Study And Preparation Of Sodium New Houttuyfonate Eyedrops

Objective:1. To observe the topical effects of sodium new houttuynia (SNH) on experimental bacterial keratitis models caused by stapHylococcus aureus and bacillus pyocyaneus. The safety and efficacy of SNH have been primarily evaluated, and the rusult showed potential clinical use. 2. To prepare the sodium new houttuynia eye drops, and the quality standard and the stability have been evaluated.Method: 1. The irritation of SNH have been observed in this experiment. The reactions of each eye, such as conjunctivitis, corneablur and iritis are scored daily. 2. To establish experimental models of stapHylococcus aureus and bacillus pyocyaneus in rabbits, stapHylococcus aureus and bacillus pyocyaneus are inoculated into the stroma of cornea. 3. To observe the therapeutic efficacy of 0.05% SNH, 0.1% SNH and 0.15% SNH on experimental bacterial corneal ulcer, compared with pHysiological saline solution (as negative control) and norfloxacin eye drops (as positive control). The therapeutic efficacy are juded by the area of corneal ulcer and the conjunctivitis scores of the infected eyes.4. To study the prescription and craftwork. 5. According to the related requests of the appendices of Chinese PHarmacopoeia (2005 edition, II part), we perform the quality analysis to the three batches of preparation. 6.With the reference to the appendix of CP, we have investigated the stability of the preparation, including the experiment for the stress testing of preparation: at 60℃and 40℃, light exposure, accelerated test of at 40℃for 6 months and the long-term testing.Results: 1. No irration have been observed at the ocular irritation test. 2. The experimental model of stapHylococcus aureus and bacillus pyocyaneus in rabbits can be successfully established by intrasteomally injection of stapHylococcus aureus and bacillus pyocyaneus. 3. SNH have evident thetapeutic efficacy on stapHylococcus aureus and bacillus pyocyaneus. The thetapeutic efficacy on stapHylococcus aureus is stronger than that on bacillus pyocyaneus. 4. The procedure of preparation was simple, and the quantitative determination was quick, and accurate while was reliable. 5. During the establishment of the detective method, the HPLC method, as well as the proper mobile pHase and temperature were determined to identify the drug and to detect the content of the sample accurately and precisely. The method is validated in the aspects of accuracy, stability and linearity. 6. In the research of quality standard, content limit, character, detection, determination, etc were detected in accordance with related regulation.Conclusions: 1. The results show that SNH have no ocular irrition, and it has good therapeutic efficacy on stapHylococcus aureus and bacillus pyocyaneus. SNHED proved to be an effective acular medication for the therapy of experimental stapHylococcus aureus and bacillus pyocyaneus.The effecitiveness of SNHED in this experiment suggests a role of this drug as a useful ocular antibiotic. 2. The procedure of preparation was simple, and the quantitative determination was quick, and accurate while was reliable.