TITLE:
Determination of Critical Influencing Factor on pH Stability of Yuxingcao Injection
AUTHORS:
Xianjun Long, Bo Liu, Zuren Peng, Ping Qiu, Xuechun Yang, Yuanxiang Yang, Meili Wang, Songmao Yin, Xingchu Gong
KEYWORDS:
Houttuyniae Herba, Chinese Medicine Injection, Quality Stability, Tween 80
JOURNAL NAME:
Pharmacology & Pharmacy,
Vol.11 No.8,
August
31,
2020
ABSTRACT: The change of drug quality of Yuxingcao injection
after formulation is considered as one of the causes for adverse reactions. In
this study, orthogonal experimental design was used to investigate the
influencing factors on the pH stability of Yuxingcao injection. Two methods of
accelerated tests were carried out in the experiments. The results showed that
using Tween 80 as the solubilizer could significantly decrease the pH value of
Yuxingcao injection after accelerated tests. There was no significant
difference in the pH value after the accelerated tests when the other 6 factors
varied, including the type of liquid processed, the dosage of activated carbon,
heating temperature, reagents for pH adjustment, pH value range after
adjustment, and sterilization conditions. In order to improve the quality
stability of Yuxingcao injection, the quality of Tween 80 should be strictly
controlled to minimize the change of pH value of Yuxingcao injection.