中药固体制剂溶出度研究与展望

随着中药质量控制水平的提高,许多化学药品的控制方法和控制理念在中药质量控制中得到广泛的应用,固体制剂溶出度试验就是化学药品控制中的一种重要方法。溶出度试验不仅是中药固体制剂质量控制的核心内容,更是中药制剂控制的一种全新理念。本文主要分析了我国当前阶段中药固体制剂溶出度的研究现状以及如何建立基于生物效价检测的中药固体制剂质控模式,旨在帮助提高我国的中药固体制剂溶出度的试验水平和质控质量。     

无细胞百日咳菌苗质量控制指标的探讨

本文介绍了美国、日本关于无细胞菌苗质量控制的检定项目,并就两国不同的质量控制体系进行分析和比较。特别对无细胞百日咳菌苗的效力测定和毒性试验存在的问题提出看法。同时对国内如何加强对无细胞菌苗的质量控制提出建议,以进一步开展研究工作,从而制定出中国国内无细胞百日咳菌苗质量控制的合适指标。     

医药中间体胆酸的稳定性研究

本文考察了高温度、强光照、高湿度对医药中间体胆酸质量是否产生影响,通过影响因素试验、加速试验以及长期试验,探讨胆酸稳定性,为胆酸贮存条件以及质量控制提供科学的参考。     

重组DNA技术生产的生物制品的质量控制

本文回顾了医用生物制品生产中重组DNA技术的应用,并扼要叙述控制这些产品安全有效方面将采用的各种试验。主要目的在于告诉尚未生产这些生物制品的国家中的科学家和行政官员们在其质量控制和使用上的问题。     

麻疹疫苗生产连续培养多次收获工艺研究

本研究对连续培养多次收获工艺用于麻疹疫苗生产的可行性、疫苗维持液保护剂、冻干保护剂及冻干过程等进行了大量反复试验,结果表明在现行条件下,本生产工艺具有重复性好、成本低、投入产出率高、易于质量控制等优势。对本工艺生产疫苗进行全面检定,表明成品滴度和稳定性试验指标等均高于９０版《生物制品规程》要求,并在试验基础上制定出了生产工艺流程。     

盐酸头孢卡品酯片溶出度试验方法的建立

目的:建立盐酸头孢卡品酯片溶出度试验方法,为本品质量控制提供参考依据。方法:依据相关文献和指导原则,用原研产品进行试验,根据实验结果确定溶出度参数。结果:确定溶出装置、转速、溶出主介质和检测波长、检测仪器,最终确定取样时间点,规定限值。结论:建立的盐酸头孢卡品酯片溶出度试验方法是可行的。     

人巨细胞病毒IgM抗体国家参考品的研制

目的为了对人巨细胞病毒(Human cytomegalovirus,HCMV)IgM抗体检测试剂进行统一评价,研制HCMVIgM抗体国家参考品,用于控制试剂盒的质量。方法收集正常人与感染者的标本,采用多实验室联合标定的方法确认参考品的试验结果,并经一系列的破坏条件进行稳定性和均匀性考核。结果考核的敏感性和准确性符合国家参考品的要求。结论该参考品能用于临床检测试剂的质量控制。     

紫外吸收度快速检测医用热硫化硅橡胶生物学性能初探

医用热硫化甲基乙烯基硅橡胶具有许多综合优点,目前正广泛应用于临床。由于我国专业医用高分子材料生产部门较少,制品的安全性及质量控制就显得尤为重要。根据以往的研究,二段硫化过程是控制热硫化甲基乙烯基硅橡胶质量的一个关键。虽然制品的测试可参照卫生部医用热硫化甲基乙烯基硅橡胶标准中的溶出物试验及生物学试验等方法,但这些在生产质控过程中就显得较为繁琐费时。曾通过研究溶出物试验发现,在一定工艺条件下,溶出物于220nm处的紫外吸收度     

微生物培养基质量控制技术和标准

微生物培养基的酸碱度、凝胶强度和选择性等直接影响到培养基的质量,在理化试验方法中采用连接可渗透陶器型液体接头的电极和平头电极或者连接微型探头的电极可分别测定液体和固体培养基的pH值,而采用Gelometer和the LFRA Texture Analyser可测定固体培养基的凝胶强度。在微生物学方法中固体培养基采用倾注平板法、涂布法、划线法（半定量法）、改良的Miles-Misra法等测定生长情况,液体培养基采用稀释法测定生长率,用目标菌和杂菌的混合菌株评价选择性增菌培养基的选择性,利用OD值评价液体培养基生长率等。ICFMH（国际食品微生物学和卫生学委员会培养基工作组）、ISO、FDA以及我国卫生部等相继制定了培养基质量控制的标准,但目前还没有一个系统的适合我国国情的培养基质量控制国家标准,以致各相关单位采用的标准不一致,所以制定培养基质量控制国家标准非常关键。     

实验室质量与实验室条件建设的关系概论

对测量误差的处理、控制和评定方法是决定测量数据质量即实验室质量水平的基础。实验室条件建设是降低和控制测量误差的保障,实验室质量控制的有效手段是建立适合的实验室条件。     

Quality meets quantity - quality control, data standards and repositories

In recent years, standardization and quality control have become important key points in industry, e.g. in drug discovery and for developing medical products. Is quality control in academic Proteomics a minor problem nowadays, where standard data formats and public repositories for data sharing exist? In this article, it is discussed how standard formats and repositories already support the documentation of quality control criteria in protein identification and quantification, and what has to be improved in the future: It is stated that the Proteomics community (represented by a group like the Proteomics Standards Initiative) will have to define a minimum document regarding quality control and to extend existing standards with additional quality control criteria enabling a substantial and standardized quality control process.     

