文章摘要
刘艳林,谢兰桂,赵霞,孙会敏.三维模型重建法测定药用冷冻干燥用胶塞的表面积[J].中国药事,2020,34(8):934-939
三维模型重建法测定药用冷冻干燥用胶塞的表面积
The Surface Measurement of Medical Freeze-drying Rubber Stoppers by 3D Model Reconstruction Method
  
DOI:10.16153/j.1002-7777.2020.08.012
中文关键词: 三维模型重建法  表面积  测定  冷冻干燥用胶塞
英文关键词: three-dimensional model reconstruction  surface area  measure  freeze-drying rubber stopper
基金项目:
作者单位
刘艳林 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 
谢兰桂 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 
赵霞 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 
孙会敏 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 
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中文摘要:
      目的:建立三维模型重建法测定冷冻干燥用胶塞表面积,并评价其可行性。方法:采用三维模型重建法测定20批冷冻干燥用胶塞的表面积,与传统手工法的测量结果进行对比,评价其准确性和精密性。结果:采用三维模型重建法测量冷冻干燥用胶塞表面积,可以避免胶塞因产生形变而造成的测量误差,相对标准偏差由手工法的1.36%~13.12%降低到0.09%~1.32%。结论:三维模型重建法是一种简单、 高效的表面积测量方法,特别适用于复杂形状的药用冷冻干燥用胶塞表面积的测量。
英文摘要:
      Objective: The three-dimensional model reconstruction method was established to determine the surface area of medicinal freeze-drying rubber stoppers and evaluate its feasibility. Methods: The surface area of 20 kinds of medical freeze-drying rubber stoppers was determined by 3D model reconstruction method, the results of which were compared with those determined by the traditional manual method in order to evaluate their accuracy and precision. Results: The measurement errors caused by deformation of the plastic plug could be avoided by using 3D model reconstruction method to measure the surface area of the freeze-drying rubber stoppers. The relative standard deviation was reduced from 1.36%-13.12% by manual method to 0.09%-1.32%. Conclusion: The 3D model reconstruction method is a simple, efficient, reliable and practical method for surface area measurement and it is especially suitable for measuring the surface area of freeze-drying rubber stoppers with complex morphology.
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