Application Study Of Hl60-Il6 Method In The Detection Of Collagenase And Urokinase Pyrogen For Injection
Keywords
Hl60-Il6 Monocyte Activation Reaction Method, Collagenase, Urokinase
Abstract
Objective To explore the application of HL60-IL6 monocyte activation reaction method in the detection of collagenase and urokinase pyrogen for injection. Methods: The minimum effective dilution concentration of collagenase and urokinase for injection was determined with reference to General Chapter 1193 of the 2015 edition of the Chinese Pharmacopoeia. Through the cell proliferation inhibition test, pyrogen interference test and interleukin-6 (IL-6) interference test, the concentration of the test substance that has no effect on the growth of HL60 cells and the determination of pyrogen and IL-6 is determined to determine the appropriate HL60-IL6 method for in vitro pyrogen determination of collagenase and urokinase for injection. Use this method to conduct pyrogen determination on 2 batches of collagenase for injection and 19 batches of urokinase for injection. Results The minimum effective dilution concentration of collagenase for injection was 0.04 U¡¤mL-1. When the concentration was ¡Ü 60 U¡¤mL-1, it had no effect on the growth of HL60 cells. When the concentration was ¡Ü 6 U¡¤mL-1, it had no effect on IL-6 and pyrogen. No impact on the measurement. The minimum effective dilution concentration of urokinase for injection is 100 U¡¤mL-1. When the concentration is ¡Ü 1 000 U¡¤mL-1, it has no effect on the growth of HL60 cells. When the concentration is ¡Ü 500 U¡¤mL-1, it has no effect on IL-6 and pyrogen. No impact on the measurement. Therefore, the concentrations of collagenase and urokinase for injection suitable for the HL60-IL6 monocyte activation reaction method are 6,500U¡¤mL-1 respectively. This method was used to measure pyrogens on the test products, and no pyrogens were detected in the results. Conclusion The HL60-IL6 method is suitable for the determination of collagenase and urokinase pyrogen for injection.
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Original research was done by Wang Can, Wang Naruto, Shao Hong, Zheng Luxia, Chen Gang
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