Butylphthalide soft gel capsule and its preparation procedure

Abstract

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 flavor 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.

1 . A butylphthalide soft gel capsule characterized by a composition comprising capsule materials and pharmaceutical components in drug-containing oil form, wherein the pharmaceutical components in drug-containing oil comprising substantially butylphthalide and vegetable oil with the weight ratio in between 1:0 and 1:10. 
     
     
         2 . The butylphthalide soft gel capsule according to  claim 1 , wherein the characterized weight ratio between butylphthalide and vegetable oil ranges from 1:1 to 1:8. 
     
     
         3 . The butylphthalide soft gel capsule according to  claim 2 , wherein the characterized weight ratio of said butylphthalide and said vegetable oil ranges from 1:2 to 1:5. 
     
     
         4 . The butylphthalide soft gel capsule according to  claim 3 , wherein the characterized weight ratio between butylphthalide and vegetable oil is 1:3.5. 
     
     
         5 . The butylphthalide soft gel capsule according to  claim 1 ,  2 ,  3 , or  4 , wherein the characterized vegetable oil is selected from the group consisting of sesame oil, corn oil, peanut oil, soybean oil, almond oil, peach kernel oil, cottonseed oil, sunflower seed oil, olive oil, or their mixture. 
     
     
         6 . The butylphthalide soft gel capsule according to  claim 1 ,  2 ,  3 , or  4 , wherein the characterized butylphthalide includes the optically inactive, mixed L and D forms of butylphthalide, levorotatory optical isomer of butylphthalide, dextrorotatory optical isomer of butylphthalide. 
     
     
         7 . The butylphthalide soft gel capsule according to  claim 1 , wherein the characterized drug-containing oil further includes dibutyl carboxyl methyl benzene (dibutyl carboxyl toluene) as antioxidant with 0 to 0.2% weight ratio in respect to drug-containing oil. 
     
     
         8 . The butylphthalide soft gel capsule according to  claim 1 , wherein the characterized capsule materials includes the basic components of gel, plasticizer and water with the weight ratio of 1:0.2 to 0.4:0.8 to 1.3. 
     
     
         9 . The butylphthalide soft gel capsule according to  claim 8 , wherein the characterized gel is selected from the group consisting of gelatin or acacia gum (Gum Arabic), or a mixture of gelatin and acacia gum. 
     
     
         10 . The butylphthalide soft gel capsule according to  claim 8 , wherein the characterized plasticizer is selected from the group consisting of glycerol (glycerin) or sorbitol (sorbierite), or a mixture of glycerol and sorbitol. 
     
     
         11 . The butylphthalide soft gel capsule according to  claim 8 , wherein the characterized capsule materials further includes antiseptic agents.