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1.
中药生产过程质量控制关键技术研究进展 总被引:10,自引:8,他引:2
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。 相似文献
2.
《Journal of Clinical Orthopaedics and Trauma》2019,10(2):380-386
Additive manufacturing is a rapidly emerging technology which is being successfully implemented in the various field of medicine as well as in orthopaedics, where it has applications in reducing cartilage defects and treatments of bones. The technology helps through systematic collection of information about the shape of the "defects" and precise fabrication of complex 3D constructs such as cartilage, heart valve, trachea, myocardial bone tissue and blood vessels. In this paper, a large number of the relevant research papers on the additive manufacturing and its application in medical specifically orthopaedics are identified through Scopus had been studied using Bibliometric analysis and application analysis is undertaken. The bibliometric analysis shows that there is an increasing trend in the research reports on additive manufacturing applications in the field of orthopaedics. Discussions are on using technological advancement like scanning techniques and various challenges of the orthopaedic being met by additive manufacturing technology. For patient-specific orthopaedic applications, these techniques incorporate clinical practice and use for effective planning. 3D printed models printed by this technology are accepted for orthopaedic surgery such as revision of lumbar discectomy, pelvic surgery and large scapular osteochondroma. The applications of additive manufacturing in orthopaedics will experience a rapid translation in future. An orthopaedic surgeon can convert need/idea into a reality by using computer-aided design (CAD) software, analysis software to facilitate the manufacturing. Thus, AM provides a comprehensive opportunity to manufacture orthopaedic implantable medical devices. 相似文献
3.
Robert A. Mischkowski Max J. Zinser Alexander C. Kübler Barbara Krug Ulrich Seifert Joachim E. Zller 《Journal of cranio-maxillo-facial surgery》2006,34(8):478-483
BACKGROUND: An augmented reality tool for computer assisted surgery named X-Scope allows visual tracking of real anatomical structures in superposition with volume rendered CT or MRI scans and thus can be used for navigated translocation of bony segments. METHODS: In a feasibility study X-Scope was used in orthognathic surgery to control the translocation of the maxilla after Le Fort I osteotomy within a bimaxillary procedure. The situation achieved was compared with the pre-operative situation by means of cephalometric analysis on lateral and frontal cephalograms. RESULTS: The technique was successfully utilized in 5 patients. Maxillary positioning using X-Scope was accomplished accurately within a range of 1mm. The tool was used in all cases in addition to the usual intra-operative splints. A stand-alone application without conventional control does not yet seem reasonable. CONCLUSION: Augmented reality tools like X-Scope may be helpful for controlling maxillary translocation in orthognathic surgery. The application to other interventions in cranio-maxillofacial surgery such as Le Fort III osteotomy, fronto-orbital advancement, and cranial vault reshaping or repair may also be considered. 相似文献
4.
Elizabeth Campbell Ph.D. Danna Peterkin R.N. Richard Abbott M.B. B.S. John Rogers M.B. B.S. 《Preventive medicine》1997,26(6):801-807
Background.Computers that collect data from patients and provide both patients and practitioners with printed feedback on a range of health risks are a tool for assisting general practitioners with preventive care. This study assessed the impact of computer-generated printed feedback on cervical screening among women who were underscreened for cervical cancer.Method.Female attenders at two Australian general practices were randomly allocated to Experimental or Control groups. Women in both groups completed a health risk survey on a touch screen computer prior to their consultation. Those in the Experimental group received printed pages summarizing their results, including their eligibility for cervical screening and last Pap test, for themselves and their doctor. The number and proportion of underscreened women who had a Pap test in the 6 months after completing the computer survey, as determined by pathology records, were examined.Results.Of the 679 participants, 139 were classified as underscreened on the basis of self-report (74 Experimental, 65 Control) and 272 on the basis of their pathology records (148 Experimental, 124 Control). Overall about one-third of women had a test in the 6-month period, and the differences between the groups were not significant for women overall (18–70 years) or for women 18–49 years. Among women 50–70 who were underscreened based on self-report, those receiving the printout were more likely to have a Pap test in the next 6 months (P< 0.05). This pattern was also evident, but did not reach statistical significance, for older women who were underscreened based on pathology records.Conclusions.We are unable to draw conclusions regarding the effectiveness of the computer system due to the modest proportions of women screened, the small numbers, and the fact that the computer survey may have created an intervention effect in the Control group. As the study suggests the computer system is acceptable to women and may be effective for encouraging screening among older women, further exploration of the system is desirable. 相似文献
5.
