Study On Prepration Process And Quality Of The Risperidone Oral Solution

Risperidone is the benzisoxazole derivatives,which is also a new generation of antipsychotics and potent D2 antagonist that can improve positive symptoms of schizophrenia,while causing less drug-induced motor functional inhibition and catalepsy than classical antipsychotics.This paper focuses on the research of preparation process and quality of risperidone oral solution.During the research of preparation process and technology,we used the clarity of the solution,impurities,the main-drug content etc.as the evaluation index for prescription screening of risperidone oral solution,ultimately determined the prescription of risperidone oral solution as follows: risperidone 1g,the benzoic 2g,tartaric acid 6g,sodium hydroxide(appropriate amount),add water to a total volumn of 1000 ml(1000ml).Meanwhile the procedural control points during the preparation such as p H value,temperature etc,of the oral solution were investigated,thus the preparation process was finally determined.Also the detection results for three batches of amplification tests indicate that risperidone oral solution is stable in prescription and process we determined in this paper,suitable for industrial production.In the study of quality standard for risperidone oral solution,the following items were conducted for research in three batches of samples from pilot-scale test,such as inspection for the characteristics and p H value of the oral solution,HPLC identification for risperidone and benzoic acid,test and determination for related substances and content of main ingredients and so on.Hence,the corresponding detection methods were established with good specificity,reproducibility and stability,which can be used for the quality control of the risperidone oral solution effectively.