注射用泮托拉唑钠的细菌内毒素检查

目的建立注射用泮托拉唑钠细菌内毒素的检查方法。方法按《中国药典》2005年版(二部)附录ⅪE进行实验和结果判断。结果用标示量灵敏度0.25EU.mL-1的鲎试剂,注射用泮托拉唑钠的有效检测浓度为0.13mg.L-1,3批注射用泮托拉唑钠内毒素均小于1.88EU.mL-1。结论本品可以用细菌内毒素检查法代替家兔热源检查法。     

藻酸双酯钠注射液细菌内毒素检查方法探讨

目的:建立藻酸双酯钠注射液细菌内毒素的检查方法.方法:依照2000年版<中国药典 > 附录Ⅺ E细菌内毒素检查法检查.结果:藻酸双酯钠注射液在 0.3 mg/mL浓度下无干扰作用,可进行细菌内毒素检查.结论:凝胶法检查藻酸双酯钠注射液中细菌内毒素的方法为,取本品依照药典方法检查,每1 mg中含内毒素量应小于1.67 EU.     

注射用唑来膦酸的细菌内毒素检查

目的建立注射用唑来膦酸细菌内毒素检查方法。方法根据2010年版《中国药典》（二部）附录收载的细菌内毒素检查方法进行试验。结果注射用唑来膦酸稀释至0.0033mg.mL-1溶液,用标示灵敏度0.25EU.mL-1的鲎试剂检测细菌内毒素,无干扰因素影响。结论注射用唑来膦酸可应用鲎试剂进行细菌内毒素法检查,细菌内毒素限度确定为75Eu.mg-1。     

唑来膦酸细菌内毒素检查方法的研究

目的：改进并提高唑来膦酸质量标准的细菌内毒素检查项。方法：按2015年版《中国药典》(四部)通则细菌内毒素检查法,用不同厂家的鲎试剂对唑来膦酸注射液和注射用唑来膦酸分别进行干扰试验。结果：不同厂家生产的唑来膦酸注射液和注射用唑来膦酸均在0.05mg﹒ml_-1及以下浓度对细菌内毒素检查法无干扰作用。结论：可将唑来膦酸注射液和注射用唑来膦酸的细菌内毒素检查法统一限值为：每1mg唑来膦酸含细菌内毒素的量应不高于5.0EU。     

注射用核糖核酸Ⅲ细菌内毒素检查方法的研究

目的建立注射用核糖核酸Ⅲ细菌内毒素检查方法。方法按《中国药典》2010年版(二部)附录ⅪE细菌内毒素检查法进行实验和结果判断。结果用两个生产厂家的鲎试剂进行研究,注射用核糖核酸Ⅲ的最大不干扰浓度为1.25 mg·mL-1,并对三批样品进行检查,均无干扰作用,其细菌内毒素均小于15 EU·mg-1。结论本品采用细菌内毒素检查法(凝胶法)控制细菌内毒素的含量合理可靠。     

硫酸鱼精蛋白注射液细菌内毒素检查法标准研究

目的:建立硫酸鱼精蛋白注射液细菌内毒素的检查方法.方法:按<中国药典>2000年版二部附录ⅪE、ⅪX F进行实验和结果判断.结果:用三个不同生产厂家,不同标示灵敏度鲎试剂进行研究,硫酸鱼精蛋白注射液最大不干扰浓度为0.042mg/ml,并对两个生产厂家的6批样品进行检查,均无干扰作用,其细菌内毒素量均小于6EU/mg.结论:本品可以用细菌内毒素检查法(凝胶法)代替热原检查法控制细菌内毒素的含量,硫酸鱼精蛋白注射液的细菌内毒素理论限值为6EU/mg.     

注射用盐酸托泊替康的细菌内毒素检查法研究

目的建立注射用盐酸托泊替康的细菌内毒素检查法。方法按中国药典2010年版二部附录ⅪE细菌内毒素检查法。结果本品稀释为0.04 mg.mL-1的溶液对细菌内毒素检查无干扰作用。按拟定标准检验,该品种3批样品细菌内毒素检查结果均符合规定。结论本品可用细菌内毒素检查法代替家兔热原检查法,其细菌内毒素的限值（L）为50 EU.mg-1。     

维生素B12注射液细菌内毒素检查方法的建立

目的：建立维生素B12注射液的细菌内毒素检查方法。方法：按《中国药典》2010年版二部（附录Ⅺ E）的细菌内毒素检查方法及指导原则进行实验。结果：维生素B12注射液的最大不干扰浓度为0.25 mg·mL-1。在内毒素限值确定为400 EU·mg-1情况下,用灵敏度为0.25 EU·mL-1的鲎试剂按凝胶限度检查法对6批次供试品进行细菌内毒素检查,结果均符合规定。结论：建议药典增加维生素B12注射液的细菌内毒素检查项,规定每1 mg维生素B12中含内毒素的量应小于400 EU。     

