Study on Analytical Method of Leachable Substances of Allogeneic Products / 中国医疗器械杂志

Products made from allogeneic tissue are largely used in clinical treatment due to its wide source compared with autologous tissue, causing less secondary trauma of patients and the good biocompatibility. Various organic solvents and other substances introduced in the production process of allogeneic products will leach down into the human through clinical treatment, thus bringing varying degrees of harm to patients. Therefore, it is very necessary to detect and control the leachables in such products. Based on the classification and summary of leachable substances existing in the allogeneic products, the preparation of extract and the establishment of the detection techniques for known and unknown leachable are briefly introduced in this study, in order to provide research method for the study of leachable substances of allogeneic products.

Review of Leachable Substances in Hemodialyzer / 中国医疗器械杂志

With the rapid development of my country's hemodialysis industry, the application of hemodialysis machines has become more and more extensive, but at the same time, the quality control technology of hemodialysis machines is not perfect. Especially for a wide range of leachable substances in dialyzers, there are few studies and detection methods. This study first briefly describes the development of hemodialyzers, and then expounds the common types of leachables, extraction methods, and chromatography and mass spectrometry conditions. It is summarized that the research plan of leachable substances is to determine the type first, then formulate the extraction plan, and then establish the detection method. Finally, we look forward to the research prospects of hemodialyzer leachables, and point out that with the deepening and extensive development of research, it can further promote the healthy development of the hemodialyzer industry.