| Domperidone was producted in batches as the second generation of gastro-kinetic agent, and used widely in medicine for human being, but few reports on veterinary medicine. The study aimed to prepare domperidone injection, and perform its study on quality control, stability, safety test, and pharmacodynamics in order to reach the possibility of use in veterinary clinic, and provide scientific basis for apllication.1. The preparation of Domperidone injection and quality control: According to the norm of injection, Domperidone injection was prepared, and was carried through quality control experiment, The results showed that the Domperidone Injection preparated is transparent and colourless, which pH was 4.4. Sterility test measure up the requirements of the injection.2. Establish the method for determine content of Domperidone in Domperidone Injection:The content of Domperidone in Domperidone injection can be measured by UV-Vis at 284 nm. Method of UV-vis spectrophotometry was established to determine content of Domperidone in Domperidone Injection. The standard curve equation is A = 0.0261C +0.0016 (r=0.9992) in the concentration range of 1~10μg/mL with its recovery rate of 97.07%, (RSD=0.45) and the method was extremely steady. Method of UV-vis spectrophotometry established could be used to determine Domperidone in Domperidone injection.3. Stability experiment of Domperidone injection:Stability of Domperidone injection was assessed by means of illumination stability test, accelebrated test and long-term test. The results show that the contents decreased by 5.19% under fluorescent lamp after 10 days, 2.04% under natural illumination after 7 days with no obvious change of color and content. The color and content didn't change under the condition of 40±2℃, relative humidity (RH)75% for 6 months, only with slight decrease of pH. The validity duration of three batchs of preparation reached 18 months in the long-term test, temperature 25±2℃, RH 60±5%, so validity duration was set 18 months tentatively.4. The security of Domperidone injection:Thrill experiment show it has no stimulate to muscle and blood vessel, hemolysis experiment was negative, pyrogen examine show that Domperidone injection cannot enhance the animal heat of rabbit obviously, indicating the injection accord with the codex. Toxicity experiment show this injection LD50>5 000 mg/kg and its was innocuity .5. pharmacodynamics experiment of domperidone injection: Experiment on rabbit's intestine movement in vivo and in vitro and goat's rumen peristalsis were done. The results indicated that the intestine contracted obviously on condition that domperidone injection was dropped. Compared to the control group, rabbit's intestine moved more quickly, contracted intensely when flushing dose was administrated. The tracing results of domperidone injection's effect on rabbit's intestine in vivo showed that frequency of small bowel peritalsis incresed obviously when the injection was administrated. The result of injection's effect on rumen's peristalsis of goat indicated that the frequency increased obviously after administration 1 hour, peaked 2 hours later, then decreased gradually. The whole course lasted over 8 hours.
|
PDF Full Text Request