金钱草等几种饮片与其混乱品种的鉴别

目的探讨金钱草等几种饮片与其混乱品种如何进行鉴别。方法以《中华人民共和国药典》、《北京市中药饮片炮制规范》2008版为依据，结合检验中总结的实际经验并参考有关文献资料，对金钱草等5种饮片与其混乱品种的性状、显微鉴别等不同点进行比较分析，以此得出结论。结果与结论顺义药检所在检验中发现金钱草、大青叶、法半夏、山豆根、通草5种中药饮片有用混乱品种代替的情况，依据相关规定标准，对其鉴别进行阐述，以期为今后工作提供了技术支持。     

中药饮片商品的现状与教材内容的合理设置

在中药饮片商品现状调查的前提下，分析总结了中药饮片商品品种混乱的类型，认为医与药、教与用结合不够，学科间欠沟通是中药饮片商品品种混乱的原因之一；提出了对中药学、中药鉴定学、中药商品学中中药饮片教学内容合理设置的建议。     

中药饮片标准

随着医药卫生体制改革的深入以及医学药学科技的发展,对药学技术人员的需求将不断增加,同时对药学技术人员素质的知识更新及再教育提出了要求。 另一方面,目前药品市场,尤其是中药材市场仍然较为混乱,假劣药品时而出现,增强药学技术人员的真伪药品鉴别能力及合理用药水平也已被提上日程。 鉴此种种,本刊特辟《药师指南》栏目。应广大临床及药店药师要求,因最新版《北京市中药饮片标准》发行量有限,很难买到,本刊从本期起连续刊载该版《北京市中药饮片标准》,供诸位药学技术人员在工作中学习与掌握。 《北京市中药饮片标准》在《中国药典》基础上,兼顾北京地方习惯用药品种,突出了中药饮片标准的特点。该标准增加了[质量规定]项及[鉴别]项,对中药饮片的生产与经营、使用与管理、监督与检验具有指导作用,为北京市中药饮片生产、经营、调剂及监督与检验的法定依据。 欢迎各位读者整理惠存。     

我国中药饮片质量问题及强化监管的对策

目的强化监管措施,提高我国中药饮片质量。方法总结目前我国中药饮片存在的主要质量问题,分析产生质量问题的根源,提出相应的对策建议。结果中药饮片存在混伪品代用、掺伪,染色、增重,含量测定不合格,有害物质残留等质量问题,主要原因为中药种植不规范、生产企业不规范,流通市场混乱,监管能力不足等。结论应通过完善政策法规,强化生产、流通领域监管,建立中药材流通溯源体系,转变监管理念等方法,加强中药饮片综合监管,从而提高中药饮片质量。     

医院中药饮片质量控制中的问题及对策初探

中药是祖国医学用于防病治病的重要武器,中药质量的好坏直接影响临床疗效及用药安全。目前对中药材市场难以实行科学有效的监管,医院中药房很难控制所购进的饮片质量,中药饮片掺假现象尤为突出。因中药饮片质量问题而发生不良反应,甚至致死事件屡见不鲜。中药饮片质量控制量化指标少,可操作性不强,也影响到中医药事业的健康发展。多年来,根据实际工作情况,摸索了一些饮片质量管理的办法。现阐述如下。1目前中药饮片质控存在的主要问题1·1品种混乱、用药部位混杂中药饮片因地区用药习惯不同及同名异物或同物异名的药材,因药源紧张而全国各地…     

我院2014年中药饮片入库验收质量分析

目的：分析我院中药饮片入库验收质量,建立中药饮片质量管理措施,保障患者用药安全、有效。方法：对我院2014年中药饮片库房验收记录进行整理,统计并分析中药饮片入库验收情况,总结中药饮片质量不合格的原因。结果：我院2014年验收中药饮片2286个批次,不合格119个批次（5.21%）;中药饮片质量不合格的原因主要有变质、水分超标、等级品种不符、杂质超标、炮制不规范、非药用部分过多等。结论：目前,中药饮片质量不合格的情况比较突出,不合格比例较大,造成中药饮片质量不合格的原因众多,在医院药品入库验收过程中需要工作人员认真检查,规范验收手段和验收环节,提高验收质量,确保中药饮片入库质量。     

