米氮平口崩片的制备及初步稳定性考察

Preparation and Stability of Mirtazapine Orally Disintegrating Tablets

目的:采用正交试验筛选米氮平口崩片的处方,并进行初步稳定性考察。方法:以甘露醇(A)、微晶纤维素(B)、低取代羟丙基纤维素(C)及交联聚乙烯吡咯烷酮(D)用量为考察因素,以崩解时间、溶出度为评价指标进行正交试验,并采用相似因子(f2)对自制片剂和原研制剂在溶出介质中的累积溶出度进行比较。通过高温,高湿,光照试验初步考察制剂稳定性。结果:A、B、C、D用量分别为70,20,2.5,10 mg时,制备的片剂外观光洁,崩解较快,溶出度高。自制片剂和原研制剂在溶出介质中的累积释放度f2为63.38。影响因素试验结果表明本品应防潮,避光保存。结论:米氮平口崩片处方设计合理,制备工艺可行,质量稳定。

Objective：To optimize the formula of mirtazapine orally disintegrating tablets by orthogonal experiment and determine the stability preliminarily. Methods：The formula was optimized by orthogonal experiment based on 4 impacting factors：the amount of mannotil （A）, microcrystalline mellulose （B）, low substituted hydroxypropyl cellulose （C） and cross-linked polyvinylpyrrolidone （ D） , respectively with 2 indices of disintegration time and dissolution. The release rate of the orally disintegrating tablets and the ref-erence tablets was studied by similarity factors. The stability was respectively studied by high temperature test, high humidity test and photostability test. Results：The optimum formula of the tablets was as follows：the amount of A, B, C and D was 70, 20, 2. 5 and 10 mg, respectively. The f2 for the orally disintegrating tablets and the reference tablets in the dissolution medium was 63. 38. Conclu-sion：The formula is reasonable, the preparation process is feasible and the quality is stable.