中、澳两国药品召回制度比较研究

目的:为完善我国药品召回制度提供借鉴。方法:通过比较中、澳两国药品召回制度,分析目前我国药品召回制度仍存在的问题。结果与结论:我国应借鉴澳大利亚药品召回制度中适用于我国的经验,从完善法律制度和跟踪措施,确定药品召回分层和政府职责等多方面入手完善我国药品召回制度。     

中美两国药品召回制度比较

为了解我国药品召回过程中存在的问题,完善我国药品召回制度,通过比较中美两国药品召回制度产生的文化背景、法律依据、药品缺陷发现的途径、药品召回执行环节等,借鉴美国药品召回制度中适合于我国的经验。我国药品召回制度尚处于实践发展的探索期,需要进一步完善。     

关于我国药品召回制度中几个问题的探讨

目的探讨药章召回制度中召回的责任主体,召回的范围,以及药品召回制度与药品不良反应报告和监测制度之间的关系。方法对药品召回责任主体进行界定,辨析药品召回的范围,分析药品召回制度与药品不良反应监测与报告制度的关联。结论药品召回制度促使我国对缺陷药品的管理更加规范,有利于人民群众的用药安全。药品不良反应报告与监测制度的完善是药品召回制度运行的前提,药品召回降低药品不良反应发生几率,两种制度相互促进。     

论药品召回制度存在的问题及对策

目的通过对《药品召回管理办法》的研究,探索建立药品召回制度的必要性,药品召回的实施情况,以及对医药企业的影响。方法从监管部门和医药企业两个不同的角度分析我国药品召回实施的不利因素以及改进措施。结果与结论在国际上召回制度早已存在,我国有必要建立药品召回制度;由于我国的药品召回尚处于起步阶段,在开展工作中会存在不利的因素,监管部门和医药企业都要采取积极的应对措施。     

美国药品召回制度对我国药品安全的启示

目的 :为我国建立药品召回制度提供参考。方法 :介绍美国药品召回制度 ,探讨其对我国药品安全的启示。结果与结论 :借鉴美国的药品召回制度 ,完善我国的法律规范体系 ,全面推行药品召回制度。     

对构建我国药品召回制度的探讨

药品召回制度是一项保护消费者用药安全的缺陷药品规制制度.药品召回在美国、澳大利亚及我国台湾、香港地区等国家和地区已有比较成熟的立法和丰富的实践.我国构建药品召回制度的关键在于制定和完善相关法律制度,正确界定召回范围,并进一步建立和完善实施这一制度的相关配套措施.     

借鉴美国经验完善我国药品召回制度的对策探讨

目的 为完善我国药品召回制度提供借鉴.方法 对中美两国的药品召回制度进行时比.结果 与结论应借鉴美国药品召回制度中适合于我国国情的成功经验,从完善立法、明确召回对象、加大处罚力度、完善缺陷药品信息收集系统等方面入手,完善我国的药品召回制度.     

完善我国药品召回制度的研究

目的为完善我国药品召回制度提出建议与措施。方法全面剖析我国药品召回制度中各要素,分析存在的问题。结果与结论可以通过建立健全药品召回法律制度、企业完善自身体系、政府主导监管扶持、加强消费者教育、发展产品召回险种、建立第三方评价等方式完善我国药品召回制度。     

一起药品召回案例的讨论与思考

目的探讨药品召回制度在我国实行过程中的完善及改进。方法通过对一例典型的跨辖区药品召回事件进行讨论分析,了解药品召回过程中的制度缺陷及执行困难。结果与结论目前的药品召回制度存在处罚方式、召回方式、行政成本运用效率、允许退货操作条件等几方面的问题,我国建立药品召回制度、完善药品市场管理还需从多方面进行改进,要求药监工作人员对其有准确的理解。     

对我国建立药品召回制度的回顾与思考

药品召回制度是一项保护消费者用药安全的缺陷药品管制措施。本文对我国建立药品召回制度的必要性、可能性以及美国的召回经验进行了回顾,并且对我国的《药品召回管理办法》在实际执行过程中可能会遇到的问题进行了思考。     

中药五味药性理论的现代研究进展

五味作为中药药性理论的核心内容，近年来有许多学者从不同方面对中药五味理论进行一系列的研究。由于传统中医药理论与现代药学思维方式和认识途径存在差异，导致人们对于中药五味药性理论的认识不尽相同。从中药五味的源流，哲学思想对五味属性的推演以及四气、归经、升降浮沉、功效与五味的联系对中药五味药性理论的脉络进行梳理，进一步从真实滋味和功效属性两方面对中药五味药性的现代研究进行探讨，通过探究五味的真实滋味的标定及五味物质基础与功效的关联关系，对其进行客观的描述，以期寻求一种更加科学化的现代方法阐明中药五味药性理论。     

