RESUMO
OBJECTIVE@#Improve the quality of testing in medical device manufacturers clean workshops to ensure the authenticity and reliability of testing data.@*METHODS@#Analyze the problems and influencing factors found in the process of testing of medical device manufacturers clean workshops from 2016 to 2020, and put forward reasonable suggestions to ensure the quality of testing.@*RESULTS@#In the process of testing, there are six factors that affect the quality of testing, including testing personnel, instruments and equipment, testing consumables, testing methods, testing environment and actual operation.@*CONCLUSIONS@#To improve the quality of testing, should strengthen the training of testing personnel, continuously improve the testing quality management system, establish an effective information communication mechanism, find out the influencing factors in time, provide objective, real and effective testing data for medical device manufacturing enterprises, and provide technical support for the production and supervision of medical devices.
Assuntos
Comércio , Equipamentos e Provisões , Reprodutibilidade dos TestesRESUMO
BACKGROUND: α-lipoic acid is named as “nature antioxidant” and “mitochondrial nutrition”. But it is unclear whether α-lipoic acid can be used to protect skeletal muscle with chronic hypoxia exposure, as wel as the relative mechanism. OBJECTIVE: To observe the effect of α-lipoic acid on the antioxidant enzymes and oxidative stress in rat skeletal muscle with chronic hypoxia exposure, and to investigate the relative signaling pathway of α-lipoic acid. METHODS: Thirty-six Sprague Dawley rats were randomly divided into three groups: normoxia control group, hypoxia control group, and hypoxia+α-lipoic acid group. Rats in the hypoxia control group were subjected to hypoxia exposure in normobaric hypoxic tent with 11.3% oxygen concentration. Rats in the hypoxia+α-lipoic acid group were induced by adding α-lipoic acid (0.25%) in the normal diet. Al the interventions were lasted for 4 weeks. RESULTS AND CONCLUSION: α-lipoic acid in hypoxia could markedly enhance the mitochondrial Sirtuin-3 expression, improve the mitochondrial adenosine triphosphate synthesis activity and membrane potential, up-regulate the mitochondrial state 3 respiratory rate, respiratory control ratio and ratio of phosphorus to oxygen, down-regulate the mitochondrial state 4 respiratory rate and promote and up-regulate the activity of mitochondrial antioxidant enzymes such as manganese superoxide dismutase, glutathione peroxidase and catalase, thus inhibiting mitochondrial H2O2 generation rate and reducing mitochondrial malondialdehyde level. The results indicated that α-lipoic acid could improve the efficiency of energy metabolism of chronic hypoxia skeletal muscle mitochondria and inhibit reactive oxygen generation, and it could inhibit the oxidative stress through improving antioxidant enzyme activity of mitochondria. The protection mechanism of α-lipoic acid on hypoxia skeletal muscle mitochondria may be related to the increasing of mitochondrial state 3 respiratory rate.