Formulation, quality control and shelf life of the experimental cytostatic drug cyclopentenyl cytosine

This paper describes the formulation and quality control of an aqueous sterilized formulation of the experimental cytostatic drug cyclopentenyl cytosine (CPEC) to be used in Phase I/II clinical trials. The raw drug substance was extensively tested. A High Pressure Liquid Chromotography (HPLC) method was validated for the quality control of the formulated product. The aqueous formulation was found to be stable for at least 2 years at 2-8°C. Sterilization (15 min at 121°C) showed no influence on drug stability. The results show that CPEC can be formulated in an aqueous solution. The described HPLC method is a useful tool in the pharmaceutical quality control.     

省级药品检验机构整合后实验室质量管理的控制点

本文通过对内外部环境变化的分析,结合广西食品药品检验所在检验检测机构整合实践案例,分析实验室质量管理的控制点,探究综合性实验室向专业型实验室转变的意义,并对机构整合后进行思考和展望.     

Formulation and Physiological and Biopharmaceutical Issues in the Development of Oral Lipid-Based Drug Delivery Systems

The rapidly increasing availability of drug receptor structural characteristics has permitted the receptor-guided synthesis of potential new drug molecules. This synthesis strategy frequently results in the creation of polycyclic and highly hydrophobic compounds, with attendant poor oral bioavailability resulting from low solubility and slow dissolution rate in the primarily aqueous contents of the gastrointestinal (GI) tract. In an attempt to improve the solubility-limited bioavailability associated with these compounds, formulators have turned to the use of lipid excipients in which the compounds can be solubilized prior to oral administration. This new class of excipients presents the pharmaceutical scientist with a number of new challenges at all stages of the formulation development process, beginning with the excipient selection and stability assessment of the prototype formulation, up to and including scale-up and mass production of the final market-image product. The interaction of lipid-based formulations with the gastrointestinal system and associated digestive processes presents additional challenges and opportunities that will be understood more fully as we begin to unravel the intricacies of the GI processing of lipid excipients. For example, an increasing body of evidence has shown that certain lipids are capable of inhibiting both presystemic drug metabolism and drug efflux by the gut wall mediated by p-glycoprotein (PGP). And, it is well known that lipids are capable of enhancing lymphatic transport of hydrophobic drugs, thereby reducing drug clearance resulting from hepatic first-pass metabolism. This review addresses the current state of knowledge regarding oral lipid-based formulation development and scale-up issues and the physiological and biopharmaceutical aspects pertinent to the development of an orally bioavailable and efficacious dosage form.     

Formulation and Physiological and Biopharmaceutical Issues in the Development of Oral Lipid-Based Drug Delivery Systems

The rapidly increasing availability of drug receptor structural characteristics has permitted the receptor-guided synthesis of potential new drug molecules. This synthesis strategy frequently results in the creation of polycyclic and highly hydrophobic compounds, with attendant poor oral bioavailability resulting from low solubility and slow dissolution rate in the primarily aqueous contents of the gastrointestinal (GI) tract. In an attempt to improve the solubility-limited bioavailability associated with these compounds, formulators have turned to the use of lipid excipients in which the compounds can be solubilized prior to oral administration. This new class of excipients presents the pharmaceutical scientist with a number of new challenges at all stages of the formulation development process, beginning with the excipient selection and stability assessment of the prototype formulation, up to and including scale-up and mass production of the final market-image product. The interaction of lipid-based formulations with the gastrointestinal system and associated digestive processes presents additional challenges and opportunities that will be understood more fully as we begin to unravel the intricacies of the GI processing of lipid excipients. For example, an increasing body of evidence has shown that certain lipids are capable of inhibiting both presystemic drug metabolism and drug efflux by the gut wall mediated by p-glycoprotein (PGP). And, it is well known that lipids are capable of enhancing lymphatic transport of hydrophobic drugs, thereby reducing drug clearance resulting from hepatic first-pass metabolism. This review addresses the current state of knowledge regarding oral lipid-based formulation development and scale-up issues and the physiological and biopharmaceutical aspects pertinent to the development of an orally bioavailable and efficacious dosage form.     

