| 邓晓媚,王晓宇,吴妍,等.注射用血栓通正交试验优化调配技术及其在不同溶媒中稳定性考察[J].安徽医药,2018,22(10):2026-2030. |
| 注射用血栓通正交试验优化调配技术及其在不同溶媒中稳定性考察 |
| The orthogonal test of admixture technology about xueshuantong for injection and its stability in different infusions |
| 投稿时间：2017-01-03 |
| DOI： |
| 中文关键词: 药物稳定性 正交试验 药物调剂 药物配伍禁忌 色谱法,高压液相 注射,静脉内 血栓通 |
| 英文关键词: Drug stability Orthogonal test Drug compounding Drug incompatibility Chromatography,high pressure liquid Injections,intravenous Xueshuantong |
| 基金项目:安徽省卫生和计划生育委员会中医药科研课题(2014zy20) |
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| 中文摘要: |
| 目的 为了优化注射用血栓通调配工艺,并考察其与0.9%氯化钠注射液(sodium chloride injection)、葡萄糖氯化钠注射液(glucose and sodium chloride injection)、5%葡萄糖注射液(5% glucose injection)和10%葡萄糖注射液(10% glucose injection)配伍的稳定性。 方法 通过正交试验优化注射用血栓通的调配工艺,测定成品输液的不溶性微粒:pH值及主成分(三七皂苷R1、人参皂苷Rg1,人参皂苷Rb1)的相对含量变化,考察注射用血栓通在不同溶媒中的8 h内的配伍稳定性。 结果 注射用血栓通用注射用水溶解完全。四种溶媒配制的成品输液在存放8 h内pH值以及不溶性微粒较稳定。5%葡萄糖注射液和10%葡萄糖注射液配制的成品输液主要成分呈下降趋势。 结论 注射用血栓通最佳调配工艺为使用灭菌注射用水6 mL作为溶媒注入药品西林瓶中,振荡5 min溶解,振荡频率为1 000 r·min-1；0.9%氯化钠注射液和葡萄糖氯化钠注射液调配的成品输液8 h内稳定；5%葡萄糖注射液调配的成品输液6 h内稳定,10%葡萄糖注射液调配的成品输液建议现用现配。 |
| 英文摘要: |
| Objective To optimize the admixture technology of xueshuantong for injection,and to explore the compatible stability with 0.9% sodium chloride injection,glucose and sodium chloride injection,5% glucose injection and 10% glucose injection. Methods Orthogonal test was used to optimize the admixture technology of xueshuantong for injection.Insoluble particles in finished injection,pH value and the relative content of the main components (notoginsenoside R1,ginsenoside Rg1 and ginsenoside Rb1) were measured and the compatible stability of xueshuantong for injection in different infusions was observed within 8h at the room temperature. Results Xueshuantong for injection is dissolved well in the sterile water for injection.No significant changes were found in the pH value and the number of insoluble particles in mixture within 8 h.The main components decreased within 8 h in 5% glucose injection and 10% glucose injection. Conclusions The best admixture technology is using 6mL of sterile water for injection as dissolving solvent which was injected into the ampoule,and shaken at the rate of 1 000 r·min-1 for 5 min.Xueshuantong for injection could be mixed by 0.9% sodium chloride injection and glucose and sodium chloride injection and should be used within 8h.It could also be mixed by 5% glucose injection and used within 6 h or mixed by 10% glucose injection and used immediately. |
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