Study On Quality Criteria And Stability Of Controlled Release Osmotic Pump Tablets

In recent years, due to osmotic pump controlled release formulation with medication to reduce the number of plasma concentration fluctuations can be reduced to maintain the role in a long time, improve patient compliance and so on, which have become a hot research point with domestic and foreign agents. This paper with 5-isosorbide mononitrate and vinpocetine as a model drug, laboratory-made both osmotic pump tablets, the quality criteria and stability of the system depth.The first part (Chapter 2-3) mainly 5-isosorbide mononitrate osmotic pump tablets, the quality criteria and stability of a detailed, thorough and specification. Quality of its character, identification, content, release and related materials etc. have been studied, then, methods for measuring the content of the method validation. The results are in line with the index methodology requirements, in this basis, developed a 5-ISMN osmotic pump tablets draft provisional quality criteria, so as to achieve the quality of its safe, effective, controllable purposes. By influencing factor test, acceleration test, a long-term test, the drugs obtained by the analysis of the stability of information systems to ensure safe and effective clinical use of drugs. The stability study were to determine the 5-ISMN controlled release tablets of the storage conditions for the sunscreen, sealed and kept cool and dry; packaging materials: aluminum seal with outer pocket, inner eye blister packaging using aluminum foil plates, invalid is still investigating.The second part(Chapter 4-5)mainly vinpocetine osmotic pump tablets of the quality criteria and stability were studied in detail. Quality traits, respectively, on the preparation, identification, content and content of the substances were studied, and methods for measuring the content of the method validation. Test showed that the indices method are in line with the requirements on this basis, developed vinpocetine osmotic pump tablets draft provisional quality criteria, so as to achieve the quality of its safe, effective, controllable purposes. By influencing factor test, acceleration test, a long-term experiment, on access to medicines systematic analysis of the stability information, were confirmed vinpocetine osmotic pump tablets of the storage conditions as:sunscreen, sealed and kept cool and dry; packaging materials:aluminum seal with outer pocket, inner eye blister packaging using aluminum foil plates, invalid is still investigating.