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In recent years, with the wide application of magnetic resonance imaging (MRI) equipment in clinical practice, the quality of the equipment causes adverse events, which put pressure on manufacturers, at the same time, it puts forward higher requirements for medical device supervisors. In order to help the medical device supervisors to clarify the key points of verification, this paper analyzes the main risk points in the production process of the product according to the medical device good manufacturing practice(GMP), and puts forward the suggestions for field verification, which has practical significance for the submission of verification efficiency.
Subject(s)
Commerce , Magnetic Resonance ImagingABSTRACT
BACKGROUND:Intra-articular injection of sodium hyaluronate or dexamethasone can relieve pain and increase range of motion after traumatic arthritis. OBJECTIVE:To observe the effect of dexamethasone combined with sodium hyaluronate on traumatic arthritis of rat knees. METHODS:Forty-eight Sprague-Dawley rats were randomly divided into four groups. The anterior ligament of the left knee was resected and the medial meniscus was removed to establish models of traumatic arthritis in al the rats. After 3 weeks, the four groups were respectively injected dexamethasone+sodium hyaluronate (combined group), dexamethasone, sodium hyaluronate, and nothing (control group). After 4, 8, 12 weeks of injection, the samples were obtained for gross observation, anteroposterior and lateral X-ray films and hematoxylin-eosin staining. RESULTS AND CONCLUSION:At 12 weeks after injection, X-ray films showed that there was no stenosis in the combined group, mild stenosis in the dexamethasone and sodium hyaluronate groups, and obvious stenosis in the control group (indicating severe osteoarthritis);hematoxylin-eosin staining exhibited the fibrous cartilage-like tissue grew wel in the combined group, varying degrees of proliferation of fibrous cartilage-like cells were visible in the dexamethasone and sodium hyaluronate groups, and there was a smal amount of fibrosis in the control group. These findings suggest that the combination of dexamethasone and sodium hyaluronate can improve the cartilage repair and restore the joint function.
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<p><b>OBJECTIVE</b>To study the technique of dual-color fluorescence in situ hybridization(D-FISH) and its application value in sperm chromosomes of Robertsonian translocation carriers.</p><p><b>METHODS</b>The technique of dual-color fluorescence in situ hybridization was used. Biotin labelled 13q14.3 specific probe and Digoxigenin labeled 14q11.1 specific probe were used for in situ hybridization of sperm specimens in 2 Robertsonian translocation carriers. Hybridization signals for chromosomes 13 and 14 in the sperm interphase nucleus were counted.</p><p><b>RESULTS</b>Under the microscope, Biotin labeled 13q 14.3 specific probe showed 1 green hybridization signal and Digoxigenin labeled 14q 11.1 specific probe showed 1 red hybridization signal. Interphase nucleus counter-stained with DAPI showed blue. From the total of 3,000 sperm interphase nuclei, the positive rate for 1 green hybridization signal and 1 red hybridization signal was 13q/14q(39.33%), for 1 green and 2 red was 13q/14q, 14q(11.57%), for 1 green was 13q/-(9.27%), for 2 green and 1 red was 13q,13q/14q(12.87%), for 1 red was -/14q(9.87%) and for 2 green and 2 red was 13q,13q/14q, 14q(12.26%).</p><p><b>CONCLUSIONS</b>D-FISH of the human sperm interphase nucleus can be applied to the determination of sperm chromosomes of Robertsonian translocation carriers and the analysis of the laws of chromosomal segregation in the meiosis. The technique can be widely used in such aspects of human reproduction as insemination under the microscope and preimplantation embryos genetic diagnosis.</p>
Subject(s)
Adult , Humans , Male , Chromosomes, Human, Pair 13 , Chromosomes, Human, Pair 14 , In Situ Hybridization, Fluorescence , Spermatozoa , Translocation, GeneticABSTRACT
Objective To investigate the correlation between testicular volume and sex hormone and the pathogenesis of male sterility in Klinefelter syndrome.Methods The sex hormones of the Klinefelter syndrome group(n=20) and control group(n=10) were determined by radioimmunassay.The biopsy of testicular tissues were pathologically sectioned and ultra-thin sections were examined by electron-microscopy.Results There was a significant deference(P
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Objective We studied the ultrastructure of seprmiogenesis of Takydromus septentrionalis. Methods After double fixed with 2.5% glutaric dialdehyde and 1% osmic acid,we observed the paraffin section and ultrathin section by light microscope and transmission electron microscopy respectively. Results There is a series of considerable changes in morphology and structure during the spermiogenesis of Takydromus septentrionalis.These changes include gradual nuclear elongation,chromatin condensation,formation of acrosome,development and fusion of mitochondria,cytoplasmic sloughing and flagellar formation.The course of spermiogenesis can be devided into four stages:Stage Ⅰ,the spermatid nucleus concaved when the preacrosomal vesicle reached the nucleus,increasingly,acrosomal vesicle came into being and acrosomal granules appeared at the bottom of acrosomal vesicle,in a thin layer of granular cytoplasm.the subacrosomal granule was formed,it contacts both the acrosomal granule and the outer nuclear membrane;Stage Ⅱ,the spermatid acrosomal vesicle flattened and chromatin condensed into fibers like short filaments and the nucleus prolonged; Stage Ⅲ,the spermatid nucleus went on prologing and the chromatin fibers in it went on condensing and the chromatin fibers was put in a order of parallel to the longitudinal axis of the nucleus.The proximal centriole and flagellum appeared.Stage Ⅳ,the longitudinal microtubules in Sertoli cells cytoplasm appeared around the sperm head and disappeared till sperm was mature.The acrosomal complex of spermatid was well-developed,and annulus was appeared.The nuclear chromatin condensed to the greatest extent and the nucleus was electron-dense.Conclusion It has great significance of nucleus and cell organelle as taxonomic character of Squamate lizard in the ultrastructure of spermiogenesis of Takydromus septentrionalis.
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The iodine concentration, MIT/DIT and T3/T4 ratios and peroxidase activity in thyroid of the rats fed on endemic goiter region diet of county Chefong in the Inner Mongolia Autonomous Region and control rats injected with 30% iodine oil 0.2 ml besides the same diet were investigated.The result demonstrated that the iodine concentration of thyroid was decreased with increasing of thyroid weight, and the MIT/DIT ,T3/T4 ratios in thyroid and thyroid peroxidase activity of the rats fed on endemic region diet were higher than that of control.These metabolic patterns showed that the rats fed on endemic region diet were in iodine deficient state and consistent with those rats fed on artificial low iodine diet.