BUTYLPHTHALIDE SOFT GEL CAPSULE AND ITS PREPARATIN PROCEDURE.

摘要

The present invention discloses a novel dosage form of butylphthalide soft capsule and its preparation procedure. Butylphthalide soft capsule is composed of a coating material and a drug-containing oil. The drug-containing oil is basically composed of butylphthalide and diluent - vegetable oil, wherein the weight ratio of butylphthalide to oil ranges from 1:0~10. The coating material is composed of gelatin, plasticizer and water, wherein the weight ratio of gelatin to plasticizer to water is in the range of 1:0.2~0.4:0.8~0.3. The butylphthalide soft capsule described in this invention can mask the strong and specific flavour of butylphthalide, and overcome the difficulties associated with formulating oily active agents into other oral preparations. The disintegration time of the soft capsule complies with the requirement of Pharmacopoeia of P.R. China.