红霉素肠溶片包衣处方工艺

Study on the prescription and method for coating of erythromycin enteric-coated tablets

目的 :解决红霉素肠溶片贮存过程中释放度易下降导致不合格的问题。方法 :通过改进肠溶包衣材料处方及包衣工艺 ,采用聚丙烯酸II、III混合树脂作包衣材料 ,粉衣层中用羟丙甲纤维素代替明胶 ,包衣工艺采用在肠衣层表面喷上一层保护液。结果 :红霉素肠溶片在贮存 3年后 ,释放度高于标示量的 85 %。结论 :此包衣处方及包衣工艺能够保证红霉素肠溶片在有效期 3年内释放度符合中国药典规定。

OBJECTIVE To prevent the dissolution change of erythromycin enteric-coated tablets during the course of storage.METHODS By improving the formula of enteric coating and the coating technique.Using the mixture of polyacrylic resin Ⅱ and Ⅲ as coating material and using hypromellose in place of agar as sugar coat. In the new technique,we spray liquid protective envelope on the surface of enteric coat.RESULTS After 3 years storage,the dissolution of erythromycin enteric-coated tablets still upon 85% of the criteria.CONCLUSIONS This formula and technique of coating can ensure the dissolution of erythromycin enteric-coated tablets to be in accordance with the requirement of the Chinese Pharmacopoeia during period of validity(3 years).