| 摘要 |
<p>PROBLEM TO BE SOLVED: To provide a capsule preparation which contains nalfurafine hydrochloride in a stable state, and a manufacturing method of the preparation.SOLUTION: There is provided a capsule preparation in which capsule content fluid containing nalfurafine hydrochloride, base agent, and antioxidant is coated by coating, in which the base agent is at least one type selected from the group consisting of polyethylene glycol (PEG), propylene glycol, glycerin monocaprylate ester and the like, and the antioxidant is at least one type selected from the group consisting of sodium thiosulfate, gallic acid n-propyl, sodium hydrogen sulfite and the like capsule preparation. There is also provided a manufacturing method of the preparation comprising: (a) a step of dissolving nalfurafine hydrochloride in buffer solution or water to prepare nalfurafine hydrochloride liquid concentrate; (b) a step of mixing the nalfurafine hydrochloride liquid concentrate, the base agent, and the antioxidant to prepare capsule content fluid; and (c) a step of coating said capsule content fluid by coating.</p> |
