Preparation And Clinical Trials Of Effervescent Suppositories Of Gongdejian

Gongdejian, as a kind of traditional Chinese medicine preparation, had been used to treat the endometritis in dairy cows. Prophase clinical experiment of Gongdejian effervescent suppositories had achieved very good curative effect. The cure rate and the pregnancy rates after an insemination achieved92%and67%, respectively. This research on the dosage forms had been modified, and had successful developed effervescent suppositories of Gongdejian. The quality, the security, anti-inflammatory effect, the minimal inhibitory concentration in vitro, effect of medication in goats suffered the experimental endometritis and endometritis in cattle treated with Gongdejian effervescent suppositories were studied.On the basis of the studies and the literature reported, Polyethylene glycol-1000was chosed as the matrix of effervescent suppositories of Gongdejian, and citric acid and sodium bicarbonate as effervescent disintegrating agents, and Twain-80as surfactant, and1%of potassium sorbate as a preservative, and PEG-1000and anhydrous alcohol (a mixture ratio of9:1) as the effervescent suppositories coating material. Quality inspection of Gongdejian effervescent suppositories show that the appearance characters, the weight difference, the color and luster all conform to China pharmacopoeia (2005edition) regulation. Stability test showed that the Gongdejian effervescent suppositories were sensitive to temperature and humidity.In acute toxicity tests, Mice stomach were irrigated with the maximum concentration (lg/mL)and the maximum volume drug (0.4mL/10g body weight), the LD50had been not measured, so we changed to do maximum dosage experiment, the results showed the maximum dosage was more than40g/kg body weight.In the anti-inflammatory experiments of Gongdejian effervescent suppositories, both of 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 effervescent suppositories to the E coli, Staphylococcus, Pseudomonas Aeruginosa and Streptococcus were0.05,0.25,0.25,0.1g/mL, respectively.The establishment of endometritis model in goats:The E coli that was separated and purified from the clinical cases suffered endometritis as strains; the establishment of the goat’s endometritis model was through the intraoperative intubation of uterine horns. Goat’s endometritis model had been successfully established, according to the clinical symptoms inspection and laboratory tests.Gongdejian effervescent suppositories for the treatment of goat endometriosis:18goats were randomly divided into3groups, Ciprofloxacin group, Gongdejian effervescent suppositories group and physiological saline group. After3-4times medication at a3d-interval, the systemic situation and physic-chemical characteristics of uterine effluent were recovered.From secretion of diseased cows E.coli, staphylococcus aureus, pseudomonas aeruginosa, streptococcus were isolated. Susceptibility test results showed that cephalosporin and quinolone had highly sensitive to the above bacteria. After three times in medicine, systemic situation of cows and uterine effluent physical-chemical status were be improved obviously. Treatment effect of Gongdejian effervescent suppositories resembles that of ciprofloxacin group.