In-vitro Drug Release Study For PH Sensitive Drug文献综述

开题报告内容：

1. 文献综述

In-vitro drug release testing, is a measure of release of the active pharmaceutical ingredient (API) from the drug product matrix in controlled laboratory environment, is a key evaluation in drug development and quality control. It involves subjecting the dosage form to a set of conditions that will induce drug release and quantitating the amount of drug released under those conditions. In development, it is an essential test in assessing differences between prototypes, predicting the timeframe of API release, and modeling in vivo behavior. During this phase, in vitro conditions are generally selected to simulate in vivo conditions. In quality control it is used to assess conformance of a batch to pre-determined criteria at time of manufacture and to assess the long-term API release stability. Drug delivery offers alot of advantages than conventional free dosage forms does,[1] it does improved efficacy, reduced toxicity, and improved patient compliance and convenience. In this experiment, we compare the anti cancer drug (Doxirubicin) and the Doxirubicin with pH sensitive drug carrier (HH-PAMAM and Histidine) to be released in diffeent pH PBS. [2]Doxirubicin was approved for medical use in the United States in 1974 and it is on the World Health Organizationrsquo;s List of Essential Medicines and known as the most effective and safe medicines, dox is readily available,[3] its also easy to work with since there is alot of researchs done wiith doxirubicin so if we need any references about it, we can easily find it in the journals of previous researchers. Doxirubicin was originally made from bacteria Streptomyces peucetius.[4] The reason we are choosing these pH drug carrier (HH-PAMAM and Histidine) is beause it was previously proved as a pH sensitive drug carrier. As this carrier was designed by one of our senior in lab the person im working with. pH sensitive drugs is the drugs composition which will release itself more to their appropriate pH of the surrounding area inside the body, they will reacts most in expected pH.[5]

1. 研究目标、研究内容及试验设计

1. 研究目标

The purpose of this experiment is to discover a formulation of drugs that will released in intended pH media, to aim a maximum use of drugs to the expected area of the body without damaging any other organs.

2. 研究内容

This researchrsquo;s content of this experiment is the preparation of making pbs in diferent pH for the drugs media, study of pH sensitive drugs behavior in different medium,in vitro testing of drug release.[6]

a. Characterize and determine the drug content, drugrsquo;s medium, and drug release rate in vitro with a dynamic dialysis model.

b.Investigate how much drugs will be released in different pH of the medium and take samples in different interval of time.

c. Evaluate the amount of drugs released in each medium, and calculate the results.

3. 试验设计