J.I. Smedberg E. Lothigius I. Bodin A. Frykholm K. Nilner 《Clinical oral implants research》1993,4(1):39-46
In order to satisfy the need to restore the aesthetics, phonetics and comfort and to facilitate optimal hygiene procedures, 20 edentulous patients were treated with a new concept of overdenture therapy on implants ad modum Brånemark. After 24±3.5 months the patients were re‐examined. They were asked to answer a questionnaire and use a Visual Analogue Scale (VAS) to give their opinion on the prosthetic treatment. The results indicate that an implant‐retained overdenture in the maxilla with this design can satisfy the patients needs in aesthetics, phonetics and comfort and can 1 facilitate oral hygiene measures. 相似文献
6.
目的:在建立先天性髋脱位(CDH)的计算机三维交互模型的基础上,建立三维骨刀模型,模拟截骨。方法:利用螺旋体积CT获得患儿髋关节扫描数据,用B+树组织按marching cubes方法完成骨刀模型的重建。通过对B+树的不完全遍历和回溯,定位表面模型间的交点并分割髋关节模型。结果:重建的骨刀模型与CDH三维模型之间,可进行实时交互。初步实现了对骨性三维交互模型任意位置的平面切割、球面切割、拾取和拼合。结论:此建模、切割方法可行有效,可用于计算机模拟骨性手术的研究。 相似文献
7.
Many important pharmaceutical agents, including vancomycin, bleomycin, cyclosporin, and several antibiotics, are produced by non‐ribosomal peptide synthetase (NRPS) enzymes in microorganisms. The NRPS pathway produces an extensive library of products using multienzyme complexes acting in an assembly‐line fashion. Engineering an NRPS system to produce an even greater variety of products, some of which may also have beneficial therapeutic value, would be an enormous advantage. Several approaches have been successful in generating novel NRPS products: mutational biosynthesis during which nonnatural substrates are fed to an organism; domain and module swapping between different species to generate hybrid enzymes; and rational site‐directed mutagenesis, based either on phylogeny or computational prediction, intended to switch substrate specificity and produce altered products. This review will highlight the progress in these areas and describe research in the future that will extend the capacity for re‐engineering NRPS systems. Drug Dev. Res. 66:9–18, 2006. © 2006 Wiley‐Liss, Inc. 相似文献
8.
Design and conduct of occupational epidemiology studies: III. Design aspects of case-control studies
Currently available approaches for the design of occupational case-control studies are reviewed. An accompanying paper reviews methods of analysis. We commence by drawing a distinction between cohort-based and registry-based studies. Methods for selecting cases and controls are then reviewed, including cumulative incidence and incidence density sampling, matching, sources of controls, and issues in control selection. Finally, the advantages and disadvantages of the case-control approach are summarized. 相似文献
9.
10.
J. M. McGree J. A. Eccleston S. B. Duffull 《Journal of pharmacokinetics and pharmacodynamics》2009,36(2):101-123
We consider nested multiple response models which are used extensively in the area of pharmacometrics. Given the conditional
nature of such models, differences in predicted responses are a consequence of different assumptions about how the models
interact. As such, sequential versus simultaneous and First Order (FO) versus First Order Conditional Estimation (FOCE) techniques
have been explored in the literature where it was found that the sequential and FO approaches can produce biased results.
It is therefore of interest to determine any design consequences between the various methods and approximations. As optimal
design for nonlinear mixed effects models is dependent upon initial parameter estimates and an approximation to the expected
Fisher information matrix, it is necessary to incorporate any influence of nonlinearity (or parameter-effects curvature) into
our exploration. Hence, sequential versus simultaneous design with FO and FOCE considerations are compared under low, typical
and high degrees of nonlinearity. Additionally, predicted standard errors of parameters are also compared to empirical estimates
formed via a simulation/estimation study in NONMEM. Initially, design theory for nested multiple response models is developed
and approaches mentioned above are investigated by considering a pharmacokinetic–pharmacodynamic model found in the literature.
We consider design for situations where all responses are continuous and extend this methodology to the case where a response
may be a discrete random variable. In particular, for a binary response pharmacodynamic model, it is conjectured that such
responses will offer little information about all parameters and hence a sequential optimization, in the form of product design
optimality, may yield near optimal designs. 相似文献