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OBJECTIVE:To investigate the compatible stability of Levetiracetam(Lev)injection with 3 injections. METHODS:Each Lev injection 1000 mg mixed with 0.9% Sodium chloride injection 100 mL,5% Glucose injection 100 mL or Sodium lactate Ringer's injection 100 mL respectively. Under the light condition,at 25 ℃,the color and clarification degree of mixtures were ob-served at different time points within 24 h after mixing;pH value and the number of insoluble particles were determined. The contents of related impurities(impurity A,B,C,D,2-hydroxypyridine)and Lev in mixtures were determined by HPLC. RESULTS:Under above condition,all mixtures were colorless clear liquid within 24 h;pH value had no significant change (RSD<1%,n=7);the number of insoluble particles was no more than the range stated in Chinese Pharmacopeia(2015 edition). Impurity B and C were not detected;the contents of other impurities were in line with the requirements of foreign pharmacopeia. No marked change was noted for relative content of Lev(RSD<1%,n=7). CONCLUSIONS:After mixing with 0.9% Sodium chloride injection,5% Glucose injec-tion or Sodium lactate Ringer's injection,Lev injection keep stable at 25℃within 24 h under the light condition.
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Objective To observe the influences of infusion with normal saline (NS), Ringer solution and hydroxyethyl starch 130/0.4 sodium chloride on blood coagulation/fibrinolysis in rabbits with acute respiratory distress syndrome (ARDS) induced by two-hit of oleic acid (OA) and lipopolysaccharide (LPS).Methods According to random number table, 40 healthy adult male rabbits were divided into sham operation, model, NS, Ringer and colloid groups (8 rabbits in each group). The ARDS model was replicated by sequential injection of OA (0.1 mL/kg) and LPS (500μg/kg) into the ear marginal vein of rabbit. Immediately after injection of LPS, the NS, Ringer and colloid groups were treated by intravenous infusion of NS, lactate Ringer solution and hydroxyethyl starch 130/0.4 sodium chloride, respectively at a speed of 7 mL·kg-1·h-1 for 210 minutes. There was no liquid infusion in model and sham operation groups. At 30 minutes and 210 minutes after LPS injection, the arterial blood was collected and the partial pressure of arterial blood oxygen (PaO2) was measured and the oxygenation index (PaO2/FiO2) was calculated. At 5, 30, 120 and 210 minutes after LPS injection, venous blood was collected, and activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fib), antithrombase Ⅲ (AT-Ⅲ), serum procollagen peptide Ⅲ (PⅢP), tissue plasminogen activator (t-PA) were measured, respectively. After the rabbits were killed by bloodletting at the end of experiment, the lung tissues were obtained, collagen Ⅰ and collagen Ⅲ in lung tissues were detected by immunohistochemistry staining, lung wet/dry weight ratio (W/D) and pathologic score of lung tissues were calculated.Results Compared with sham operation group, at 30 minutes and 210 minutes in model group the levels of PaO2/FiO2 were significantly decreased, and the lung W/D ratios as well as pathologic scores of pulmonary tissues were increased. In model group, the APTT began from 30 minutes while the PT began from 120 minutes to gradually prolong, and the value of Fib was progressively decreased; with a tendency of mild decline, the levels of AT-Ⅲ at all time-points were lower in model group than those in sham operation group (allP < 0.05). The levels of t-PA and PⅢP at all time-points were significantly higher, and the expression levels of collagen Ⅰ and collagen Ⅲ in model group were obviously more strengthened compared to those in sham operation group. Among the three infusion groups, the improvement degrees of PaO2/FiO2, lung W/D ratio and pathologic score of pulmonary tissues were the highest in NS group, lowest in colloid group, and no significant changes in Ringer group. APTT in NS group except 120 minutes was longer, the APTTs at 30 minutes and 210 minutes were shorter in NS group than those in model group (s: 30 minutes: 52.26±18.65 vs. 76.22±16.64, 120 minutes: 90.60±10.66 vs. 83.01±15.88, 210 minutes: 70.44±17.80 vs. 77.04±13.32, allP < 0.05); the prolongation of amplitudes of APTT in Ringer and colloid groups were greater than that in model group, particularly in colloid group, the greatest; the PT in three infusion groups were gradually prolonged, and at 120 minutes and 210 minutes were all longer than that in model group (allP < 0.05). The levels of Fib in those treatment groups were all gradually decreased, the amplitude descent of Fib in NS group was the smallest and that in colloid group, the biggest; the levels of AT-Ⅲ in three infusion groups and model group had similar decline tendency, the descending amplitude being the most significant in colloid group. The levels of t-PA at all time-points in the three treatment groups were lower than those in model group (allP < 0.05). The levels of PⅢP in serum at all time-points were lower in Ringer and NS groups than those in model group (μg/L: Ringer group: 5 minutes: 250.60±36.53 vs. 285.77±65.55, 30 minutes: 248.73±44.41 vs. 302.16±37.73, 120 minutes: 249.14±43.16 vs. 296.09±38.64, 210 minutes: 246.62±44.72 vs. 295.45±42.75; NS group: 5 minutes: 261.89±50.74 vs. 285.77±65.55, 30 minutes: 247.71±50.40 vs. 302.16±37.73, 120 minutes: 246.58±42.27 vs. 296.09±38.64, 210 minutes: 222.73±18.51 vs. 295.45±42.75, allP < 0.05), but there were no statistically significant differences between the colloid group and model group. The expression levels of collagen Ⅰ and collagen Ⅲ in all liquid infusion groups were lower than those in model group (P < 0.05 orP < 0.01), whereas in colloid group were higher than those in NS and Ringer groups (allP < 0.05).Conclusions The infusion of NS, lactate Ringer solution and hydroxyethyl starch 130/0.4 sodium chloride have different influences on the blood coagulation function in ARDS rabbits, among which the effect of NS is the least, while of the hydroxyethyl starch 130/0.4 sodium chloride appears the greatest. The infusion of these three liquids can all decrease the pulmonary fibrous tissue in rabbits with ARDS, and in the mean time can alleviate the lung tissue pathological lesion for a certain degree, the effect of NS and Ringer solution being greater than that of hydroxyethyl starch 130/0.4 sodium chloride.
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OBJECTIVE:To study the compatible stability of Ceftriaxone Sodium with Compound Sodium Chloride Injection or Sodium Lactate Ringer's Injection and study the compatible stability of the simulated in vivo peak concentration of ceftriaxone sodium with instant high concentration of calcium gluconate ion injection. METHODS: The concentration of Ceftriaxone Sodium in the mixture was determined by HPLC,meanwhile,the changes of the mixture in appearance,pH value,and the insoluble particles at room temperature were observed. RESULTS: At 0～2 hours,the mixture of Ceftriaxone Sodium and Compound Sodium Chloride Injection was clear in appearance;however,at 2 hours,it was white cloudy macroscopically,and its pH valued increased,ceftriaxone sodium content decreased and insoluble particles increased. The ceftriaxone sodium content reduced when mixed with sodium lactate ringer's injection. After mixing of simulated in vivo peak concentration of ceftriaxone sodium with instant high concentration of calcium gluconate ion injection,the appearance of the mixture was stable but the concentration of Ceftriaxone Sodium reduced slightly. CONCLUSION: Ceftriaxone Sodium can't be used in combination with Compound Sodium Chloride Injection or Sodium Lactate Ringer's Injection. Whether it is suitable to infuse calcium gluconate when ceftriaxone sodium (iv gtt) reached peak concentration remains to be confirmed in future study.