Study on Quality Control and Evaluation of Pudilan Xiaoyan Tablets

OBJECTIVE To analyze and evaluate the current quality standards and quality status of Pudilan Xiaoyan tablets for providing evidence for its standard and quality improvement production. METHODS According to the problems found in the standard test, combined with the original medicinal material processing and preparation production process, exploratory research was carried out from the three aspects of authenticity, safety and effectiveness of the drug. Detection and evaluation methods including thin-layer chromatography, baicalin/wogonoside peak area ratio, heavy metals and harmful elements, and determination of the content of multi-index components were established and improved. RESULTS Three companies might have problems such as low-quality feeding, less feed, and irregular processing technology of the original medicinal material, one company had artificially added baicalin index components, and some samples had high levels of arsenic residue. CONCLUSION The overall quality status of Pudilan Xiaoyan tablets is normal. The standards and processes need to be improved.