Toxicological Experimental Study On The Postoperative Analgesia Of Amitriptyline For Anorectal Disease

Object:To lay the foundation for further development of new drug, the article evaluated the safety of Analgesia on the surface of wound which after the rectum and anus operation by using the Simiaojunyi ointment.Method:1. Anus mucous membrane acute and toxicity test:20 rats were divided into comparison group, experimental group. In the experiments, the experimental group gives Simiaojunyi ointment to make the suppositories, integrates the mouse anus by the 20g/kg dosage.The comparison group was applied to vehicle carbomer 20g/kg. The rats were observed the general situation, the performance of poisoning and death, continuous observation of the week.2. Anus mucous membrane irritation test:14 rabbits were divided into experimental group, vehicle carbomer comparison group, blank comparison group. In the experiments, the experimental group gives Simiaojunyi ointment to make the suppositories, integrates the mouse anus by the 1g dosage.The vehicle carbomer comparison group was applied to vehicle carbomer 1g. The blank comparison group was applied to Physiological saline 1ml. Observed anus rectum mucous membrane hyperemia, dropsy situation. Anus mucous membrane Pungency experience which are applied to repeatedly:After applied to them continually for one week,the above mentioned methods were observed anus rectum mucous membrane hyperemia, dropsy situation.3. Skin irritation test:One rabbit unhairing were divided into intactal and damaged skin group and comparison group. Experimental group was applied with Simiaojunyi ointment 1g, comparison group was applied to vehicle carbomer 1g. After applying, the rats were observed the erythemas and dropsy situation and restoreing conditions after excluding subjects. Skin Pungency experience which are applied to repeatedly:After applied to them continually for one week,the above mentioned rabbits and methods were observed not only the daily erythema, edema and mark, but also observe whether there is calm, bleeding points, rough skin or skin is thinner on the application site, and the happening time and extinction time.4. Skin’anaphylaxis test:30 rats were divided into experimental group, negative control group and positive control group. Experimental group wers applied to Simiaojunyi ointment 0.1g, negative control group was applied to vehicle carbomer O.lg, positive control group was applied to 2,4-benzene 0.1ml. The rats were abserved by the skin anaphlaxis reaction conditions.Results:1. Anus mucous membrane acute and toxicity test:After applied with Simiaojunyi ointment, the rats’s diet, urine, activity were normal. The weight, the hemogram and the liver and kidney functions of the experimental rats compared before applied to the body and after 7 days to the control group, no significant difference.2. Anus mucous membrane irritation test:Anus mucous membrane which were applied with Simiaojunyi ointment didn’t have hyperemia and edema.3. Skin irritation test:The intactal skin which one side was applied with Simiaojunyi ointment didn’t have erythema and edema.The same as the side of beening applied with vehicle and the stimulated strength was 0 points without the stimulated reaction. Damaged skin’s irritation test zone which was applied with Simiaojunyi ointment and vehicle has one case each which has erythema (1 point), stimulation intensity was 0.25 points, lower than 0.5 points that without stimulated reaction. Repeated skin irritation test:intactal skin and damaged skin which were applied with Simiaojunyi ointment didn’t have erythema and edema.The same as the side with vehicle stimulate, the strength is 0 points without stimulated reaction.4. Skin’anaphylaxis test:The skin of 10 rats each in the experimental group and negative control group didn’t appear erythema and edema; The stimulate the skin test area of Allergens chloro 2,4 dinitro benzene group appeared erythema since the emergence of drug after 1h,100% allergic test.Conclusion:1. Simiaojunyi ointment did not cause acute toxicity integrity to the rat’s anus mucous membrane.2. Simiaojunyi ointment didn’t have stimulating effect on the the rat’s anus mucous membrane.3. Simiaojunyi ointment didn’t have stimulating effect on the the rat’s intactal skin and damaged skin.4. Simiaojunyi ointment didn’t cause allergic reactions to the skin of the rats.