Objective: Establish an effective experimental strategy to determine the compatibility of rubber closures for drugs.
Significance: Various types of rubber closures with different compositions are available for drug packaging. Many additives of rubber closures can be released from rubber closures and may affect the quality of drugs and pose a risk to human health. In this study, we aimed to determine the relationship between cephalosporin structure, solution clarity, and rubber closure compatibility using volatile components profile of butyl rubber closures.
Methods: Two opposite polarity gas chromatography (GC) systems and GC-mass spectrometry (MS) were used to achieve rapid qualitative determination of the main volatile components in rubber closures. Simulated adsorption experiment was performed to investigate the adsorption of main volatile components in rubber closures by cephalosporins with different side chain structures, and to determine the effects of adsorption on solution clarity.
Results: A volatile components screening library of rubber closures was established and the structures of some volatile component were confirmed. The specific adsorption of the structure of cephalosporins on volatile components from rubber closures was studied.
Conclusion: Based on the results of this study, rubber closures with good compatibility for cephalosporins with different side chain structures can be selected rapidly. This experimental strategy not only facilitates the screening of suitable rubber closures more effectively, but also enables the quick determination of volatile components adsorbed by drugs. 相似文献
Being restricted by the relative larger size requirement, traditional and standard fracture specimens are not applicable for the estimation of fatigue crack growth behavior of some very finite-sized components and precious materials. This study develops a small-sized C-shaped inside edge-notched tension (CIET) specimen which has an advantage of specimen minimization and a wide range of adaptability. A systemic compliance technique for estimating fatigue crack growth behavior of CIET specimen has been successfully constructed and experimentally verified. Groups of fatigue crack propagation rate tests of both CIET specimen and CT specimen for 5083-H112 aluminum alloy were carried out. The resulted da/dN ∼ ΔK curves are heavy affected by specimen configuration and load ratio, and the difference between these da/dN ∼ ΔK curves has been successfully removed by introducing the correction of plasticity-induced crack closure effect. Consequently, the feasibility of CIET specimen for estimating fatigue crack propagation behavior for small-sized components and precious materials has been evidently confirmed. 相似文献