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目的:考察多因素对丹参注射液与溶媒配伍后稳定性的影响,优选出最佳配伍方案。方法:选择温度、剂量、放置时间、溶媒、溶媒用量5个影响因素,采用L_(18)(3~7)正交试验表,用CWF-5J型微粒分析仪测定溶液中微粒含量,用HPLC法测定溶液申丹参素钠、原儿茶醛、丹酚酸B和迷迭酸含量。结果:配伍温度、放置时间对溶液中丹参素钠、原儿茶醛、丹酚酸B的含量有显著性影响;剂量对溶液中微粒的含量有显著性影响。结论:丹参注射液合理配伍条件为25℃、剂量20ml、与100ml0.9%氯化钠注射配伍放置2h、稳定性较好。
OBJECTIVE: To investigate the effect of multiple factors on the stability of Salvia miltiorrhiza injection combined with vehicle, and to optimize the best compatibility plan. Methods: Five influencing factors such as temperature, dosage, storage time, solvent and solvent dosage were selected. The orthogonal test table of L_ (18) (3-7) was used to determine the content of microparticles in the solution by HPLC Method Determination of sodium Shen Danshen solution, protocatechuic aldehyde, salvianolic acid B and Diego acid content. Results: Compatibility temperature and storage time had significant effects on the content of Danshensu sodium, protocatechuic aldehyde and salvianolic acid B. The dosage had a significant effect on the content of microparticles in solution. Conclusion: Salvia miltiorrhiza injection compatibility reasonable conditions 25 ℃, dose 20ml, and 100ml0.9% sodium chloride injection compatibility placed 2h, good stability.