Objective: To determine the LD50 value of mice injected intravenously with Asarone injection, and to establish a standard for the detection of abnormal toxicity of the product.
Method: The weighted regression random unit method (Bliss method) was used to determine the LD50 value of intravenous administration to mice. At the same time, according to the requirements of the 2010 edition of the Chinese Pharmacopoeia, the limit of abnormal toxicity test was determined and the abnormal toxicity standard was formulated.
Result: The LD50 of mice used to determine the amount of Asarum injection was 51.9-153.1mg/kg, which was added to the standard for abnormal toxicity inspection items. The recommended limit value of abnormal toxicity check items is 15mg/kg, and the test results meet the requirements.
Conclusion: Asarum injection is more toxic, and the company's manufacturing process is also toxic. An abnormal toxicity check should be carried out in the quality standard to reduce the adverse effects of the product in the clinic.