| The prescription of Tianlou Jiedu Xiaozhong Powder came from a folk prescription.It was composed of Paris Root、Arisaema erubescens Schott、Polygonum bistorta 、Kaempferia galanga and Cinnamomum camphora Presl.Tianlou Jiedu Xiaozhong Powder had the efficacy of clearing heat-toxin、detumescence and hemostasis.So the efficacy was significant when it was used to treat diabetic foot ulcers which were caused by wind-heat and stagnation of toxin 、 stagnation of fire and toxin or accumulated dampness-toxin.The study focused on the preparation process,the main pharmacodynamics,acute toxicity and clinical trials of Tianlou Jiedu Xiaozhong Powder,whose object was the folk prescription.Furthermore,the study had got the approval number of hospital preparations of Tianlou Jiedu Xiaozhong Powder.1 The preparation processwe got the preparation process : putting the decotion pieces of Paris Root、Arisaema erubescens Schott、Polygonum bistorta in the drying oven for 8 hours under 80℃,then taking them out for reserving;putting the decotion pieces of Kaempferia galangal in the drying oven for 8 hours under 50℃,then taking them out for reserving;mixing the above decotion pieces had been dried,grinding them into very fine powder,sieving（the seventh sifter）,blending;then getting some Cinnamomum camphora Presl,grinding them into very fine powder;blending all the fine powder by running-in process,sieving;distributing the powder into polypropylene bottles of oral solid drug by 30g/bottle,sealing,putting the bottles sealed into Cobalt 60 ray irradiation sterilization device in the condition of 1GY irradiation intensity,one irradiation in intervals of 4h,each irradiation for 1h,repeated 3 times.2 Research of the main pharmacodynamics（1）Bacteriostasis in vitro test: to observe the effect of bacteriostasis in vitro of Tianlou Jiedu Xiaozhong Powder by liquid test tube method,the result showed that it had certain antibacterial activity for Staphylococcus aureus,Escherichia coil and Pseudomona saeruginosa.（2）Analgesic test: to observe the wrighting times of murine caused by glacial acetic acid,the result showed that Tianlou Jiedu Xiaozhong Powder(1g?kg-14g?kg-1)had certain analgesic action.（3）Mouse auricle swelling test: to observe the inhibiting effect of Tianlou Jiedu Xiaozhong Powder on mice auricle swelling,the result showed that it had certain detumescence effect.（4）Antifebrile experiment: to make fever in rats by subcutaneous injection of household starter cluture,then to observe the antipyretic effect of Tianlou Jiedu Xiaozhong Powder,the result showed that it had certain antipyretic effect.3 Research of acute toxicityAcute toxicity tests on mice,using the product of the dose 3g crude drug·kg-1 or 5g crude drug·kg-1 respectively,once a day,no mouse died;continuously observed for 14 days,no toxic reaction occurred.Therefore,the maximum tolerated dose in mice which were external use with the product was greater than 5g crude drug· kg-1.4 Summary of the clinical research（1）For the improvement in DF,the treatment group had a significantly higher overall respose rate than the control group（90% vs 68%,P < 0.01）.（2）For the improvement in TCM syndromes,the treatment group had a significantly higher overall respose rate than the control group（90% vs 74%,P<0.05）.（3）For the decline in the total score of TCM syndromes,there was significant difference（P < 0.05）between post-treatment and before treatment in both groups and the treatment group had a significantly higher overall respose rate than the control group（P<0.05）.（4）For the decrease in ulcer area,there was significant difference（P < 0.05）between post-treatment and before treatment in both groups and the treatment group had a significantly higher overall respose rate than the control group（P<0.05）. |
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