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Objective:To investigate the compatibility stability of muscular amino acids and peptides and nucleosides for injection in different infusions to provide basis for clinical application .Methods: The compatibility stability of muscular amino acids and pep-tides and nucleosides for injection respectively in 0.9%sodium chloride injection , 5% glucose injection , 10%glucose injection and glucose and sodium chloride injection was studied , and the indices included the appearance , pH value , number of insoluble particles and contents of hypoxanthine and polypeptides .Results:All the solutions were transparent .The pH value and the contents of hypoxan-thine and polypeptides showed no significant changes .When muscular amino acids and peptides and nucleosides for injection was mixed with 10%glucose injection , the number of insoluble particles (≥10 μm) was the smallest , which met the requirement in Chi-nese pharmacopoeia (2015 edition,volume Ⅳ).When it was mixed with 0.9% sodium chloride injection, 5% glucose injection and glucose and sodium chloride injection , the number of insoluble particles (≥10 μm) was beyond the limits .The number of insoluble particles (≥25 μm) in all the solutions met the requirement .Conclusion: The most suitable solvent for muscular amino acids and peptides and nucleosides for injection is 10%glucose injection .
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OBJECTIVE:To explore the stability of levofloxacin hydrochloride and carbazochrome sodium sulfonate in 0.9%So-dium chloride injection,and provide reference for their compatible use in clinic. METHODS:HPLC was performed on the column of Phenomenex Gemini C18 with mobile phase A of acetonitrile and B of 0.01 mol/L Ammonium biphosphate solution(adjusted to pH 3.0 with phosphoric acid)(gradient elution)at a flow rate of 1.0 ml/min,the detection wavelength was 295 nm for levofloxa-cin hydrochloride and 364 nm for carbazochrome sodium sulfonate,temperature was 30 ℃,and the injection volume was 20 μl. The changes of contents,appearance and pH value of the solution in the mixture were investigated. RESULTS:The linear range was 7.03-80.06 μg/mL for levofloxacin hydrochloride(r=0.9995)and 1.70-34.04 μg/mL for carbazochrome sodium sulfonate(r=0.9998);RSDs of precision and reproducibility tests were no more than 2.0%;recoveries were 98.75%-100.63%and 98.00%-100.83%, and RSDs were 0.65% and 0.99%(n=9),respectively. In normal temperature,the contents of levofloxacin hydrochloride and car-bazochrome sodium sulfonate after mixing with 0.9% Sodium chloride injection within 6 h showed no significant decrease,and the appearance and pH value showed no obvious changes. CONCLUSIONS:The mixing of levofloxacin hydrochloride and carbazo-chrome sodium sulfonate with 0.9% Sodium chloride injection in room temperature is stable within 6 h,they can compatibly use synergistically in clinic.
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A novel, rapid, and sensitive ultra-performance liquid chromatography (UPLC) method has been developed and validated as per ICH guidelines for the determination of tramadol HCl impurities in the tramadol HCl injection after reconstitution by infusion fluids (5% dextrose and 0.9% sodium chloride). The tramadol HCl injection is for the treatment of patients with moderate-to-severe pain. The stability of the reconstituted solution is critical before intravenous injection. The literature search resulted in few published articles on assays of tramadol in infusion fluids by conventional HPLC. No attempts have yet been made to determine the impurities in infusion fluids, as the concentration of tramadol after reconstitution is extremely low (0.4 mg/mL) and that of impurities is even lower. The proposed method is novel as it allows the quantitation of the impurities of tramadol HCl and is based on modern chromatographic techniques like UPLC. The method was developed using the Waters Acquity BEH C18 column with a mobile phase consisting of a gradient mixture of solvent A (trifluroacetic acid buffer) and solvent B (methanol: acetonitrile). The model stability study was designed by diluting the tramadol HCl injection in the 5% dextrose injection and 0.9% sodium chloride injection. Each mixture was kept under storage at room temperature (25 ± 2°C) for testing at initial, 2, 4, 8, 12, 18 & 24 hours. The validation study illustrates that the proposed method is suitable for the determination of tramadol and its impurities. The proposed method makes use of the LC-MS-compatible mobile phase. It can be useful for the determination of tramadol HCl and its impurities in plasma samples and other pharmaceutical dosage forms.
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OBJECTIVE:To study the chemical stability of disposable infusion bag of total parenteral nutrition.METHODS:0.9% sodium chloride injection was infused into the disposable infusion bag of total parenteral nutrition and set at 8 ℃ or 37 ℃ for different duration(0,24,48,and 72 h) as sample solution.The sample solution was compared with blank control(0.9% sodium chloride injection contained in glass bottle) in respect of pH value,metal ion,indissoluble particle,chloride,reduction substance,UV absorbance and dissolution of cyclohexanone.RESULTS:Each index was stable when sample solution was set at 8 ℃ for 24 h.Reduction substance and dissolution of cyclohexanone increased when solution was set at 37 ℃ with time prolonged,as compared with blank control.At 37℃ UV absorbance is more than that at 8 ℃.CONCLUSION:It is suitable to set disposable infusion bag of total parenteral nutrition at 8 ℃ after infusing with injection and use up within 24 h.