钢箱梁制作过程质量控制浅谈

箱型结构梁（以下简称箱型梁）作为钢梁的一种结构型式,以其结构新颖、承载能力强、刚性大、稳定性好等优点,在铁路桥梁、公路桥梁、水利电力、工民建等行业的钢结构工程中应用非常广泛。本文主要从下料、拼配、焊接、矫正等工序的过程控制要点,阐述箱梁制作的主要工序和各工序的质量控制。     

液压胀形三通的质量控制

简述了液压胀形三通管件的特性，分析了胀形过程中各工艺环节对三通管件质量的影响。     

基于小批量多品种生产环境的统计过程质量控制研究

分析了先进制造技术环境下实施统计过程质量控制所存在的问题,给出了一种基于正态过程的改进的标准化控制图,适用于小批量多品种生产环境下对过程均值、过程方差的有效控制。     

Quality control results of the drift tubes for the ATLAS MDT-BIS chambers

ATLAS (A Toroidal LHC ApparatuS) is a general purpose experiment, which will start its operation at the Large Hadron Collider (LHC) at CERN in 2007. The ATLAS detector is designed to study the products of proton–proton collisions at c.m.s. energies of up to 14 TeV. Three Greek Universities have taken the responsibility to construct 112 BIS-MDT (Barrel Inner Small) chambers using 29 000 drift tubes of 170 cm length and 3 cm diameter that have been quality tested before assembly. This work describes the Quality Assurance and Quality Control (QA_QC) procedures for the drift tubes, followed at the High Energy Physics Laboratory of the National Technical University of Athens, while emphasis is given on the obtained results for the above mentioned number of tubes.     

舰船应用钢/铝结构过渡接头质量控制的分析

结构过渡接头(STJ)的使用直接决定舰船钢/铝结构连接的可靠性.本文从保证连接可靠性角度,分析STJ自身质量及用于舰船上STJ的焊接质量控制的全过程,指出控制措施,为STJ的设计、施工提供技术依据.     

磁共振乳腺检查的质量控制

乳腺疾病史女性常见的病症,近年来发病率明显上升,特别是恶性肿瘤的发病率上升的很快,早期诊断、早期治疗意义重大。磁共振检查具有多成像参数、多层面扫描、多角度、创伤小,检查精确、误诊率低等优点,已经广泛应用于临床,但是在检查过程中,由于种种原因会影响检查的质量,笔者结合工作实际和国内外有关文献报道,对病人的准备工作、扫描技术方面、伪影分析及去除方面和磁共振乳腺检查主要适应症进行阐述,旨在提高磁共振乳腺检查的质量．     

壳聚糖作为药物缓释载体的应用及进展

壳聚糖是一种天然聚氨基葡萄糖,也是一种安全无毒、可生物降解的天然高分子,不但具有生物相容性,而且具有抗菌、止血、抑制癌细胞转移等作用,具有优良的生物降解性能和生物亲和性。简单介绍了壳聚糖的性能及作为药物缓释载体的生物学特点,并简要综述了其作为缓释载体的类型及研究应用。     

军品包装设计开发的过程控制及质量管理探析

概述了军品包装的设计开发程序和过程控制要求.介绍了如何通过对军品包装设计开发的方案设计、工程样机研制、试制以及设计定型等各阶段进行有效过程控制和质量管理,设计开发出满足现代武器装备需求的军用包装产品.     

露天土岩爆破工程的质量与安全控制

文章介绍了阜新(西)露天一期工程深孔爆破剥离11559 m3土岩的质量与安全控制过程及爆破参数的选择和确定.提出了几点质量与安全的注意事项,对于类似工程有借鉴作用.     

膜元件质量控制的意义及实施

简要论述了膜元件生产现状及质量控制在膜元件生产过程中的重要性和社会经济意义,并根据膜元件生产的特点提出了膜元件控制的措施及实施办法和获得的效果。并根据膜元件发展的趋势提出了进一步提高膜元件质量的方向。     

SPRT Calibration Uncertainties and Internal Quality Control at a Commercial SPRT Calibration Facility

