ABSTRACT
To explore the innovation trend of Chinese materia medica (CMM) and provide reference for domestic research and development workers, we sorted out the drugs of CMM approved by China Food and Drug Administration (CFDA) during 2011-2015 through database retrieval, analyzed their drug categories, components, dosage forms, and therapeutic areas, and there were 176 approved CMM registration applications. Among all the 176 approved CMM registration applications, only two approved in class 3, and class 5 has 10, class 6 has 42, and others are three additional CMM categories of class 7-9. There are more compound preparations than on single preparations, and components focus on several key herbs such as Bupleurum and Salvia. Nine dosage forms are mostly focus on capsules and tablets. Therapeutic areas are focus on diseases of genitourinary system and circulatory system. It concludes that innovation of CMM needs to combine CMM theory, learn from modern research and development production technology, and focus on the urogenital system and other areas of increasing demand, and CFDA should also improve the efficiency of the review.
ABSTRACT
Danggui, Agelicae Sinensis Radix, is a widely used Chinese herb to enrich blood, but its quality cannot be effectively assessed by the known chemical markers such as ferulic acid, ligustilide, polysaccharides, etc. A new bioassay was therefore developed to quantify the Enrich-Blood Bioactivity (EBB) for the quality assessment of Danggui raw materials. Danggui sample was first extracted with ethanol and water, respectively. Then the ethanolic extract and water extract were mixed as a test sample to quantify the amount of EBB by mice experiment. The blood deficiency mode in mice was developed by intraperitoneal injecting cyclophospharmide and phenylhdrazine hydrochloride. The quantity of red blood cell was chosen as EBB marker. Cyclosporine A was chosen as a control substance. EBB in analytes was quantified by the amount reaction of parallel line analysis (3, 3') method. The results indicated that the reliability test for quantifying EBB was passed through and the measured value was valid. The analytes showed the significant EBB (P < 0.05). The correlation coefficient was 0.9984 (n=5) between the amount of cyclosporine A (0.035-0.56 g x kg(-1)) and the increased number of red blood cell. The relative standard deviation (RSY) on the amount of EBB was estimated to be 6.15% (n = 6) by six replicated tests, and the confidence limit rate was 26.68% (n = 6). Five Danggui samples, which were collected from different cultivation areas with various morphological characters, showed the variety of EBB in the range of 21.95-44.16 U x g(-1). It is concluded that the developed method is accurate to quantify the EBB of Danggui raw materials, and is therefore suitable to assess its quality.