聚氯乙烯固体药用硬片水蒸气透过量测定不确定度评定

详细介绍了聚氯乙烯固体硬片水蒸气透过量测定不确定度评定方法,分析了不确定度来源。     

The Use of Fractal Geometry in Pharmaceutical Systems

The nature of surface irregularity affects many phenomena including adsorption/desorption, catalysis, crystal growth, drug dissolution and chromatography. Many excellent models have been developed with the oversimplified assumption that all particles are smooth spheres; fractal geometry allows these models to be expanded to irregular surfaces by providing a quantitative means of assessing surface roughness.

An overview of fractal analysis is presented in the following, and the state of the art, as far as pharmaceutical systems are concerned are outlined. Erroneous approaches, as well as the directions pharmaceutical research and technology might take in the area of fractal analysis are suggested.

From a historical perspective, micromeritics (the science of particle size, shape and surface area) were first developed with the assumptions that all particles were smooth spheres.

Much excellent work has been developed with such an oversimplified model. For example, numerous workers have shown that particle flow through an orifice is a function of “particle diameter”, and experiments have most often been carried out on particles as close to spherical as possible, and as monodisperse as possible.

The science of micromeritics, the science of small particles, is the making of Dalla Valle (1943) who coined the term in a book of the same name which describes methods of particle size measurement, mostly used by soil scientists.¹     

The Use of Fractal Geometry in Pharmaceutical Systems

Abstract

The nature of surface irregularity affects many phenomena including adsorption/desorption, catalysis, crystal growth, drug dissolution and chromatography. Many excellent models have been developed with the oversimplified assumption that all particles are smooth spheres; fractal geometry allows these models to be expanded to irregular surfaces by providing a quantitative means of assessing surface roughness.

An overview of fractal analysis is presented in the following, and the state of the art, as far as pharmaceutical systems are concerned are outlined. Erroneous approaches, as well as the directions pharmaceutical research and technology might take in the area of fractal analysis are suggested.

From a historical perspective, micromeritics (the science of particle size, shape and surface area) were first developed with the assumptions that all particles were smooth spheres.

Much excellent work has been developed with such an oversimplified model. For example, numerous workers have shown that particle flow through an orifice is a function of “particle diameter”, and experiments have most often been carried out on particles as close to spherical as possible, and as monodisperse as possible.

The science of micromeritics, the science of small particles, is the making of Dalla Valle (1943) who coined the term in a book of the same name which describes methods of particle size measurement, mostly used by soil scientists.¹     

Application of Near-Infrared Spectroscopy in the Pharmaceutical Solid Dosage Form

Near-infrared (NIR) spectroscopy, one of the most rapidly growing methodologies in pharmaceutical analysis, has been used to analyze the pharmaceutical solid dosage form. The objective of this study was to examine the information that can be gathered from NIR spectroscopy and demonstrate the potential utility of the technique as an alternative to current methods of tablet performance testing. The tablet formulation included active drug (acetaminophen or theophylline), binder (hydroxyethylcellulose), filler (lactose, calcium sulfate, dibasic calcium phosphate dihydrate, or microcrystalline cellulose), and lubricant (magnesium stearate). The compression forces were varied from 5 to 25 kN. A Foss/NIRSystems scanning near-infrared spectrometer was used to measure the diffuse reflectance from the tablet surface. Each tablet was scanned on opposite sides to reduce the effects of positioning. First derivative and multiplicative scatter correction data treatments were explored. A calibration for compression force, independent of the filler, was developed. In addition, the spectra were able to distinguish among the fillers used. A comparison of these spectra with data collected earlier suggests that the technique could differentiate among drugs as well. Near-infrared diffuse reflection spectroscopy, when properly calibrated, can determine the compression force used to prepare a tablet. This measurement may be independent of the different active drugs or fillers used in the tablet formulations.     

Fda Inspections of Systems in a Pharmaceutical Manufacturing Establishment

Since the late 1960_s, and increasingly as the years have passed, FDA has been using the systems approach to establishment inspections. FDA's Compliance Programs for drug process inspections state, in effect, that if one system is out of control the entire process may be deemed to be out of control. When is a system out of control? There seem to be no two FDA Investigators who do inspections precisely the same way, but they all must follow certain defined policy during inspections. Systems inspections will be presented from the vantage point of an experienced FDA Investigator.     

大型医药物流中心流程优化研究

为提高医药物流中心的运作效率，提出了面向大型医药物流中心的流程优化方法，该方法针对医药物流中心普遍存在的问题，以流程图为载体，依照诊断、分析、应用、反馈和改进的过程对医药物流中心物流流程做系统化的改造，使流程简明规范、信息化水平提高，从而使得流程效率和服务水平均得到提高，降低了物流费用。文中给出了流程优化的具体步骤。     

Factors Affecting Terminal Solid Solubility in Alloy Systems

Pattern recognition method is applied to investigation of the factors affecting the terminal solid solubility in binary alloy systems. lt has been found that the atomic volume, the valence eltectron number and the melting point of the solute etements exhibit good correlation with the terminal solid solubility.     

