摘要
Objective: To establish an HPLC method for the determination of the related substances in edaravone and sodium chlo-ride injection. Methods: The column was Kromasil C18(250 mm×4. 6 mm, 5 μm) at the temperature of 30℃. The mobile phase A for gradient elution was a solution containing 0. 2% acetic acid and 0. 2% trimethylamine, and methanol was used as the mobile phase B. The flow rate was 0. 8 ml·min-1, the detection wavelength was 244 nm, and the injection volume was 20 μl. Results: Under the described chromatographic conditions, edaravone was completely separated from its impurities. Edaravone and its impurities had good linear relationships within the range of 0.1 μg·ml-1-3 μg·ml-1(r >0.998). The average recoveries ranged from 90.0% to 110. 0% (RSD<10% , n=9), and the contents of their related substances were all below the limits (0. 3% ). Conclusion: The method is accurate, simple and convenient, which can be used for the determination of the related substances in edaravone and sodium chloride injection.
摘要
Objective: To research and establish an analysis model for chemical drug standards to provide the reference for the standard exploration jobs. Methods:The standard variation was studied by comparing and analyzing every version standard for the same drug to look for the change rule. Results:The standard items of the drug had some change rules in indicator numbers, testing methods and limits according to the order of issue time. The standard development trends could be described by making specific indicators and drawing evolution figures of the items. Conclusion:By the standard analysis model, the same item of the same drug can be compared to provide the reference for data collecting of experts. Meanwhile, formulate standard can be calculated to provide the reference for the standard improvement without drug standards.
摘要
Objective:To enhance the management level of drug emergency inspection. Methods: The emergency inspection of plasticizers was used as the example, and the management in the whole inspection procedures was reviewed to summarize the difficulties and solutions and analyze the management features of drug emergency inspection. Results and Conclusion: There are three keys in successful drug emergency inspection, including correct top-level design, high efficient execution teams and necessary guarantee sys-tems.
摘要
Objective:To provide a new idea for the management of drug inspection standards. Methods: The current manage-ment mode for drug inspection standards was analyzed and studied, the problems and difficulties were summarized, and then a novel i-dea and method of electronic management was formulated. Results: The electronic management for drug inspection standards could solve the problems encountered in the traditional management effectively and improve the management efficiency. Conclusion: The standard management information system can provide drug inspection standards in time and ensure the effectiveness, which is very help-ful to the drug inspection.