OBJECTIVE: To investigate the compatible stability of Xiao’aiping injection combined with 3 kinds of common injections. METHODS: Referring to package inserts, Xiao’aiping injection 40 mL was compatible with 5% Glucose injection, 10% Glucose injection or 0.9% Sodium chloride injection 160 mL, respectively. At room temperature (about 25 ℃) and high temperature (40 ℃), the appearance of mixtures were observed at 0, 1, 2, 4, 8, 12, 24, 48 h; pH value and the number of insoluble particles were detected. The contents of tenacissoside A and tenacissoside I in mixtures were determined by HPLC. RESULTS: Under above condition, the mixtures were brownish yellow liquid within 48 h after Xiao’aiping injection was compatible with 5% Glucose injection or 10% Glucose injection; 24 h after mixed with 0.9% Sodium chloride injection, the mixture changed from brownish yellow to reddish brown, but no precipitation was found. The pH value of mixtures had no significant change (RSD<1%,n=8). The number of particles ≥25 μm was in line with the requirements of Chinese Pharmacopeia (2015 edition). Forty-eight hours after mixing, the number of particles ≥10 μm in the mixtures exceeded the pharmacopoeia limits. Within 48 h after mixing, the relative contents of tenacissoside A and tenacissoside I in mixtures had no significant change (RSD<2%,n=8). CONCLUSIONS: The mixture should be used up within 24 h after Xiao’aiping injection combined with 5% Glucose injection, 10% Glucose injection or 0.9% Sodium chloride injection.
关键词
消癌平注射液配伍稳定性通关藤苷A通关藤苷I
Keywords
Xiao’aiping injectionCompatible stabilityTenacissoside ATenacissoside I