养殖海水固体颗粒物含量分布及其对铜质板式换热器腐蚀影响分析

铜质板式换热器是一种新型换热节能材料,在水产养殖、船舶运输、地热资源、化工等领域,具有广阔的应用前景。本文结合其在海水养殖领域的使用情况,对养殖海水固体颗粒物含量和分布进行了调查,并通过现场调查和模拟冲刷实验分析了固体颗粒物对铜质板式换热器的腐蚀影响。结果表明:养殖系统海水固体颗粒物含量很低,其中天然、砂滤和养殖池内3种海水颗粒物含量范围分别在1.3~2.7 mg/L,0.04~0.4mg/L,0.02~0.26 mg/L。天然海水含有大量不规则细小颗粒,池内海水含有大量片状颗粒物,砂滤海水的颗粒特征不明显。许多大颗粒是由纳米颗粒团聚堆积而成的。由于颗粒物含量低,海水流速小,冲刷力小,养殖海水固体颗粒物对铜质板式换热器腐蚀影响轻微。现场腐蚀调查和模拟冲刷实验结果也证明这一点。该研究结果可为铜质板式换热器在海水养殖领域的推广应用提供参考。     

固体深层渗硼中元素的分布

本文介绍用自行研制的固体粉末深层渗硼剂对45钢进行渗硼,研究了元素的分布特点,且与45钢浅层渗硼作了比较。     

Water Vapour Interaction with Pharmaceutical Cellulose Powders

Since interaction between water and particulate solid is a major factor in formulation, processing and product performance of pharmaceuticals, the moisture sorption properties of four grades of microfine cellulose (MFC) and three grades of microcrystalline cellulose (MCC) were investigated.     

Physical and Chemical Properties of Calcium Phosphates for Solid State Pharmaceutical Formulations

The physical and chemical properties of pharmaceutical phosphates are reviewed, with particular emphasis on chemistry of syntehsis, nomenclature, physico-chemical properties and tableting characteristics (other than Athy-Heckel qualities, which are covered elsewhere (Carstensen et al., 1989) and dissolution characteristics.     

利用输送系统提高医药包装的生产力

现代输送技术可以为自动包装作业提供许多优势。除了提供基本的运输，输送设备还可以通过最佳的物流路线和物流效率，最大限度地提高包装生产线的生产效率。在医药包装业中，输送设备被作为一种类似“高速公路”系统用于协调连续生产过程中的各机械之间的产品生产流程，同时平衡生产能力。     

Physical and Chemical Properties of Calcium Phosphates for Solid State Pharmaceutical Formulations

Abstract

The physical and chemical properties of pharmaceutical phosphates are reviewed, with particular emphasis on chemistry of syntehsis, nomenclature, physico-chemical properties and tableting characteristics (other than Athy-Heckel qualities, which are covered elsewhere (Carstensen et al., 1989) and dissolution characteristics.     

Pharmaceutical and Medical Aspects of Bioadhesive Systems for Drug Administration

Abstract

Bioadhesion could lead to the solution of bioavailability problems resulting from a too short stay of the pharmaceutical dosage form at the absorption or activity level of the active ingredient. Bioadhesion stages are: intimate contact resulting from a good wetting of the bioadhesion surface and the swelling of the bioadhesive polymer, then penetration of the bioadhesive into the crevice of the tissue surface or interpenetration of bioadhesive chains with those of the mucus, and finally low chemical bonds. date, the most important bioadhesive polymers are polycarbophil a Carbopol 934. Methods of studying bioadhesion are described as well as the existing bioadhesive dosage forms.     

空调冷却水的水质控制及杀菌方法

介绍了臭氧及电子除垢仪用于空调冷却水的缓蚀、阻垢、杀菌灭藻的机理及应用现状.并根据当前研究的现状,提出了今后应该研究的方向.     

Enhancement of Dissolution and Bioavailability of Piroxicam in Solid Dispersion Systems

Solid dispersion systems of water-insoluble piroxicam in polyethylene glycol (PEG) 4000 and in urea were prepared by fusion and solvent methods and were characterized in this study. The in vitro dissolution studies showed that the dispersion systems containing piroxicam and PEG4000 or urea gave faster dissolution than the corresponding simple mixtures. The differential scanning calorimetry (DSC) study indicated that the piroxicam-PEG system prepared by the fusion method is a solid dispersion, while the piroxicam-urea system prepared by the solvent method is likely to be a solid solution of piroxicam in urea. The storage testings showed that all dispersions were stable, except that uptake of water during storage may occur in the PEG system. A single-dose study with rabbits showed that the dispersion systems provided statistically significant to a higher extent and rate of bioavailability than the corresponding physical mixture (p < 0.05).     

Some Regularities of Continuous Solid Solutions of Alloy Systems

A modified Miedema model and pattern recognition technique are used to establish the criteriafor the formation of continuous solid solutions in alloy systems, and to study the occurrence ofthe melting temperature minimum of continuous solid solutions.     

Evaluation of an in Vitro Dissolution and Permeation Apparatus for Oral Solid Pharmaceutical Dosage Forms

An apparatus based in the USP dissolution test, the F-C-SL apparatus (Ferreira-Costa-Sousa Lobo), was developed that allowed the simultaneous evaluation of the in vitro release and permeation of oral solid pharmaceutical dosage forms. The release rate in both dissolution devices (USP and F-C-SL apparatus) was evaluated with acetaminophen tablets. Different test conditions (stirring rate and solvent volume ratio) were investigated and no significant differences in acetaminophen release rate were found between these apparatuses. In the F-C-SL apparatus, the in vitro permeation kinetics of acetaminophen were evaluated using synthetic membranes and followed a zero-order kinetic.     

Decomposition of Water Distribution Networks

This paper generalizes the class of design problems for water supply systems which can be solved by mathematical programming. The goal is to design a least cost water supply system to satisfy minimal pressure head requirements at specified rates of usage for multiple customers. The generalization shows how parametric linear programming can be used to analyze subnetworks of a large supply system and to decompose the large problem into a series of smaller problems. An example is included.