中药超微粉制备技术及其质量控制研究OA

In recent years,ultrafine powder technology of traditional Chinese medicine has become one of the research hot spots in the moderni-zation of traditional Chinese medicine because of its advantages of significantly improving bioavailability,enhancing efficacy and improving the uniformity of preparations.This paper systematically reviews the progress in this field.In terms of preparation technology,mechanical crushing and low-temperature ultrafine grinding technology tend to be mature,which can effectively solve the problems of thermosensitive component deg-radation and fiber material agglomeration.The new auxiliary means further optimize the particle size distribution and promote the retention rate of active ingredients.In the field of preparation application,ultrafine powder technology drives the upgrading of traditional dosage forms and ex-pands to new drug delivery systems such as nanosuspensions and cataplasms.The quality control research focused on the multi-dimensional eval-uation system.The particle size,wall breaking rate,component dissolution and quality consistency were accurately analyzed by laser particle size analysis,combined with microscopic imaging techniques such as scanning electron microscopy(SEM),chromatography(HPLC,TLC)and fingerprint.In addition,the quality evaluation system based on the QbD concept was gradually established,and the process parameters were correlated with the efficacy to provide a basis for industrial production.In the future,it is necessary to strengthen the process-quality-efficacy correlation research and solve the long-term stability and standardization problems.This paper provides a theoretical reference for the develop-ment and application of ultrafine powder of traditional Chinese medicine.