中药饮片质量的现状、形成原因与质控措施

本文阐述了中药饮片流通市场存在以假充正、品种混淆的10种形式和医疗单位中药饮片质量问题的3种类型,分析了中药饮片质量现状的形成原因,提出了解决中药饮片质量问题的控制措施。     

浅析传统中药饮片常见问题与应对对策

目的:分析中药饮片常见的质量问题,从源头和贮藏上确保中药饮片的质量。方法:从中药饮片的品种来源、炮制方法、药库储藏,总结中药饮片目前的常见问题。结果:中药常见问题有品种混淆、炮制不当、储藏不当等。结论:建议加强中药饮片的入库验收管理,加强中药饮片贮藏管理,保证中医医疗水平的发挥,使中药饮片更好地服务于患者。     

我院3年间中药饮片入库验收情况分析及体会

目的总结中药饮片入库验收的方法和经验.方法统计湖南中医学院附属二医院2002年11月～2005年11月间中药饮片入库验收情况,分析拒收中药饮片的原因.结果3年中验收中药饮片7 659品种次,其中拒收不合格饮片425品种次,不合格原因有15个方面.结论中药饮片劣品和掺伪品比例逐渐提高,其中炮制不合规范的饮片居首位,提高中药炮制质量、制订饮片标准是中药现代化的当务之急.     

中药材及饮片质量状况的专题调查

目的:探讨市场中药材及饮片的质量状况,并寻求解决问题的办法.方法:利用近五年来我们在市场上药品抽检与现场检查所见中药饮片质量问题进行归纳分析.结果:中药饮片质量问题比较突出,已经严重影响了中医药的发展.结论:中药饮片问题亟待解决,统一药品质量标准是基础,规范管理与市场准入是关键.     

反相高效液相色谱法测定大花红景天及其混淆品中红景天苷的含量

目的建立RP-HPLC测定市场上大花红景天及其混淆品中红景天苷含量的方法。方法色谱柱为Phe-nomenex C18（250 mm×4.60 mm,5μm）,流动相为甲醇-水（15∶85）,等度洗脱,流速为1.0 mL.min-1,检测波长为223 nm,柱温为25℃。结果红景天苷在62.5～1 000μg.mL-1与峰面积线性关系良好（r=0.999 7,n=5）,平均加样回收率为100.1%,RSD为0.40%（n=6）。结论本方法简便、准确、重复性强,可用于市面上大花红景天及其混淆品中红景天苷的含量测定。     

Hydroxyethylated cationic cholesterol derivatives in liposome vectors promote gene expression in the lung

Three cationic cholesterol derivatives (CCDs), which differ in their types of amine and bear a hydroxyethyl group at the amine group, were synthesized and formulated into liposomes and nanoparticles as gene delivery vectors. In vitro transfection into A549 cells proved that liposomes formulated with CCDs and dioleoylphosphatidylethanolamine (DOPE) of 1/2 molar ratio were more effective than the corresponding nanoparticles with CCDs and Tween 80 at charge ratios (+/-) of 1/2, 3/1 and 5/1. Among the liposomal formulations, non-hydroxyethylated CCDs were more effective than hydroxyethylated ones in vitro. However, gene transfection in the lung through intratracheal injection showed opposite results to those in vitro, with liposomes containing hydroxyethylated CCDs being more potent than those containing non-hydroxyethylated CCDs. Transfection by liposomes with N,N-methyl hydroxyethyl aminopropane carbamoyl cholesterol iodide (MHAPC) showed the highest luciferase activity, resulting in 2- and 60-fold higher gene expression than jet-PEI and naked DNA, respectively. The distribution of MHAPC lipoplex after intratracheal injection was heterogeneous, and luciferase was expressed in epithelial cells lining the bronchi and bronchioles. All the lipoplexes led to higher TNF-alpha levels in the lung compared to the nanoplex and jet-PEI, but our findings suggested that modification of the cationic cholesterol with a hydroxyethyl group at the tertiary amine terminal, MHAPC, promoted gene expression in the lung without increasing the toxicity compared with other CCDs. This work firstly proved that liposomes containing hydroxyethylated CCDs could promote gene expression in the lung through intratracheal injection.     

