ABSTRACT
Objective: To analyze various factors that affect the verification result in the verification by using ELISA analyzer and assess the accuracy of verification results of ELISA analyzer. Methods: Through the comparison of verification results and the calculation for the repeatability of measurement standard, the accuracy of standard device was analyzed and verified. Results: Through analyzed the effect of repeatability of operation and standard device, the factors that affected verification results were eliminated. And the accuracy of verification results were guaranteed. Conclusion: In the process of verification for ELISA analyzer, operators should pay attention to the setting of the verification instrument. And the operation regulation can ensure the accuracy and reliability of the measured value of spectrophotometer. Besides, operators also should pay attention to the analysis of verification results and confirm whether the repeatability of the verification results can meet the requirement of practice.
ABSTRACT
Objective To improve medical equipment quality control management module to report medical equipment adverse events,evaluating medical equipment,managing medical metrology certificate and etc.Methods The module with four functions was developed with the original equipment management information system as well as the list structures of eq_measuring and eq_measuring_detailed and Microsoft Visual Studio 2010.Rwesults The system realized the management of adverse events,evaluation,scrapping and certificate,and could be used to master the quality of in-use equipment based on data analysis.Conclusion The system behaves well in stability and usage,and thus is worthy promoting for enhancing medical equipment quality coutrol and management.
ABSTRACT
Objective To improve medical equipment quality control management module to report medical equipment adverse events,evaluating medical equipment,managing medical metrology certificate and etc.Methods The module with four functions was developed with the original equipment management information system as well as the list structures of eq_measuring and eq_measuring_detailed and Microsoft Visual Studio 2010.Rwesults The system realized the management of adverse events,evaluation,scrapping and certificate,and could be used to master the quality of in-use equipment based on data analysis.Conclusion The system behaves well in stability and usage,and thus is worthy promoting for enhancing medical equipment quality coutrol and management.
ABSTRACT
The study is aimed to develop a method in evaluation of the bioactive consistency of cardiotonic pill (CP). HepG2 cell line was employed as a biological detector. After treated with CP for 24 h, gene chip and qRT-PCR were used to select mRNAs that can represent the bioactivity of CP. Then similarity between different batches of CP were calculated based on expression levels of marker genes to evaluate the bioactive consistency of CP. Marker genes were selected according to the criteria as follows:① fold change 1.5; ② potential relevance to curative effects; ③ extensive involvement in the cellular functions and clustering analysis categories; ④ dose-dependent effect. A total of 10 genes were selected as bioactive markers of CP. Angular cosine was calculated to evaluate the similarity between two samples. The method was validated using intra-day precision and inter-day precision. Using angular cosine similarity, the intra-day and inter-day precision were 0.4% and 0.6%, respectively. The similarities of 6 batches of CDPs ranged from 0.992 to 0.999, and 1 batch of Compound Danshen Tablet was 0.534. The established method is specific and accurate, and provides comprehensive and objective evaluation of bioactive quality of CDPs. It can also benefit the bioactive consistency evaluation of other compounds in traditional Chinese medicines.
ABSTRACT
In order to clarify the chemical constituents in Yangxue Qingnao granule, we established a rapid ultra-performance liquid chromatography/orthogonal acceleration time-of-flight mass spectrometry (UPLCQ- TOF/MSE) method. According to the high resolution MS spectra data, fragmentation ion information and retention time, 142 peaks were identified or tentatively presumed by comparison with reference standards data and literature reports. The herbal sources of these peaks were assigned. The results implied that phenolic acids, alkaloids, anthraquinones, phthalides, monoterpene glycosides were included in the main components of Yangxue Qingnao granule. The method is rapid for systematically elucidation of the constituents of Yangxue Qingnao granule and the results would facilitate the quality control of Yangxue Qingnao granule for safe and efficacious use.