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| Study on the stability of clinical compatibility of elemene emulsion injection |
| Mei Dongxue, Yang Youjian, Liu Xiaodan, Wang Yihui, Xu Wenshu |
| Dalian Huali Jingang Pharmaceutical Corporation Ltd., Dalian 116000, China |
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Abstract To investigate the stability of elemene emulsion injection after clinical compatibility and guide clinical medication. The changes of appearance, pH value, particle size distribution, elemene content and related substances of elemene emulsion injection after compatibility with three diluents (0.9% sodium chloride injection, 5% glucose injection and 20% fat emulsion injection) within 0 ~ 30.0 h were investigated by using pH meter, particle size distribution meter and gas chromatograph. Elemene emulsion injection showed no significant change in appearance over time in three diluents; The fluctuation of pH value, 90% particle size, 100% particle size, and average particle size over time is relatively small; Content: The amount of β、δ＋γ elemene is relatively stable and does not fluctuate significantly over time; Related substances, the sum of 0.96 peak+ β-butylene, total impurities, and maximum impurities are relatively stable, with little fluctuation over time. Within 0 ~ 30.0 hours, the stability of elemene emulsion injection in 0.9% sodium chloride injection, 5% glucose injection, and 20% fat emulsion injection is good, which can ensure medication safety.
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