6种常用中药注射液与溶媒配伍前后不溶性微粒的测定

Detection of Insoluble Particles in 6 Commonly Used TCM Injections before and after Mixed with Solvents

目的:考察6种常用中药注射液与溶媒配伍前后的不溶性微粒数变化。方法:将艾迪注射液、华蟾素注射液、热毒宁注射液、复方当归注射液、舒肝宁注射液、痰热清注射液按临床使用的质量浓度,分别与0.9%氯化钠注射液、5%葡萄糖注射液配伍,按《中国药典》方法测定其配伍前与配伍后放置30min、1h、2h、6h的微粒数,比较配伍液滤过前后的微粒数差别,并进行统计分析。结果:滤过前,仅热毒宁注射液同2种溶媒配伍的微粒数符合标准;舒肝宁注射液同0.9%氯化钠注射液配伍的微粒数符合标准,同5%葡萄糖注射液配伍≥25μm的微粒数符合标准,但≥10μm的微粒数不符合标准;其余4种配伍液的微粒数均不符合标准。经一次性输液器滤过后,6种配伍液的微粒数均符合标准。配伍液的微粒数在配制后1h有减少的趋势,放置6h后逐渐增加。结论:应持续加强中药注射剂的质量控制,密切注意不溶性微粒的监控。

OBJECTIVE： To investigate the number of insoluble particles in 6 commonly used TCM injections before and after mixed with solvent. METHODS：Aidi injection, Cinobufotalin injection, Reduning injection, Compound Angelica sinensis injection, Shuganning injection, Tanreqing injection were mixed with 0.9% Sodium chloride injection and 5% Glucose injection according to mass concentration in the clinic respectively. The number of particles was determined and analyzed statistically with the method stated in Chinese Pharmacopeia before and 30 min,1 h, 2 h, 6 h after the compatibility. RESULTS： Before filtering, the number of particles was in line with the standard in Reduning injection after mixed with 2 kinds of solvents; the number of particles was in line with the standard in Shuganning injection after mixed with 0.9% Sodium chloride injection; the number of particles（≥25 μm）was in line with the standard in Shuganning injection after mixed with 5% Glucose injection,while that ≥10 μm was not in line with the standard;the number of particles in other 4 mixtures were all not in line with the standard. After filtering with the disposable infusion apparatus, the number of particles in 6 mixtures was in line with the standard. The number of particles in the mixture decreased within 1 h after preparation but increased gradually 6 h later. CONCLUSIONS： It is necessary to strengthen the quality control of TCM injection and great importance should be attached to the monitoring of insoluble particles.