Preparation And Evaluation Of The Gel Of Gongdejian

Gongdejian, as a kind of uterus perfusion solution, was a single TCM used to treat the endometritis in dairy cows. It was based on the modern research materials of Chinese herbal medicine and effectively medical prescription. The curative effect of prophase clinical experiment was predominance. The recovery rate and the pregnancy rate at first insemination were 92% and 67%. But the shortcoming of big usage amount and some medicine's discharging when uterus contracted had cut down its availability and action time. Based on this reason, we tried to make it have the characteristics of adhesion and slow-release effect and changed the aqua to gels by follow experiments.On the basis of the studies and the literature reported, we chosed carbopol,a kind of polymers,as the excipient---matrix of Gongdejian gelata,propylene glycol, glycerin as humectant, ethanol as bacteriostatic or transdermal enhancers, trolamine as pH regulation. Take carpool's concentration, flow ability, rotation speed and temperature into account, Gongdejian gels was optimized by orthogonal design method.we chosed 0.8% CP solution as the best concentration, The preliminary stability was observed through the tests of heat proof and cold-resistant,centrifugation acceleration and remained sample observing, the result showed that the drug content of the gels was not obviously changed during the above experiments;Its pH was 6.9;The content of berberine hydrochloride was 0.1921 mg/mL through assaying to the gel with spectrophotometric method.In the test of pharmacodynamics and Toxicology, The result of anti-inflammatory test indicated that the high dosage group (0.2mg/10g.b.w) and the middle dosage group (0.1mg/10g.b.w) could obviously inhibit (P<0.05) the swelling of mice's ears which was caused by xylene, as well as the accrementition of granulation tissue caused by cotton balls. The antibacterial test in vitro showed that the minimum inhibitory concentration (MIC) of Gongdejian gel to the Escherichia coli, Staphylococcus, Pseudomonas and Streptococcus were 0.025, 0.1, 0.25, 0.5g /ml, respectively. In acute toxicity tests, there was no Guinea pig dead no paradoxical reaction,also no pathological change in tissue slice of vaginal wall,so the Gongdejian gel is avirulent and nonirritant to vaginal mucosa; The dermal sensitivity test showed that there is no adverse reaction as erythema, papula and bubble, so the Gongdejian gel had no sensitization to Guinea pig.In the test of adhesive force in virto,Compared to physiological saline and Gongdejian aqua, the relative adhesive force of Gongdejian gel was16.68 g/cm2;Results of in vitro release study revealed that the accumulative release rate of Gongdejian was 54.26%% 2h after incubation and it rose to72.16% 24h later. The release process went to a balance condition48h later. We fitting the release curve by first order kinetic equation and Higuchi equation, the result was that it conforms to Higuchi equation(.regression coefficient were 0.9951), so the Gongdejian gel accords with the standard of slow-release medicine.The goat endometritis model was set up in therapeutic test, we made uterus intubation at first, then Escherichia coli, Staphylococcus aureus, streptococcus,Pseudomonas aeruginosa were injected into cavitary uteri;24 goats were randomly divided into 4 groups, physiological saline group, Ciprofloxacin group, Gongdejian aqua group and Gongdejian gel group, we infused the above-mentioned material into the cavity of uterus by uterine horn intubation respectively, 5 days as a course of treatment,after 3 course of treatment,the physics and chemistry character of uterus secretion of Gongdejian gel group and Ciprofloxacin group improved obviously,the goats recovery at last. So Gongdejian gels had a good curative effect to goat endometritis.