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盐酸替罗非班在与其他药物模拟Y型接口给药过程中的稳定性和相容性。

Stability and compatibility of tirofiban hydrochloride during simulated Y-site administration with other drugs.

作者信息

Bergquist P A, Manas D, Hunke W A, Reed R A

机构信息

Merck and Co., Inc., WP78-204, Sumneytown Pike, West Point, PA 19486-0004, USA.

出版信息

Am J Health Syst Pharm. 2001 Jul 1;58(13):1218-23. doi: 10.1093/ajhp/58.13.1218.

DOI:10.1093/ajhp/58.13.1218
PMID:11449879
Abstract

The stability and compatibility of tirofiban hydrochloride injection during simulated Y-site administration with various other drugs were studied. Tirofiban hydrochloride, dobutamine, epinephrine hydrochloride, furosemide, midazolam hydrochloride, and propranolol hydrochloride injections were each prepared from their respective concentrates in both 0.9% sodium chloride injection and 5% dextrose injection at both the minimum and maximum concentrations normally administered. The high-concentration solutions of midazolam hydrochloride and furosemide were used as is. Morphine sulfate was diluted in 5% dextrose injection only. Nitroglycerin premixed infusions, atropine sulfate injection, and diazepam injection were used as is. Tirofiban hydrochloride solutions were combined 1:1 with each of the secondary drug solutions in separate glass containers. Samples were stored for four hours at room temperature under ambient fluorescent light and were assayed for drug content and degradation by high-performance liquid chromatography and for pH, appearance, and turbidity. All mixtures except those containing diazepam remained clear and colorless, with no visual or turbidimetric indication of physical instability. Mixing of tirofiban hydrochloride and diazepam solutions resulted in immediate precipitation. all remaining mixtures remained clear. There was no significant loss of any of the drugs tested, no increase in known degradation products, and no appearance of unknown drug-related peaks. The pH of all test solutions remained constant. Tirofiban hydrochloride injection 0.05 mg/mL was stable for at least four hours when combined 1:1 in glass containers with atropine sulfate, dobutamine, epinephrine hydrochloride, furosemide, midazolam hydrochloride, morphine sulfate, nitroglycerin, and propranolol hydrochloride at the concentrations studied. Tirofiban hydrochloride was incompatible with diazepam.

摘要

研究了盐酸替罗非班注射液在模拟Y型接口给药时与其他各种药物的稳定性和配伍性。盐酸替罗非班、多巴酚丁胺、盐酸肾上腺素、呋塞米、盐酸咪达唑仑和盐酸普萘洛尔注射液分别由各自的浓缩液在0.9%氯化钠注射液和5%葡萄糖注射液中按正常给药的最低和最高浓度配制。盐酸咪达唑仑和呋塞米的高浓度溶液直接使用。硫酸吗啡仅在5%葡萄糖注射液中稀释。硝酸甘油预混输液、硫酸阿托品注射液和地西泮注射液直接使用。盐酸替罗非班溶液在单独的玻璃容器中与每种辅助药物溶液按1:1混合。样品在室温下于环境荧光灯下储存4小时,并通过高效液相色谱法测定药物含量和降解情况,同时测定pH值、外观和浊度。除含有地西泮的混合物外,所有混合物均保持澄清无色,无视觉或比浊法表明的物理不稳定性迹象。盐酸替罗非班和地西泮溶液混合后立即出现沉淀。所有其余混合物均保持澄清。所测试的任何药物均无明显损失,已知降解产物无增加,也未出现未知的药物相关峰。所有测试溶液的pH值保持恒定。在所研究的浓度下,0.05 mg/mL的盐酸替罗非班注射液在玻璃容器中与硫酸阿托品、多巴酚丁胺、盐酸肾上腺素、呋塞米、盐酸咪达唑仑、硫酸吗啡、硝酸甘油和盐酸普萘洛尔按1:1混合时至少稳定4小时。盐酸替罗非班与地西泮不相容。

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