ニトログリセリン・β-シクロデキストリン複合体舌下錠の安定性及び生物学的同等性

Journal of the Nippon Hospital Pharmacists Association Pub Date : 1989-02-20 DOI:10.5649/JJPHCS1975.15.36

源市井津, 隆信寺田, 宏之二宮, 康彦古田, 功一吉田, 敏信青山, 正義堀岡

{"title":"ニトログリセリン・β-シクロデキストリン複合体舌下錠の安定性及び生物学的同等性","authors":"源市井津, 隆信寺田, 宏之二宮, 康彦古田, 功一吉田, 敏信青山, 正義堀岡","doi":"10.5649/JJPHCS1975.15.36","DOIUrl":null,"url":null,"abstract":"Vaporization of nitroglycerin (TNG), thermoanalysis (DTA/TG) and X-ray diffractometry (X-RD) for the complex with TNG and β-cyclodextrin (TNG·β-CD) prepared by saturated solution method and kneading method, and TNG dispersed β-CD and lactose powder were evaluated. The stabilities of strip packaged sublingual tablet of TNG·β-CD (β-CD Tab, TNG content 0.3mg) and conventional sublingual tablet (JP Tab, TNG content 0.3mg, vehicle: lactose) were compared under the each storage condition of room temperature, 37°and 50°C. Pulse pressure in anesthetized dogs, and systolic blood pressure and plasma TNG concentration in 10 healthy male volunteers were measured after sublingual administration of β-CD Tab and JP Tab.The results showed that vaporization of TNG from TNG·β-CD was extremely smaller than that from TNG dispersed β-CD and lactose powder. DTA/TG and X-RD curves for TNG·β-CD showed specific patterns differed from dispersed powder. The decrease of TNG content in β-CD Tab was extremely lower than that of JP Tab under strip packaging. It is also ascertained that β-CD Tab has the same bioequivalency as JP Tab.","PeriodicalId":17399,"journal":{"name":"Journal of the Nippon Hospital Pharmacists Association","volume":"29 1","pages":"36-42"},"PeriodicalIF":0.0000,"publicationDate":"1989-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the Nippon Hospital Pharmacists Association","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5649/JJPHCS1975.15.36","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 0

Abstract

Vaporization of nitroglycerin (TNG), thermoanalysis (DTA/TG) and X-ray diffractometry (X-RD) for the complex with TNG and β-cyclodextrin (TNG·β-CD) prepared by saturated solution method and kneading method, and TNG dispersed β-CD and lactose powder were evaluated. The stabilities of strip packaged sublingual tablet of TNG·β-CD (β-CD Tab, TNG content 0.3mg) and conventional sublingual tablet (JP Tab, TNG content 0.3mg, vehicle: lactose) were compared under the each storage condition of room temperature, 37°and 50°C. Pulse pressure in anesthetized dogs, and systolic blood pressure and plasma TNG concentration in 10 healthy male volunteers were measured after sublingual administration of β-CD Tab and JP Tab.The results showed that vaporization of TNG from TNG·β-CD was extremely smaller than that from TNG dispersed β-CD and lactose powder. DTA/TG and X-RD curves for TNG·β-CD showed specific patterns differed from dispersed powder. The decrease of TNG content in β-CD Tab was extremely lower than that of JP Tab under strip packaging. It is also ascertained that β-CD Tab has the same bioequivalency as JP Tab.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

硝酸甘油- β-环糊精复合物舌下片的稳定性和生物等效性

采用饱和溶液法和揉捏法对硝酸甘油(TNG)与β-环糊精(TNG·β-CD)配合物进行蒸发、热分析(DTA/TG)和x射线衍射(X-RD)，并对TNG分散的β-CD和乳糖粉进行评价。比较了TNG·β-CD条包装舌下片(β-CD片，TNG含量0.3mg)和常规舌下片(JP片，TNG含量0.3mg，载体:乳糖)在室温、37°和50°C各贮存条件下的稳定性。研究了麻醉犬舌下给药β-CD和JP后的脉压、收缩压和血浆TNG浓度。结果表明，从TNG·β-CD中提取的TNG的汽化量远小于从TNG分散的β-CD和乳糖粉中提取的汽化量。TNG·β-CD的DTA/TG和X-RD曲线表现出不同于分散粉末的特殊模式。条形包装下，β-CD Tab中TNG含量的下降幅度极低于JP Tab。β-CD Tab与JP Tab具有相同的生物等效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Journal of the Nippon Hospital Pharmacists Association

自引率

0.00%

发文量