Primary Study On The Pyrolysis Database Of Antibiotics

In order to combat the counterfeit and substandard drugs distributed in rural areas of China, the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) have developed a mobile laboratory vehicle system for drug screening tests. However, qualitative and quantitative analysis by traditional chromatographic methods requires reference standards to compare with, which shows limitations during the on-the-spot Mobile Lab screening tests. To solve this problem, according to previous study, reference standards can be well digitalized by Pyrolysis Gas Chromatography. When the data are processed and standardized, a Pyrolysis base will be established, so drug qualitative analysis can be carried out without reference standards in the Mobile Lab.Pyrolysis is defined as the breaking apart of large molecules into smaller ones using only thermal energy. The way a large molecule behaves at elevated temperature is dependent on relative strengths of the bonds which hold the molecule together. The series of pyrolysis products are separated by high performance capillary column. To introduce Pyrolysis gas chromatography to drug analysis and establish a set of rapid, effective and economical methods for evaluation of the quality of drugs is the final destination of the study.The basic research on Pyrolysis gas chromatography data base is carried out and discussed in this thesis. The method developed by previous researcher has been well studied and modified to obtain better results. The influential factors, based on which the new and general method is developed, such as pre-treatment, solvent and capillary column that adopted pyrolysis temperature and parameters of gas chromatography are mainly discussed in the first chapter. Then the new method is applied to analyze the antibiotic reference standards. The standard pyrolysis database with high and low concentrations of the 37 reference standards is elementarily established. At last, different formulations, such as injection and troche are analyzed to study the practicability and limitations of the method.