Standardized Study Of Liposome Release Assay Methods

In recent years,liposomes preparation and other new preparations have been largely developed and marketed.Due to the unique preparation process,structure and properties,the quality control of liposomes differ from traditional preparations.Currently,no matter for research and development of liposomes drug or for quality control of marketed liposomes,lack of validation methods,poor standardization,variation in the release test,and even lack of relese test in some lipomes have made it urgent to establish and optimize the quality control of liposomes,especially release test,to ensure its safe,efficacy and stability.In our research,we firstly studied dialysis method which have been studied by a large number of experts and scholars in recent years.To optimize the uncontrollable factors affecting test results and further achieve standardize mearsurement device,we studied the apparatus of dialysis method,in addition,by studying model drugs with different properties including doxorubicin hydrochloride,vinscritine sulfate and paclitaxel,we examined the scope of dialysis method and the key factors influencing the dialysis method,summarizedthe basic pricinples of establishing and verifyng the dialysis method,standardized the basic requirements for method establishment,verification and usage.We designed and improved the dialysis membrane device which achieved its desired effect in stability,repeatability,and operation feasibility.Currently,the dialysis membrane device is under further in-depth optimization.dialysis method for the Self-designed dialysis membrane device was developed to determine influencing factors related to the three kinds of liposomes drug related and we gained the validation data.Further,with the aim to provide some basic researches and references for testing other liposomes and microparticle systems we established dialysis release test of liposomes doxorubicin hydrochloride,Summarized the applicability and feasibility of dialysis method.