Comparative evaluation of chemical profiles of three representative 'snow lotus' herbs by UPLC‐DAD‐QTOF‐MS combined with principal component and hierarchical cluster analyses

Herbal healthcare products are used worldwide as relatively safe and effective alternatives to allopathic drugs. Saussurea laniceps Hand.‐Mazz. (SL), S . medusa Maxim. (SM) and S . involucrata (Kar. et Kir.) Sch.Bip. (SI) are three sources of the renowned 'snow lotus', Chinese materia medica for treating inflammatory diseases. The three species have different therapeutic effects, among which SL has been proved to be the most potent, but they are frequently confused on the market and in the academic community. An ultra‐high performance liquid chromatography‐diode array detector‐quadrupole time of flight‐mass spectrometry (UPLC‐DAD‐QTOF‐MS) method was developed and used to analyze 49 herbal samples for species analysis and overall quality evaluation. With 25 simultaneously identified constituents, of which 12 were quantified, the three herbs showed different chemical profiles. Four‐dimensional principle component analysis (4D‐PCA) and orthogonal hierarchical cluster analysis (2D‐HCA) results illustrated that SL should be grouped away from SM and SI, contradicting the botanical record in Flora of China . The present chemical determination and pattern recognition results directly explain the therapeutic potency of SL and distinguish the three confused snow lotus herbs. Furthermore, the findings suggest a possible extensive quality evaluation model for multi‐origin medicinal plants and help monitor falsification of snow lotus herbal products on the market, contributing to a more regulated pharmaceutical industry. Copyright © 2016 John Wiley & Sons, Ltd.     

北京口岸进口抗感染药物的现状和趋势分析

目的 了解北京口岸抗感染类药物进口情况的现状及变化趋势.方法 对2008年11月1日至2011年10月31日北京口岸进口的抗感染类药物的数量和品种进行定量研究并做出相关分析.结果 2008年11月1日至2009年10月31日(2009年),通过北京口岸进口的药品总批次为3995批,其中进口抗感染药物877批;2009年11月1日至2010年10月31日(2010年)进口药品总批次为3756批,抽检件数为12704件,包括进口抗感染药物1157批;2010年11月1日至2011年10月31日(2011年)进口药品总批次为3806批,其中进口抗感染药物1182批.进口抗感染类药物进口量逐年递增且品种较单一,喹诺酮类和头孢菌素类药物占抗感染类药物比重最大.结论 进口抗感染类药物的数量变化,与医药市场行业发展和相关政策出台密切相关.     

加强家庭用保健、康复性医疗器械市场监管的思考

目的为加强新形势下医疗器械的市场监管提供参考意见。方法分析违规违法销售家庭用保健、康复性医疗器械的特点。结果与结论应从把好市场准入关、加强主动监管、注重社会监督、完善监管法规、集聚执法合力等五个方面,加强药械市场监管。     

搞好批发企业经营管理规范药品流通秩序

药品批发企业经营管理混乱是药品购销渠道混乱的重要原因之一。必须健全法律、法规，加大执法力度，切实加强药品市场的监督管理。     

基层药品监督工作存在的问题及对策

目的：调整基层药品监督的思路和方法。方法：分析近年来药品监督形势的变化,提出合理化修改建议。结果与结论：药品监督抽样制度改革有利于更好的市场监督。     

2004年北京市4种常用口服降糖药物质量分析

目的评价2004年北京市的口服降糖药物的质量,为生产企业、患者和质量监督管理部门提供参考。方法对2004年北京市药品市场应用普遍的236件口服降糖药物格列本脲片、格列喹酮片、盐酸二甲双胍片和盐酸苯乙双胍片进行抽验并作质量分析。结果不合格者4件,不合格率为1.7%。结论2004年北京市销售的4种常用口服降糖药物整体质量较好。     

