Application of improved drug preparation method in piperacillin sodium tazobactam sodium for injection
Objective To investigate the application efficacy of modified drug formulation method in piperacillin sodium tazobactam sodium for injection.Methods Five hundred injections of piperacillin sodium tazobactam sodium were taken and two different methods of drug preparation were used.The conventional method of preparation(according to the instructions)was used in the control group and the modified methods of drug preparation including negative pressure dissolution,drug pretreatment dissolution,increased solvent dissolution and oscillator dissolution were applied in the experimental one.High performance liquid chromatography-mass spectrometry(HPLC-MS)was used to detect the effective content of the drug and the number of insoluble particles at different time points.Furthermore,drug dispensing time was counted and qualification rate compared.Results The drug preparation time was(7.13±1.22) min,(7.02±1.34) min,(6.24±1.20) min and(5.16±0.69) min for the negative pressure disso-lution method,drug pretreatment dissolution method,increasing solvent dissolution method and oscillator dissolution method in the experimental group,which was significantly shorter than that of(11.68±2.34) min in the control,demonstrating statistically signif-icant difference(P<0.05).There was no statistical significance in the comparison of the qualification rate between the two groups(P>0.05).The number of insoluble particles 2,4,6,8,10,and 15 min after addition of solvent was(45.45±7.67) microparticle·mL-1,(26.58±3.02) microparticle·mL-1,(8.12±1.47) microparticle·mL-1,(1.43±0.55) microparticle·mL-1,(2.19±0.75) microparticle·mL-1 and(3.43±0.88) microparticle·mL-1 by the negative pressure dissolution method,(44.16±6.98) microparticle·mL-1,(25.66±3.19) microparticle·mL-1,(8.08±1.45) microparticle·mL-1,(1.36±0.48) microparticle·mL-1,(1.98±0.67) microparticel·mL-1 and(3.12±0.82) microparticle·mL-1 by the drug pretreatment dissolution method,(44.05±6.86) microparticle·mL-1,(25.47±3.23) microparticle·mL-1,(6.14±1.28) microparticle·mL-1,(1.45±0.46) microparticle·mL-1,(2.07±0.71) microparticle·mL-1 and(3.25±0.83) microparticle·mL-1 by the increased solvent dissolution method,(44.28±7.23) microparticle·mL-1,(26.05±3.11) microparticle·mL-1,(0.99±0.42) microparticle·mL-1,(1.42±0.50) microparticle·mL-1,(2.06±0.68) microparticle·mL-1 and(3.48±0.85) microparticle·mL-1 by the oscillator dissolution method,which was significantly lower than that of(50.20±8.19) microparticle·mL-1,(38.67±6.54) microparticle·mL-1,(26.23±4.71) microparticle·mL-1,(18.31±3.57) microparticle·mL-1,(13.22±2.34) microparticle·mL-1 and(6.56±1.25) microparticle·mL-1 in the control(P<0.05).The effective drug content 2,4,6,8,10,and 15 min after the addition of the solvent was(64.53±1.77)%,(82.42±1.13)%,(91.65±0.76)%,(99.62±0.16)%,(99.51±0.22)%,(99.17±0.30)%by negative pressure dissolution method,(65.04±1.82)%,(82.79±1.36)%,(93.68±0.73)%,(99.64±0.17)%,(99.56±0.23)%,(99.20±0.28)%by drug pretreatment dissolution method,(64.78±1.69)%,(81.82±1.20)%,(98.70±0.64)%,(99.65±0.15)%,(99.54±0.26)%,(99.22±0.31)%by the increased solvent dissolution method,and(65.11±1.75)%,(82.26±1.25)%,(99.68±0.14)%,(99.62±0.17)%,(99.50±0.21)%,(99.24±0.26)%by the oscillator dissolu-tion method in the experimental group,which was significantly higher than that of(46.84±2.45)%,(55.93±2.36)%,(67.38±1.74)%,(79.47±1.25)%,(86.24±1.31)%,(98.39±0.84)%in the control(P<0.05).Conclusion Compared with the conventional blending method,the use of modified drug blending method to complete the blending of piperacillin sodium tazobactam sodium for injection in about 5 min can minimize the number of insoluble particles,providing a guarantee for the effective content of the drug.It is recommended a ready-to-use principle in the clinical application of this configuration scheme be followed and the infusion be conducted as soon as possible to ensure the medication effect and safety.
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