ABSTRACT
The Chinese herbal compound formula preparation,which is guided by traditional Chinese medicine (TCM) theories,and based on long-term clinical application,has its unique value.The multi-compound and multi-target characteristics are also features of Chinese materia medica (CMM).The finding and exploration of innovation CMM in modern times should be based on TCM theory and clinical application,as well as the combination of efficacy in the concept of holism and biomedical technology.Key issue in the research,development and evaluation of innovation Chinese medicine is to use to the methodology to illustrate the scientific meaning in according to the clinical application characteristics of Chinese herbal compound formula preparation.During the research and development process,considerations on CMM characteristics should be taken from research evidence,to pharmacodynamics and toxicology studies.Pharmacodynamics researches should reflect the properties of TCM syndrome.Aspects,such as research and application of TCM syndrome model,correspondence between disease and syndrome model,research method of correspondence between syndrome and prescription,identification of biological markers corresponding to CMM pharmacologic effect,are important.So we should catch up the historical chance for TCM development,speedily develop the advantage areas,and promote the modernization and innovation of TCM.
ABSTRACT
The Chinese herbal compound formula preparation was made based on theory of Chinese medicine, which was confirmed by long period clinical application, and with multi-compound and multi-target characteristics. During the exploitation process of innovation medicine of Chinese herbal compound formula, selecting and speeding up the research development of drugs with clinical value shall be paid more attention, and as request of rules involved in new drug research and development, the whole process management should be carried out, including project evaluation, manufacturing process determination, establishment of quality control standards, evaluation for pharmacological and toxic effect, as well as new drug application process. This reviews was aimed to give some proposals for pharmacodynamics research methods involved in exploration of Chinese herbal compound formula preparation, including： ①the endpoint criteria should meet the clinical attribution of new drugs; ②the pre-clinical pharmacodynamics evaluation should be carried on appropriate animal models according to the characteristics of diagnosis and therapy of Chinese medicine and observation indexes; ③during the innovation of drug for infants and children, information on drug action conforming to physiological characteristics of infants and children should be supplied, and the pharmacodynamics and toxicology research shall be conducted in immature rats according to the body weight of children. In a summary, the clinical application characteristics are the important criteria for evaluation of pharmacological effect of innovation medicine of Chinese herbal compound formula.
ABSTRACT
Objective To investigate the effects of Chinese herbal compound formula on plasma endothelin and serum nitric oxide of diabetic rats. Methods The selected SD male rats were induced by streptozotoc (53 mg/kg i.p) and the model rats were divided at random into model contrasted group (MCG), Chinese herbal compound formula treated group (CTG) and ramipri treated group (RTG) while the normal contrasted group (NCG) was set up.CTG were supplied with decoctions of Chinese herbal compound formula, RTG were supplied with solution of ramipri, MCG and NCG were supplied with water. Eight weeks later, the rats were killed and their blood were collected at the same time. Changes of PG, RW/BW, 24 hUAlb, plasma ET, serum NO were observed. Results BG, RW/BW, UAlb, ET and NO of MCG, CTG and RTG were more evidently increased than that of NCG (P