EMA对药用辅料右旋糖酐新的安全性评价

欧洲药品局（EMA）于2018年11月发布了"人用药品辅料右旋糖酐的包装说明书资料"，该文件引用大量文献全面评价了右旋糖酐的安全性，特别指出含有右旋糖酐辅料的注射和吸入制剂的疫苗与药品，应在说明书中描述有关其过敏反应信息的新要求。介绍该文件的主要内容，期望对我国这类药品说明书的撰写和监管有所帮助。     

马齿苋“成分-活性-中药功效-疾病”研究进展及关联分析

马齿苋是一种药食同源品,具有清热解毒、凉血止血、止痢的功效,为常见中药,作为药物安全性高。马齿苋具有多种活性成分及药理作用,为了充分开发利用马齿苋,加快马齿苋研究的现代化进程,综述马齿苋的研究进展并在此基础上对于其"成分-活性-中药功效-疾病"进行关联分析,为马齿苋的现代化研究提供思路。     

Pharmacy in transition: A work sampling study of community pharmacists using smartphone technology

Introduction

The nature of community pharmacy is changing, shifting from the preparation and distribution of medicines to the provision of cognitive pharmaceutical services (CPS); however, often the provision of traditional services leaves little time for innovative services. This study investigated the time community pharmacists spend on the tasks and activities of daily practice and to what extent they are able to implement CPS-related services in daily practice.

Fluorimetric assay of rufloxacin in serum and in pharmaceutical formulations

A simple and rapid fluorimetric method for the determination of 9-fluoro-10-[N-(4′-methyl)piperazinyl]-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-d,e][1–4]benzothyazin-6-carboxylic acid hydrochloride (MF 934), in serum and in pharmaceutical formulations, has been developed based on its strong fluorescence, in 0.1 N H₂SO₄, at 526 nm (excitation wavelength at 340 nm). The procedure which involves the direct dilution of the sample requires only a few minutes and the sample volume is only 20–100 μl of serum, depending on the drug concentration. Tedious sample preparation procedures such as extraction, deproteinization, or centrifugation are not necessary. The minimum concentration that can be detected is 0.3 ng ml⁻¹, the standard curve in 0.1 N H₂SO₄ was found to be linear from 0.005 to 1.5 μg ml⁻¹ and from 0.01 to 0.07 g in plasma after dilution with 0.1 N H₂SO₄.     

胎盘组织液氨基酸的含量测定及层析鉴别

本文采用层析法进行鉴定,用氨基酸分析仪测氨基酸的含量,为胎盘组织液的质量标准提供可靠依据。本法准确率为99%。     

肠杆菌科新种细菌的分离鉴定及致病性研究

报告了从辽宁省部分地区腹泻和感染标本中检出的成团肠杆菌、非脱羧勒克氏菌、克吕沃尔氏菌、彭氏变形菌、霍堆氏肠杆菌的分离、鉴定，药敏试验及致病性研究结果．部分菌株可引起动物、生物模型病变，证明有致病力．与人的腹泻和感染有关．致病性研究中，溶血性阳性率最高，依次为乳鼠灌胃，ＨｅＰ—２细胞、Ｖｅｒｏ细胞病变，兔肠袢结扎．豚鼠角膜侵袭试验无阳性．药敏试验证实，５组细菌抗药谱已很广，临床可用的敏感药物不多，一旦发生感染，治疗将十分困难．     

A perspective on measurement of mutations in vivo.

The development of transgenic mouse lines with target genes that are suitable for tissue-specific mutagenesis studies is an important contribution to the field of environmental mutagenesis. These models can accommodate many of the questions relating to metabolism, distribution and relative potency of mutagens as well as providing a more comprehensive system for the identification of mutagens. However, the lesions that the field has learned about methods, development and validation from the use of in vitro systems must be applied to the development and validation of transgenic models.     

Automatic discrimination of myoelectric signals via parallel cascade identification

It has recently been shown that it is possible to discriminate accurately among myoelectric signals underlying different muscle contraction types, specifically elbow flexion and extension and forearm pronation and supination. It was reported that once a number of distinctive features had been extracted from the myoelectric signals, a neural network could be trained to distinguish the contraction types with an impressively high accuracy. In the present paper, we show that a technique known as parallel cascade identification can be used to construct classifiers that can also accurately, differentiate the contraction types. The use of parallel cascades has the benefit of dispensing with the need for feature extraction, so that raw myoelectric signal data can be used directly. In addition, very little data are required to train the parallel cascades to distinguish accurately novel incoming myoelectric signals. Results of using parallel cascades to distinguish foream pronation, supination, and elbow flexion are presented.     

定坤丹的显微鉴定研究

对定坤丹(蜜丸)进行了显微鉴定研究,将29种组成药物全部检出,对各组成药物的显微鉴别特征作了简明描述,并附显微特征图。