螺旋CT胸部重建与纤支镜在儿童气道畸形诊断中的应用比较

探讨螺旋CT胸部重建与纤支镜在儿童气道畸形诊断中的应用价值。方法对反复咳喘疑气道畸形的患儿行螺旋CT胸部重建及纤支镜检查并比较两种方法的差异。结果螺旋CT胸部重建与纤支镜均可发现气道的病变,另螺旋CT胸部重建技术还可显示气道与周围组织的关系,阻塞远端的气道情况。但对3级以下支气管管内病变准确性下降,且不能同时进行治疗。结论螺旋CT胸部重建可部分代替纤支镜检查,尤其对危重症不能耐受手术的患儿,提高了儿童气道病变的诊断水平,与纤支镜联用可更全面地诊断儿童气道病变。     

抗菌药物用药规则的精细化设置在门诊处方前置审核中的应用实践

目的分析抗菌药物用药规则的精细化设置在处方前置审核中的应用成效,促进抗菌药物合理应用。方法借助我院"临床合理用药智能管理系统"的审核规则知识库,根据临床实际应用抗菌药物的情况,对抗菌药物在不同适应证下的用法用量、用药疗程以及特殊人群用药等规则进行精细化设置。分析评价抗菌药物精细化规则的建立对2018年9月至2019年4月门诊抗菌药物处方审核及干预的影响。结果处方前置审核抗菌药物问题处方占比和事后抗菌药物处方占比及药费占比呈下降趋势;事后抗菌药物处方合格率呈上升趋势。结论抗菌药物用药规则的精细化设置可促进处方前置审核的顺利开展,提高抗菌药物的处方质量,保障患者安全合理用药。     

Effect of corazole on the dynamics of oxidative-reductive processes in cerebral cortical neurons

By using the complex of techniques on the basis of life-time microscopy and spectrophotometry of the structures of II, III layers of the cat brain motor cortex there was studied the effect of ionophoretically delivered corazole on the dynamics of integral redox-state of pyramidal cells bodies, the surrounding neuropil as compared to the changed bioelectrical activity. The development of the convulsant activity of neurons coincided with the shift of their redox-state towards the accumulation of intracellular reducing equivalents. Both in the bodies of neurons and in the structures of neuropil a stable pronounced increase of restoration of intracellular redox-systems was preceded by the process of wave-like fluctuating changes in the content of reducing equivalents. The role of the revealed disturbances of oxidation-reduction processes in the mechanisms of corazole-induced lesions of neurons is discussed.     

Packaging in the process of radiation sterilization. II. Physicochemical studies

The penetrability of the ionizing radiation through the matter makes possible the sterilization of the medical devices in the packed form by radiation method. The effect of the radiation should not bring any destructive changes in the material used for the package. In this paper have been discussed the results of the investigations of the one--and multilayer packaging materials from the point of view their utility for the radiation sterilization purposes. The changes of the useful parameters of the investigated materials have been determined in the dependence on the absorbed dose immediately after irradiation and the period of the durable keeping after the sterilization. The results of the mechanical investigations in the correlation to the results of the microbiological effects of the sterilized materials enabled to draw practical conclusions concerned the usability of the particular packages.     

金丝桃提取物对DNA损伤的保护作用

目的观察金丝桃提取物对DNA损伤的保护作用。方法配制硫酸铜 邻啡罗啉反应体系，制备DNA损伤模型体系，在该模型体系中分别加入金丝桃3个化学成分部位（F002、F003、F004）的甲醇提取物，每个化学成分部位提取物设5个不同浓度，观察金丝桃3个不同化学成分部位提取物对损伤DNA化学发光动力学曲线的影响。结果随着金丝桃各化学成分部位提取物的加入，DNA损伤发光动力学曲线峰明显下降且后移；且提取物浓度越高，发光动力学曲线峰下降越明显。金丝桃3个不同化学成分部位的抗氧化能力强弱顺序为F002＞F004＞F003。结论金丝桃属于预防型和断链型抗氧剂，对DNA损伤有明显保护作用，而且这种作用与化合物的极性有关。     

Dynamics of interferon in the rhinopharyngeal secretions of adults vaccinated with the NIVGRIP inactivated influenza vaccine by the nasal route

The study of the kinetics of interferon in the nasopharyngeal secretions (NPS) of adults vaccinated by intranasal route with the NIVGRIP inactivated influenza vaccine and of unvaccinated controls led to the following observations: the large variety of the individual reactions to the IFN inducing action of the NIVGRIPR vaccine: the presence of low titers of a "physiological" IFN in the NPS of 26% of the patients before vaccination; a positive conversion to IFN in 60% of the patients after the first and in 33% after the second administration of the vaccine. No changes were noted in the percentage of IFN positive controls during the observation period. A "physiological" IFN was detected in the NPS of 10% of the controls.     

