Current situation and the trend in impurity profiling of chemical drugs / 药学学报

Impurity profiling is one of the most important activities in both assuring drug safety and improving the quality of domestic drugs. Since the basic strategy of impurity profile control was put forward in 2010, a mature control procedure for impurity profile in drugs has been formed in China after nearly ten years of continuous efforts. The progress in impurity profiling before 2010 and from 2010 to 2015 have been reviewed. Since 2015, the concepts, analytical techniques and the application of these techniques in this field have developed rapidly. As a result, the progress in impurity profiling of chemical drugs since 2015 was reviewed in this paper. And the views on future development of impurity profiling in drugs were also put forward.

Data mining analysis of prescription rules of traditional Chinese patent medicine containing prepared rehmannia root / 国际中医中药杂志

Objective To analyze the treatment and medication rules of formulae containing prepared rehmannia root in Pharmaceutical Standard of Ministry of Public Health of the People's Republic of China-Traditional Chinese Patent Medicine (referred to as Traditional Chinese Patent Medicine). Methods Through Traditional Chinese Medicine Inheritance Support Platform (V2.5), prescriptions containing prepared rehmannia root in traditional Chinese patent medicine were selected and collected to build the database. Frequency counts,association rules and other data mining methods were used to analyze the frequency of indication syndromes and medicine combination of prescription containing prepared rehmannia root, and the compatibility rule of high frequency drug pairs and the rescription rule of core syndromes were analyzed. Results There were a total of 467 prescriptions containing pepared rehmannia root, involving 28 combinations of commonly used Chinese herbals (support degree 30%). The compatibility source of high-frequency drug pairs of prepared rehmannia root and Angelicae Sinensis, prepared rehmannia root and Astragalus embranaceus were both of Shiquan-Dabu decoction in Taiping Huimin Heji Ju Fang (support degree 40%). There were a total of 81 indication syndromes, and among them, there were 16 kinds of high-frequency indication syndromes (the frequency greater than or equal to 10). The core drug combination of high-frequency indication syndromes of "deficiency of both qi and blood" (137 times) and "deficiency of kidney yang" (63 times) were the subtract of Shiquan-Dabu decoction and Yougui pill in Jingyue Quanshu respectively. Conclusions Prepared rehmannia root is mainly compatible with herbs of nourishing blood, supplementing qi and invigorating yang in the traditional Chinese patent medicine containing prepared rehmannia root. The traditional Chinese patent medicine containing prepared rehmannia root were based mainly on classical prescriptions. This study can provide reference for clinical application and new drug development of pepared rehmannia root.