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。     

不同非密闭雾化治疗方式在不合作患儿中的应用效果

目的 探讨不同非密闭雾化方式在不合作患儿接受布地奈德雾化治疗中的应用效果。方法 选取本院门诊270例3岁以下使用布地奈德雾化治疗的患儿,采用随机数字表法将患儿分为Pari雾化系统、Philips雾化系统及Salter雾化系统3个治疗组,毎组90例,各组又依据面罩距离面部0 cm、2 cm、4 cm分为3个小组,毎组30例,分别测量各组雾化气流流速及吸入雾化颗粒量占总雾化颗粒量的比例。采用方差分析及Bonferroni进行统计分析。结果 雾化气流流速及雾化吸入量在不同雾化系统组间差异有统计学意义(P<0.05)。在3种距离下,Pari系统均能使患儿吸入最多量的雾化颗粒,其次是Salter系统,再是Philips系统,与此相反,气流流速Pari系统最低。Pari系统离开面部4 cm及Salter系统离开面部2 cm的吸入量均高于Philips系统0 cm的吸入量。结论 选择合适的非密闭雾化系统方式,是提高不合作患儿布地奈德雾化治疗的有效方式。     

抗结核药物对泪膜功能的影响

<正>我国结核患者在2011年统计已达500万例,仅次于印度位居世界第二[1]。临床多见抗结核药物引起肝损害及过敏反应,对眼部的副反应关注较少[2]。笔者临床中发现部分结核患者在抗结核治疗早期可出现视物模糊、异物感、干涩及视物不持久等类似干眼的主诉,眼科常规检查未发现明显视神经病变,更多为眼表的改变。笔者观察抗结核药物对眼表的毒副反应,报道如下。1资料与方法1.1研究对象收集2012年1月—2014年10月     

Biomedical microelectromechanical systems (BioMEMS): Revolution in drug delivery and analytical techniques

Advancement in microelectromechanical system has facilitated the microfabrication of polymeric substrates and the development of the novel class of controlled drug delivery devices. These vehicles have specifically tailored three dimensional physical and chemical features which together, provide the capacity to target cell, stimulate unidirectional controlled release of therapeutics and augment permeation across the barriers. Apart from drug delivery devices microfabrication technology’s offer exciting prospects to generate biomimetic gastrointestinal tract models. BioMEMS are capable of analysing biochemical liquid sample like solution of metabolites, macromolecules, proteins, nucleic acid, cells and viruses. This review summarized multidisciplinary application of biomedical microelectromechanical systems in drug delivery and its potential in analytical procedures.     

Treatment strategies for hypertension in patients with type 1 diabetes

ABSTRACT

Introduction

Type 1 diabetes mellitus (T1DM) is a chronic, autoimmune disease that is characterized by total absence of insulin production. Hypertension is a common comorbidity in T1DM with complex pathophysiology, while it is also a well-recognized risk factor for the development of cardiovascular disease (CVD), as well as other microvascular diabetic complications.     

New Zealand Emergency Medicine Network: A collaboration for acute care research in New Zealand

The specialty of emergency medicine in Australasia is coming of age. As part of this maturation there is a need for high‐quality evidence to inform practice. This article describes the development of the New Zealand Emergency Medicine Network, a collaboration of committed emergency care researchers who share the vision that New Zealand/Aotearoa will have a world‐leading, patient‐centred emergency care research network, which will improve emergency care for all, so that people coming to any ED in the country will have access to the same world‐class emergency care.     

