Testing of the Safety and the Effectiveness of Using SamjeongPharmacopuncture Solution as Eye drops

OBJECTIVE: This experimental study was designed to investigate the safety and the effectiveness of Samjeong pharmacopuncture solution (SPS) manufactured by using a the lowtemperature extract on process. METHODS: To identify the safety and the effectiveness of using SPS as eye drops, we performed applied eye irritation tests on rabbits and antibacterial tests for Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans. The eye irritation test was performed according to the toxicity testing regulation of the Korea Food & Drug Administration (2009. 8. 24, KFDA 2009-116). After SPS had been applied on the left eye of the rabbits, eye irritation in the cornea, iris and conjunctiva was observed on the 1st, 2nd, 3rd, 4th & 7th day. After SPS had been dropped on bacterial species that cause keratitis, the minimum inhibition concentration and the size of the inhibition zone were measured. The anti-bacterial potency was also measured by taking the size of inhibition zone. RESULTS: After SPS had been administered on the left eye of the rabbits, none of nine rabbits were found to show abnormal signs or weight changes. After SPS had been administered on the left eye of the rabbits, no eye irritation in the cornea, iris and conjunctiva was observed on the 1st, 2nd, 3rd, 4th & 7th day. No specific response was detected in MIC for bacterial species Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans after SPS had been applied. CONCLUSIONS: This study suggests that SPS is a non-toxic and non-irritant medicine that does not cause any of eye irritation in rabbits, but it has no antibacterial effects on bacterial species that are well known to cause keratitis. These results suggest that more research is required on extracts from herbal medicines for treating keratitis.