流化床颗粒包衣法制备替米沙坦氢氯噻嗪片

Study on Preparation of Telmisartan Hydrochlorothiazide Tablets by Fluidized Bed Particles Coating

关键词:  颗粒包衣  包衣增重  替米沙坦氢氯噻嗪片  单层片  双层片  稳定性

Key words:  particles coating  coating weight  telmisartan hydrochlorothiazide tablets  one-layered tablets  two-layered tablets  stability

摘要:

目的 采用流化床颗粒包衣法制备替米沙坦氢氯噻嗪片，并对其稳定性进行考察。方法 采用流化床一步造粒工艺制备替米沙坦颗粒，然后将替米沙坦颗粒进行不同包衣增重后与氢氯噻嗪以及合适的辅料混合，用普通旋转压片机进行压片制备替米沙坦氢氯噻片，并利用正交试验设计，优化替米沙坦氢氯噻嗪片处方；用HPLC进行含量和杂质检测，通过加速试验和长期试验考察片剂稳定性和溶出度。结果 该方法制备的替米沙坦氢氯噻嗪片质量稳定。羧甲基淀粉钠外加用量20.4 mg、氢氧化钠用量8.5 mg溶出指标最为理想，最终优化的处方与原研制剂溶出特征一致。结论 以流化床颗粒包衣法制备的替米沙坦氢氯噻嗪片质量稳定，工艺较双层片简单，具有可行性。

Abstract:

OBJECTIVE To prepare telmisartan hydrochlorothiazide tablets by the methods of fluidized bed particles coating and assess its stability. METHODS Telmisartan particles were prepared by the fluidized bed one step granulation. Telmisartan particles of different coating weight, hydrochlorothiazide and pharmaceutical excipients were mixed. Then telmisartan hydrochlorothiazide tablets were prepared by rotary tablet machine. The optimization formulation were selected by orthogonal experiment. The assay and impurty were assayed by HPLC. The stability and dissolution study were conducted in an accelerated testing and long-term testing. RESULTS The optimal method of preparing telmisartan hydrochlorothiazide tablets showed a good stability. The formulation contained, external additional sodium carboxymethyl starch 20.4 mg and sodium hydroxide 8.5 mg showed the best dissolution. The final optimized prescription had similar dissolution behavior to brand drug. CONCLUSION The telmisartan hydrochlorothiazide tablets produced by fluidized bed particles coating show a good quality, and the process is more simple than two-layered tablets, the optimal method is feasible.