| The study on quality evaluation of amiodarone hydrochloride tablet and other generic drugs in vitro/ vivo is an important content of drug pre-clinical studies. During the study on quality evaluation of generic drugs, it needs to do a thorough check of drug quality to guarantee the safety and reliability of drugs, and ensure the smooth progress of pre-clinical research, as well as the safety of post-marketing drugs. Drug storage conditions and validity of drugs are determined by the stability.Based on Chinese Pharmacopoeia, Britain Pharmacopoeia and relevant guidance of technical regulations, the contents and methods of the quality evaluation of amiodarone hydrochloride in vivo and quality evaluation of Metformin hydrochloride in vitro were established. Quality control is an important means of monitoring the quality of medicines, and it is a concrete manifestation of the quality of controllability. To ensure the quality of amiodarone hydrochloride tablets, its quality standards was studied and compared to foreign quality standards in the first part of this paper. In order to ensure whether the bioequivalence of metformin hydrochloride to the original products, four cycle and four cross bioequivalence study of the four kinds of metformin hydrochloride was conducted in the second part. In this study, HPLC method was established for the main components analysis. This method is of good specificity, sensitivity, precision and stability, and the outcome is reliable. This study make a comprehensive quality control and evaluation for amiodarone hydrochloride tablets, and provide a good quality control and evaluation methods for ensuring the quality of generic drug amiodarone hydrochloride tablets. While the method was established to determine the concentrate of metformin hydrochloride in Beagles plasma by RP-HPLC The method is simple, reliable, accurate, high sensitivity, also in line with the requirement of metformin hydrochloride plasma analysis. The stability research was conducted according to drug stability test guidelines, including high temperature test, humidity test, high light experiments respectively.In chapter 1,study on the quality evaluation of amiodarone hydrochloride tablets which is based on the Chinese Pharmacopoeia, Britain Pharmacopoeia, the relevant generic quality standard technical specifications. The appropriate method was elected for quality evaluation according to the structure and nature of amiodarone hydrochloride.Traits, hardness and friability, dissolution, the main component assay, related substances and other research projects were conducted in the chapter and the appropriate test methods and results of the project was determined finally. Dissolution and related substances is the focus of this chapter. UV spectrophotometry for determining the dissolution and the RP-HPLC method for the determination of related substances as well as the main ingredients content are in line with the requirements of methodology. According to the findings, amiodarone hydrochloride tablets should be in a dry, dark place kept.In Chapter 2, the method was established to determine the concentrate of the metformin hydrochloride in Beagles plasma. In order to speculate the acceptability of the differences in the clinical treatment, that is, substitutability between different formulations, the extent and the rate of absorption of active ingredients were compared to the original products whether there is statistical difference based on the pharmacokinetic parameters under the same experimental conditions. The RP-HPLC method was established to determine Beagles metformin concentrations in plasma, and the linear range was 0.10-15.0μg/mL, in this range, a good linear correlation coefficient r= 0.9996.The lowest detectable concentration of metformin was 0.050 μg/mL, RSD of less than 7%, and accuracy of 83% to 106%, and the recovery was 70% to 90%. Metformin hydrochloride in plasma is freeze-thaw stable, in accordance with the analysis requirements biological samples. |
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