左炔诺孕酮片是国家基本药物，为事后紧急避孕药，收载于《中国药典》2010年版二部［1］。左炔诺孕酮为全合成的强效孕激素，是消旋炔诺孕酮的光学活性体，活性比炔诺孕酮强1倍。为确保药效，药典采用旋光度鉴别其左旋体。按照国内药检...左炔诺孕酮片是国家基本药物，为事后紧急避孕药，收载于《中国药典》2010年版二部［1］。左炔诺孕酮为全合成的强效孕激素，是消旋炔诺孕酮的光学活性体，活性比炔诺孕酮强1倍。为确保药效，药典采用旋光度鉴别其左旋体。按照国内药检实验室对药典标准使用的一般理解，由于药典标准在起草前已征集过国内企业样品，起草时做过方法学验证，发布前也向社会公开征集过意见，因此药典标准被认为是适用于国内产品的。同时，按照《实验室资质认定评审准则》［2］和《检测和校准实验室能力认可准则》［3］建立的质量管理体系要求，如果实验室在首次使用标准方法检验甲企业产品时，进行了方法确认，那么当该实验室再次使用该标准方法检验乙企业产品时，则无明确规定需要再次进行方法确认。而世界卫生组织（ WHO ）制定的《WHO药品质量控制实验室良好操作规范》（ WHO GPCL ）［4］中却明文规定，虽然药典各论中叙述的方法已经过验证，但实验室在首次检验某特定制剂成品时，仍需确认没有辅料来源的干扰因素。本文中左炔诺孕酮片旋光度测定时遇到的问题恰好说明了WHO GPCL这项规定的实际意义。展开更多
Objective： To present a self-developed experimental system for basic studies of blood perfusion imaging and time-intensity evaluating based on ultrasound contrast agent. Methods ： The experimental system performed t...Objective： To present a self-developed experimental system for basic studies of blood perfusion imaging and time-intensity evaluating based on ultrasound contrast agent. Methods ： The experimental system performed the image reconstruction and time-intensity processing with radio frequency signals. The system was comprised of ultra-high speed hardware data acquisition interface and low computational cost algorithms. The self-made contrast agent ,blood mimic phantom and capillary phantom model were used to validate the experimental system. Results： The images acquired in blood phantoms with linear-array and curve-array transducers were given. The time-intensity curves corresponding to selected region of interestsequence were demonstrated. It was also shown the time-intensity based decay curves and a decay of ultrasound contrast agent under different ultrasound powers. Conclusion： Several suited from two in vitro phantom models show that the experimental system can be used to f blood perfusion and further clinical studies of microvasculature perfusion.展开更多
文摘左炔诺孕酮片是国家基本药物，为事后紧急避孕药，收载于《中国药典》2010年版二部［1］。左炔诺孕酮为全合成的强效孕激素，是消旋炔诺孕酮的光学活性体，活性比炔诺孕酮强1倍。为确保药效，药典采用旋光度鉴别其左旋体。按照国内药检实验室对药典标准使用的一般理解，由于药典标准在起草前已征集过国内企业样品，起草时做过方法学验证，发布前也向社会公开征集过意见，因此药典标准被认为是适用于国内产品的。同时，按照《实验室资质认定评审准则》［2］和《检测和校准实验室能力认可准则》［3］建立的质量管理体系要求，如果实验室在首次使用标准方法检验甲企业产品时，进行了方法确认，那么当该实验室再次使用该标准方法检验乙企业产品时，则无明确规定需要再次进行方法确认。而世界卫生组织（ WHO ）制定的《WHO药品质量控制实验室良好操作规范》（ WHO GPCL ）［4］中却明文规定，虽然药典各论中叙述的方法已经过验证，但实验室在首次检验某特定制剂成品时，仍需确认没有辅料来源的干扰因素。本文中左炔诺孕酮片旋光度测定时遇到的问题恰好说明了WHO GPCL这项规定的实际意义。
基金Supported by the National Natural Science Foundation of China(30270404)Specialized Research Fund for the Doctoral Program of Higher Education(2003069816)
文摘Objective： To present a self-developed experimental system for basic studies of blood perfusion imaging and time-intensity evaluating based on ultrasound contrast agent. Methods ： The experimental system performed the image reconstruction and time-intensity processing with radio frequency signals. The system was comprised of ultra-high speed hardware data acquisition interface and low computational cost algorithms. The self-made contrast agent ,blood mimic phantom and capillary phantom model were used to validate the experimental system. Results： The images acquired in blood phantoms with linear-array and curve-array transducers were given. The time-intensity curves corresponding to selected region of interestsequence were demonstrated. It was also shown the time-intensity based decay curves and a decay of ultrasound contrast agent under different ultrasound powers. Conclusion： Several suited from two in vitro phantom models show that the experimental system can be used to f blood perfusion and further clinical studies of microvasculature perfusion.
