论文部分内容阅读
28种静脉用中药注射剂按治疗剂量加入各自溶媒后不溶性微粒的检测表明：每种药物均含有不同粒径及数量的微粒。其中多数符合《中国药典》标准，但有4种药物≥10μm的微粒数在20个以上或≥25μm的微粒多于2个，超过《中国药典》标准。值得注意的是，中药静脉注射剂中小于10μm的微粒个数明显多于西药静脉注射液。提示中药静脉注射剂质控的难度和改善工艺质量的迫切性。本实验对国产精密药液过滤器的滤过作用亦作了考察。
The detection of insoluble particles after 28 kinds of intravenous injections of traditional Chinese medicines were added to each vehicle showed that each drug contained particles of different particle sizes and amounts. Most of them meet the standards of the “Chinese Pharmacopoeia”, but there are more than 2 particles with more than 20 particles or ≥25 μm particles with more than 10 μm ≥10 μm, exceeding the “Chinese Pharmacopoeia” standard. It is worth noting that the number of microparticles smaller than 10 μm in intravenous injections of traditional Chinese medicine is significantly more than that of western medicine intravenous injections. The difficulty of quality control of intravenous injections of traditional Chinese medicine and the urgency to improve the quality of the techniques are indicated. In this experiment, the filtering effect of domestic precision liquid filter was also examined.