ABSTRACT
Objective:To discuss the necessity of upgrade and verification laboratory information management system( LIMS) in drug control institutes. Methods:LIMS was upgraded and validated in a laboratory. Results:The upgrade and verification of LIMS en-sured the primitiveness and accuracy of laboratory date, and improved the work efficiency. Conclusion:The application of LIMS sys-tem ensures the reliability of the date and is of great significance to the development of drug testing organizations.
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Objective:To evaluate the quality status of lithium carbonate tablets and lithium carbonate sustained-release tablets. Methods:The samples were examined in accordance with the statutory standard,and the exploratory studies were carried out. The results were statistically analyzed. Results:In accordance with the statutory standard,among 120 batches of samples, only one was unqualified in dissolution,and the others were qualified. The qualified rate was 99. 2% . Conclusion:The quality of the most products meets the current standard and the quality evaluation standard needs to be improved.
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Objective:To establish a detection method for bacterial endotoxins in nedaplatin for injection. Methods:The experi-ment was carried out and the result was evaluated according to the appendix XIE of Chinese Pharmacopoeia 2010 Vol. II. Results:There was no interference from nedaplatin for injection to bacterial endotoxin in TAL reaction. Conclusion:The method is feasible to detect bacterial endotoxin in nedaplatin for injection, which can replace the rabbit pyrogen test.
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AIM:To construct nine novel L-asparaginase mutants and study their enzyme-activity.METHODS:The mutants were constructed using overlap extension PCR according to the principle of alanine-scanning mutagenesis. The enzyme-activity was detected by Nessler's method. RESULTS:The DNA sequencing showed that the mutagenesis was consistent with the theoretical prediction. The enzyme-activity assay demonstrated that each mutant possessed enzyme activity equal to the original enzyme. CONCLUSION:Through gene modification,epitop of L-asparaginase was changed without activity loss.These results provide foundation for further study of the structure-function relationship of L-asparaginase.