Pain Posted Toxicity Experiments And Clinical Studies Of Three Formulations

Objective:Study on cancer pain paste toxicity; comparison of coating agent, ointment patch Babu agents, clinical efficacy.Methods:Experimental study on the skin irritation test using animal: both sides self contrast method, observation of medication side skin and skin compared with the control side, no erythema, edema, skin irritation. Includes a single delivery of the skin irritation test and repeated dosing skin irritation test. Acute toxicity experiments comparing pain plaster plaster plaster plaster blank experimental groups of guinea pigs with medical glue paste control guinea pigs in the14d weight gain, the appearance of symptoms, behavioral activity, glandular secretion, breathing, eating, excrement and other toxic manifestations and death, and blood from the heart, determination of blood routine, biochemical index of blood, see pain paste in the short term on guinea pig blood composition and liver function, renal function, electrolyte, blood glucose, blood lipid, myocardial enzymes have no effect. Long term toxicity test is two groups of experimental groups of guinea pigs continuous sticking pain paste45d after taking a group of blood from the heart, compared with the control group at the blood routine, biochemical index of blood had no obvious change, another group of stopping feedingl4d after the blood from the heart, compared with the control group, blood routine, biochemical index of blood without obvious change, stopping medicine after a certain period of time has no effect, if has certain effect after stopping short of these effects is still there.Clinical observation:met the inclusion criteria, participate in the experiment study of the patients with cancer pain in60cases, divided into coating agent group, ointment patch group and Babu group of agents, each giving the corresponding dosage form drugs, after a period of observation and comparison of the groups of patients, pain relief, the antinociceptive effect of the start time and duration, medication quality of life of patients before and after improvement. Result:Cancer stick on guinea pig skin without irritation, single-dose and multiple-dose experiment in guinea pig skin showed no obvious erythema, edema and other skin reaction. Cancer pain with general condition had no effect on guinea pig. Cancer stick on guinea pig weight had no significant effect (P>0.05). Cancer stick in the short term on guinea pig blood composition and liver function, renal function, electrolyte, blood glucose, blood lipid, myocardial enzyme had no significant effect, i.e., no acute toxicity. Blood from the heart to detect blood routine, blood biochemical index, the experimental group and the control group had no significant difference (P>0.05). Cancer stick on guinea pigs showed no long-term toxicity. Blood from the heart to detect blood routine, blood biochemical index, the experimental group and the control group had no significant difference (P>0.05).Ointment plaster group and Babu agent group efficacy similar (P>0.05), coating agent efficacy significantly weaker than the other two groups (P<0.005). Three groups of drugs the onset time of no significant difference (P<0.005). The longest duration of analgesic ointment patch, a Babu agent, coating agent of the shortest.Conclusion:lpain plaster paste is a kind of skin without irritation to the body, no obvious toxic side reaction, high safety and analgesic plaster.2this study observation of three formulations are green environmental protection new topical agents, there are no obvious toxic and side effect of skin. Film coating agent for drug loading is small, the efficacy is not ideal, coating on the surface, has a certain effect on patients’quality of life; ointment plaster has large drug-loading rate, good efficacy, pain duration, convenient use, drug stability, no obvious influence on patients’life and other advantages, disadvantages to save for a short time; Babu agent having the large amount of the drug, moisturizing and strong, good effect, convenient use, long storage time, can be pasted and terminate delivery advantages, disadvantages for melt flow, has certain influence on the quality of life of patients with.