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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
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M. R. D. Maslin S. K. Lloyd S. Rutherford S. Freeman A. King D. R. Moore K. J. Munro 《Journal of the Association for Research in Otolaryngology》2015,16(5):631-640
Individuals with sudden unilateral deafness offer a unique opportunity to study plasticity of the binaural auditory system in adult humans. Stimulation of the intact ear results in increased activity in the auditory cortex. However, there are no reports of changes at sub-cortical levels in humans. Therefore, the aim of the present study was to investigate changes in sub-cortical activity immediately before and after the onset of surgically induced unilateral deafness in adult humans. Click-evoked auditory brainstem responses (ABRs) to stimulation of the healthy ear were recorded from ten adults during the course of translabyrinthine surgery for the removal of a unilateral acoustic neuroma. This surgical technique always results in abrupt deafferentation of the affected ear. The results revealed a rapid (within minutes) reduction in latency of wave V (mean pre = 6.55 ms; mean post = 6.15 ms; p < 0.001). A latency reduction was also observed for wave III (mean pre = 4.40 ms; mean post = 4.13 ms; p < 0.001). These reductions in response latency are consistent with functional changes including disinhibition or/and more rapid intra-cellular signalling affecting binaurally sensitive neurons in the central auditory system. The results are highly relevant for improved understanding of putative physiological mechanisms underlying perceptual disorders such as tinnitus and hyperacusis. 相似文献
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Accuracy and Precision of Acetabular Component Placement With Imageless Navigation in Obese Patients
Leonard T. Buller Alexander S. McLawhorn Jose A. Romero Peter K. Sculco David J. Mayman 《The Journal of arthroplasty》2019,34(4):693-699
Background
Obesity is a risk factor for acetabular component malposition when total hip arthroplasty is performed with manual techniques. The utility of imageless navigation in obese patients remains unknown. This study compared the accuracy and precision of imageless navigation for component orientation between obese and nonobese patients.Methods
A total of 459 total hip arthroplasties performed for osteoarthritis using imageless navigation were reviewed from a single surgeon’s institutional review board–approved database. Einzel-Bild-Roentgen Analyse determined component orientation on 6-week postoperative anteroposterior radiographs. Mean orientation error (accuracy) and precision were compared between obese (body mass index ≥ 30 kg/m2) and nonobese patients. Regression analysis evaluated the influence of obesity on component position.Results
The difference in mean inclination and anteversion between obese and nonobese groups was 1.1° (43.0° ± 3.5°; range, 35.8°-57.8° vs 41.9° ± 4.4°; range, 33.0°-57.1° and 24.9° ± 6.3°; range, 14.2°-44.3° vs 23.8° ± 6.6°; range, 7.0°-38.6°, respectively). Inclination precision was better for nonobese patients. No difference in inclination accuracy or anteversion accuracy or precision was detected between groups. And 83% of components were placed within the target range. There was no relationship between obesity (dichotomized) and component placement outside the target ranges for inclination, anteversion, or both. As a continuous variable, increased body mass index correlated with higher odds of inclination outside the target zone (odds ratio, 1.06; P = .001).Conclusion
Using imageless navigation, inclination orientation was less precise for obese patients, but the observed difference is likely not clinically relevant. Accurate superficial registration of landmarks in obese patients is achievable, and the use of imageless navigation similarly improves acetabular component positioning in obese and nonobese patients.Level of Evidence
Therapeutic Level IV. 相似文献7.
