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硫酸新斯的明注射液在聚丙烯注射器中于室温及4℃下的稳定性。

Stability of neostigmine methylsulfate injection at ambient temperature and 4 deg C in polypropylene syringes.

作者信息

Storms Meredith L, Stewart James T, Warren Flynn W

机构信息

Department of Pharmaceutical and Biomedical Sciences, University of Georgia College of Pharmacy, Athens, Georgia.

出版信息

Int J Pharm Compd. 2002 Nov-Dec;6(6):475-7.

Abstract

The stability of 1.0-mg/mL neostigmine methylsulfate injection in 6-mL polypropylene syringes stored at ambient temperature under continuous fluorescent light and at 4 deg C for up to 90 days was investigated. Concentration levels of neostigmine methylsulfate injection were determined at 0, 1, 4, 7, 15, 30, 45, 60, and 90 days after preparation of the syringes by means of a high-performance liquid chromatographic stability-indicating assay. Phenol, which was present as a preservative in the injection, did not interfere with the assay. The injections in plastic syringes were stable for up to 90 days at both ambient temperature and at 4 deg C. The pH of neostigmine methylsulfate injection did not change appreciable over the 90-day study period. These data support the stability of neostigmine methylsulfate injection under the storage conditions investigated in this study.

摘要

研究了1.0毫克/毫升硫酸新斯的明注射液在6毫升聚丙烯注射器中,于室温下连续荧光照射以及在4℃下储存长达90天的稳定性。通过高效液相色谱稳定性指示测定法,在制备注射器后的0、1、4、7、15、30、45、60和90天测定硫酸新斯的明注射液的浓度水平。注射液中作为防腐剂存在的苯酚不干扰测定。塑料注射器中的注射液在室温和4℃下均稳定长达90天。在90天的研究期内,硫酸新斯的明注射液的pH值没有明显变化。这些数据支持了硫酸新斯的明注射液在本研究中所考察的储存条件下的稳定性。

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