Application of improved quality evaluation method to Fufang Danshen products / 中成药

ABSTRACT

AIM:To apply improved quality evaluation method for improving current quality criteria of Fufang Danshen products. METHODS:Considering both hydrophilic and lipophilic active components-danshensu,protocatechuic aldehyde,salvianolic acid B,cryptotanshinone and tanshinone ⅡA were selected as five markers. A HPLC method was developed to simultaneously determine their contents,which were used to compare the products from different companies,and different batches from the same company. Similarity factor method was used to evaluate the similarities of in-vitro dissolution profiles. Moreover,accelerated and long-term stability tests were performed to predict the shelf-life of Fufang Danshen products. RESULTS:All of the Fufang Danshen products passed the content requirements of Chinese Pharmacopeia. However,the content variations of the hydrophilic components were much higher than those of the lipophilic components. In dissolution tests,most of the hydrophilic components were dissolved completely while all of the lipophilic components could not be detected. The f2 values showed that there were no similar dissolution profiles among different brands of Fufang Danshen products. The contents of five markers degraded compatible with first-order kinetics processes in both the accelerated and long-term stability tests. The predicted shelf-life of Fufang Danshen products were shorter than those labelled on the products. CONCLUSION:It is suggested that more markers with defined content range instead of lower content limit are required for better control of Fufang Danshen products. Dissolution and stability tests need to be added into the quality control criteria in the Chinese Pharmacopeia.