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OBJECTIVE:To investigate the compatible stability of Voriconazole for injection after mixed with Fructose injec-tion or Invert sugar injection. METHODS:Referring to package inserts,Voriconazole for injection 200 mg was dissolved with Wa-ter for injection to 20 mL,and then combined with Fructose injection 250 mL and Invert sugar injection 250 mL,respectively. At room temperature,the appearance of mixtures were observed 0,1,2,3,4,5 h after mixing,and pH value and the number of in-soluble particles were determined;the content of voriconazole was determined by HPLC. RESULTS:Under above condition,the appearance and pH value of mixtures had no significant change within 5 h;the number of particles ≥10 μm and ≥25 μm were all in line with the standard of Chinese Pharmacopoeia (2015 edition);the relative content of voriconazole was decreasing (95.28%-100%),but it changed within ±5%(RSD<2%,n=6). CONCLUSIONS:Voriconazole for injection could keep stable within 5 h after mixed with Fructose injection or Invert sugar injection.
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OBJECTIVE:To investigate the compatibility stability of Salvianolic acid for injection (SAFI) combined with 8 kinds of common solvents. METHODS:Referring to package inserts,SAFI was collected and combined with 0.9% Sodium chlo-ride injection,5% Glucose injection,10% Glucose injection,Compound sodium chloride injection,Mannitol injection,Glycerol fructose and sodium chloride injection,Sodium lactate Ringer's injection,Glucose and sodium chloride injection,250 mL each re-spectively,and then sealed in the dark at the room temperature. The appearance of mixtures were observed,pH value,the number of insoluble particles,maximal absorption wavelength and maximal absorbance were detected,and the contents of salvianolic acid B,rosmarinic acid,lithospermic acid and salvianolic acid Y in mixtures were determined by HPLC at 0,1,2,4,8 h after mix-ing. RESULTS:Under above condition,no obvious change was found in appearance or pH values of the mixtures within 8 h. Maxi-mal absorption wavelength ranged 284.5-286.0 nm. After mixed with Mannitol injection,the number of particles≥10μm(1-8 h af-ter mixing)and particles ≥25 μm(4-8 h after mixing)exceeded the scope of Chinese Pharmacopoeia(2015 edition);the maxi-mal absorbance changed significantly(RSD=9.17%,n=5);the relative content of salvianolic acid B,rosmarinic acid,lithosper-mic acid and salvianolic acid Y decreased by more than 10%(RSD=14.65%,6.45%,8.97%,12.49%,n=5);after mixed with Sodium lactate Ringer's injection,the relative content of rosmarinic acid and lithospermic acid changed greatly (RSD=14.57%, 7.28%,n=5);after mixed with 5% Glucose injection(4-8 h after mixing)and Glycerol fructose and sodium chloride injection(8 h after mixing),the relative content of rosmarinic acid were less than 90%(RSD=6.30%,4.86%,n=5);and the number of particles ≥25μm exceeded the scope of phamcopoeia after mixing with Glycerol fructose and sodium injection(0 h). The number of insoluble particles in other mixtures were in line with the standard of pharmacopoeia;maximal absorbance had no significant change(RSD<5%,n=5),and the relative content change of analytes were all less than 10%. CONCLUSIONS:Clinical appli-cation of SAFI combined with Mannitol injection,Sodium lactate Ringe's injection and Glycerol fructose and sodium injecrion should be avoided. After mixed with 5% Glucose injection,SAFI should be used within 4 h. SAFI can be compatible with 0.9%Sodium chloride injection,10% Glucose injection,Compound sodium chloride injection and Glucose and sodium chloride injec-tion.
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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 study the compatibility stability of Shuxuening injection and meglumine adenosine cyclophosphate injection . Methods The compatibility program of Shuxuening injection and meglumine adenosine cyclophosphate injection was optimized by orthogonal experimental design, with the main components total flavone of Ginkgo biloba ( quercetin, kaempferide and isorhamnetin as control substance) and Ginkgo lactone ( ginkgolide A, B and C as control substance) of Shuxuening injection, the principal components adenosine cyclophosphate ( denosine cyclophosphate as control substance) of meglumine adenosine cyclophosphate injection as the main index to draw calibration curve, select temperature (A), illumination (B),storage time (C) and solvent (D) as factor, the change of insoluble particles and pH in solution was studied also.Results The optimal compatibility conditions of orthogonal experimental design was A2B1C1D1(25℃, lucifugal, storage time of 1 h,5% glucose solution), ANOVA results showed that temperature (A), illumination (B) and storage time (C) have significant effects on quercetin and kaempferide contents in Shuxuening injection (P<0.05), however, solvent (D) has no significant effect on them.The temperature (A), illumination (B),storage time (C) and solvent (D) have significant effects on the other five substances (P<0.05).At 0, 1, 4, 6 h, the appearance and pH value of compatible solution (A2B1C1D1) were not significantly changed and the number of insoluble particles in accordance with the relevant provisions of the Chinese Pharmacopoeia with storage time increasing.Conclusion The compatible stability of Shuxuening injection and meglumine adenosine cyclophosphate injection is good under certain conditions, and could use compatibility in clinical therapy.
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Objective To study the stability of tramadol hydrochloride with fentanyl citrate in 0.9%sodium chloride injection. Methods The changes in appearance and pH value of the mixture of the two injections in 0.9%sodium chloride injection within 72 hours at ambient temperature were observed .The concentrations of the two drugs were determined by HPLC .The chromatographic separation was achieved on SinoChrom ODS-BP column, and the mobile phase consisted of acetonitrile:0.05 mol/L potassium dihydrogen phosphate (25:75) at a flow rate of 1.0 ml/min..Results No significant differences were found in the pH value and appearance of the solution . The contents of tramadol hydrochloride and fentanyl citrate were high than 98%within 72 hours.Conclusion The mixture of tramadol hydrochloride with fentanyl citrate in 0.9%sodium chloride injection was stability within 72 hours under room temperature .
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OBJECTIVE:To investigate the compatible stability of isosorbide mononitrate(ISO) and dopamine(DA) hydrochloride in glucose injection.METHODS:The contents of ISO and DA in the mixture of ISO and DA at 20 ℃ and 30 ℃ under natural illumination within 24 h,and the pH and appearance of the mixture were monitored.RESULTS:No significant change was noted in the concentrations of ISO and DA,the pH and the appearance of the mixture at 20 ℃ or 30 ℃.CONCLUSION:The mixture of ISO and DA in glucose injection was stable at 20 ℃ or 30 ℃,but which should be used up within 18 h after mixing.
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OBJECTIVE: To study the compatibility stability of Chinese material medica injection for reference of clinical rational administration. METHODS: The pertinent literature about the compatibility stabililty of Chinese material medica injection during 1999-2006 retrieved from CHKD were statistically analyzed. RESULTS: The analysis on temperature, pH, corpuscle and concentration et exactly and directly revealed that Chinese material medica injection was stable under any infusion condition, which serves as reference for clinical medication. CONCLUTION: Because of the complexity of the components and process of preparation or extraction, the Chinese material medica injection often induce adverce reaction during intervenous drop infusion, thus great importance should be attached to the compatibility stability in centralized pharmacy admixture to ensure the clinical medication safety and decrease the incidence of adverse drug reaction.