中药质量控制现状与研究进展

OBJECTIVETo promote and develop the Quality Control of Traditional Chinese Medicines (TCM). METHODTo compare the number and methods of quality control in the Chinese pharmacopoeias (I) published in different periods. To analyze the controlling level, d     

中成药中无机元素标准制订方法的研究

目的:获得中成药中无机元素的限量标准.方法:采用对应分析法对乌鸡白凤丸等中成药中的4种无机元素(Cu,Zn,Co,Fe)的化学分析数据进行聚类,并用人工神经网络法进行验证.结果:应用此2种方法均可将种类不同的中成药明显分开,并找出根据无机元素所分类作为研究对象的乌鸡白凤丸样本,用区间估计法获得了乌鸡白凤丸中Cu,Zn,Co,Fe 4种无机元素的限量标准.结论:对应分析法和人工神经网络法用于中成药的分类和区间估计法用于中成药的限量标准制订是可行的.     

试论抗真菌中药研究战略

在认真分析前一阶段抗真菌中药研究状况的基础上，本文阐述了对今后如何开展其研究的看法：进一步从有抗真菌活性的中药中提取有效成分；加强抗深部感染真菌中医研究、抗真菌中药复方研究及利用动物真菌性疾病模型进行研究；开展中药对抗真菌抗生素和化学合成药物减毒增效作用研究以及中药抗真菌机理研究等。     

民国中西药学汇通代表作《汉药新觉》考略

郭若定《汉药新觉》为民国时期中西药学汇通的代表作,其上集曾被民国时期北平杂志《明日医药》连载,并刊有单行本.续集内容由其家属收藏,全书完整本于2010年由上海科学技术文献出版社出版,载药208种,以单味中药为主,并收部分复方药及西药.该书中西药学汇通思想,体现在3个方面：中西药物,兼收并蓄;衷中参西,继承创新;中西合参,旨在汇通.     

Potential health risks to adults and children in the UK from exposure to dietary lead in gamebirds shot with lead ammunition

We estimate potential risks to human health in the UK from dietary exposure to lead from wild gamebirds killed by shooting. The main source of exposure to lead in Europe is now dietary. We used data on lead concentrations in UK gamebirds, from which gunshot had been removed following cooking to simulate human exposure to lead. We used UK food consumption and lead concentration data to evaluate the number of gamebird meals consumed weekly that would be expected, based upon published studies, to result in changes, over and above those resulting from exposure to lead in the base diet, in intelligence quotient (IQ), Systolic Blood Pressure and chronic kidney disease (CKD) considered in a recent opinion of the European Food Safety Authority (EFSA) to be significant at a population level and also in SAT test scores and in rates of spontaneous abortion. We found the consumption of <1 meal of game a week may be associated with a one point reduction in IQ in children and 1.2–6.5 gamebird meals per week may be associated with the other effects. These results should help to inform the development of appropriate responses to the risks from ingesting lead from ammunition in game in the UK and European Union (EU).     

医保目录与医疗服务的错位

"脊柱内固定钢板"按医保目录可以报销,而固定钢板的钉子却由患者全额自付;五六年前制定的目录中仅有黑白超床旁检查项目,而未设床旁彩超项目,目前二级以上医院几乎全部淘汰黑白超,改用彩超,可彩超没有收费标准……诸如此类的问题让人难以理解。建议相关部门建立互通机制。     

Innovation in Chemistry,Manufacturing, and Controls—A Regulatory Perspective From Industry

This review describes the landscape of novel modalities such as cell and gene therapies, viruses, other novel biologics, oligomers, and emerging technologies, including modern analytics. We summarize the regulatory history and recent landmark developments in some major markets and examine specific chemistry, manufacturing, and controls (CMC) challenges, including suggestions for exploration of potential science-based approaches in support of regulatory strategy development from an industry perspective. In addition, we evaluate the economic factors contributing to patient access to innovation and discuss the impact of regulation. There is a desperate need for a consistent form of regulation where global approaches to regulatory strategies can be harmonized, and specific CMC challenges can be dealt with using the appropriate science and risk-based tools. Although these tools are well described in current guidance documents, the specifics of applicability to complex novel modalities can still result in differing regulatory advice and outcomes. The future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization, regulatory education, and industry cooperation through consortia, enabling industry to supply key information to regulators in a transparent yet well-defined manner, and utilizing mutually understood risk-benefit analyses to produce drugs with appropriate safety, efficacy, and quality characteristics.