Quality Analysis of Compound Yinqiao and Paracetamol and Chlorphenamine Maleate Capsules / 中国药师

ABSTRACT

Objective: Combining with national drug sampling program,to evaluate the current quality situation and problems of compound Yinqiao and paracetamol and chlorphenamine maleate capsules by testing and analyzing 78 batches of samples collected from the realm of drug production and circulation all over the country in 2015.Methods: As the current standard could not control the product quality, and combined the prescribed examination with exploratory research, the method of HPLC was used to determine the contents.GC and TLC was respectively used to identify peppermint oil and study on forsythin.Near infrared spectrum database was established by near-infrared spectroscopy (NIRS), which provided the basis for rapid testing.The results of the prescribed examination and exploratory research were statistically analyzed.Results: There were significant differences in the results of the prescribed examination and exploratory research.Conclusion: The results of exploratory research show that there are many defects in the statutory standards.The product quality of different manufactures was divers, and it is necessary to guide them to improve the preparation process and the quality.More exclusive, accurate and sensitive methods should be used to comprehensively control the quality.