| 吴妍,耿魁魁,史天陆,等.注射用丹参多酚酸盐成品输液的稳定性[J].安徽医药,2018,22(6):1203-1206. |
| 注射用丹参多酚酸盐成品输液的稳定性 |
| Research on the stability of finished salvianolate transfusion |
| 投稿时间：2017-02-05 |
| DOI： |
| 中文关键词: 丹参酚 药物稳定性 药物配伍禁忌 |
| 英文关键词: Salviol Drug stability Drug incompatibility |
| 基金项目:安徽省卫生计生委中医药科研课题(2014zy20) |
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| 中文摘要: |
| 目的 考察注射用丹参多酚酸盐成品输液稳定性。 方法 分别考察室温(25 ℃)和冷藏(4 ℃)条件下,注射用丹参多酚酸盐的3种临床常用成品输液在0～8 h间的有效成分的含量、输液外观、pH值及不溶性微粒的数量的变化。 结果 注射用丹参多酚酸盐与胰岛素在5%葡萄糖注射液中混合调配后,无论在室温或冷藏条件下,2 h内成品输液丹酚酸B含量下降均超过10%,溶液pH值超过6,≥10 μm不溶性微粒的数量超过25个/毫升,≥25 μm不溶性微粒的数量超过3个/毫升。使用5%葡萄糖注射液和0.9%氯化钠注射液稀释的成品输液,室温保存8 h稳定。然而,在冷藏条件下,0.9%氯化钠注射液稀释后的成品输液6 h内不溶性微粒数超出规定范围,而5%葡萄糖注射液稀释后的成品输液2 h内不溶性微粒的数量超出规定范围。 结论 注射用丹参多酚酸盐不宜与胰岛素配伍使用。在冷藏条件下,建议采用0.9%氯化钠注射液稀释后的成品输液保存不得超过6 h,采用5%葡萄糖注射液稀释后的成品输液保存不得超过2 h。 |
| 英文摘要: |
| Objective To research the quality and stability of finished Salvianolate transfusion. Methods The content of active ingredients,appearance,pH value and insoluble particles of 3 clinical commonly used products of Salvianolate within 8 hours were measured under the room temperature (25 ℃) and refrigeration (4 ℃),respectively. Results When Salvianolate and insulin were mixed in 5% glucose injection,the content of Salvianolic acid Bdropped more than 10% in 2 h at room temperature (25 ℃) or in refrigerator (4 ℃),the pH value of the solution was higher than 6,the number of insoluble particles with diameters greater than 10 μm and 25 μm were more than 25/mL and 3/mL,respectively.When Salvianolate was diluted by 5% glucose injection or 0.9% sodium chloride injection,the solution remained stable for 8 hours under room temperature.Under refrigeration condition,the insoluble particles in the finished product infusion after diluted with 0.9% sodium chloride injection did not meet regulation criteria within 6 hours,and the insoluble particles in the finished product infusion after diluted with 5% glucose injection did not meet regulation criteria within 2 hours. Conclusions Salvianolate should not be mixed with insulin due to the incompatibility.Under refrigeration condition,the solution diluted by 0.9% sodium chloride injection should not be kept for more than 6 hours and the solution diluted by 5% glucose injection should not be kept for more than 2 hours. |
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