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| 舒肝宁注射液与3种临床常用药物配伍稳定性研究 |
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张林慧1,2, 沈鹏宇1,2, 黄小超1,2, 侯晓桐1,2, 胡艺雯1,2, 蹇瑞鸿1,2, 杨翠萍3, 何峰4, 皮佳鑫1,2
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1.天津中医药大学组分中药国家重点实验室, 天津 301617;2.天津中医药大学现代中药发现与制剂技术教育部工程研究中心, 天津 301617;3.贵州瑞和制药有限公司, 黔南 551200;4.贵州医科大学药学院, 贵阳 550025
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| 摘要: |
| [目的] 研究舒肝宁注射液与临床常用的3种注射剂（注射用谷胱甘肽、异甘草酸镁注射液、多烯磷脂酰胆碱注射液）的配伍稳定性。[方法] 测定舒肝宁注射液与3种注射液配伍后8 h内，pH值、不溶性微粒、渗透压摩尔浓度的变化、同时采用高效液相色谱（HPLC）测定四种指标成分绿原酸、栀子苷、黄芩苷、腺苷的含量变化。[结果] 舒肝宁注射液与3种注射液配后8 h内，性状无明显变化，pH值，渗透压摩尔浓度、不溶性微粒的变化均在规定的范围内；4种指标成分含量稳定，无显著变化（RSD<3%，腺苷含量约0.5 μg/mL，RSD为3.08%~11.13%）。[结论] 舒肝宁注射液与3种注射液配伍后8 h内稳定。 |
| 关键词: 舒肝宁注射液 注射用谷胱甘肽 异甘草酸镁注射液 多烯磷脂酰胆碱注射液 配伍稳定性 |
| DOI：10.11656/j.issn.1673-9043.2026.02.08 |
| 分类号:R969.2;R285.5 |
| 基金项目:贵州省科技计划项目；基于药效物质的中药大品种舒肝宁注射液体内过程及药物相互作用研究（黔科合支撑[2023]一般158）。 |
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| Study on the stability of Shuganning Injection with other three clinical-used injections |
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ZHANG Linhui1,2, SHEN Pengyu1,2, HUANG Xiaochao1,2, HOU Xiaotong1,2, HU Yiwen1,2, JIAN Ruihong1,2, YANG Cuiping3, HE Feng4, PI Jiaxin1,2
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1.State Key Laboratory for Component-based Chinese Medicines, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;2.Ministry of Education Engineering & Research Center for Modern Chinese Medicine Discovery and Preparation Technique, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;3.Guizhou Ruihe Pharmaceutical Co. Ltd., Qiannan 551200, China;4.School of Pharmaceutical Sciences, Guizhou Medical University, Guiyang 550025, China
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| Abstract: |
| [Objective] To investigate the stability of Shuganning Injection（SGN）after it was compatible with three commonly clinical-used injections（Glutathione for Injection，Magnesium Isoglycyrrhizinate Injection and Polyene Phosphatidylcholine Injection）. [Methods] SGN and the above injections were prepared separately according to the instructions for use，and then mixed. After mixing，the pH，insoluble particles，and ingredients（chlorogenic acid， gardenin，baicalin and adenosine）of SGN were investigated at different time points. [Results] There was no significant change in the properties of the finished solution of Shuganning injection；the pH value decreased slightly， and the sub-visible particles did not exceed the limit within 8 h，which was in line with the provisions of the pharmacopoeia. The contents of the four components chlorogenic acid，gardenin，baicalin and adenosine did not change much. [Conclusion] Shuganning Injection can be used in combination with Glutathione for Injection， Magnesium Isoglycyrrhizinate Injection and Polyene Phosphatidylcholine Injection. |
| Key words: Shuganning injection glutathione for injection magnesium isoglycyrrhizinate injection polyene phosphatidylcholine injection compatibility stability |
