缓控释制剂的研究进展。方法通过检索近年来相关文献资料,阐述我国中药口服缓控释制剂的研究现状。结果中药缓控释制剂的研究相对滞后,发展中存在一些困难。结论中药缓控释制剂是顺应现代医疗需要的新剂型,有很多显著的优点,发展前景广阔。     

儿童口服缓控释制剂研究进展

口服缓控释制剂可减少给药次数、提高患者依从性、减少不良反应发生率,与特定年龄儿童的需求相匹配,是目前药物剂型研发的热点。我们通过调研国内外口服缓控释制剂发展现状及儿童可用的上市口服缓释制剂药品品种情况,对儿童口服缓控释制剂发展现状进行阐述和总结,以期为中国儿童用药研发和应用提供参考意见。     

多组分、多靶点中药整体药代动力学研究的思考与探索

中药药代动力学研究是中药现代化研究链上一个不可分割的重要组成部分,在创新中药及现代复方中药研发中发挥着重要作用,但目前尚缺乏符合中药自身特征的药代动力学研究与评价技术体系,对于中药药代动力学学科关键科学问题的认识不够清晰。本文扼要概述了本课题组近年来在中药多组分整合药代动力学、体内外物质组分析、基于机制的方剂组分配伍规律研究及中药有效成分药代动力学研究进展,并试从面向中药现代化研究实际需求的角度,分析和讨论了中药药代动力学学科的关键科学问题,以期能够起到“抛砖引玉”的作用,共同促进我国中药药代动力学研究水平的提高。     

SFINX—a drug-drug interaction database designed for clinical decision support systems

Objective  The aim was to develop a drug-drug interaction database (SFINX) to be integrated into decision support systems or to be used in website solutions for clinical evaluation of interactions. Methods  Key elements such as substance properties and names, drug formulations, text structures and references were defined before development of the database. Standard operating procedures for literature searches, text writing rules and a classification system for clinical relevance and documentation level were determined. ATC codes, CAS numbers and country-specific codes for substances were identified and quality assured to ensure safe integration of SFINX into other data systems. Much effort was put into giving short and practical advice regarding clinically relevant drug-drug interactions. Results  SFINX includes over 8,000 interaction pairs and is integrated into Swedish and Finnish computerised decision support systems. Over 31,000 physicians and pharmacists are receiving interaction alerts through SFINX. User feedback is collected for continuous improvement of the content. Conclusion  SFINX is a potentially valuable tool delivering instant information on drug interactions during prescribing and dispensing.     

中药审评审批改革与中药注册分类——2020第四届中国创新药论坛发言

本文讲述了2020年中药审评审批制度改革的缘由,详细阐述了中药注册分类改革的内容,论述了本次改革的几个创新的理念,包括中药新药研发中的三结合审评证据体系、中药新药研发中的质量控制和临床定位,并且介绍了这次中药审评审批制度改革的实施进度安排,为中药新药研发提供了重要指导.     

Do bacterial cellulose membranes have potential in drug-delivery systems?

Introduction: Bacterial cellulose (BC) is an extremely pure form of cellulose, which, due to its unique properties, such as high purity, water-holding capacity, three-dimensional nanofibrilar network, mechanical strength, biodegradability and biocompatibility, shows a high potential as nanomaterial in a wide range of high-tech domains including biomedical applications, and most notably in controlled drug-delivery systems.

Areas covered: This appraisal is intended to cover the major characteristics of BC, followed by the key aspects of BC production both in static and agitated conditions, and a glance of the major applications of BC, giving some emphasis to biomedical applications. Finally, a detailed discussion of the different applications of BC in controlled drug-delivery systems will be put forward, with focus on topical and oral drug-delivery systems, using either native BC or composite materials thereof.

Expert opinion: The limited number of studies carried out so far demonstrated that BC, or materials prepared from it, are interesting materials for drug-delivery systems. There is, however, a large field of systematic research ahead to develop new and more selectively responsive materials and eventually to conjugate them with other biomedical applications of BC under development.     

泻下类中药质量的生物控制方法及基本问题探讨

本文以建立泻下中药质量的生物控制方法为实例,针对中药质量易受多种因素影响,样本总体波动范围大的特点,比较了不同生物检定数学模型的适用性,建议中药质量生物控制方法首选准确度相对较高的量反应平行线法,若供试品不能通过可靠性检验,可按质反应平行线法检测。对准确性要求不太高时,也可首选质反应平行线法,操作相对更简单。根据生物检定对参照物质和待测样品同质性的要求,建议采用对照药材提取物作为中药质量生物控制的标准物质,并采用化学参照物进行效价赋值,为效价传递及法定标准物质的建立提供参考。实际检测不同品种大黄药材及其复方制剂的致泻效价,取得较好结果,表明本文建立的生物检定方法及参照物质可用于泻下类中药的质量控制。
     

Advances in nanotechnology-based carrier systems for targeted delivery of bioactive drug molecules with special emphasis on immunotherapy in drug resistant tuberculosis – a critical review