Autophagy machinery promotes the chaperone-mediated formation and compartmentalization of protein aggregates during appressorium development by the rice blast fungus

The chaperone-mediated sequestration of misfolded proteins into specialized quality control compartments represents an important strategy for maintaining protein homeostasis in response to stress. However, precisely how this process is controlled in time and subcellular space and integrated with the cell''s protein refolding and degradation pathways remains unclear. We set out to understand how aggregated proteins are managed during infection-related development by a globally devastating plant pathogenic fungus and to determine how impaired protein quality control impacts cellular differentiation and pathogenesis in this system. Here we show that in the absence of Hsp104 disaggregase activity, aggregated proteins are spatially sequestered into quality control compartments within conidia, but not within terminally differentiated infection cells, and thus spatial protein quality control is cell type–dependent. We demonstrate that impaired aggregate resolution results in a short-term developmental penalty but has no significant impact upon appressorium function. Finally, we show that, somewhat unexpectedly, the autophagy machinery is necessary for the normal formation and compartmentalization of protein aggregates. Taken together, our findings provide important new insight into spatial protein quality control during the process of terminal cellular differentiation by a globally important model eukaryote and reveal a new level of interplay between major proteostasis pathways.     

生物制品原辅料及其质量控制

生物制品原辅料的质量控制是保证产品质量的重要因素,就生物制品原辅料分类及质量控制进行了阐述和归纳,并就国家对生物制品原辅料的质量控制要求进行了探讨。     

北京市属三级医院单病种质量管理现况研究

目的 调查北京市市属22家三级医院在单病种质量管理工作的开展现况,评估单病种质量管理水平。方法 采用调查问卷和深入访谈法对22家北京市市属三级医院单病种质量管理的开展数量、管理模式进行调查。结果 北京市市属22家三级医院开展单病种质量管理的占54.5%,单病种开展率为57.5%。实现实时监测单病种质控管理模式的仅4家医院。结论 单病种质控管理需要提升电子病历系统建设水平,结构化的电子病历对于质控数据的提取至关重要。     

Pathology background of targeted therapy; quality control in pathology

The administration of targeted therapy of gastric carcinoma is a very important recent improvement of its treatment and prognosis. The basis of the successful treatment is the excellent quality of pathology, now including HER2 testing: the use of validated methods and strict criteria. This is especially important if we consider that many gastric cancers are diagnosed in small biopsy material, in which HER2 testing is challenging. This requires standardized, validated methods and experienced pathologists. Being of diagnostic and predictive significance, high quality of both the technique and the interpretation of the test is mandatory. In order to achieve general high quality in this field, technical and interpretation external quality control of HER2 testing is necessary. Hungarian pathologists with the help of Roche Hungary Ltd. completed an external quality control round which showed that most of the participating laboratories are able. Kulka J, Szirtes I, Szász AM, Kupcsulik P, Kenessey I, Lotz G, Tímár J. Pathology background of targeted therapy; quality control in pathology.     

Validation and Quality Control of Protein Microarray-based Analytical Methods

Protein microarray technology is used mainly in the research laboratory and it is being used to uncover important diagnostic and prognostic markers that may one day emerge as routine clinical laboratory tests. It is important that these methods are subject to control procedures, in order to ensure that data of the highest quality are obtained. If quality is not controlled, the assay may yield erroneous results that would mask or confound meaningful diagnostic or prognostic associations. This chapter surveys the range of strategies designed to assure the analytical quality of protein microarray methods and it also highlights some of the potential pitfalls when moving these arrays into routine clinical practice. With the development of appropriate quality control and assurance measures, we anticipate protein microarray-based assays will be of substantial benefit in the future practice of laboratory medicine.     

加强医院病理科管理与质量控制的5点建议 ——1例临床标本混淆引起的思考

病理学诊断是临床诊断和疾病治疗的重要参考依据,病理科的质量控制也是医院管理中的重要环节之一。通过回顾分析病理科发生的1例标本混淆,寻找管理流程中存在的问题,提出改进措施和意见,以达到完善病理科管理、提高病理质量控制水平的目的。     

Advances in the mechanism and treatment of mitochondrial quality control involved in myocardial infarction

Mitochondria are important organelles in eukaryotic cells. Normal mitochondrial homeostasis is subject to a strict mitochondrial quality control system, including the strict regulation of mitochondrial production, fission/fusion and mitophagy. The strict and accurate modulation of the mitochondrial quality control system, comprising the mitochondrial fission/fusion, mitophagy and other processes, can ameliorate the myocardial injury of myocardial ischaemia and ischaemia-reperfusion after myocardial infarction, which plays an important role in myocardial protection after myocardial infarction. Further research into the mechanism will help identify new therapeutic targets and drugs for the treatment of myocardial infarction. This article aims to summarize the recent research regarding the mitochondrial quality control system and its molecular mechanism involved in myocardial infarction, as well as the potential therapeutic targets in the future.     

Construction of optimal quality control for oligo arrays

MOTIVATION: Oligo arrays are important experimental tools for the high throughput measurement of gene expression levels. During production of oligo arrays, it is important to identify any faulty manufacturing step. RESULTS: We describe a practical algorithm for the construction of optimal quality control designs that identify any faulty manufacturing step. The algorithm uses hillclimbing, a search technique from combinatorial optimization. We also present the results of using this algorithm on all practical quality control design sizes. AVAILABILITY: On request from the authors.