Compatible Stability Study About Oxiracetam Injection And Other Correlation Medicines

Objective:1. To study the compatible stability of oxiracetam injection and NS, GS and GNS.2. To observe external appearance, determine pH values and oxiracetam concentration after Oxiracetam Injection was mixed with Coenzyme Complex Injection, Citicoline Sodium Injection, Buflomedil Hydrocloride Injection,Ozagrel Sodium Injection, Cinepazide Maleate Injection, Aceglutamide Injection, Meglumine Adenosine Cyclophosphate Injection and Isosorbide Mononitrate Injection in 5% GS, respectively.3. To guide rational administration of oxiracetam injection.Methods:HPLC for determination of oxiracetam was proformed, using Waters 515 system on a Hypersil NH2 column, with the mobile phase of acetonitril:water(95:5), at the detective wavelength of 210nm, with the flow rate of 1.0 ml/min at room temperature. According to the chromatography conditions, content of oxiracetam was determined Oh, 1h, 2h,4h and 6h after mixture.Results:The retention time of oxicaretam was 6.368min under the chromatography condition. The linear range of the calibration curve for determination of oxicaretam was 10～200μg·mL-1, and the LOD was 100ng/ml. At room temperature in 6h, there were no significant changes in pH value and external appearance for mixed solution.3. The content of oxicaretam was decreased after 6h mixed with other correlation medicine.Conclusion:1. Oxicaretam was stable after mixed with 5% GS, so the 5% GS was preferred as the solvent of oxicaretam injection in clinical. But Oxicaretam was not stable after mixed with 0.9% NS,5% GNS and polarized solution, so oxicaretam injection should be prepared just before injection, and the time of infusion should be kept in 2 hours. Oxicaretam injection was avoid mixing with 10% GS.2. The content of oxicaretam was stabled in 4 hours, and decreased in 6 hours after combined with Buflomedil Hydrochloride Injection, Cimetidine Injection, Meglumine Adenosine Cyclophosphate Injection and Buflomedil Hydrocloride Injection, mixed with 5% GS, respectively. So oxicaretam injection should be prepared just before injection when combined with the above injection, and the time of infusion should be kept in 4 hours 3. The content of oxicaretam was stabled in 2 hours after combined with Cinepazide Maleate injection, Acelgutamide injection, mixed with 5% GS, respectively. So oxicaretam injection should be prepared just before injection when combined with the above injection, and the time of infusion should be kept in 2 hours.4. The content of oxicaretam was unstabled after combined with Conenzyme Complex for Injection, Citicoline Sodium Injection, Ozagrel Sodium Injection, Meglumine Adenosine Cyclophosphate Injection, Citicoline Sodium Injection and Buflomedil Hydrochloride Injection, mixed with 5% GS, respectively. Therefore, oxicaretam injection should not be combined with the above injection in clinical.