中药生产过程质量控制关键技术研究进展

中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。     

我国各地区医药制造业竞争力的比较分析

文章阐述了我国医药制造业的基本现状,对31个省市区(港、澳、台地区除外)的医药制造业竞争力,主要从市场占有率和市场竞争优势系数两个方面,进行了比较分析。市场占有率的优势主要集中在东部发达地区,但是市场竞争优势系数的优势分布较为均匀,各地区均有其自身的优势。     

诺氟沙星合成工艺概述

对诺氟沙星的生产工艺作了简要述评,着重对生产上存在的技术问题及可能解决的途径提出了看法。     

槐耳的研制及临床应用

槐耳是一种人药1500余年但已湮没300余年的重要药用真菌。它和其原料药材槐耳菌质近年来已被批准为中药国家一类新药，就有关槐耳的研制及其在肿瘤疾病方面的应用作一综述。     

强制循环蒸发器的设备设计及制造

蒸发器产品在医药、化工等生产中应用广泛,是各种溶液的蒸发、浓缩、提纯的关键设备.介绍了一种强制循环蒸发器的设备参数和整体结构,针对设计和制造过程中的实际问题进行了阐述.     

3D bioprinting in orthopedics translational research

Abstract

The repair of critical-size bone defect remains a challenge for orthopedic surgeons. With the advent of an aging society and their accompanying chronic diseases, it is becoming more difficult to treat bone defects, especially large segmental bone defects that are caused by trauma, tumors, infections, and congenital malformations. New materials and technologies need to be developed to address these conditions. 3D bioprinting is a novel technology that bridges the biomaterial and living cells and is an important method in tissue engineering projects. 3D bioprinting has the advantages of replacing or repairing damaged tissue and organs. The progress in material science and 3D printing devices make 3D bioprinting a technology which can be used to create various scaffolds with a large range of advanced material and cell types. However, in regard to the widespread use of bioprinting, biosafety, immunogenicity and rising costs are rising to be concerned. This article reviews the developments and applications of 3D bioprinting and highlights newly applied techniques and materials and the recent achievements in the orthopedic field. This paper also briefly reviews the difference between the methods of 3D bioprinting. The challenges are also elaborated with the aim to research materials, manufacture scaffolds, promote vascularization and maintain cell viability.     

Retrospective Assessment of Exposure to Chemicals for a Microelectronics and Business Machine Manufacturing Facility

A retrospective exposure assessment was performed for use in a health outcomes study of a facility manufacturing circuit boards, business machines, and other equipment during the years 1969–2002. A matrix was developed identifying chemical use by department-year based on company-provided information. Use of six chemical agents (fiberglass, lead, methylene chloride, methyl chloroform, perchloroethylene, and trichloroethylene) and six chemical classes (acid-base, aromatic hydrocarbons, chlorinated hydrocarbons, other hydrocarbons, chlorofluorocarbons, and metals), and general (including unspecified) chemicals was identified. The matrix also contained an assignment for each department-year categorizing the potential for use of chemicals as negligible, intermittent/incidental, or routine. These department-based exposure matrix data were combined with work history data to provide duration of potential chemical use for workers. Negligible, intermittent/incidental or routine extent-of-chemical-use categories comprised 42.6%, 39.4%, and 17.9%, respectively, of total person-years of employment. Cumulative exposure scores were also developed, representing a relative measure of the cumulative extent of potential exposure to the six chemical agents, six chemical classes, and general (including unspecified) chemicals. Additionally, the study period was divided into manufacturing eras showing trends in chemical use, and showing that process use of trichloroethylene and methylene chloride ended in the mid-1980s and the mid-1990s, respectively. This approach may be useful in other assessments addressing a variety of chemicals, and with data constraints common to retrospective chemical exposure studies.     

世界卫生组织药品检查分析

对世界卫生组织(WHO)药品检查技术指南及其药品检查基本程序进行梳理总结,对近年来WHO对我国药品生产企业检查情况及缺陷进行了统计分析,进一步明确了WHO药品检查技术指南结构框架及检查基本程序.识别出我国药品生产企业在WHO检查中存在的主要缺陷分布情况及常见问题,为我国制药行业质量管理能力的提升提供参考与借鉴,为药品生产企业顺利接受WHO检查提出改进方向与建议.     

计算机辅助设计与辅助制作种植体上部全瓷冠的六年临床随访

目的:对Cerec3计算机辅助设计与辅助制作(CAD-CAM)系统制作的种植体上部全瓷冠进行6年随访,评价其远期效果,以期为临床提供参考。方法:使用Cerec3 CAD-CAM系统对植入36例患者的缺牙区的40颗种植体进行上部全瓷冠的CAD-CAM修复,定期随访,末次随访时参照改良美国加州牙科协会评价标准对CAD-CAM全瓷冠进行评价,同时对患者进行满意度问卷调查,并进行Kapl an-Mei er生存率分析。结果:除7件CAD-CAM全瓷冠失败外,其余33件CAD-CAM全瓷冠随访70个月-80个月。除费用外,患者对其余指标的满意度达100%。Ka-pl an-Mei er生存率分析显示,CAD-CAM全瓷冠的6年留存率为82.5%。结论:Cer ec3 CAD-CAM系统制作的种植体上部全瓷冠可在口腔环境中长期保存并行使功能。