1.Review of Leachable Substances in Hemodialyzer.
Ziqi LIU ; Zhuoying CHEN ; Haiyang FU ; Bufang FU
Chinese Journal of Medical Instrumentation 2022;46(4):417-421
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.
Humans
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Kidney Failure, Chronic/therapy*
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Kidneys, Artificial
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Renal Dialysis
2.Study on Analytical Method of Leachable Substances of Allogeneic Products.
Zhuoying CHEN ; Ziqi LIU ; Lijing HAO ; Bufang FU
Chinese Journal of Medical Instrumentation 2023;47(3):332-336
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.
Humans
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Hematopoietic Stem Cell Transplantation
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Drug Packaging
3.Research on Characterization and Biocompatibility of 3D Printed Ti-6Al-4V Pelvic Prosthesis
Yuchen CAI ; Jiale GUO ; Bufang FU
Chinese Journal of Medical Instrumentation 2024;48(3):257-263
The treatment of bone defects caused by fractures or bone tissue lesions has always been a difficult problem in the field of orthopedics.Implantation of high-performance titanium alloy prosthesis is an effective method to treat bone defects.3D printing technology can produce low-modulus titanium alloy implants with porous structures,providing a better solution to the above problems.This technology is convenient to design and has a huge advantage in making orthopedic implants.The article used electron beam melting in 3D printing technology to create two samples of Ti-6Al-4V prosthesis,including solid structural pelvic prosthesis and porous structural pelvic prosthesis.The mechanical properties of the prosthesis showed that the yield and tensile strengths of the rod tensile specimen were 894 MPa and 956 MPa,respectively,and the compressive modulus and compressive strength of the porous pelvic prosthesis were 55 GPa and 65.2 MPa,respectively.The results of the L929 cytotoxicity assay and the MC3T3-E1 cell adhesion assay demonstrated good biocompatibility of the prosthetic samples.New Zealand white rabbits were used to prepare the femoral joint cavity defect models and two pelvic prostheses were implanted.A microscopic CT scan 4 weeks after implantation showed that the bone defect caused by the drill had healed and that the porous structure of the pelvic prosthesis formed a new trabecular structure within the hole.In conclusion,the 3D printed Ti-6Al-4V pelvic prosthesis has excellent mechanical properties,biocompatibility,and the ability to promote new bone growth.