{"title":"硝酸甘油- β-环糊精复合物舌下片的稳定性和生物等效性","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":"{\"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}","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}
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.
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