| Objective To examine the physical properties of 29 traditional Chinese medicine (TCM) injections when infused with0.9% sodium chloride injection (NS) and 5% dextrose injection (5% GS), thus providing reference for quality control and testing meth.ods of TCM injections.Methods From July to December 2022, the 29 intravenous TCM injections were prepared using NS or 5% GSin a clean environment according to the commonly used clinical dosage and drug concentration. The finished infusions were observedfor physical characteristics, Tyndall effect, turbidity, color intensity, insoluble particles, pH, and absorbance at 550 nm and 420 nm,within 4 hours at room temperature (20-23 ℃ ). Acceptable quality of the finished infusion was defined as follows: clear liquid, nochange in color, no gas, no crystallization or precipitation, no Tyndall effect, insoluble particles complying with the Chinese Pharmaco. poeia, turbidity change < 0.5NTU, pH change < 1.00, D(λ)550 nm change < 0.010, and colorless finished infusion with D(λ)420 nm change <0.040 when compared to the initial state (0 hours).Results The 29 intravenous TCM injections were prepared using both NS and 5%GS, resulting in a total of 58 finished infusions. Among them, the finished infusion of Kuhuang injection prepared with NS immediately exhibited a weak tyndall effect. The finished infusions of Guanxinning injection, Kuhuang injection, Shuganning injection, Shuxuening injection, Huangqi injection, Shuanghuanglian injection, Xingnaojing injection, Tanreqing injection prepared with NS, as well as Deng. zhanxixin injection, Shenkang injection, Xingnaojing injection, Tanreqing injection prepared with 5% GS, showed no apparent changesin appearance. The turbidity and pH parameters met the requirements. However, the insoluble particles exceeded the standards speci. fied in the Chinese Pharmacopoeia 2020 edition, or the D(λ)550 nm ≥ 0.010 when compared to the initial state (0 hours). The remaining 46 finished infusions met all the specified criteria.Conclusions Among the 29 types of TCM injections, Kuhuang injection, Guanxinning injection, Shuganning injection, Shuxuening injection, Huangqi injection, and Shuanghuanglian injection are recommended to be pre. pared using 5% GS, and Dengzhanxixin injection and Shenkang injection are recommended to be prepared using NS. Other medica.tions can be prepared using either NS or 5% GS. However, the finished infusions of Xingnaojing injection and Tanreqing injectionshould be used within 2 hours. The physical parameters and their changes, including solution appearance, can serve as quality controlindicators for finished infusions of intravenous TCM injections, which is simple and feasible. |
