Study On Preparation Process And Quality Standard Of Amisulpride Tablets

Schizophrenia is a kind of severe mental disease that is liable to disability. As a representative of the 2nd generation of atypical anti-psychosis drugs, Amisulpride has a good tolerance in clinical experiments. Amisulpride results in less occurrence of side-effect to the pyramid peripheral system than Haloperidl, while it produces less body weight increase than Risperidone or Olanzapine. At the same time, unlike those drugs, Amisulpride seems to create no occurrence of diabetes. Amisulpride (ASP) is a new version of atypical anti-psychosis drug with outstanding advantages especially used to treat those patients with negative symptoms. The drug was approved to put on market by the FDA of the United States in January of 1997. It has not been approved to produce within China now.This study was carried out on the basis of the development of Amisulpride's raw material composition, and focused on the preparation and its quality control, so as to provide lab data of Amisulpride Tablet for the preclinical and clinical study.Firstly, considering the fact that the drug has a low dissolubility in water, the formulation and process were optimized with the index of the preparation's fragility and disintegration time limit. Based on the study above, the optimal formulation was determined. The result showed that the formulation is reasonable, and the preparation has a good disintegration as it can disintegrate completely within 3.5 minutes. Secondly, the preparation's quality control was studied. UV spectrometry and HPLC methods were established for the analysis. The dissolubility test method was also established. The above methods were proved to be exact and sensitive. Microbial limits assay was also carried out for Amisulpride Tablet. To study the preparation's stability, the affected factor test, speed-up test and long-term test were conducted.The formulation and production process of Amisulpride Tablet were confirmed by the study. On the meantime, the quality standard of the preparation was established on this basis.