中国组织工程研究与临床康复2009，Vol.13Issue(38)：7543-7546,4.DOI:10.3969/j.issn.1673-8225.2009.38.031
氯硝西泮口腔崩解片的研制及质量评价
Preparation and quality evaluation of clonazepam orally disintegrating tablets
李丙英 1侯侠2
作者信息
- 1. 江苏恩华药业股份有限公司,江苏省,徐州市221004
- 2. 江苏联合职业技术学院徐州医药分院,江苏省,徐州市,221116
- 折叠
摘要
Abstract
OBJECTIVE: To prepare clonazepam oral disintegrating tablets and to evaluate its quality. METHODS: Gelatian and aspartame were used as tastes masking. Microcrystalline celluose, low substituted hydroxypropylcellulose and polyvininylpolyrrolidone were used as disintegrants. Clonazepam orally disintegrating tablets were prepared by wet granules. The in vitro and in vivo disintegration time, the relationship between hardness and disintegration time and the relationship between the usage of magnesium stearate and disintegration time were investigated, while taste and dissolution rate were also evaluated. RESULTS: When the gelatian/aspartame/poloxamer ratio was 30:0.5:1, the tablets had good oral feel and the uppermost dissolution rate. The dissolution rate of clonazepam oral disintegrating tablets which was evaluated by the method of common tablets could exceed 95% after 20 minutes. When the microcrystalline celluose / low substituted hydroxypropylcellulose / polyvininylpolyrrolidone ratio was 9:1: 3, the in vitro and in vivo disintegration time Was within 30 s. When the usage of magnesium stearate was 0.5% and the hardness ratio was in the range of 3-4 kg, disintegration time was within 30 s. CONCLUSION: According reasonable prescription and simple product craft, we can product qualified clonazepam oral disintegrating tablets.关键词
口腔崩解片/崩解时限/氯硝西泮分类
医药卫生引用本文复制引用
李丙英,侯侠..氯硝西泮口腔崩解片的研制及质量评价[J].中国组织工程研究与临床康复,2009,13(38):7543-7546,4.
