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Objective: hopane Su heat particles Prescription, clinical application and pharmacodynamic study of exogenous fever in children \heat particles may cause adverse reactions. Method: pharmacodynamic study: pyrogenic test in rats, mice writhing test and carrageenan the proinflammatory test, the animals were divided into three dose groups, at the same time set the negative control group and positive control group were observed hopane Su antipyretic, analgesic and anti-inflammatory effects of the heat particles; using double dilution method MIC50, MIC90 values ??and in vivo protection test, observed the heat particles hopane Su vitro and in vivo antibacterial effect; using cell culture experiments, observed heat particles hopane Su antiviral activity. Toxicology studies: Wistar juvenile rats 80 (male and female) were randomly divided into the hopane Su heat particles 40,80,160 g crude drug / kg dose group and vehicle control group, of four test groups, respectively (equivalent to clinical children intended dose of 3.17g crude drug / kg of 12.5,25.0 and 50.0-fold). Ig every day, the intragastric volume 2.OmL/100g, animals consecutive gavage for 30 days and 14 days, withdrawal recovery. Observe general signs of animals, food intake and body weight changes during the test, various anatomical the end of the administration period and recovery of the end of each group of 10 animals (five male and a female), blood hematology, serum biochemical index detection, visual observation of the various organs and organizations weighing organs, to calculate organ coefficient and histopathological examination. RESULTS: Pharmacodynamic Study: the hopane Su heat particles brewer's yeast-induced fever antipyretic effect, can significantly reduce the number of writhing induced by acetic acid (0.6%), swelling of experimental inflammatory also shows a good anti-inflammatory effects; vitro antibacterial test results show that the heat particles hopane Su has a strong kill or inhibit both Gram-positive and Gram-negative bacteria in the test, wider antibacterial spectrum, can be Staphylococcus aureus infections significantly reduce mortality in mice, the mice caused by Staphylococcus aureus infection better protection; vitro antiviral testing results show that the hopane Su heat particles of respiratory syncytial virus and adenovirus significantly inhibited. Toxicological studies: the group of young rats during administration of eating normal activities. Of drug-treated animal body weight compared with the drug before both growth in body weight and food intake of each dose group and the control group showed no significant differences (P gt; 0.05). High-dose group young rats administered 30 days and 14 days withdrawal, serum urea nitrogen was significantly higher (P lt; 0.05). Remaining serum biochemical indicators and hematology testing targets were no obvious abnormalities, between the two groups was not statistically significant (P gt; 0.05). Anatomy animal naked eye the smooth surface of the main organs of the animals in each group, normal color, adhesions, hyperemia. The organ weight coefficient were no obvious abnormalities between the two groups had no statistical significance (P gt; 0.05). Administration of the late and the various organs and tissues of the recovery period, the low-dose group and the control group showed no abnormalities; administered the final pathology prompted middle dose group and high dose group kidney organ toxicity, cortical tubular cloudy swelling and tube type check see; medullary stromal vascular dilatation and congestion, and inflammatory cell infiltration; restore the end, the middle dose group kidneys has been restored, kidney lesions of the high-dose group were still 1/10 did not recover. Conclusion: pharmacodynamic studies, the heat particles hopane Su antipyretic, analgesic, anti-inflammatory, and in vitro and in vivo antibacterial, antiviral activity. The clinical studies have shown that the the hopane Su heat particles in the treatment of children with exogenous fever, TCM belongs the wind thermal relying wet (lag) syndrome type patients with good clinical efficacy. The the young rats long-term toxicity test the hopane Su heat particles 160, 80 g crude drug / kg daily orally administered 2 times, continuous gavage for 30 days, the target organ toxicity of young rats kidney, its toxic dose - response relationship, but resume after the withdrawal. Experiments: hopane Su heat particles administered orally young rats to toxic doses ≥ 80g crude drug / kg, safe dose of 40g crude drug / kg in the dose range of the test.
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