论文部分内容阅读
目的:观察中药注射液在常温下(20℃~23℃)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:在常温条件下,按说明书要求,将5种中药注射液分别加入溶媒,配置后放置0min、30min、60min、120min、180min,在不同的时间段里,观察溶液的外观,应用微粒分析仪,pH计测定溶液中微粒数、pH值的变化结果:5种中药注射液在常温下配伍后,各时间段溶液的pH波动在正常范围,溶液外观基本无改变;≥25μm的微粒数基本符合药典规定;≥2 um的小粒径微粒数非常可观,其中艾迪、刺五加、银杏达莫3种中药注射液配伍后放置0min测定的≥2μm微粒数与放置120min、180min所测得的微粒数相比,前两者中小粒径微粒数随时间推移逐渐增多,康艾、苦碟子放置0min所检测的≥2μm微粒数与放置120min、180min相比,数量明显下降(P<0.05);≥10μm的微粒数目,除苦碟子注射液外,其余4种中药注射液与溶媒配伍后都大大超过药典标准。结论:临床在使用中药注射液时应慎重,配制后应视药品的不同特性,在合适的时间里使用,有条件的应使用精密输液过滤装置,减少微粒对人体造成的损害。
OBJECTIVE: To observe the changes of the appearance, pH value and the number of microparticles of Chinese traditional medicine injection at different temperature after compatibility at room temperature (20 ℃ ~ 23 ℃). Methods: Under normal temperature conditions, according to the instruction manual, 5 kinds of traditional Chinese medicine injection were added to the vehicle, and placed in 0, 30, 60, 120, 180 minutes after configuration. The appearance of the solution was observed in different time periods. , pH meter to determine the changes in the number of particles in the solution, the pH value of the results: 5 kinds of Chinese medicine injection compatibility at room temperature, the pH of the solution in each period of fluctuation in the normal range, the solution appearance almost no change; Pharmacopoeia; ≥ 2 um particle size is very significant particle size, Adidas, Acanthopanax senticosus, ginkgo dipyridamole injection of three kinds of traditional Chinese medicine placed 0min after the determination of the number of particles ≥ 2μm and placed 120min, 180min measured The number of particles with small size increased gradually with the passage of time compared with the number of particles. The numbers of particles ≥2μm detected by Kangyi and Kudiezi at 0min were significantly lower than those at 120min and 180min (P <0.05). In addition to Kudie injection, the remaining four kinds of Chinese medicine injection and the solvent compatibility are greatly exceeded Pharmacopoeia standards. Conclusions: When using traditional Chinese medicine injection, clinical patients should be cautious. After preparation, they should be treated according to the different characteristics of drugs and used at the right time. Precise fluid infusion filtration devices should be used to reduce the damage to human body caused by particles.