Development Of RSTD'S Stability And Praeparatum

This research focus on investigating the pyrolytic degradation kinetics of RSTD water solution. The HPLC method was used to determine the constents of the RSTD under different pH, ionic strength, dielectric constant, concentration of surface active agent condition. The effect of linear equation indicate that the pyrolytic degradation kinetics orders of RSTD water solution was 1.The pH_m was about 3. The increase of ionic strength could inhibit the degradation rate. And the decrease of dielectric constant could inhibit the degradation rate. The degrade rate was affected by pH conspicuously. RSTD was steady in acid condition. The addition of surface active agent could inhibit the degradation rate,but the effect wasn't conspicuous. By the experiment of pyrolytic degradation kinetics of RSTD water solution,we could find that the RSTD water solution was not stable,and pH, ionic strength, dielectric constant cluld affect the stability of RSTD. For this reason, we consider that put the RSTD into gelsiccation praeparatum, so we could elevate the RSTD's stability and avoid to add more adjuvant in prescription.Based on the research of pyrolytic degradation kinetics of RSTD water solution, we investigate the prescription and technology of RSTD for injection. According to the characteristic of injection, requirement of technologyand physico-chemical property of RSTD, we bolting the important factor which could effect the quality of injection such as dissolubility, pH, ampoule, frame agent, freeze drying technology. The HPLC method to determine the constents of the RSTD wasn' t reported on literature and only ultraviolet spectrophotometry was reprted. So We established a method for determination of the content and related substances in Roxatidine Acetate Hydrochloride for injection. HPLC method was adopted with a Diamonsil C₁₈ columm (200mm×4.6mm, 5μm),and the mobile phase consisted of methyl alcohol-0.02mol·L^-1 KH₂PO₄ (65: 35, adjust to PH 3.80±0.1 with phosphoric acid ). The UV detection was at 275 nm and flow rate was 1.0ml·min^-1. The columm temperature was 35℃. The linear range for the content of prulifloxacin was 2.0～900.0μg·L^-1(r=0.9999,n=7). The average recovery was from 100.8 % to 101.7 % for the three different levels of the amount of Roxatidine Acetate Hydrochloride,with RSD was from 0.98 % to 1.24 %. This method is simple, rapid, accurate and effective for testing content and related substances in Roxatidine Acetate Hydrochloride for injection. This method is suitable for the quality control of Roxatidine Acetate Hydrochloride for injection.We have investigated the stability of RSTD for injection initially. We evaluatedof praeparatum's appearance, related substances, content in different experiment condition. According to the experiment of influencing factor,we could find that illumination and humidity haven't effected the RSTD's content and related substances, and in megatemperature condition, the RSTD's content and related substances have decreased.