Studies On Topotecan Hydrochloride For Injection

Topotecan hydrochloride which has been sold at home and abroad has definite effect on small cell lung cancer and has low effect.Therefore,as the first choice for treatment the small cell lung cancer drugs.The Topotecan hydrochloride has a huge market and wide prospect.According to the new classification requirements for drug registration,this product belongs to the four categories in chemical medicine.In accordance with the relevant requirements,the developed product should guarantee the feasible and the quality of the product is consistent with the reference preparation.In tiis way,it can replace the original drug in clinic.As the same time,it can reduce the medical costs.For this purpose,we began to study th Topotecan hydrochloride.According to the characteristics of dosage forms and material,in the course of research on prescription technology,we study the following indicators:material selection,pH range temperature,liquid temperature,avoiding light or not,filling nitrogen in liquor or not,selection and optimization of freeze-drying process parameters and establishment the technological parameters and preparation of this product.Take 80%of the total injection water into the liquid tank,and then add indirect materials into the tank and stir to dissolve.Adjusting the pH to 2.8 with 0.2 mol/L sodium hydroxid.Subsequently,add the main medicinein into the tank and stir to dissolve.We tested the intermediate,aseptic filtration,bottling,partially stoppered,freeze-dried,tamponade and rolling cover,light inspection,full inspection and the product finished.We have established some method for measuing injection of Topotecan hydrochloride quality standard including the character,identification,solution acidity,the clarity and color of dissolve,moisture content,completeness and dissolving time,related substances,the bacterial endotoxin,sterile and content.We also tested the related substance and the content by HPLC).As the same time,we had carried out relevant methodological verification test;We performed some method for related substances,including screening material inspection methods,durability test,solution stability test,the specificity test,determination of relative corresponding factor and detection limit;For determination Content,suitability test,durability test,the specificity test,linear test,stability test,repeatability test solution and test accuracy had been used;The results show that the method is good repeatability and high accuracy.Research results show that this technology is feasible and the product is stable.The developed product is consistent with the reference preparation quality.