Evaluation of models for analysis of radioligand binding data

In the presence of agonists, many neurotransmitter receptors interact with regulatory components, resulting in the formation of a ternary complex composed of agonist, receptor, and a regulatory component, and in biphasic or shallow dose response curves for inhibition of the binding of a radiolabeled antagonist by agonists. Complex dose response curves are often analyzed using equations that describe a model that assumes the presence of two independent populations of receptors (two-independent-receptor model) or equations that describe a model that assumes the reversible interaction of agonist-occupied receptors with a regulatory component (ternary complex model). In this study, the ability of these models to provide good estimates of the concentration of the regulatory component and of the affinities involved in formation of the ternary complex was evaluated. Dose response curves were generated by a computer using an equation that describes the ternary complex model. Analysis of the dose response curves with the two-independent-receptor model resulted in good estimates of the concentration of the regulatory component and of the affinity of the receptor for the agonist. Reliable estimates of the other affinity constants that relate to formation of the ternary complex could not be obtained. Analysis of the dose response curves with the ternary complex model resulted in good estimates of the concentration of the regulatory component and of the affinity constants that relate to formation of the ternary complex. Random error was added to the data points that made up the dose response curves to simulate error observed in experiments with biological systems. Analysis of the dose response curves that contained random error with the two-independent-receptor model yielded results similar to those obtained from analysis of dose response curves that did not contain random error. Analysis of the dose response curves that contained random error with the ternary complex model resulted in good estimates of the concentration of the regulatory component and of the affinity of the receptor for the agonist. However, reliable estimates of the other affinity constants involved in formation of the ternary complex could not be obtained. Thus, caution should be exercised when interpreting results of the analysis of dose response curves with either the two-independent-receptor model or the ternary complex model.     

The preparation by extrusion/spheronization and the properties of pellets containing drugs, microcrystalline cellulose and glyceryl monostearate.

Pellets have been prepared by extrusion and spheronization containing microcrystalline cellulose (MCC) and four model drugs with decreasing order of solubility, paracetamol (P), diclofenac sodium (D), ibuprofen (IB) and indomethacin (IN) at a 10% level with and without the addition of a range of levels of glyceryl monostearate (GMS). The drugs differed in their response to extrusion in that all formulations containing the drug D had a 'steady state' extrusion profile whereas the other three drugs exhibited 'forced flow' indicating the possibility of water migration during the process of ram extrusion. The presence of GMS did not influence this effect. The drug D also required consistently less water to function than the other three drugs. In spite of these differences in extrusion performance, it was possible to prepare satisfactory pellets from formulations of all the drugs with 0, 30 and 60% GMS combined with 90, 60 or 30% of MCC at a range of water levels. It was also possible to prepare pellets containing the drug D with 70, 80 and 90% GMS, with corresponding quantities of 20, 10 and 0% of MCC. It was also possible to prepare the pellet formulations by dispersing the drugs in molten GMS, grinding and processing this with MCC and water. Such systems retained the processing characteristics of the composition made by the blending of the powder. The presence of GMS in all cases reduced the quantity of water required for the process to function. The steady state or the mean of the range of the forces observed during forced flow, were dependent on the composition and the quantity of water added. The surface of the extrudate appeared smooth and measurements of surface roughness established that the value of the rugosity R(a) for any of the extrudates did not exceed 6 microm. The extrudate diameter was found to increase with the quantity of GMS in the formulation. The pellets produced were all within a relatively narrow size range (three sieve fractions of a root two progression), the median value of which increased with the level of GMS. For the drug D, there was a linear increase of pellet diameter with increase in the extrudate diameter. For the three other drugs this relationship was less certain but nevertheless there was a similar trend for the pellet diameter to increase as the extrudate diameter increased, suggesting the mechanism of the process is the same irrespective of the composition. Considering the value of the shape factor e(R), all the pellets produced from the various formulations were well within acceptable levels for further processing and the only observable trend in the values was that the formulations with the lower water contents were the least round. The porosity of the pellets of the different formulations generally decreased with the increase in water used to prepare the pellets, the extent of this decrease being dependent on the drug and the level of GMS. The in vitro drug release from the pellets was controlled by the solubility of the drug, the lower the value of the solubility, the longer the mean dissolution time (MDT). This was not influenced by the presence of GMS or the method of incorporation of the drug into the formulation.     

胶态二氧化硅对盐酸莫西沙星片的影响

目的 考察胶态二氧化硅对盐酸莫西沙星片的影响。方法 通过改变胶态二氧化硅的用量、改变胶态二氧化硅的过筛目数、改变胶态二氧化硅的混合时间,制备不同盐酸莫西沙星片。通过对比总混颗粒的粉体性质、片剂的溶出。综合评价胶态二氧化硅对盐酸莫西沙星片影响。结果 胶态二氧化硅的用量、胶态二氧化硅的过筛目数、胶态二氧化硅的混合时间均会对盐酸莫西沙星片质量造成影响。结论 提高胶态二氧化硅的用量,减小筛网的孔径,增加混合的时间,均会提高总混颗粒的流动性及可压性,提高片剂硬度,减小片剂的脆碎度,并能加快片剂的崩解,提高溶出速率。