环境因素对含中药针剂输液中不溶性微粒的影响

 目的 考察静脉用中药注射液中不溶性微粒数目及各环境因素如洁净程度、放里时间，温度等对其产生的影响。方法 分别对纯中药针剂和与输液配伍后在各考察因素条件下不同时间点采取的样品，采用智能输液微粒分析仪测定微粒数目。 结果 7种纯中药针剂不溶性微粒较多；临床非洁净条件下的配伍可增加注射剂中不溶性微粒数1:在15，25℃条件下随放里 时间延长，经配伍的含中药注射别的输液中10≥μm微粗数明显婚加；而在20℃条件下其变化不大。在相同放里时间，巧， 25℃时多数样品中≥10μm，≥25μm不溶性微杜数明显高于加℃时的数目。结论生产厂家应进一步改善制剂工艺，提高 产品质童。提示临床应在洁净环境、适当温度(20℃较好)及临用前配伍药品，并应在较短的时间内滴注完毕。

Effect of the environmental factors on the particulate matter of Chinese materia medical injection

OBJECTIVE To investigate the amount of the unsoluble particulate matter(PM) in Chinese materia medical injection (CMMI) and the effect of the other fators on PM. METHODS Using ZWF-6F partical counter to measure the particles in original and mixed injections in different conditions. RESULTS Seven kinds of CMMI have more PM than normal. At 15 and 25，the mixture's particles increase obviously follow the time,at 20,no obvious change, but the PM of 15,25 are more than 20 at the same time. CONCLUSIONS We suggest the factories could improve the qulities of the products. And pay more attention to using CMMI in clinic.