Application Progress and Quality Control Points of Pre-mixed and Co-processed Pharmaceutical Excipients

OBJECTIVE To summarize and analyze the production technology, application progress and quality control points of pre-mixed and co-processed pharmaceutical excipients. METHODS Domestic and foreign related literatures and pharmacopoeia standards in recent years were reviewed to introduce, comment and prospect the excipients. RESULTS Pre-mixed and co-processed excipients prepared by different processes were various in their properties and applications in pharmaceutical preparations. Therefore, the key points of quality control of those excipients were also different. CONCLUSION Pre-mixed and co-processed excipients play an important role in quality and efficacy of pharmaceutical preparations. Related quality indicators that reflect product safety, functionality and quality uniformity should be improved according to the characteristics of excipients.