| abstract |
The invention provides a pharmaceutical composition of polyethylene glycol-modified camptothecin derivatives and a preparation method thereof, which are mainly prepared from the following components: polyethylene glycol-modified camptothecin derivatives, pH adjustment preparations and water for injection, and the pharmaceutical composition contains 100-500 mg of polyethylene glycol-modified camptothecin derivatives. The pharmaceutical composition of the polyethylene glycol-modified camptothecin derivatives of the present invention has high stability and meets the requirements for molding and quality of the preparation. In the preparation method, adjusting the pH of the drug-containing solution effectively improves the preparation of the preparation. The stability of the pharmaceutical composition, and through the industrial scale-up production, the pharmaceutical composition has been proved to have very good process stability through the investigation of the influence factor test, the compatibility stability test, the accelerated test and the long-term test. |