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地西泮注射液用静脉输液稀释后的配伍性与稳定性。

Compatibility and stability of diazepam injection following dilution with intravenous fluids.

作者信息

Morris M E

出版信息

Am J Hosp Pharm. 1978 Jun;35(6):669-72.

PMID:665679
Abstract

The compatibility and stability of diazepam injection were studied following dilution to 10 different concentrations in dextrose 5% in water, normal saline, Ringer's injection and lactated Ringer's injection. Prepared solutions were examined for clarity and pH throughout a 24-hour period. Clear solutions were filtered and then assayed 24 hours after preparation using UV spectrophotometry. Solutions which formed visible precipitates before 24 hours or which did not demonstrate acceptable potency (greater than or equal to 90%) were assayed after shorter time periods. Dilutions lower than 1:20 (5 mg in 20 ml) resulted in immediate visible precipitates in all four diluents. The 1:20 dilution was compatible with all four diluents and maintained acceptable potency for four hours, whereas at 1:40 dilution (5 mg in 40 ml) diazepam was stable for at least 6-8 hours in the same diluents. At higher dilutions of 1:50, 1:75 and 1:100 (5 mg in 50, 75 and 100 ml, respectively) the injection was compatible with and stable in all four diluents for 24 hours. Further studies are required before the use of diazepam injection as an infusion can be recommended. However, if in some circumstances it is necessary to administer diazepam as an infusion, it is recommended that it be diluted in dextrose 5% in water, normal saline, Ringer's injection or lactated Ringer's injection to a dilution of at least 1:40 and used within 6 hours or to a dilution of 1:50 and used within 24 hours.

摘要

研究了地西泮注射液在5%葡萄糖注射液、生理盐水、林格氏注射液和乳酸林格氏注射液中稀释至10种不同浓度后的配伍性和稳定性。在24小时内对配制好的溶液进行澄清度和pH值检查。澄清溶液经过过滤,然后在配制后24小时使用紫外分光光度法进行测定。在24小时前形成可见沉淀或未显示出可接受效价(大于或等于90%)的溶液在较短时间段后进行测定。低于1:20(20 ml中含5 mg)的稀释液在所有四种稀释剂中均立即出现可见沉淀。1:20的稀释液与所有四种稀释剂均配伍,且在4小时内保持可接受的效价,而在1:40稀释(40 ml中含5 mg)时,地西泮在相同稀释剂中至少稳定6 - 8小时。在1:50、1:75和1:100(分别为50、75和100 ml中含5 mg)的更高稀释度下,该注射液在所有四种稀释剂中24小时均配伍且稳定。在推荐将地西泮注射液用作输注液之前,还需要进一步研究。然而,在某些情况下,如果有必要将地西泮作为输注液给药,建议将其在5%葡萄糖注射液、生理盐水、林格氏注射液或乳酸林格氏注射液中稀释至至少1:40,并在6小时内使用,或稀释至1:50并在24小时内使用。

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