注射用头孢呋辛钠细菌内毒素检查法研究

目的 建立注射用头孢呋辛钠的细菌内毒素检查方法。方法 采用2000年版《中国药典（二部）》附录Ⅺ E细菌内毒素检查法和附录ⅪⅩF细菌内毒素检查法。结果 注射用头孢呋辛钠在6.68mg/mL稀释浓度时对细菌内毒素检查法无干扰作用，其细菌内毒素限值L=0.15EU/mg。结论 可采用细菌内毒素检查法代替家兔热原法对注射用头孢呋辛钠进行细菌内毒素检查。     

注射用尿激酶细菌内毒素检查的研究

目的：研究注射用尿激酶的细菌内毒素检查方法。方法：参照中国药典2000年版二部附录Ⅺ E细菌内毒素检查法和附录ⅪXF细菌内毒素检查法应用指导原则进行试验。结果：供试品在222．22u／ml浓度下无干扰作用。结论：获得了可靠的实验数据和结果并为本品细菌内毒素检查法的确立提供了依据。     

Search for the optimal conditions for the distillation of the antibacterial agent glyciphon

Preparation of the high-boiling-point organophosphate antiblastoma agent glyciphon at maximal yield and purity was addressed at the experimental production stage by studying its vacuum distillation by mathematical modeling. The optimum conditions for performing this final stage of the technical process allowed the number of distillations to be decreased and the yield of pharmacological purity product to be increased by an average of 20%. __________ Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 41, No. 6, pp. 35–38, June, 2007.     

Retinoids for the treatment of psoriasis: outlook for the future

Despite the demonstrated clinical success of retinoid therapy in psoriasis, its mechanism of action has not been fully elucidated, and investigators are confronted with two paradoxes. Firstly, the binding of retinoids to nuclear retinoic acid receptors (RARs) does not match their therapeutic efficacy. Secondly, formation of retinoic acid is probably increased in the psoriatic lesions. Answering these questions should result in: (i) the better use of acitretin, an oral synthetic retinoid, and tazarotene, the first compound for topical use; (ii) the development of new retinoids with specific pharmacological profile such as subtype-selective retinoids including molecules with an 'antiretinoid' activity and dissociating antiproliferative retinoids; and (iii) the better characterization of non-genomic effects of retinoids.     

老年人肾脏疾病的B超诊断研究

目的对老年人肾脏疾病采用B超进行观察分析,以提高老年人肾脏疾病的诊断正确率。方法选择我院60例患有肾脏疾病的老年人,根据年龄分为两组,采用B超对两组患者进行观察分析,并比较结果。结果第二组大部分患者肾脏形态不规则,包膜呈波浪状,尤以纵断面明显,可见多处凹凸不平,皮质内回声尚均匀,无明显占位效应。第二组肾脏的长径和宽径均较对照组缩小,差异有统计学意义(P<0.05),而厚径差异无统计学意义(P>0.05)。结论老年人的肾脏由于年龄增大可引起肾脏不规则,集合系统回声增强,局部的隆起,皮质相对变薄等现象。     

Meeting the societal need for new antibiotics: the challenges for the pharmaceutical industry

The rise of antibiotic resistance is leading to clinicians being increasingly faced with clinical failure due to the lack of effective and safe treatment options. New antibiotics are needed now for current multi-drug resistant infections but also in preparation for emerging and anticipated threats. There are significant challenges for the pharmaceutical industry to discover and develop new antibiotics including a business model that balances reasonable reimbursement with appropriate use. This summary reviews the key challenges and collaborative interventions that may contribute to addressing a societal problem.     

Collaborative study for the establishment of the second international standard for gramicidin

An international collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish the WHO second International Standard (IS) for gramicidin as the stocks of the 1st IS, established in 1964, were close to depletion. The candidate material did not show any sign of potency loss when kept at elevated temperatures of + 4 °C, + 20 °C, + 37 °C and + 45 °C for 3 months. Six laboratories from 5 countries as well as the EDQM laboratory participated in the collaborative study. Potencies of the candidate material were estimated by microbiological assays with sensitive micro-organisms. To ensure continuity between consecutive batches, the 1st IS for gramicidin was used as standard. Based on the results of the study, the 2nd IS for gramicidin was adopted at the meeting of the WHO Expert Committee on Biological Standardization (ECBS) in 2008 with an assigned potency of 1070 International Units per mg (IU/mg). The 2nd IS for gramicidin is available from the EDQM.