动物造模 z-bio 2022-09-02 674

　　OBJECTIVE: To determine the LD50 value of mice intravenously administered with Asarum injection preparation, and to draft the abnormal toxicity inspection standard of this product.

　　Methods: The weighted regression probability unit method (Bliss method) was used to determine the LD50 value of mice administered intravenously. At the same time, the abnormal toxicity inspection limit was determined according to the requirements of the 2010 edition of the Chinese Pharmacopoeia, and the abnormal toxicity standard was drafted.

　　Results: The LD50 of mice determined by Asarum injection preparation was 51.9-153.1 mg/kg, which is the abnormal toxicity check item to be added in the standard. The limit of abnormal toxicity check item is recommended to be 15 mg/kg. The results are in compliance.

　　CONCLUSION: Asarum injection preparations are highly toxic, and the toxicity of different production processes in different enterprises is also quite different. In order to reduce the occurrence of adverse reactions in clinical use of this product, abnormal toxicity check items should be added to its quality standards.