氨氯地平混悬液包衣替米沙坦片芯的制备.PDFVIP

氨氯地平混悬液包衣替米沙坦片芯的制备  施祥杰，刘洁凝，刘晓鸣，彭俊清，陈浩，胡李斌(浙江华海药业股份有限公司，浙江 临海 317024) 摘要：目的 采用氨氯地平混悬液包衣替米沙坦片芯制备替米沙坦氨氯地平片，并对其溶出行为和稳定性进行评价。方 法 采用流化床一步造粒工艺制备替米沙坦颗粒，用普通旋转压片机制备替米沙坦片芯，然后用氨氯地平混悬液对替米 沙坦片芯进行包衣，并以溶出曲线相似性f 2 值作为评价指标，通过正交设计进行处方优化，用 HPLC 进行含量和杂质检 测，通过加速和长期试验考察片剂稳定性和溶出度。结果 制备的替米沙坦氨氯地平片质量稳定，具有与原研制剂一致 的溶出特征。结论 以氨氯地平包衣替米沙坦片芯制备替米沙坦氨氯地平片具有一定的可行性。 关键词：混悬液包衣；溶出曲线相似性；替米沙坦氨氯地平片；稳定性 中图分类号：R943 文献标志码：B 文章编号：1007-7693(2018)08-1146-04 DOI: 10.13748/ki.issn1007-7693.2018.08.006 引用本文：施祥杰, 刘洁凝, 刘晓鸣, 等. 氨氯地平混悬液包衣替米沙坦片芯的制备 [J]. 中国现代应用药学, 2018, 35(8): 1146-1149. Study on the Preparation of Telmisartan Tablets Coated with Amlodipine Suspension SHI Xiangjie, LIU Jiening, LIU Xiaoming, PENG Junqing, CHEN Hao, HU Libin(Zhejiang Huahai Pharmaceutical Co., Ltd., Linhai 317024, China) ABSTRACT: OBJECTIVE To prepare Telmisartan and Amlodipine tablets by the methods of Telmisartan tablets coated with Amlodipine suspension and assess the dissolution and stability. METHODS Telmisartan blend was prepared by the one step granulation process using fluidized bed. The blend was compressed by rotary tablet press and then coated with amlodipine suspension. The formulations were optimized by orthogonal experiment design utilizing dissolution similarity f 2 as an evaluation index. The drug content and impurity were analyzed by HPLC. The stability study was conducted under both accelerated and long-term conditions. RESULTS The optimized formulation of Telmisartan and Amlodipine tablets showed acceptable quality and stability and similar dissolution profiles with the reference. CONCLUSION The process prepared Telmisartan and Amlodipine tablets is feasible. KEY WORDS: suspension coating; dissolution of the similarity; Telmisartan and Amlodipine tablets; stability 替米沙坦氨氯地平片为血管紧张素Ⅱ受体阻 压片收率低，通常只有 80%，