Chinese to English: 关于核酸检测试剂有效性的研究
General field: Medical
Detailed field: Medical (general) | |
Source text - Chinese
对于尚无同类产品批准的核酸检测试剂，考虑到病毒分离培养鉴定方法的灵敏度问题，申请人应当采用病毒核酸序列测定方法或者国家公布的检测方法作为参比方法。
细胞培养采用流加培养工艺，所用培养基均为无动物源培养基，主要步骤包括细胞复苏、逐级细胞扩增、细胞流加培养和产品收获。小试纯化工艺的研究结果为中试规模纯化奠定了基础。
对于各组动物，给药前和给药后于不同时间点进行临床毒性反应观察，血常规、血生化、凝血等临床病理检测，以及免疫表型的检测，并于不同时间点采血进行血药浓度和免疫原性检测。在试验结束后进行毒性反应解剖观察，并对大体解剖发现有变化的组织进行组织病理检查 | Translation - English
As sensitivity of identification method to isolate and culture virus effect the test result of nucleic acid testing reagents, for those reagents, their similar product have not yet been approved, applicants should adopt the viral nucleic acid sequencing method or the test method published by the state as the reference method.
Feeding culture approach is used to culture cells. All culture medium is animal-free culture medium. Main process includes cell resuscitation, cell proliferation step by step, cell feeding and harvest. The results of the small-scale purification process provide foundation for the medium ones.
At first, clinical toxicity reaction should be observed at different time before and after medication. Results of clinical toxicity observation should also take account of the data of Clinicopathologic tests include blood routine, blood biochemistry, coagulation, immunophenotype detection, blood drug concentration collected at different time as well as immunogenicity detection. Anatomic observation of toxic reaction should be taken after the first process. In this stage, tissue with visible changes should be submitted to histopathologic examination. |
English to Chinese: Advanced biomimetic nanomaterials for disease diagnosis
General field: Medical
Detailed field: Medical (general) | |
Source text - English
The physical and mental burden of diseases such as cancers, tumors, cardiovascular diseases and others, required advanced materials and methods for non-invasive disease marker detection, large-scale screening and diagnosis. Biomimetic medical materials are synthetic materials designed to be biocompatible or biodegradable, then developed for use in the medical industry. In recent years, with the development of technology, a variety of biomimetic medical materials with advanced properties have been introduced. Great efforts have been made in the progress of biomimetic medical materials in tissue engineering, regenerative medicine, bioimaging, biosensing and other fields. The latest advance of biomimetic medical materials in disease diagnosis has attracted tremendous interest. | Translation - Chinese
癌症、肿瘤、心血管疾病等其他病症给患者带来巨大的身心负担，需要运用先进的材料和方法进行无创性疾病标志物检测、大规模筛查和诊断。仿生医学材料是一种运用于医学领域，具有良好生物兼容性和可降解性的合成材料。近年来，科技日新月异，各种具有先进性能的仿生医学材料不断被研发出来。仿生医学材料在组织工程、再生医学、生物成像、生物传感等领域取得了长足的进步。仿生医用材料在疾病诊断上的最新进展引起了人们极大的兴趣。 |
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