摘要
在处方研究中，以体外崩解时限为指标，着重考察了影响氯氮平口腔崩解片崩解时限的制剂因素，并以此对口腔崩解片处方进行筛选，对氯氮平口腔崩解片的内在质量进行严格控制。对可能影响氯氮平121腔崩解片崩解时限的因素（崩解剂的内加和外加之比、L-HPC和MCC比例、PVPP的用量、粘合剂的种类、压片压力等）进行考察，确定了组成氯氮平口腔崩解片处方各辅料的种类。经过正交设计实验，得出最佳处方工艺。选6例健康志愿者，将药片置于舌面（舌面不动），用秒表记录片剂完全崩解的时间。结果表明6例志愿者口腔内的崩解时限为（35．82±2．17）s,且口感良好无明显的砂砾感。
In the formulation study, the intrisic quality had been strictly controlled after emphasizing the formulation factors by the disintegrating time limit. All kinds of adjuvants were determined which could effect the disintegrating time limit, such as the adding proportion of the inner and the outer, the proportion of MCC and H-LPC, the PVPP quantity, the kind of adhesives and the press. On the basis of the orthogonal experimental study, we found the optical formulation and the preParing process. The completely distegrating time limit was 35.82 （ ± 2.17） s without the obvious gravel feeling after the 6 volunteers＇ experiments that the tablets were placed on the tongue and the integrating time recorded by the stopwatch.
关键词
氯氮平
口腔崩解片
处方工艺
Clozapine
Oral Disintegration Tablets
Formulation and process
