ABSTRACT
OBJECTIVE: To explore a new research mode of TCM quality control, provide new ideas and perspectives for TCM quality control and research, improve the quality of TCM products, and promote the healthy development of TCM industry. METHODS: Under the theoretical system of Q-marker proposed by academician LIU Chang-xiao, we put forward the concept of chemical markers, looking for sources of some medicinal herbs (slices) unique and not from other medicinal chemistry as a chemical Marker used for the identification and quality control of Chinese traditional medicine. RESULTS AND CONCLUSION: Cynanchi Atrati Radix Et Rhizoma, Asini Corii Colla and Melanteritum were used as the representatives of plant medicine, animal medicine and mineral medicine respectively to study the chemical markers of genuine and fake products, and to apply them in the preparations such as Nvjin pill and Yigan jiedu capsule, which played an important role in the national drug evaluation sampling test.
ABSTRACT
OBJECTIVE： To provide reference for the formulation of regulatory policies, revision and improvement of standards with the research and summary of Chinese medicine glues in recent years. METHODS： The quality problems of Chinese medicine glues found in national drug sampling inspection since 2012 were summarized, and based on this, the screening of 41 Chinese medicine glues with large production batches and large market share was carried out, and relevant supplementary inspection methods were established. RESULTS AND CONCLUSION： By summarizing the drug quality notices issued by the state and provincial and municipal drug administrations, from 2012 to 2015, it was found that the cowhide feeding in donkey-hide gelatin was serious. From 2015 to 2017, no cowhide feeding problems were found, but the feeding problems of mule and horse skins were extremely prominent. In view of the market problems, seven units completed the screening of 41 Chinese medicine glues, and established 15 supplementary inspection methods, which effectively strengthened the quality control and standardized the industrial order of Chinese medicine glues.
ABSTRACT
OBJECTIVE: To establish an HPLC-MS/MS method for the inspection of illegal use of Woodwardia unigemmata, an adulterant of Dryopteris crassirhizoma, in Kanggan granules. METHODS: The content of kaempferitrin in Woodwardia unigemmata is significantly higher than that in Dryopteris crassirhizoma. Therefore, the content of kaempferitrin can reflect the material usage(Woodwardia unigemmata or Dryopteris crassirhizoma) in Kanggan granules. C18 column was applied with a mobile phase consisting of 0.02% formic acid acetonitrile(V/V)-0.02% formic acid H2O(V/V) in gradient elution mode. The mass spectral analysis was performed in a positive electrospray ionization mode, and scanned by a multiple reaction monitoring mode. The precursor/product ion pair used for quantification was m/z 579.2→287.1. RESULTS: A good linear relationship was obtained in the range of 272.46-5 449.25 pg for kaempferitrin, with the linear regression equation of Y=139.217 2X-2 901.93(r=0.999 6); the average recovery was 94.97%(RSD=0.85%, n=6). Among 12 batches of Kanggan granules, 7 batches from 2 enterprises showed abnormally high contents of kaempferitrin, which indicated illegal use of Woodwardia unigemmata. CONCLUSION: The method is simple, accurate, and reliable, which can be applied to detect the use of Woodwardia unigemmata in Kanggan granules.