Yiqi Fumai freeze-dried powder for injection was used as a model drug to establish an evaluation method mainly based on bio-thermodynamics profile detection. Fischer function was used to analyze the chemical and biological data In general, chemical chromatogram can distinguish the expired sample and thermal spectrum of biological activity can distinguish special samples exactly. Thus, we established the evaluation method regarding the quality volatility of Yiqi Fumai freeze-dried powder for injection. The method can be used as a useful supplement in quality control as, and it could provide some technical information for quality control of other varieties of traditional Chinese medicine for injection.
Biological Assay ; methods ; Chromatography, High Pressure Liquid ; methods ; Drug Therapy ; Drugs, Chinese Herbal ; chemistry ; pharmacology ; standards ; Escherichia coli ; chemistry ; drug effects ; growth & development ; Humans ; Kinetics ; Powders ; chemistry ; pharmacology ; standards ; Quality Control ; Thermodynamics

Establishment of bioassay methods is the technical issues to be faced with in the bioassay of Chinese materia medica. Taking the bioassay of Coptis chinensis Franch. as an example, the establishment process and application of the bioassay methods (including bio-potency and bio-activity fingerprint) were explained from the aspects of methodology, principle of selection, experimental design, method confirmation and data analysis. The common technologies were extracted and formed with the above aspects, so as to provide technical support for constructing pattern and method of the quality control for Chinese materia medica based on the dao-di herbs and bioassay.
Berberine ; isolation & purification ; pharmacology ; Berberis ; chemistry ; Biological Assay ; methods ; Cluster Analysis ; Coptis ; chemistry ; Drugs, Chinese Herbal ; chemistry ; pharmacology ; standards ; Escherichia coli ; drug effects ; Materia Medica ; standards ; Phellodendron ; chemistry ; Plants, Medicinal ; chemistry ; Quality Control

To set up a new pattern of quality control and evaluation for Chinese medicine. By investigating the limitation of quality control pattern for Chinese medicine, the differences and similarities in the chemical substantial style as well as quality control patterns among Chinese medicine, chemical synthetic drugs and Biologicals, combining with the author's experience on the research of geo-authentic medicinal material and theory of Chinese medicinal nature, a new pattern of quality control for Chinese medicine has been explored and designed. A more rational pattern of quality control for Chinese medicine should be referred to Biologicals instead of chemical synthetic drugs, there are more similarity in chemical substantial style and quality control pattern for Chinese medicine between Chinese medicine and Biologicals than that between Chinese medicine and chemical synthetic drugs. Based on geo-authentic medicinal material and bioassay or biopotency detection, a new pattern of quality control for Chinese medicine could be built and applied.
Biological Assay ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; standards ; Energy Transfer ; Evaluation Studies as Topic ; Medicine, Chinese Traditional ; standards ; Pattern Recognition, Automated ; Plants, Medicinal ; chemistry ; Quality Control ; Technology, Pharmaceutical ; methods

OBJECTIVETo measure the endocrine disrupting chemicals (EDCs) in wastewater and evaluate the EDCs removal efficiencies in the municipal wastewater treatment plants (WWTP).

METHODSA battery of in vitro recombinant yeast bioassays incorporated with exogenous metabolic activation system (rat liver preparation, S9 mix) was conducted to assess the estrogen receptor (ER), androgen receptor (AR), progesterone receptor (PR), and thyroid receptor (TR) ant/agonistic activities of effluents collected from Datansha WWTP.

RESULTSThe indirect estrogenic, anti-androgenic, anti-progesteronic, and anti-thyroidic activities were observed in the influent. The removal efficiencies of EDCs were above 74%, suggesting that the present wastewater treatment processes were good enough to remove most of these indirect endocrine disrupting chemicals.

CONCLUSIONThe incorporation of exogenous metabolic capacity into the test system was valid for the study of indirect effects on ER, AR, PR, and TR.

Biological Assay ; methods ; Endocrine Disruptors ; chemistry ; toxicity ; Environmental Exposure ; Environmental Monitoring ; methods ; Saccharomyces cerevisiae ; genetics ; metabolism ; Waste Disposal, Fluid ; methods ; Water ; chemistry ; Water Pollutants, Chemical ; toxicity ; Water Purification ; standards

Based on the biological activity of endotoxin, we propose a possible new method for detecting endotoxin using a pH- indication system of macrophage culture media. After RAW 264.7 macrophage cells were treated with lipopolysaccharide (LPS), the addition of fluorescein to the LPS-treated media reproductively reduced its absorption and emission spectra (it was a dose-dependent reduction). The advantages of this LPS- detection method were compared with the Limulus Amebocyte Lysate (LAL) test by using purified bacterial LPS (Salmonella minnessota, Escherichia coli, and Pseudomonas aeruginosa). Additionally, the absorption and fluorescence intensity of fluorescein, following treatment of RAW 264.7 cells with a high concentration of Staphylococcus aureus (Gram-positive, lysed bacteria), could not generally be detected by the LAL test, but they were found to be reduced, in a dose-response relationship, with this new system. The macrophage culture system-method might be a good supplement to the LAL assay for detection of LPS, Gram-negative and Gram-positive bacteria.
Animals ; Biological Assay/*methods/standards ; Cells, Cultured ; Comparative Study ; *Contrast Media ; Culture Media/chemistry ; Endotoxins/*analysis ; *Fluorescein ; Hydrogen-Ion Concentration ; Limulus Test ; Lipopolysaccharides/analysis ; Macrophages/*chemistry ; Mice ; Research Support, Non-U.S. Gov't