基于GRAS的两种肠溶包衣在鱼油肠溶软胶囊中的应用

The Application of the Two GRAS Enteric Coating System for Fish Oil Soft Gel Capsule

目的应用市售的两种符合GRAS的肠溶包衣材料制备鱼油肠溶软胶囊并比较其性能差异。方法包衣法制备符合USP肠溶性能的鱼油软胶囊,并对两者材料的使用方法、包衣液性质、包衣膜性质和肠溶性能及稳定性进行比较研究。结果二者材料制备的鱼油肠溶软胶囊经1个月加速考察,均符合USP肠溶软胶囊的性能要求。结论两种肠溶包衣材料在欧美市场广泛应用于鱼油肠溶软胶囊,法规适应广、工艺简单,可为国内食品或保健品的肠溶软胶囊包衣提供应用参考。

OBJECTIVE Use the two commercial enteric coating systems which are GRAS complains to prepare the fish oil enteric soft capsule and compare the properties. METHODS The fish oil soft capsules with USP enteric properties were prepared by coating, the application methods, coating suspension properties, coating film properties, enteric properties and stability were studied. RESULTS The quality of the two enteric coating fish oil soft capsules stored under the accelerated testing for one month were complied with the requirement of USP enteric properties. CONCLUSION The two enteric coating systems are widely used in fish oil enteric soft capsules in Europe and America with regulatory compliance and simple process, which can provide application reference for the enteric coat- ing of food or health care soft capsule in China.