[1]贾丽华,李佳奇,郭欢迎.长春西汀注射剂小粒径不溶性微粒倍增现象及风险分析[J].医学信息,2023,36(20):89-93,102.[doi:10.3969/j.issn.1006-1959.2023.20.016]
　JIA Li-hua,LI Jia-qi,GUO Huan-ying.Multiplication Phenomenon and Risk Analysis of Small Particle Size Insoluble Particles in Vinpocetine Injection[J].Journal of Medical Information,2023,36(20):89-93,102.[doi:10.3969/j.issn.1006-1959.2023.20.016]
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长春西汀注射剂小粒径不溶性微粒倍增现象及风险分析()
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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
36卷
期数:
2023年20期
页码:
89-93,102
栏目:
论著
出版日期:
2023-10-15

文章信息/Info

Title:
Multiplication Phenomenon and Risk Analysis of Small Particle Size Insoluble Particles in Vinpocetine Injection
文章编号:
1006-1959（2023）20-0089-06
作者:
贾丽华; 李佳奇; 郭欢迎
（1.陕西省食品药品检验研究院，陕西 西安 710065；2.陕西中医药大学药学院，陕西 咸阳 712046）
Author(s):
JIA Li-hua; LI Jia-qi; GUO Huan-ying
JIA Li-hua1,LI Jia-qi1,2,GUO Huan-ying1(1.Shaanxi Institute for Food and Drug Control,Xi’an 710065,Shaanxi,China;2.College of Pharmacy,Shaanxi University of Traditional Chinese Medicine,Xianyang 712046,Shaanxi,China)
关键词:
长春西汀; 小粒径不溶性微粒; 倍增现象; 风险分析
Keywords:
Vinpocetine; Small size insoluble particles; Multiplication phenomenon; Risk analysis
分类号:
R944
DOI:
10.3969/j.issn.1006-1959.2023.20.016
文献标志码:
A
摘要:
目的 探讨长春西汀注射剂小粒径不溶性微粒倍增现象与pH值、溶媒和配伍用药的关系，以及可能引起的风险。方法 采用不溶性微粒测定仪测定长春西汀注射液在不同pH值、不同溶媒及不同配伍用药条件下不溶性微粒，特别是小粒径（粒径在10 μm以下）的微粒的变化。结果 随着溶液pH值的增加，长春西汀氯化钠溶液不溶性微粒数迅速增加，其中倍增最多的是2~5 μm和5~10 μm的微粒数，分别增加了约70和50倍。尤其是将长春西汀氯化钠溶液与模拟人体液的培养基混合以后，2~5 μm的颗粒数激增至原来的200多倍。长春西汀在不同溶媒中的不溶性微粒差异较大，溶媒成分越复杂，不溶性微粒数增加越多，特别是在右旋糖酐40氯化钠注射液、碳酸氢钠林格注射液中的不溶性微粒是氯化钠注射液中的150倍左右。长春西汀与多种中药注射液、抗生素配伍后微粒数显著增加，倍增较多的是2~5 μm和5~10 μm的微粒数，特别是与碱性样品配伍以后，不溶性微粒增加更多。结论 小粒径不溶性微粒倍增可能是长春西汀注射剂不良反应数量较多的原因之一。为了避免长春西汀注射剂临床应用过程中的风险问题，使用过程中应注意用法、用量及pH值的影响，建议选择氯化钠注射液和葡萄糖注射液为溶媒，并注意长春西汀注射液使用过程中的配伍问题。
Abstract:
Objective To explore the relationship between the multiplication phenomenon of small size insoluble particles of vinpocetine injection and pH value, solvent and compatible drugs, as well as the possible risk analysis.Methods The changes of insoluble particles of vinpocetine injection under different pH values, different solvents and different compatibility conditions were determined by insoluble particle analyzer, especially the small size particles (particles that smaller than 10 μm).Results The number of insoluble particles increased rapidly with the increase of pH value of vinpocetine sodium chloride solution, and the particles of 2-5 μm and 5-10 μm increased by 70 and 50 times, respectively. The particles of 2-5 μm surged to more than 200 times of the original, after mixing vinpocetine sodium chloride solution with the culture medium of simulated human body solution. The insoluble particles of vinpocetine in different solvents vary greatly. The number of insoluble particles increased rapidly with the complexity of solvent composition increased. The insoluble particles were about 150 times higher than those in sodium chloride injection, after vinpocetine injection was mixed with dextran 40 sodium chloride injection or sodium bicarbonate ringer injection. The number of particles increased significantly after vinpocetine was combined with a variety of traditional Chinese medicine injections and antibiotics. The particles of 2-5 μm and 5-10 μm increased sharply. The number of insoluble particles increased more, when vinpocetine was mixed with alkaline samples.Conclusion The multiplication phenomenon of small insoluble particles may be one of the reasons for the large number of adverse reactions of vinpocetine injection. Attention should be paid to the influence of usage, dosage and pH value in the clinical use of vinpocetine injection. It is suggested to select sodium chloride injection and glucose injection as the solvent, and pay attention to the compatibility of vinpocetine injection.

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更新日期/Last Update: 1900-01-01