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| 疏血通注射液与2种常用溶媒配伍的稳定性研究 |
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谢佳蓉1,2,3, 马旭彤1,2,3, 闫宏丽1,2,3, 梁春霞1,2,3, 皮佳鑫1,2,3, 刘志东1,2,3
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1.天津中医药大学, 天津 301600;2.天津中医药大学中医药研究院, 天津 301600;3.天津中医药大学, 现代中药发现与制剂技术教育部工程中心, 天津 301600
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| 摘要: |
| [目的]考察疏血通注射液与0.9%氯化钠注射液、5%葡萄糖注射液配伍的稳定性。[方法]依据临床用量，将疏血通注射液分别加入到3种规格的0.9%氯化钠注射液、5%葡萄糖注射液中，在配伍后0、1、2、4、6、8 h取样，测定次黄嘌呤含量、外观、pH值、渗透压摩尔浓度、不溶性微粒、粒径等指标以及进行蛋白质检查。[结果]疏血通注射液与3种规格的0.9%氯化钠注射液、5%葡萄糖注射液配伍后8 h内颜色正常，溶液澄清。pH值、渗透压摩尔浓度、不溶性微粒、粒径均在合理范围内，蛋白质检查符合限度规定。疏血通注射液与0.9%氯化钠注射液配伍后2 h内次黄嘌呤含量稳定，2 h后随时间呈缓慢降解趋势；疏血通注射液与5%葡萄糖注射液配伍后8 h内次黄嘌呤含量稳定。[结论]疏血通注射液与0.9%氯化钠注射液、5%葡萄糖注射液配伍后在8 h内各指标基本稳定，可应用于临床，建议在临床使用中即配即用。 |
| 关键词: 疏血通注射液 临床配伍 稳定性 注射液溶媒 |
| DOI：10.11656/j.issn.1673-9043.2019.04.06 |
| 分类号:R284 |
| 基金项目: |
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| Stability study of Shuxuetong injection in two common solvents |
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XIE Jiarong1,2,3, MA Xutong1,2,3, YAN Hongli1,2,3, LIANG Chunxia1,2,3, PI Jiaxin1,2,3, LIU Zhidong1,2,3
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1.Tianjin University of Chinese Traditional Medicine, Tianjin 301600, China;2.The Institute of Traditional Chinese Medicine, Tianjin University of Chinese Traditional Medicine, Tianjin 301600, China;3.Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique, Ministry of Education, Tianjin University of Traditional Chinese Medicine, Tianjin 301600, China
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| Abstract: |
| [Objective] To investigate the compatibility of Shuxuetong injection with 0.9% sodium chloride infusion and Shuxuetong injection with 5% glucose infusion.[Methods] According to the clinical dosage, Shuxuetong injection was added respectively to three types of 0.9% sodium chloride infusions and three types of 5% glucose infusions. Determine the content of hypoxanthine, appearance, pH, osmolality, insoluble particles, particle size and protein examination within 8 h after mixing.[Results] After the common solvents were mixed with Shuxuetong injection, the pH value, osmolality, insoluble particles and particle size were reasonable within 8 h. No protein substances were detected out. In the detection of hypoxanthine content, the content was stable within 2 h after mixing Shuxuetong injection with 0.9% sodium chloride infusion, and slowly degraded after 2 h. The content was stable within 8 h after mixing Shuxuetong injection with 5% glucose infusion.[Conclusion] After mixing Shuxuetong injection with 0.9% sodium chloride infusion and Shuxuetong injection with 5% glucose infusion, the indicators were basically stable within 8 h. So 0.9% sodium chloride infusion and 5% glucose infusion are suitable for the clinical compatibility of Shuxuetong injection. In addition, it is recommended to use it as soon as possible after mixing in clinical use. |
| Key words: Shuxuetong injection clinical compatibility stability study injection vehicle |
