[01] Jian Ke, Guangdong Province Key Laboratory of Pharmacodynamics Constituents of TCM and New Drugs Research, College of Pharmacy, Jinan University, Guangzhou, China. [02] Yong Luo, Cell Biology Department, College of Life Science and Technology, Jinan University, Guangzhou, China. [03] Xian-Peng Ma, Guizhou Jingfeng Injection Co. Ltd., Guiyang, China. [04] Chang-Qiong Bi, Guizhou Jingfeng Injection Co. Ltd., Guiyang, China. [05] Wei Wei, Guizhou Jingfeng Injection Co. Ltd., Guiyang, China. [06] Jian-Hao Pan, Guangdong Province Key Laboratory of Pharmacodynamics Constituents of TCM and New Drugs Research, College of Pharmacy, Jinan University, Guangzhou, China. [07] Jing Zhao, State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China. [08] Fa-Huan Ge, School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou, China. [09] Hong Nie, Guangdong Province Key Laboratory of Pharmacodynamics Constituents of TCM and New Drugs Research, College of Pharmacy, Jinan University, Guangzhou, China.

This article is to evaluate safety risk of Salivae Miltiorrhizae Liguspyragine Hydrochloride and Glucose Injection (SGI) with six injections, which are used in combination with SGI in clinical practice, by isothermal titration calorimetry (ITC). The six injections are as follows: Levofloxacin Hydrochloride and Sodium Chloride Injection (LSI), Cefoperazone Sodium and Sulbactam Sodium for Injection (CSI), Alprostadil Injection (AI), Dextran 40 Glucose Injection (DI), Ossotide Injection (OI) and Glycerol Fructose and Sodium Chloride Injection (GSI). SGI was titrated by six injections and the thermodynamical parameters of each titration were obtained by ITC. In addition, changing information in appearances, pH values and insoluble particles of each samples during 4 hours after mixed at room temperature (25°C) were determined respectively. Among the six titration reactions, five of their Gibbs free energy values are negative (LSI, CSI, AI, OI and GSI); one of its Gibbs free energy value is positive (DI). Appearances and pH values of six injections mixed with SGI showed no obvious change during 4 hours at ambient temperature. And the total number of insoluble particles in the admixture of the two injections was exceeded upper limit standard of Chinese Pharmacopoeia (Ch.P.). In general, combined with appearances, pH values and insoluble particles results, this research indicated that using SGI in combination with the five injections (i.e. LSI, CSI, AI, OI and GSI) in clinical practice should pay attention to the ADR because Gibbs free energy values of the five titrations are negative, which means spontaneous reaction took place when they are mixed. While SCI suits to be combination with DI because Gibbs free energy value of the titration is positive, which means there is no energy changes and no reaction occurred.

Compatibility Evaluation, Isothermal Titration Calorimetry, Salivae Miltiorrhizae Liguspyragine Hydrochloride, Glucose Injection

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