A soft capsule of butylphthalide and a process for preparing...

Details A soft capsule of butylphthalide and a process for preparing... A soft capsule of butylphthalide and a process for preparing...

A - Human Necessities

61

K

A61K 9/48 (2006.01) A61K 31/34 (2006.01)

Patent

CA 2549498

The present invention discloses a novel soft capsule of butylphthalide and a process for preparing the same. The soft capsule of butylphthalide is composed of a capsule wall material and a drug-containing oil, wherein the drug-containing oil is essentially composed of butylphthalide and a vegetable oil as the diluent in a weight ratio of about 1:0-10. The capsule wall material is composed of a capsule wall matrix, a plasticizer and water in a weight ratio of 1:0.2-0.4:0.8-1.3. The soft capsule of butylphthalide described in the present invention can mask the strong and special flavour of butylphthalide, and overcome the difficulties associated with formulating oily active ingredient into other oral formulation. The disintegration time of the soft capsule satisfies the requirement of Pharmacopoeia of P.R. China.

Cette invention concerne une nouvelle forme posologique de capsule molle de butylphthalide et le procédé de préparation correspondant. La capsule molle de butylphthalide est composée d'un matériau d'enrobage et d'une huile contenant un médicament. L'huile contenant un médicament est essentiellement constituée de butylphthalide et d'un diluant d'huile végétale ; le rapport pondéral butylphthalide/huile est compris entre 1:0 et 1:10. Le matériau d'enrobage est composé de gélatine, d'un plastifiant et d'eau ; le rapport pondéral gélatine/plastifiant/eau est compris entre 1:0,2 à 1:04 sur 1:0,8 à 1:0,3. La capsule décrite dans cette invention peut permettre de masquer le goût fort et spécifique du butylphthalide, et elle permet de résoudre les difficultés associées à la formulation de principes actifs huileux dans d'autres préparations orales. Le temps de délitement de la capsule molle répond aux exigences de la pharmacopée de la République Populaire de Chine.

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