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丁丙诺啡、氟哌啶醇与格隆溴铵混合物在0.9%氯化钠溶液中的稳定性

Stability of buprenorphine, haloperidol and glycopyrrolate mixture in a 0.9% sodium chloride solution.

作者信息

Jäppinen A, Kokki H, Naaranlahti T J, Rasi A S

机构信息

Central Finland Hospital, Jyväskylä, Finland.

出版信息

Pharm World Sci. 1999 Dec;21(6):272-4. doi: 10.1023/a:1008771621812.

Abstract

Combinations of opioids and adjuvant drug solutions are often used in clinical practice while little information is available on their microbiological or chemical stability. Currently there are no commercially available, prepacked, ready-to-use epidural or subcutaneous mixtures. Thus, epidural and subcutaneous analgesic mixtures must be prepared in the pharmacy on an as-needed basis. Such mixtures are typically used for the treatment of severe pain in cancer patients. The aim of this study was to investigate the microbiological and chemical stability of a buprenorphine, haloperidol and glycopyrrolate mixture in a 0.9% sodium chloride solution. A high performance liquid chromatographic (HPLC) method and pH-meter were used to conduct the analyses. Antimicrobial activity of each component was studied by an agar dilution method. According to the results from the chemical and microbiological stability studies, this mixture can be stored in polypropylene (PP) syringes and polyvinyl chloride (PVC) medication cassettes for at least 30 days at either 21 degrees C or 4 degrees C, and for 16 days in PP syringes at 36 degrees C, and for 9 days in PVC medication cassettes at 36 degrees C.

摘要

阿片类药物与辅助药物溶液的组合在临床实践中经常使用,但其微生物学或化学稳定性方面的信息却很少。目前尚无市售的预包装即用型硬膜外或皮下混合制剂。因此,硬膜外和皮下镇痛混合制剂必须在药房根据需要配制。此类混合制剂通常用于治疗癌症患者的重度疼痛。本研究的目的是考察丁丙诺啡、氟哌啶醇和格隆溴铵在0.9%氯化钠溶液中的微生物学和化学稳定性。采用高效液相色谱(HPLC)法和pH计进行分析。通过琼脂稀释法研究各组分的抗菌活性。根据化学和微生物稳定性研究结果,该混合制剂可在聚丙烯(PP)注射器和聚氯乙烯(PVC)药盒中于21℃或4℃下储存至少30天,在PP注射器中于36℃下储存16天,在PVC药盒中于36℃下储存9天。

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