注射用丹参多酚酸与氯化钠注射液配伍稳定性研究  

Study on the compatibility stability of salvianolic acids for injection mixed with sodium chloride injection

作　　者：李莉 王江辉 李春 李德坤[1,2] Li Li;Wang Jianghui;Li Chun;Li Dekun(Tianjin Tasly Pride Pharmaceutical Co Ltd,Tianjin 300410;Tianjin Enterprise Key Laboratory for Safety Evaluation of TCM Injections,Tianjin 300410;Dagang Hospital of Tianjin Binhai New Area,Tianjin 300270;Tianjin Beichen Institute for Drug Control,Tianjin 300400)

机构地区：[1]天津天士力之骄药业有限公司,天津300410 [2]天津市中药注射剂新技术企业重点实验室,天津300410 [3]天津市滨海新区大港医院,天津300270 [4]天津市药品检验研究院北辰药品检验所,天津300400

出　　处：《天津药学》2023年第1期27-35,共9页Tianjin Pharmacy

摘　　要：目的:考查不同温度和光照条件下,注射用丹参多酚酸(SAFI)与氯化钠注射液(玻璃瓶和PP瓶)的配伍稳定性,为临床合理用药提供参考。方法:模拟临床应用,按说明书要求以氯化钠注射液(玻璃瓶和PP瓶)为溶媒与SAFI进行配伍,考查配伍溶液在室温、高温、日光、避光条件下,6 h内溶液颜色、性状、pH值、不溶性微粒、丹酚酸B含量、丹参多酚酸含量、指纹图谱、特征峰峰面积百分比和非共有峰峰面积百分比的变化。结果:配伍溶液(玻璃瓶和PP瓶)在6 h内,室温、高温、日光、避光条件下,其颜色及外观、pH值变化不明显,不溶性微粒均符合《中国药典》2020年版规定;丹酚酸B和丹参多酚酸含量变化相对标准偏差RSD不超过1.6%和0.9%;且各时间点指纹图谱与0 h相比,相似度均为1.000;特征峰峰面积百分比RSD不超过0.5%。结论:SAFI与氯化钠注射液(玻璃瓶和PP瓶包装)配伍后6 h内,在室温、高温、日光和避光条件下,溶液均较稳定。Objective:To investigate the compatibility stability of salvianolic acids for injection(SAFI)combined with sodium chloride injection(packed in glass bottle and PP bottle)under different temperatures and light conditions to provide a reference for clinical rational drug use.Methods:To simulate clinical application,sodium chloride injection(packed in glass bottle and PP bottle)was used as the solvent for compatibility with SAFI according to the instructions.The color,properties,pH value,insoluble particles,salvianolic Acid B content,salvia miltiorrhiza polyphenolic acid content,fingerprint,characteristic peaks proportion,and non-common peaks proportion of the compatible solutions were investigated within 6 hours under room temperature,high temperature,sunlight,and light protection conditions.Results:Within 6 hours under room temperature,high temperature,sunlight,and light protection conditions,the color,appearance,and pH value of the compatible solution(glass bottle and PP bottle)were not significantly changed.The insoluble particles were in line with the provisions of Chinese Pharmacopoeia 2020.The RSD of salvianolic acid B and salvia miltiorrhiza polyphenolic acid content did not exceed 1.6%and 0.9%.Compared with 0 h,the similarity of fingerprints at each time point was 1.000,and the RSD of characteristic peak areas did not exceed 0.5%.Conclusion:Within 6 hours after SAFI was mixed with sodium chloride injection(packaged in glass bottle and PP bottle),the solution was relatively stable under room temperature,high temperature,sunlight,and dark conditions.

关 键 词：注射用丹参多酚酸 配伍稳定性 氯化钠注射液 颜色 PH值 不溶性微粒 含量 指纹图谱 

分 类 号：R927.1[医药卫生—药学]