目的 研究凉血通瘀方对高血压大鼠急性脑出血模型脑组织miRNA表达的影响,对差异表达的miRNA靶基因进行分析,探索凉血通瘀方可能的药效机制。方法 将自发性高血压大鼠随机分成对照组(B)和实验组(C)。适应性饲养一周后,C组灌胃凉血通瘀方,B组灌胃等体积生理盐水,连续5天,每天1次。构建脑出血模型后收集脑组织,借助全转录组测序技术获得miRNA表达量,与miRBase数据库比对获取已知miRNA,使用miRDeep2预测新miRNA。差异分析软件为DESeq2,筛选阈值为|log2FC| ≥1 并且P <0.05。对显著差异表达的miRNA进行靶基因预测,对靶基因进行GO功能、KEGG通路富集和PPI网络分析。结果 实验组和对照组对比,共发现21个显著差异表达的miRNA,上调有9个,下调有12个,共预测得到1243个有统计学意义的靶基因。GO富集分析发现,生物过程中突触囊泡分泌的调节、神经递质分泌的调节和神经递质运输的调节占前三位,神经元投射终点、全膜、质膜区域和细胞投射则是主要的细胞成分。分子功能分别为小GTPase绑定、底物特异性跨膜转运蛋白活性和离子跨膜转运体活性。通路分析结果显示,靶基因在癌证通路、pI3K-Akt信号通路、人类乳头瘤病毒感染、神经活性配体-受体相互作用和MAPK通路等分布广泛。采用STRING网站和Cytoscape软件,根据MCC算法筛选出ADRA2C、CASR、CCL28、CCR1、DRD2、GNAT3、GRM2、DYNC1LI1、GABBR1、GNAI1等核心靶基因。结论 凉血通瘀方对脑出血急性期鼠脑组织内miRNA的表达有重要影响;显著差异表达miRNAs可能通过靶向核心基因调控凉血通瘀方干预急性脑出血的病理过程及预后。 相似文献
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Stephan Koter Tina U. Cohnert Korbinian B. Hindermayr Jörg Lindenmann Maximilian Brückner Wolfgang K. Oswald Georg Werkgartner Doris Wagner 《Journal of vascular surgery》2019,69(4):1227-1232
Objective
Low psoas muscle area is shown to be an indicator for worse postoperative outcome in patients undergoing vascular surgical. Additionally, it has been associated with longer durations of hospital stay in patients with cancer who undergo surgery and subsequently greater health care costs in Europe and the United States. We sought to evaluate this effect on hospital expenditure for patients undergoing vascular repair in a health care system with universal access.Methods
Skeletal muscle mass was assessed on preoperative abdominal computed tomography scans of patients undergoing open aortic aneurysm repair in a retrospective fashion. The skeletal muscle index (SMI) was used to define low muscle mass. Health care costs were obtained for all patients and the relationship between a low SMI and higher costs was explored using linear regression and cross-sectional analysis.Results
We included 156 patients (81.5% male) with a median age of 72 years undergoing elective surgery for infrarenal abdominal aortic aneurysm in this analysis. The median SMI for patients with low skeletal muscle mass was 53.21 cm2/kg and for patients without, 70.07 cm2/kg. Hospital duration of stay was 2 days longer in patients with low skeletal muscle mass as compared with patients with normal (14 days vs 11 days; P = .001), as was duration of intensive care stay (3 days vs 1 day; P = .01). The median overall hospital costs were €10,460 higher for patients with a low SMI as compared with patients with a normal physical constitution (€53,739 [interquartile range, €45,007-€62,471] vs €43,279 [interquartile range, €39,509-€47,049]; P = .001). After confounder adjustment, a low SMI was associated with a 14.68% cost increase in overall hospital costs, for a cost increase of €6521.Conclusions
Low skeletal muscle mass is independently associated with higher hospital as well as intensive care costs in patients undergoing elective aortic aneurysm repair. Strategies to reduce this risk factor are warranted for these patients. 相似文献9.
Emma J. Walker Noni E. MacDonald Nehal Islam Nicole Le Saux Karina A. Top Deshayne B. Fell 《Vaccine》2019,37(13):1725-1735
Objective
To systematically review literature on uptake and timeliness of diphtheria-tetanus-pertussis, measles-mumps-rubella, and/or polio-containing vaccines in infants who were born preterm, with a low birth weight, and/or with chronic health conditions that were diagnosed within the first 6?months of life.Methods
Using a standardized search strategy developed by a medical librarian, records were extracted from MEDLINE, Embase, Database of Abstracts of Reviews of Effects, and CINAHL up to May 8, 2018.Results
Out of the 1997 records that were screened, we identified 21 studies that met inclusion criteria. Eleven studies assessed vaccine coverage and/or timeliness in preterm infants, 6 in low birth weight infants, and 7 in children with chronic health conditions. Estimates of coverage in these populations were highly variable, ranging from 40% to 100% across the vaccines and population groups.Conclusions
There is a lack of studies reporting coverage and timeliness of routine immunizations in special populations of children.Policy implications
Our review suggests a need for improved surveillance of immunization status in special populations of infants, as well as a need for standardization of reporting practices. 相似文献10.
Julia H. Vermylen Gordon J. Wood Elaine R. Cohen Jeffrey H. Barsuk William C. McGaghie Diane B. Wayne 《Journal of pain and symptom management》2019,57(3):682-687