中国组织工程研究与临床康复
中國組織工程研究與臨床康複
중국조직공정연구여림상강복
JOURNAL OF CLINICAL REHABILITATIVE TISSUE ENGINEERING RESEARCH
2009年
38期
7543-7546
,共4页
口腔崩解片%崩解时限%氯硝西泮
口腔崩解片%崩解時限%氯硝西泮
구강붕해편%붕해시한%록초서반
目的:研制氯硝西泮口腔崩解片,并对其质量进行评价.方法:以甘露醇和阿司帕坦为矫味剂,以微晶纤维素、低取代羟丙基纤维素和交联聚乙烯吡咯烷酮为崩解剂,采用湿法制粒,制备氯硝西泮口腔崩解片,测定体内外崩解时限及口感,并考察了硬脂酸镁用量、硬度对崩解时间的影响,测定其溶出度.结果:甘露醇邝可斯巴甜/泊洛沙姆配比为30:0.5:1时口感最佳、溶出度最高,采用普通片的溶出度测定方法,测得口崩片在20 min时其溶出度已达到95%以上;当微晶纤维素/低取代羟丙基纤维素/交联聚乙烯吡咯烷酮的比例为9:1:3时,体内外崩解时间均在30 S以内;当硬脂酸镁用量为0.5%、硬度在3 0～4.0 kg时,崩解时间在30 S以内.结论:通过设计合理的处方,采用简便和常规化的制剂工艺,可以生产出合乎质量要求的氯硝西泮口腔崩解片.
目的:研製氯硝西泮口腔崩解片,併對其質量進行評價.方法:以甘露醇和阿司帕坦為矯味劑,以微晶纖維素、低取代羥丙基纖維素和交聯聚乙烯吡咯烷酮為崩解劑,採用濕法製粒,製備氯硝西泮口腔崩解片,測定體內外崩解時限及口感,併攷察瞭硬脂痠鎂用量、硬度對崩解時間的影響,測定其溶齣度.結果:甘露醇鄺可斯巴甜/泊洛沙姆配比為30:0.5:1時口感最佳、溶齣度最高,採用普通片的溶齣度測定方法,測得口崩片在20 min時其溶齣度已達到95%以上;噹微晶纖維素/低取代羥丙基纖維素/交聯聚乙烯吡咯烷酮的比例為9:1:3時,體內外崩解時間均在30 S以內;噹硬脂痠鎂用量為0.5%、硬度在3 0～4.0 kg時,崩解時間在30 S以內.結論:通過設計閤理的處方,採用簡便和常規化的製劑工藝,可以生產齣閤乎質量要求的氯硝西泮口腔崩解片.
목적:연제록초서반구강붕해편,병대기질량진행평개.방법:이감로순화아사파탄위교미제,이미정섬유소、저취대간병기섬유소화교련취을희필각완동위붕해제,채용습법제립,제비록초서반구강붕해편,측정체내외붕해시한급구감,병고찰료경지산미용량、경도대붕해시간적영향,측정기용출도.결과:감로순광가사파첨/박락사모배비위30:0.5:1시구감최가、용출도최고,채용보통편적용출도측정방법,측득구붕편재20 min시기용출도이체도95%이상;당미정섬유소/저취대간병기섬유소/교련취을희필각완동적비례위9:1:3시,체내외붕해시간균재30 S이내;당경지산미용량위0.5%、경도재3 0～4.0 kg시,붕해시간재30 S이내.결론:통과설계합리적처방,채용간편화상규화적제제공예,가이생산출합호질량요구적록초서반구강붕해편.
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.
