盐酸三氟拉嗪口腔崩解片的处方筛选及体外溶出度
Studies on the formulation and dissolution in vitro of trifluoperazine hydrochloride oral disintegrating tablets
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摘要: 目的 :优化盐酸三氟拉嗪口腔崩解片的处方,并比较其与普通市售片的体外溶出度。 方法 :正交设计法优化处方,转篮法考察溶出度,紫外分光光度法测定药物含量。 结果 :明胶／甘露醇／阿司帕坦／盐酸三氟拉嗪的配比为0.15／1／0.05／0.16时,口感良好;交联聚乙烯吡咯烷酮、低取代羟丙基纤维素和微晶纤维素的用量分别为8％、5％和30％时,崩解时间小于15s,5min内溶出大于90％。 结论 :盐酸三氟拉嗪口腔崩解片能方便服药,且显著提高盐酸三氟拉嗪片的溶出速率。Abstract: Objective :To optimize the formulation of the oral disintegrating tablets of trifluoperazine hydrochloride and compare its dissolution profiles with the marketing tablets. Methods : Orthogonal design was used to optimize the formulation of the tablets. The basket method was used to evaluate the dissolution profiles of the tablets. The content of trifluoperazine hydrochloride in the samples was analyzed by UV. Results : When the ratio of gelatia/mannitol/aspartame/trifluoperazine hydrochloride was 0. 15/1/0. 05/0. 16, the tablets has good mouth feel. When the content of crospovidone, L-HPC and microcrystalline cellulose were set at 8%, 5% and 30%, respectively, the disintegration time was within 15s. The cumulative dissolution of the tablets was more than 90% within 5 minute, respectively. Conclusion : The oral disintegrating tablets of trifluoperazine hydrochloride had the advantage of easy administratio-nand its dissolution was significantly higher than that of the market tablets.
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Key words:
- trifluoperazine hydrochloride /
- oral disintegrating tablets /
- dissolution
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