北京地区36家医院2005～2007年抗抑郁药利用分析

目的:了解北京地区抗抑郁药的应用情况及趋势。方法:采用世界卫生组织推荐的限定日剂量方法,对北京地区36家医院2005～2007年抗抑郁药的应用情况进行统计、分析。结果:该地区抗抑郁药销售金额、用药频度均逐年大幅增长,选择性5-羟色胺再摄取抑制剂(SSRIs)占抗抑郁药总销售金额的88%以上,氟西汀、帕罗西汀、西酞普兰占销售金额、用药人数的前3位,传统的三环类、四环类药市场份额有所减少,但仍有稳定的用药人群。由于抑郁症患者增加,呈现出用药需求的多样性。结论:氟西汀等SSRIs一直占据北京地区抗抑郁药市场的主导地位。我国应加大力度,尽早研发出具有自主知识产权的抗抑郁药。     

Value of component based diagnostics in IgE-mediated hymenoptera sting reactions

Background: Stings by insects can precipitate many signs and symptoms of dermatological and ocular diseases. Of particular importance is the anaphylaxis after Hymenoptera stings. Selection of the appropriate venom for immunotherapy requires a precise diagnosis, which is frequently difficult to confirm since the history presented by the patient is many times not conclusive and diagnostic tests are often positive for bee venom (BV) and vespula venom (VV). This double positivity is either caused by true double sensitization or by antibodies cross-reactive to homologous peptide sequences or to cross-reactive carbohydrate determinants (CCDs). In this study, we analyzed in 39 patients, tested positive for specific immunoglobulin E (sIgE) against BV and VV and CCDs whether the routine detection of sIgE against the recombinant species-specific major allergens (SSMAs) rApi m1 and rVes v5 enables the discrimination between genuine double sensitization and cross reactivity and therefore may be superior to other in vitro assays such as IgE-inhibition test or the basophil activation test.

Materials and methods: Thirty-nine patients each with allergic reactions to vespula and/or honey bee stings and tested positive for sIgE antibodies against CCDs were analyzed for sIgE against BV, VV, CCDs (MUFX3) and SSMAs by UNICAP (CAP) and to BV, VV, bromelain, horseradish peroxidase and ascorbat oxidase by Immulite 2000 (IMMU). In 12 cases results from a basophil activation test, in nine cases results from IgE-inhibition assays and in 10 cases an unambiguous history of the patient were taken into consideration.

Results: A definite diagnosis could be assigned to each patient: sensitization to BV n = 7, sensitization to VV n = 29 and true double sensitization to both venoms n = 3. Detection of sIgE against BV and VV by CAP leads in three cases to the diagnosis BV allergy, in 35 cases to the diagnosis double sensitization and in one case to the diagnosis VV allergy. Detection of sIgE against BV and VV by IMMU leads in five cases to the diagnosis BV allergy, in 27 cases to the diagnosis double sensitization and in seven cases to the diagnosis VV allergy. Detection of sIgE against rApi m1 and rVes v5 by CAP leads in six cases to the diagnosis BV allergy, in eight cases to the diagnosis double sensitization, in 21 cases to the diagnosis VV allergy and in four cases to a false double-nagative result implicating no allergy.

Discussion and conclusion: Detection of sIgE to rApi m 1 and rVes v 5 by CAP is the most reliable diagnostic procedure to discriminate between true double sensitization and cross reactivity in patients with double-positive IgE results to venom extracts in the presence of sIgE against CCDs. In this study, however, we demonstrate that in nine of 39 patients tested positive for sIgE against CCDs, even the allergen component based diagnostic produces false double-positive and also false double-negative test results. Thus, we conclude that especially in hard to diagnose CCD positive patients beside the detection of sIgE, in vitro assays such as the IgE-inhibition test or the basophil activation test are still of importance. Detection of sIgE against only two SSMAs is not sufficient for a precise diagnosis. We propose inclusion of further SSMAs in diagnostic procedures.