混合軟膏中のハイドロコルチゾン-17-ブチレートの安定性

概要

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The stability of hydrocortisone-17-butyrate (HC-17-B) in the admixture of Locoid^<[○!R]> Ointment with Anderm^<[○!R]> Ointment (AO), zinc oxide (10%) ointment (ZO) or Juvela^<[○!R]> Ointment (JO) was investigated by the quantitative analysis using high performance liquid chromatography. The decomposition routes of HC-17-B to hydrocorisone-21-butyrate (HC-21-B) and hydrocortisone (HC) in such ointment admixtures were also investigated. In the stability test, percentages of the residual active HC-17-B and decomposition products in the admixtures immediately after mixing and after 2, 4, 8 and 12 weeks of storage in darkness at 5℃, 25℃ or 40℃ were investigated. As a result, it was found that the admixture with AO of a white petrolatum base was stable under any of the storage conditions. In the admixture with ZO, HC-17-B was stable at 5℃ but it decomposed after storage at 25℃ or higher temperature, resulting in the formation of HC-21-B and HC. In the admixture with a JO of o/w type hydrophilic ointment base, HC-17-B decomposed under any of the storage conditions, and with the rise in storage temperature the level of HC-17-B decreased quickly while the level of HC-21-B increased rapidly first, then decreased slowly with the gradual increase in the level of HC.
日本医療薬学会の論文
1987-08-20