In Vivo Kinematics of Functional Ankle Instability Patients and Lateral Ankle Sprain Copers During Stair Descent

Patients with mechanic ankle instability experience increased tibiotalar and subtalar joint laxity. However, in vivo joint kinematics in functional ankle instability (FAI) patients and lateral ankle sprain (LAS) copers, especially during dynamic activities, are poorly understood. Ten FAI patients, 10 LAS copers, and 10 healthy controls were included in this study. A dual fluoroscopic imaging system was used to analyze the tibiotalar and subtalar joint kinematics during stair descent. Five key poses of stair descent were analyzed. Kinematic data from six degrees of freedom were calculated utilizing a solid modeling software. The range of motion and joint positions in each degree of freedom were compared among the three groups. The tibiotalar joints of FAI patients and LAS copers were significantly more inverted than those of healthy controls during the foot strike (p = 0.016, = 0.264). The subtalar joints of FAI patients were significantly more anteriorly translated (pose 2, p = 0.003, = 0.352; pose 3, p < 0.001, = 0.454; pose 4, p = 0.004, = 0.334), inverted (pose 4, p = 0.027, = 0.234; pose 5,p = 0.034, = 0.221), and externally rotated (pose 4, p = 0.037, = 0.217; pose 5; p = 0.004, = 0.331) than those of healthy controls during the mid‐stance and the heel off. The FAI patients showed excessive tibiotalar inversion and subtalar joint hypermobility during stair descent. Meanwhile, the LAS copers maintained subtalar joint stability, and only showed excessive tibiotalar inversion in foot strike. These data provide insight into the mechanisms behind the development of FAI after initial LAS. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:1860–1867, 2019     

Protocolo de estudio sobre condicionantes de desestabilización física y psicosocial en los mayores

ObjectiveThe main objective of this study is to define the factors associated with frailty and psychosocial imbalance in elderly people who live in the community.MethodsMulticentre prospective study with a representative sample of subjects older than 75 years who live in the community in the province of Huesca (Spain). 5-year follow-up with biannual assessment. Standardised individual assessment carried out by GPs trained to assess depression, anxiety, cognitive impairment, psychotic symptoms, sarcopenia, social network, dependence for basic and instrumental activities of daily living, physical severity, risk of dependence and quality of life. Further assessment two and five years later to quantify adverse events: institutionalisation, functional impairment or mortality. Possible risk factors will be assessed: gender, age, social status, functional status, mental status and physical severity. Predictive and individual risk models will be designed in order to identify elderly people with high psychosocial frailty and destabilisation risk.ConclusionsAn understanding of the possible risk factors would facilitate the identification of elderly subjects at greater risk of psychosocial frailty, thereby enabling preventive activities to be implemented aimed at reducing frailty and associated adverse events (institutionalisation, mortality, etc.).     

Melatonin reduces oxidative stress and improves vascular function in pulmonary hypertensive newborn sheep

Pulmonary hypertension of the newborn (PHN) constitutes a critical condition with severe cardiovascular and neurological consequences. One of its main causes is hypoxia during gestation, and thus, it is a public health concern in populations living above 2500 m. Although some mechanisms are recognized, the pathophysiological facts that lead to PHN are not fully understood, which explains the lack of an effective treatment. Oxidative stress is one of the proposed mechanisms inducing pulmonary vascular dysfunction and PHN. Therefore, we assessed whether melatonin, a potent antioxidant, improves pulmonary vascular function. Twelve newborn sheep were gestated, born, and raised at 3600 meters. At 3 days old, lambs were catheterized and daily cardiovascular measurements were recorded. Lambs were divided into two groups, one received daily vehicle as control and another received daily melatonin (1 mg/kg/d), for 8 days. At 11 days old, lung tissue and small pulmonary arteries (SPA) were collected. Melatonin decreased pulmonary pressure and resistance for the first 3 days of treatment. Further, melatonin significantly improved the vasodilator function of SPA, enhancing the endothelial‐ and muscular‐dependent pathways. This was associated with an enhanced nitric oxide‐dependent and nitric oxide independent vasodilator components and with increased nitric oxide bioavailability in lung tissue. Further, melatonin reduced the pulmonary oxidative stress markers and increased enzymatic and nonenzymatic antioxidant capacity. Finally, these effects were associated with an increase of lumen diameter and a mild decrease in the wall of the pulmonary arteries. These outcomes support the use of melatonin as an adjuvant in the treatment for PHN.