| 许红,李国春,尹加珍,等.国产伏立康唑调配方法优化及其稳定性研究[J].安徽医药,2022,26(11):2213-2217. |
| 国产伏立康唑调配方法优化及其稳定性研究 |
| Optimization and stability of the domestic voriconazole preparation method |
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| DOI：10.3969/j.issn.1009-6469.2022.11.021 |
| 中文关键词: 伏立康唑 溶剂 调配方法 稳定性 残留量 高效液相色谱法 |
| 英文关键词: Voriconazole Solvents Dispensing method Stability Residual amount HPLC |
| 基金项目:泸州市指导性科技计划项目；西南医科大学 -西南医科大学附属中医医院联合课题( 2018XYLH-012)；西南医科大学课题( 2018-ZRQN-059) |
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| 中文摘要: |
| 目的筛选注射用伏立康唑的最优调配方法及配伍溶媒，确保用药安全、有效，提高静脉用药调配中心( PIVAS)药品调配的工作效率。方法采用 3种不同的调配方法，方法 A按说明书方法；方法 B专用溶剂反复冲洗西林瓶约 6~7次至溶液澄清透明；方法 C注入专用溶剂，强力振荡至溶液澄清透明；并检测各调配方法下药品的残留量、成品输液质量及各调配方法所耗时间；以及模拟成品输液运送过程，观察不同条件下配伍液的外观，检测其 pH值、不溶性微粒数和伏立康唑含量变化。结果三种调配方法下，残留量合格率均为 100%，方法 A、B、C组残留量分别为( 0.004 3±0.000 1)g、(0.004 2±0.000 1)g、(0.004 0±0.000 0)g，组间比较，差异无统计学意义( P>0.05)；方法 A、B、C组调配时间分别为( 33.616 0±0.887 3)s、(2.648 0±0.428 8)s、 |
| 英文摘要: |
| Objective To screen the optimal formulation method and compatible solvent of voriconazole for injection, to ensure thesafety and effectiveness of the drug, and to improve the work efficiency of drug dispensing in the intravenous drug dispensing center (PI.VAS).Methods Three different dispensing methods are adopted. Method A follows the instructions; Method B: Rinse the vial repeat.edly with special solvent approximately 6~7 times until the solution is clear and transparent; Method C: inject special solvent and vigor.ously shake until the solution is clear and transparent. Meanwhile, the residual amount of the drug under each dispensing method, thequality of the finished product infusion and the time consumed by each dispensing method were detected, the delivery process of the fin.ished product infusion was simulated, observe the appearance of the compatibility solution was observed under different conditions, andthe pH value, the number of insoluble particles and the content of voriconazole were detected.Results Under the three preparationmethods, the qualified rate of residues was 100%, and the residues of methods A, B and C were (0.004 3±0.000 1) g,(0.004 2±0.000 1)g, (0.004 0±0.000 0) g, respectively. There was no significant difference between groups (P>0.05); the deployment times of methods A,B and C group were (33.616 0±0.887 3)s,(2.648 0±0.428 8)s,(1.670 0 ±0.326 9)s, the difference was statistically significant betweengroups (P<0.05).5% glucose injection is selected as the solvent, and the compatibility solution obtained under the three dispensingmethods is within 8 hours. Its appearance, pH value, incompatible particles, and percentage of main drug all meet the regulations. Com.patible with 0.9% sodium chloride injection, turbidity began to appear at 0.5 h, the drug precipitated and crystallized, and the percent.age decreased to 86.16% in 2 h. At this time, simulating the delivery process of the finished product infusion, the compatibility solutionunder mild and strong shaking began to appear turbid at 1.5 h and 1 h, respectively, and the drug precipitated and crystallized, and itspercentage decreased to 89.41% at 3 h under mild shaking, and its percentage decreased to 88.84% in 1.5 h under intense shaking.Conclusions In clinical practice, 5% glucose injection should be selected as the solvent of voriconazole for injection, and the fin.ished product infusion should be stable within 8 hours. To improve the dispensing efficiency of the drug, the special solvent in dispens. ing method C, a dispensing method that vigorously shakes the solution in the vial until the solution is clear and transparent after dissolv.ing is chosen. Avoid shaking the finished product infusion. |
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