The Hart Scientific Division of the Fluke Corporation operates two accredited standard platinum resistance thermometer (SPRT) calibration facilities, one at the Hart Scientific factory in Utah, USA, and the other at a service facility in Norwich, UK. The US facility is accredited through National Voluntary Laboratory Accreditation Program (NVLAP), and the UK facility is accredited through UKAS. Both provide SPRT calibrations using similar equipment and procedures, and at similar levels of uncertainty. These uncertainties are among the lowest available commercially. To achieve and maintain low uncertainties, it is required that the calibration procedures be thorough and optimized. However, to minimize customer downtime, it is also important that the instruments be calibrated in a timely manner and returned to the customer. Consequently, subjecting the instrument to repeated calibrations or extensive repeated measurements is not a viable approach. Additionally, these laboratories provide SPRT calibration services involving a wide variety of SPRT designs. These designs behave differently, yet predictably, when subjected to calibration measurements. To this end, an evaluation strategy involving both statistical process control and internal consistency measures is utilized to provide confidence in both the instrument calibration and the calibration process. This article describes the calibration facilities, procedure, uncertainty analysis, and internal quality assurance measures employed in the calibration of SPRTs. Data will be reviewed and generalities will be presented. Finally, challenges and considerations for future improvements will be discussed.     

离子选择电极法测定氟化物过程中的质量控制

文章从氟离子选择电极的维护及其性能的判断、相应极限、空白电位值、参比电极的维护及其对电位值的影响、滤纸的使用以及溶液的pH值、温度、搅拌、电极浸入深度与位置、测定顺序等影响离子选择电极法测定氟化物的有关因素进行了研究和探讨，并提出对较复杂样品的测定易采用标准加入法以提高测定准确度和精密度。     

大型筒体的制作工艺及质量控制

剖析了大型筒体的制作工艺,以及筒节卷制、焊接、机加工到筒节组对等过程的质量控制;介绍了为提高筒体制作质量所采取的一些措施.     

浅谈X线摄影中照片影像的质量控制

从传统X线摄影到计算机X线摄影（Computed Radiography,cR）再到数字X线摄影（Digital Radiography,DR）,历经了百年的发展,成像过程在不断的演变,但它们都已X线作为成像源的本质并没有改变。无论何种成像方法所获得的被照体影像,虽其成像过程中的影响因素不尽相同,但其照片质量的评价标准应为一致。本文将X线摄影过程中的工作体会与质控活动中的实践经验相结合,归纳出X线摄影中照片质量控制的要点,希望对我们今后的实际工作有所帮助,最终得到不但满足临床诊断需求,而且完全符合质控标准的优秀的照片影像。     

Formulation,optimization, and characterization of rifampicin-loaded solid lipid nanoparticles for the treatment of tuberculosis

Abstract

Mycobacterium tuberculosis, being the causative infectious agent, is the leading cause of death worldwide amongst the infectious disease. The low bioavailability of rifampicin (RIF), one of the vital constituent of antitubercular therapy, instigates an urge to develop nanocarrier, which can prevent its degradation in the acidic pH of the stomach. Solid lipid nanoparticles (SLNs) have been proven to be promising versatile platform for oral delivery of lipophilic drugs. Therefore, the current investigation demonstrates development of RIF-loaded solid lipid nanoparticles (RIF-SLNs) using high-pressure homogenization technique by employing a three-level, three-factor Box–Behnken design. Concentration of drug, concentration of emulsifier, and homogenization pressure were selected as an independent variables, and %drug loading (%DL), %entrapment efficiency (%EE), and particle size were selected as dependent variables. The developed RIF-SLNs were characterized for particle size, polydispersity index, zeta potential, %EE, %DL, differential scanning calorimetry, X-ray diffraction, and TEM analysis. The mean diameter of RIF-SLNs was found to be 456?±?11?nm, %EE of 84.12?±?2.78%, and %DL of 15.68?±?1.52%. The in vitro lipolysis experiments revealed that RIF-SLNs stabilized using poloxamer 188, exhibited antilipolytic effect. Furthermore, the in vitro GI stability studies (at pH 1.2, pH 4.5, pH 6.8, and pH 7.4) revealed that the developed system could withstand various gastrointestinal tract media. The in vitro dissolution studies depicted biphasic drug release profile for drug-loaded SLNs revealing best fit with Weibull model. The accelerated stability studies for 6?months does not revealed any significant change in characteristics of developed RIF-SLNs.     

基于保质期约束的生鲜品订货批量以及定价决策研究

对随机需求下生鲜品的多周期产品订货批量以及即将到期的商品打折出售的折扣价进行了研究.分别考虑了单一产品和存在替代关系的多产品的情况,建立了有保质期约束的生鲜食品的多周期订货批量模型,从零售商的角度给出了最优订货批量以及最优的折扣价格,最后通过一组算例对模型的有效性和科学性进行了分析.