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目的:研究中药注射液在低温下(4-10℃)配伍后,放置在不同的时间段,溶液的外观、Ph值及微粒数量的变化。方法:在低温环境下配置的8种中药注射液与溶媒重溶后,放置在不同的时间段里,应用微粒分析仪测定溶液中微粒数。结果:8种中药注射液在低温下配伍后,溶液外观基本无改变;除血栓通注射液与5%葡萄糖注射液重溶后溶液中>10μm和>25μm的微粒数符合药典规定,其余7种中药注射液与0.9%氯化钠注射液配伍后溶液中>10μm和>25μm微粒数均不符合药典的规定,且小于10μm的微粒占到90%以上。结论:在寒冷季节无温控条件下使用中药注射液,配置时应将药液适当加温,充分振荡混匀,输液时建议应用精密输液器,减少微粒对人体造成的损害。
OBJECTIVE: To study the changes of the appearance, pH value and the number of microparticles of traditional Chinese medicine injection at different temperatures (4-10 ℃) after being placed in different time periods. Methods: Eight kinds of traditional Chinese medicine injection prepared in low temperature environment were re-dissolved with the solvent and placed in different time periods. The particle number of the solution was measured with a particle analyzer. Results: After the compatibility of 8 kinds of Chinese traditional medicine injection at low temperature, the appearance of the solution remained almost unchanged. The numbers of particles> 10μm and> 25μm in Xueshuantong Injection and 5% Chinese medicine injection and 0.9% sodium chloride injection solution compatibility> 10μm and> 25μm particles are not in line with the provisions of the Pharmacopoeia, and less than 10μm particles accounted for more than 90%. Conclusion: In the cold season without the use of traditional Chinese medicine under the conditions of injection, the liquid should be appropriately warmed configuration, the full oscillation mixing, transfusion recommended the use of precision infusion sets to reduce the damage caused by particles on the human body.