Objective To evaluate the safety of compound gynecological lotion by using skin irritation test, skin allergy test and vaginal mucosa irritation test. Methods Skin irritation test was used to select 3 healthy skin guinea pigs, the skin of each guinea pig was evenly smeared with compound gynecologic lotion, and the other side of the skin was blank, skin smear was applied for 14d, and observed the skin after 24h of each skin smear. Skin allergy test was used to select 48 healthy skin guinea pigs, which were divided into drug group and two control groups, each group had 16 pigs, half male and half female, then observed the skin and calculated the sensitization rate after the corresponding drug induction and irritation. Vaginal mucosa irritation test was used to select 6 adult female rabbits, which were divided into drug group and control group, each group had 3 rabbits. The rabbit vaginal tissues were taken for pathological observation after continuous administration of 5d and the last dose of 24h. The above tests were all graded and evaluated according to the relevant standards. Results SI of the skin irritation was 0. No anaphylaxis was found in the skin allergy test, and the sensitization rate was 0%. There was no significant abnormality in naked eye observation in vaginal mucosa irritation test, microscopic examination showed only slight congestion and edema in individual animal tissues, no significant abnormal pathological changes were found in the other animals, and SI of vaginal mucosal irritation was 0.34. Conclusion Compound gynecological lotion had no skin irritation, no anaphylaxis, and no irritation to the vaginal mucosa of the rabbit.
Key words
Compound gynecological lotion /
Skin irritation /
Skin allergy /
Vaginal mucosa irritation /
Safety evaluation /
Toxicological test /
Experimental research
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