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。     

基于多元统计分析的银杏叶提取物中有机酸类成分含量研究

目的建立HPLC法测定银杏叶提取物中9种小分子有机酸类成分莽草酸、儿茶素、表儿茶素、没食子酸、原儿茶酸、6-羟基犬尿喹啉酸、对羟基苯甲酸、对羟基肉桂酸、咖啡酸含量的方法,并结合多元统计分析方法比较不同厂家生产的银杏叶提取物间质量差异。方法采用Inertsil ODS-3 C_(18)(250 mm×4.6 mm,5μm)色谱柱;以乙腈-0.4%磷酸水溶液为流动相,梯度洗脱,波长切换测定(220 nm检测莽草酸、儿茶素、表儿茶素,254 nm检测没食子酸、原儿茶酸、6-羟基犬尿喹啉酸、对羟基苯甲酸,310 nm检测对羟基肉桂酸、咖啡酸),柱温40℃。结果不同厂家生产的银杏叶提取物中有机酸总含量有差异,厂家内部样品中各有机酸含量同样存在差异。经聚类分析、主成分分析、相关与回归分析等多元统计方法分析,筛选出儿茶素、没食子酸、原儿茶酸及6-羟基犬尿喹啉酸为体现样品质量差异的特征成分,同时成分间具有内在相关性。结论建立的方法操作简便、重复性好、结果可靠,可用于银杏叶提取物中有机酸类成分的质量评价。筛选出的儿茶素、没食子酸、原儿茶酸及6-羟基犬尿喹啉酸是体现质量差异的特征成分,又是具有内在关联的共性成分,为提升银杏叶提取物整体质量控制能力提供了依据,同时表明银杏叶提取物的提取工艺并不统一,企业内部工艺的稳定性也有待提高。     

Anxiety sensitivity as a mediator of the association between asthma and smoking

Objective: Despite its negative effects, smoking is more common among individuals with asthma compared to those without. Anxiety sensitivity (fear of arousal-related sensations) is associated with both smoking and asthma; however, no research, to date, has examined the interplay between these three factors. Thus, the purpose of the current study was to evaluate the mediating role of anxiety sensitivity in the association between asthma diagnosis and smoking status. Methods: The current study was a secondary analysis of data from three existing datasets of non-smokers and smokers with and without asthma (n?=?433; 56.3% female, M_age?=?34.01 years, SD?=?13.9). Participants provided information on their asthma diagnosis status and smoking status and completed self-report measures. Results: As hypothesized, after controlling for gender, race and age, there was a significant indirect effect of asthma diagnosis on smoking status through anxiety sensitivity (95% CI?=?0.07–0.48). Conclusions: These results indicate that the association between asthma diagnosis and smoking status appears to be driven, in part, by anxiety sensitivity and suggest that anxiety sensitivity may serve as an important target for prevention and intervention efforts for smokers with asthma.     

儿童精神分裂症患者的预后及相关因素分析

目的探讨儿童精神分裂症的预后及其影响因素。方法收集1987—1997年首次住院的儿童(起病年龄≤14岁)精神分裂症患者(儿童组)124例和同期首次住院的成人(起病年龄25～30岁)精神分裂症患者(成人组)120例,采用社会功能缺陷量表(SDSS)、日常生活能力量表(ADL)、大体评定量表(GAS)及自制调查表,以随访与量表现场测评相结合的方法获得资料,数据采用多因素回归分析。结果(1)儿童组服药依从性(90例,77.6%)好于成人组(73例,64.0%；)χ~2= 5.11,P＜0.05)；复发率(29.3%)低于成人组(42.1%；χ~2=4.10,P＜0.05)。(2)儿童组预后良好者(91例,78.4%)显著多于成人组(65例,57.0%)。(3)儿童组的社会功能[(2.11±1.02)分]和日常生活能力[(18.78±9.17)分]优于成人组[(3.48±1.86)分和(21.82±8.67)分；P＜0.01和P＜0.05]。(4)经多因素回归分析,影响儿童精神分裂症预后的主要因素有：社会家庭关爱程度,首次住院疗效,起病形式,服药时间和病期(P＜0.01)。结论儿童精神分裂症患者总体预后较好；充分的家庭关爱,首次住院疗效好,急性起病,坚持长期治疗和病期较短者的预后更好。     

How many subjects are needed in a longitudinal birth cohort study?

One of the first decisions that needs to be taken when planning a birth cohort concerns the size of the study. This in turn will depend on the research questions to be answered and thence whether environmental exposures and outcomes are measured on a continuum or as dichotomous variables. Here we describe ways in which different birth cohorts have addressed this issue and explore the advantages of smaller detailed studies over larger less-detailed studies.     

A preliminary statistical model for identifying repeaters of parasuicide

This paper presents a statistical model constructed using logisticregression to identify those at high-risk of repeating parasuicide. Thesubjects in the study are Cork city residents who exhibited parasuicidalbehaviour between 1 January and 30 June 1995. Repetition of the behaviourwithin six months of the index episode distinguishes repeaters fromnon-repeaters. The model was designed so that it could be used bynon-clinicians and hence does not require information relating topsychiatric diagnosis or use of psychiatric services. The proportion ofsubjects correctly classified remained stable across a range of cut-pointprobabilities (mean = 86%, range: 83.9–87.5%). Using acut-point of 0.2, 96% of repeaters and 81% of non-repeaters were correctly classified. Using 0.45 led to the correct identification of81% of repeaters and 90% of non-repeaters. If these highlevels of sensitivity and specificity are maintained in validation tests onfuture cohorts in Cork city then the model could form the basis of anintervention programme designed to prevent the repetition of parasuicide.     

广州市大学生尝试自杀现况及其影响因素分析

目的了解广州市大学生尝试自杀现状及其影响因素，为高校健康教育提供理论依据。方法采用整群随机抽样方法，用自编调查表对大学生进行问卷调查，在此基础上结合专题小组讨论的定性研究方法进行分析。结果大学生近1a内尝试自杀报告率为6．0％，不同性别、学校、专业的学生尝试自杀报告率差异无统计学意义（P〉0．05）；城镇学生尝试自杀报告率为6．6％，高于农村学生的4．2％（x^2=4．71，P=0．032）。对自杀行为的态度、朋友和家人有过自杀行为、消极应对、负性生活事件等是尝试自杀的危险因素，获得社会支持是尝试自杀的保护因素。定性访谈发现，学校几乎没有开展过自杀行为的健康教育活动，绝大部分学生对自杀行为持中立态度。结论加强健康教育、消除危险因素、提高保护因素可以最大限度地预防自杀.