Study on Compatible Stability of Xiao'aiping Injection Combined with 3 Kinds of Injections
10.6039/j.issn.1001-0408.2017.23.10
- VernacularTitle:消癌平注射液与3种注射液的配伍稳定性研究
- Author:
Qimin WANG
;
Wanjun BAI
;
Jing AN
;
Qian LI
;
Ying LI
;
Xiao LI
;
Caihui GUO
;
Zhanjun DONG
- Keywords:
Xiao'aiping injection;
Compatible stability;
Tenacissoside A;
Tenacissoside Ⅰ
- From:
China Pharmacy
2017;28(23):3204-3208
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To investigate the compatible stability of Xiao'aiping injection combined with 3 kinds of common in-jections. 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 tempera-ture(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:Un-der 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). For-ty-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). CON-CLUSIONS: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.
