abstract |
The present invention provides a pharmaceutical formulation comprising an anti-Her 2 monoclonal antibody, said pharmaceutical formulation comprising: an anti-Her 2 monoclonal antibody, a buffer solution, an isoosmotic adjusting agent, a protein protective agent, a surfactant and the like. The product is stored for a certain time at room temperature or higher temperature, and the detection shows that the main detection items have no obvious change, and all detection results meet the current quality standard requirements of the product. The pharmaceutical preparation obtained by the invention can ensure the validity period of more than four weeks under the condition of not higher than 50 ℃. Compared with the original medicine preparation, the medicine preparation has better stability and is more beneficial to antibody stabilization. |