Abstract

From the early sixteenth and seventeenth centuries to the present day of life, tuberculosis (TB) still is a global health threat with some new emergence of resistance. This type of emergence poses a vital challenge to control TB cases across the world. Mortality and morbidity rates are high due to this new face of TB. The newer nanotechnology-based drug-delivery approaches involving micro-metric and nano-metric carriers are much needed at this stage. These delivery systems would provide more advantages over conventional systems of treatment by producing enhanced therapeutic efficacy, uniform distribution of drug molecule to the target site, sustained and controlled release of drug molecules and lesser side effects. The main aim to develop these novel drug-delivery systems is to improve the patient compliance and reduce therapy time. This article reviews and elaborates the new concepts and drug-delivery approaches for the treatment of TB involving solid-lipid particulate drug-delivery systems (solid-lipid micro- and nanoparticles, nanostructured lipid carriers), vesicular drug-delivery systems (liposomes, niosomes and liposphere), emulsion-based drug-delivery systems (micro and nanoemulsion) and some other novel drug-delivery systems for the effective treatment of tuberculosis and role of immunomodulators as an adjuvant therapy for management of MDR-TB and XDR-TB.     

构建数字化导向的中药质量标准体系

目的 构建数字化导向的中药质量标准体系,为解决目前中药质量标准体系面临的问题提供可能的解决策略。方法 结合日常中药检验工作,通过查阅文献和市场调研,并与相关的专家学者及中药生产企业人员进行研讨,对我国中药质量标准体系现状及问题进行分析,并提出相应的对策。结果 目前,中药质量标准存在标准滞后、缺乏整体质量评价方法、偏离中医药理论和临床实践的支撑、工艺可控性差、质量控制指标专属性不够等问题。并且,我国中药质量标准管理和执行中亦存在分类繁多、查询困难、一品种多标准、传统性状鉴别易受主客观因素影响、实物标准物质可及性差等问题。基于此,建议建立健全统一、权威的中药质量标准信息查询平台和中药数字标本馆,并应致力于进行基于数字化的中药质量标准研究。结论 构建数字化导向的中药质量标准体系,将有助于中药质量提升和标准科学制订,解决中药质量标准管理和执行中存在的各种问题。     

Synthesis of thermoresponsive composite hydrogel from Pluronic F127 reinforced by oil palm empty fruit bunches-extracted cellulose for silver sulfadiazine drug delivery

Hydrogels are modern dermal drug-delivery media which can hold a huge amount of water and modify their structure to enable spontaneous response to temperature change and are thus attractive to overcome the limitations of conventional drug-delivery media. In this study, a sustainable method was developed to synthesize thermoresponsive Pluronic F127 (PF127) composite hydrogel reinforced by cellulose extracted from oil palm empty fruit bunches (OPEFBs). The thermoresponsive cellulose/PF127 composite hydrogels were formulated by dissolving OPEFB-extracted cellulose in aqueous sodium hydroxide/urea solution prior to mixing with PF127 polymer at low temperature. The performance of the synthesized thermoresponsive cellulose/PF127 composite hydrogels was evaluated in terms of their swelling ratio, percentage of degradation, and in vitro silver sulfadiazine (AgSD) drug release. PCT20 thermoresponsive cellulose/PF127 composite hydrogel with 20 w/v% PF127 and 3 w/v% OPEFB cellulose showed high mechanical strength (storage modulus and complex viscosity values of 20.90 kPa and 2.09 kPa s, respectively), relatively high swelling ratio (3.63 ± 0.43), and prolonged release of AgSD (t_50% value of 4 h) compared with PCT17-PCT19 thermoresponsive cellulose/PF127 composite hydrogels. Besides, AgSD-loaded thermo-responsive cellulose/PF127 composite hydrogels showed relatively good inhibitory activity against the Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Enterococcus faecium, Streptococcus pyogenes, and Klebsiella pneumoniae bacteria. The exploration of thermoresponsive cellulose/PF127 composite hydrogel from OPEFBs can promote sustainable, environment-friendly, and cost-effective drug delivery systems by using abundant agricultural biomass.     

Advancing transdermal drug-delivery systems past development barriers to the clinic: an industry perspective

"In order to increase the quality of transdermal drug-delivery systems, it [quality] must be built into the systemic product development".     

基于层次分析-熵权法的中药质量标志物量化辨识方法研究——以芍药甘草汤为例

中药质量标志物是近年来中药质量研究的热点,虽有较多相关探讨与研究实践,但如何科学合理地表征质量标志物仍未有突破性进展。本文尝试建立了基于层次分析(analytic hierarchy process,AHP)-熵权法的中药质量标志物辨识方法,在构建涵盖目标层、要素层、控制层的评价体系基础上,首先采用AHP法对中药成分有效性、可测性、特有性3个核心质量属性进行权重分析,其次对各属性下的具体指标基于文献和实验数据应用熵权法进行分析,得到各具体指标的权重后加权计算各成分的综合评分并排序,从而确认中药质量标志物。采用该方法以解痉止痛经典名方芍药甘草汤为例进行研究,结果发现其质量标志物重要性排序靠前的8个成分为:芍药苷>槲皮素>芍药内酯苷>甘草酸>柚皮素>甘草苷>氧化芍药苷>苯甲酰芍药苷,为相关方剂质量标准建立与全程质量控制提供了重要支撑。该研究也为中药质量标志物的量化评价与精准辨识提供了创新思路与方法。