差示—线性组合导数光谱法测定扑咳灵片中扑尔敏和溴化丙胺太林

本文提出了差示一线性组合导数光谱法用于测定混合组分体系的基本原理和实验方法。并试用本法消除了扑尔敏、溴化丙胺太林、灵芝粉及附加剂之间的相互干扰,从而分别测定了扑咳灵片巾扑尔敏和溴化丙胺太林的含量,其平均回收率分别为100.2±1.49％(CV)和99.89±1.03％(CV)。其精密度、准确度均好。     

Effect of Spray Drying and Subsequent Processing Conditions on Residual Moisture Content and Physical/Biochemical Stability of Protein Inhalation Powders

Purpose. To understand the effect of spray drying and powder processing environments on the residual moisture content and aerosol performance of inhalation protein powders. Also, the long-term effect of storage conditions on the powder's physical and biochemical stability was presented. Methods. Excipient-free as well as mannitol-formulated powders of a humanized monoclonal antibody (anti-IgE) and recombinant human deoxyribonuclease (rhDNase) were prepared using a Buchi 190 model spray dryer. Residual moisture content and moisture uptake behavior of the powder were measured using thermal gravimetric analysis and gravimetric moisture sorption isotherm, respectively. Protein aggregation, the primary degradation product observed upon storage, was determined by size-exclusion HPLC. Aerosol performance of the dry powders was evaluated after blending with lactose carriers using a multi-stage liquid impinger (MSLI). Results. Spray-dried powders with a moisture level (~ 3%) equivalent to the freeze-dried materials could only be achieved using high-temperature spray-drying conditions, which were not favorable to large-male manufacturing, or subsequent vacuum drying. These dry powders would equilibrate with the subsequent processing and storage environments regardless of the manufacturing condition. As long as the relative humidity of air during processing and storage was lower than 50%, powders maintained their aerosol performance (fine particle fraction). However, powders stored under drier conditions exhibited better long-term protein biochemical stability. Conclusions. Manufacturing, powder processing, and storage environments affected powder's residual moisture level in a reversible fashion. Therefore, the storage condition determined powder's overall stability, but residual moisture had a greater impact on protein chemical stability than on powder physical stability.     

Quantitative coronary arteriography: design and validation

The authors assessed the performance of an automatic and rapid coronary quantification method by evaluating its accuracy in a stenosis phantom. Measurements were obtained with a lucite phantom with 2-, 3-, and 4-mm vessel diameters and concentric stenoses of 33%, 50%, 67%, and 75%. Direct digital angiographic images as well as 10 X 10 spot films and 35-mm cine angiography films were acquired with and without structural noise and mask subtraction. The films were digitized with magnification factors of one and two. An interactive analysis program was used to automatically determine the vessel edges with a Gaussian fit to the cross-sectional density profiles perpendicular to the center line of the vessel. Relative changes of the densitometric cross-sectional area along the vessel were used to assess the percentage of stenosis. Densitometric measurements were comparable in both digital and cine angiograms (r = .99 and r = .98, respectively); however, diameter measurements showed a higher variability and were dependent on the amount of magnification applied to the images.