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目的:考察注射用丹参多酚酸盐与临床常用溶剂的配伍稳定性,为临床应用提供参考。方法:模拟临床用药情况,将注射用丹参多酚酸盐与12种常用溶剂配伍,观察配制溶液外观,测定配伍后8h内pH、不溶性微粒和吸光度变化。结果:注射用丹参多酚酸盐与极化液、20%甘露醇注射液、复方氯化钠注射液、木糖醇注射液、右旋糖酐40葡萄糖注射液、5%葡萄糖氯化钠注射液、乳酸钠林格注射液配伍后8h内不溶性微粒超出或接近《中国药典》标准。与碳酸氢钠注射液配伍后溶液pH超出注射用丹参多酚酸盐的厂家质量标准。注射用丹参多酚酸盐与5%葡萄糖注射液、10%葡萄糖注射液、甘油果糖注射液、0.9%氯化钠注射液的配伍液8h内外观、pH、不溶性微粒、吸光度等皆符合规定。结论:注射用丹参多酚酸盐适宜上述4种溶液配伍在8h内基本稳定。
OBJECTIVE: To investigate the compatibility and stability of Salviae miltiorrhizae polyphenols for clinical use and to provide reference for clinical application. Methods: To simulate the clinical application of drug, Salviae miltiorrhizae polyphenols for injection were combined with 12 kinds of common solvents. The appearance of the solution was observed. The changes of pH, insoluble particles and absorbance within 8 hours after compatibility were measured. Results: Salviae miltiorrhizae polyphenols and polar liquid, 20% mannitol injection, compound sodium chloride injection, xylitol injection, dextran 40 glucose injection, 5% glucose sodium chloride injection, sodium lactate Insulin particles within 8 h after Ringer injection compatibility exceeded or approached the “Chinese Pharmacopoeia” standard. After compatibility with sodium bicarbonate injection, the solution pH exceeds the manufacturer’s quality standards for Salviae miltiorrhizae polyphenols for injection. Injection Salviae polyphenols and 5% glucose injection, 10% glucose injection, glycerol fructose injection, 0.9% sodium chloride injection compatibility within 8h appearance, pH, insoluble particles, absorbance and so on all meet the regulations. Conclusion: Salviae miltiorrhizae polyphenols for injection is suitable for the above four kinds of solution compatibility within 8h basically stable.