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。     

Family-centered Care for Sick Newborns: A Thumbnail View

Family-centered care (FCC) for sick newborns is emerging as a paradigmatic shift in the practice of facility-based newborn care. It seeks to transforming a provider-centered model into a client-centered one and thus build a new therapeutic alliance. FCC is the cornerstone of continuum of care, imparting caregiving competencies to parents/caregivers both within institutions as well as after the discharge. This has potential gains for the newborn, family members, and facility-level staff. The initial model piloted in tertiary-care settings is now undergoing translation at five sites across the country; the outcomes are keenly awaited.     

Effects of exogenous factors on spatial accuracy in neurosurgery

The study aimed to assess the effect of exogenous factors such as surgeon posture, surgical instrument length, fatigue after a night shift, exercise and caffeine consumption on the spatial accuracy of neurosurgical manipulations. For the evaluation and simulation of neurosurgical manipulations, a testing device developed by the authors was used. The experimental results were compared using nonparametric analysis (Wilcoxon test) and multivariate analysis, which was performed using mixed models. The results were considered statistically significant at p < 0.05. The study included 11 first-year neurosurgery residents who met the inclusion criteria. Hand support in the sitting position (Wilcoxon test p value = 0.0033), caffeine consumption (p = 0.0058) and the length of the microsurgical instrument (p = 0.0032) had statistically significant influences on the spatial accuracy of surgical manipulations (univariate analysis). The spatial accuracy did not significantly depend on the type of standing position (Wilcoxon test p value = 0.2860), whether the surgeon was standing/sitting (p = 0.1029), fatigue following a night shift (p = 0.3281), or physical exertion prior to surgery (p = 0.2845).When conducting the multivariate analysis, the spatial accuracy significantly depended on the test subject (p < 0.0001), the use of support during the test (p = 0.0001), and the length of the microsurgical instrument (p = 0.0397). To increase the spatial accuracy of microsurgical manipulations, hand support and shorter tools should be used. Caffeine consumption in high doses should also be avoided prior to surgery.     

Redox active or thiol reactive? Optimization of rapid screens to identify less evident nuisance compounds

Compounds that exhibit assay interference or undesirable mechanisms of bioactivity are routinely encountered in assays at various stages of drug discovery. We observed that assays for the investigation of thiol-reactive and redox-active compounds have not been collected in a comprehensive review. Here, we review these assays and subject them to experimental optimization to improve their reliability. We demonstrate the usefulness of our assay cascade by assaying a library of bioactive compounds, chemical probes, and a set of approved drugs. These high-throughput assays should complement the array of wet-lab and in silico assays during the initial stages of hit discovery campaigns to pursue only hit compounds with tractable mechanisms of action.     

《金匮要略》痈脓辨治探讨

回顾《内经》相关理论，指出痈脓病机关键在于气血凝滞、经络阻塞、脏腑失和，可分期论治。总结《金匮要略》治疗痈脓的方法，认为痈脓应尽早治疗，防邪深入；并根据证情辨证使用清热解毒，活血消散；排除脓毒，泄浊于外等治法。对现代临床仍具实用价值。      

积极主动为贫困人口服务--上海市北站医院平价病房的案例调查

目的:对上海市一所国有民营医院的平价病房进行案例调查,了解运行状况、经验及存在问题。方法:相关人员访谈和现场观察。结果:该院设立了14张床位的平价病房,收治对象是低保户、特困户及经济困难的外来务工人员。对医保病人和自费病人设定不同的减免优惠方案,包括减免50.0%的床位费和10.0%的护理、检查、治疗及手术等劳务费用(药费除外)。以收治急性病为主,住院时间原则上不超过2周。出院病人总费用的实际减免率约为6.0%￣10.0%。结论:创办平价病房的方向应予肯定。是民营机构委托管理医院的一种公益性(非营利性)的表现,对其他公立医疗机构具有促进作用。     

小儿内伤头痛辨治

74例小儿慢性头痛经辨证治疗,显效80.95%,好转16.67%,无效2.38%。痰浊头痛二陈汤或半夏白术天麻汤加减;肾虚头痛,杞菊地黄汤加减;淤血头痛,补阳还五汤;气血虚头痛八珍汤加减。指出了小儿内伤头痛的病因病机,并指出脑电图,脑阻抗血流图、CT、甲皱微循环可做为此病的诊断及疗效指标。     

Screening Mouse Genes Related to Blastocyst Implantation by Using PCR Subtraction

Objective To identify genes that may be related to embryo implantation Materials & Methods The PCR subtraction technique was applied at implantation and inter-plantation sites on day 4. 5 of pregnancy in mice. Two novel Expressed Sequence Tags (ESTs ), EST8 and EST81 were identified; their expression in tissues was analyzed by Northern blotting, and their full-length cDNAs were synthesized by PCR.Results We found that these two novel ESTs (EST8and EST81) were noticeably expressed in implantation site in the mouse on day 4. 5 of pregnancy. EST8 was expressed at high level in livers and implantation sites of the mice, while at low level in ovaries and inter-plantation sites. EST81 was predominantly expressed in implantation site and ovary, and at low level in all other tissues. Their complete cDNAs, 1 665bp and 1 264 bp respectively, were synthesized by using PCR.Conclusion The two full-length cDNAs were responsible for embryo implantation,and their functions need to be further studied.     

捻转补泻手法针刺合谷穴对其局部皮肤温度的影响

目的阐明针刺捻转补法与泻法的操作是否存在效应上的差异,并探讨其效应差异是否为补泻效应的差异.方法应用红外线热像技术,采用不同的捻转补泻手法针刺健康人合谷穴后,观察其在即刻,10、20、30min,对局部皮肤温度的影响.结果不同捻转补法与泻法的操作存在着不同程度的效应差异,其中补法可以使皮温升高,泻法可以使皮温降低,以石氏捻转补泻针法较为明显.结论1)补泻手法,补法和泻法的操作可产生不同的效应.2)不同捻转补泻手法对皮肤温度产生的升降效应为补泻效应,其中以石氏捻转补泻手法最为明显.3)证明补泻手法实施的必要性.