摘要
目的制备替米沙坦氨氯地平微丸片剂,并对其溶出度、含量均匀度及稳定性进行考察。方法采用空白丸芯对苯磺酸氨氯地平进行上药,再包不同增重的隔离衣,与采用流化床制备的替米沙坦颗粒混合后压片;考察所制备片剂稳定性并与原研产品进行了溶出度比较。结果该方法制备的替米沙坦氨氯地平片,样品质量稳定,且溶出行为与原研产品一致。结论通过对一种活性成分隔离保护后,再与另一种成分混合后压片,较制备双层片简单,工艺可行。
Objective To determine the preparation technology, dissolution, content uniformity and stability of compound amlodipine besylate and telmisartan pellet tablets. Methods The blank pellets were coated with amlodipine besylate, and barrier pellets of different weights collected. In addition, telmisartan granules were prepared by fluid-bed granulation. The two materials were mixed and pressed into tablets. Stability of the tablets was determined and the dissolution compared with that of the reference preparation. Results The quality of compound tablets prepared by this method was stable, and the dissolution characteristics were similar with those of the reference preparation. Conclusion One active ingredient is isolated and protected, and then mixed with another component, before being pressed. The preparation is simple and the process is feasible.
作者
孟淑娟
陈江
刘勇
张文君
吴小翠
王媛
MENG Shu-juan;CHEN Jiang;LIU Yong;ZHANG Wen-jun;WU Xiao-cui;WANG Yuan(Xi'an Xintong Pharmaceutical Research Co., Ltd, Xi'an 710077;Hospital of Shaanxi Armed Police Corps, Xi'an 710054;Xi'an Gelan Xintong Pharmaceutical Co., Ltd, Xi'an 710077)
出处
《中南药学》
CAS
2018年第11期1533-1537,共5页
Central South Pharmacy
