Study On The Preparation And Pharmacodynamics Of Ruyankang For Injection

Ruyankang for injection was prepared, taken Amikacin and Tilmicosin as primary medicines. Stability, security and pharmacodynamics were studied in order to provide proof for clinic practice.1. Design of prescription Anti-bacterium test was carried out using scrip diffusion method with bacteria coursed dairy cow mastitis, such as Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus aureus and E.coli in vitro. The best proportion of Amikacin and Tilmicosin was 2: 3. The result of UV scanning suggested that supplemental agents of Ruyankang for injection were citric acid and citrate sodium, and their best proportion was 7:3. According to the proportion determined above, Ruyankang for injection was prepared in asepsis environment.2. Quality control According to the standard of injection, the sterility test, clarity test, pH was inspected. The results suggested that the pH of solution of Ruyankang for injection was from5.79 to 5.82. There were no evident foreign substance, no pyrogen and no bacterium.3. Stability test The high temperature test, high humidity test and light stability test were carried out. The results showed that Ruyankang for injection was sensitive to the high temperature and high humidity, but not sensitive to the light. The results of accelerated test showed that physical chemistry property of Ruyankang for injection was stable, consistent with the test request of new drug which reported to a higher authority clinical test. The result of classical constant temperature test showed that the period of validity of Ruyankang for injection was 2.1 years. The result of moisture absorption showed that critical relative humidity of Ruyankang for injection was 65.3 percent.4. Security test Safety of Ruyankang for injection were assessed by muscle stimulating test, response irritative of eye's mucosa, hemolysis test and acute toxicity test.The tests indicated Ruyankang for injection was no irritation and also no hemolytic reaction. The LD50 of chicken was 222.62mg/kg.5. Pharmacodynamics test The minimal bactericidal concentrations (MBC) and the minimal inhibitory concentrations (MIC) of Ruyankang for injection against the bacteria coursed dairy cow mastitis, Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus aureus and E.coli in vitro were tested, and compared with the frequent medicine against dairy cow mastitis used in clinical. The result showed the effect of bacteriostasis of Ruyankang for injection was inferior to Streptomycin, equal to Penicillin G, superior to Kanamycin. The therapeutic efficacy of Ruyankang for injection against subclinical mastitis and clinical mastitis showed the efficient rate of Ruyankang for injection was above 80 percent and the cure rate of the injection was more than 60 percent, superior to Penicillin G, Streptomycin and Kanamycin.