Pharmacodynamics And Safety Study Of Fengliao Preparation

Fengliao prescription is folk recipe from Qionghai of Hainan province and mainly composed of Daphniphylium calycinum Benth.and Polygonum hydropiper L.,which has the effects of clearing away the heat-evil and expelling superficial evils,expelling wind and activating blood flow,eliminating stasis to activate blood circulation,relieving paine,eliminating dampness to stop diarrhea,killing insects and curing gastroenteritis.Fengliao fermentation broth is the extracting solution of Fengliao fermented by Bacillus subtilis.In order to study the action mechanism,drug action and clinical safety of Fengliao fermentation broth and Fengliao decoction,the purpose of this experiment was to establish the ultraviolet-spectrophotometric method for the determination of total flavonoids in Fengliao preparation and carry out a systematic study for the drug action and clinical safety.The experiment results were as follows:1.Optimization of Chinese crude drug and establishment of quality control method.According to effective component contents of raw material detected by high performance liquid chromatography（HPLC）,the fourth Polygonum hydropiper L.and the first Daphniphylium calycinum Benth.were optimized.The detecting method with convenience and precision for total flavonoids in Fengliao preparation was established.The average recovery of total flavonoids in Fengliao decoction was 100.97% with RSD of 1.66%,the average recovery of total flavonoids in Fengliao fermentation broth was 100.56% with RSD of 1.99%.2.Toxicity experiment.The toxicity of Fengliao decoction and Fengliao fermentation broth was determined through the LD₅₀ test,the maximum administration dosage test,and the 30 days feeding test.The result showed that the LD₅₀ of the Fengliao decoction and Fengliao fermentation broth was greater than 45 000 mg/kg,the maximum administration dosage was 300 g/kg,which was 166.67 times the normal persons’ oral dose.In the 30 days feeding test,all the rats were in good health,low-dose of fengliao preparation cauld increase the feed utilization rate.Low-dose,middle-dose and high-dose of Fengliao fermentation broth did not have influence on rats’ blood indexes,but the middle-dose and high-dose of Fengliao decoction could significantly increase the serum ALT levels of rats（p<0.01）.Histopathology in the rats had no abnormal change.3.Pharmacological experiment.The analgesic effect was observed by the acetic acidinduced writhing action model and hot plate induced licking paws of mouse,the anti-inflammatory effect was observed by dimethylbenzene induced ear edema model and acetic acid induced penetration increase of mouse abdominal blood capillary model.The results showed that Fengliao preparation had significant resistant on acetic acid inducing the writhing action（p<0.01）,but had no resistant on hot plate induced licking paws,Fengliao decoction had significant inhibitory action on the increase of acetic acid induced mouse abdominal capillary permeability（p<0.05）,Fengliao preparation had significant resistant effects on the level of swelling in the dimethylbenzene inducing ear edema model（p<0.01）.Fengliao preparation had significant resistant effects on spontaneous movement and intestinal spasm caused by Ach/BaCl₂ for rabbits isolated ileal smooth muscle（p<0.01）,had significant resistant effects on SD rats acute gastric ulcer caused by ethanol（p<0.01）,and significantly reduced the serum IL-1α、IL-1β levels and extravasate HIS level of rats with inflammation caused by albumen（p<0.01）.In conclusion,the pharmacodynamic effects of anti-inflammatory,analgesia,anti-spasm and protecting gastric mucosa of Fengliao preparation were obvious,the toxicity of Fengliao fermentation broth and Fengliao decoctionwas was low,and Fengliao preparation was clinical safe.