熊胆薄膜包衣片的研制

Preparation of film coated bear bile tablet

目的研制熊胆的薄膜包衣片剂。方法以微晶纤维素、羧甲基淀粉钠等为主要辅料,以HPLC法测定熊胆粉中牛磺熊去氧胆酸量为质控指标,以湿法制粒压片,用滚转包衣法包衣。结果HPLC法直接测定熊胆粉及其制剂中牛磺熊去氧胆酸的含量,操作简单、方法准确、精密度高;处方中羧甲基淀粉钠可显著影响片剂的溶出速率,而乳糖对其无显著性影响。按目的处方制备的熊胆薄膜包衣片剂达到实验设计要求。结论熊胆薄膜包衣片剂剂量准确,服用方便,可改善熊胆粉的吸潮不稳定性,是一种较为理想的口服固体剂型。

Objective: To prepare the film coated bear bile tablet (FCBBTs). Methods: Microcrystalline cellulose and carboxymethyl starch sodium (CMS Na) were used as major pharmaceutical ingredients to compress and coat the tablets with wet granule preparing and pan roll coating methods respectively and the quality of the FCBBTs was controlled by determining the content of tauroursodeoxycholic acid in bear bile powder and FCBBTs with HPLC method. Results: The quality control method was simple and accurate. The quantity of CMS Na could affect obviously the dissolution rate of FCBBTs and lactose had no effect on it. The tablets prepared by target prescription fulfilled the design requirement. Conclusion: The dosage of FCBBTs is accurate and the administration of it is convenient. FCBBTs can improve the stability of bear bile powder and is an ideal oral solid preparation. [