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醋酸奥曲肽在全营养混合液中的活性。

Activity of octreotide acetate in a total nutrient admixture.

作者信息

Ritchie D J, Holstad S G, Westrich T J, Hirsch J D, O'Dorisio T M

机构信息

St. Louis College of Pharmacy, Jewish Hospital of St. Louis, MO 63110.

出版信息

Am J Hosp Pharm. 1991 Oct;48(10):2172-5.

PMID:1781474
Abstract

The activity of octreotide acetate in a total nutrient admixture (TNA) and the effect of the drug on the stability of lipid emulsion in the TNA were studied. Octreotide acetate injection was added to a standard solution containing 3% lipids, amino acids, dextrose, electrolytes, vitamins, and trace elements to achieve a theoretical concentration of 45 micrograms/dL. Samples were stored at room temperature for 48 hours. Octreotide concentrations were determined in triplicate by radioimmunoassay; physical stability of the solutions was assessed by lipid particle-size determination, pH measurement, and visual observation of emulsion integrity at 0, 12, 24, and 48 hours. The activity of octreotide in two samples of each solution (with and without lipid) was analyzed immediately after preparation and after seven days under refrigeration. There was no evidence of emulsion breakdown or pH change in any solution over the study period. In addition, particle-size distributions at 48 hours and 7 days were comparable to those at time zero, suggesting physical stability. Octreotide acetate activity was not consistently greater than 90% (mean +/- S.D.) after storage for 48 hours. Octreotide acetate at a theoretical concentration of 45 micrograms/dL in a TNA solution containing 3% lipids appeared to be physically compatible for 48 hours at room temperature and for 7 days under refrigeration. However, the chemical activity of octreotide in TNA was not consistent after storage for 48 hours.

摘要

研究了醋酸奥曲肽在全营养混合液(TNA)中的活性以及该药物对TNA中脂肪乳剂稳定性的影响。将醋酸奥曲肽注射液加入到含有3%脂质、氨基酸、葡萄糖、电解质、维生素和微量元素的标准溶液中,使其理论浓度达到45微克/分升。样品在室温下保存48小时。通过放射免疫分析法对奥曲肽浓度进行三次测定;通过测定脂质颗粒大小、测量pH值以及在0、12、24和48小时观察乳剂完整性来评估溶液的物理稳定性。在制备后以及冷藏7天后,立即分析每种溶液(含脂质和不含脂质)的两个样品中奥曲肽的活性。在研究期间,没有任何溶液出现乳剂破裂或pH值变化的迹象。此外,48小时和7天时的颗粒大小分布与零时相当,表明具有物理稳定性。储存48小时后,醋酸奥曲肽的活性并非始终大于90%(平均值±标准差)。在含有3%脂质的TNA溶液中,理论浓度为45微克/分升的醋酸奥曲肽在室温下48小时以及冷藏7天似乎在物理上是相容的。然而,储存48小时后,TNA中奥曲肽的化学活性并不一致。

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