Method for determining dissolution curve of Rurugolix tablet
The invention belongs to the technical field of drug analysis, and provides a method for determining a dissolution curve of a Rurugolix tablet, which has good durability and reproducibility and distinguishing power, and adopts a phosphate buffer solution with pH of 5.6 as a dissolution medium; the p...
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| creator | WANG YING XIONG LING CHEN HONG QIAO ZHITAO WANG YINGJIAO PANG XIAOXING |
| description | The invention belongs to the technical field of drug analysis, and provides a method for determining a dissolution curve of a Rurugolix tablet, which has good durability and reproducibility and distinguishing power, and adopts a phosphate buffer solution with pH of 5.6 as a dissolution medium; the problem that in the prior art, a dissolution method cannot meet the requirement for comparing the similarity of dissolution curves by adopting a similarity factor (f2) method in the guidance principle of Dissolution Curve Determination and Comparative Guiding Principles of Common Oral Solid Preparation, so that the screening and in-vitro consistency evaluation of a rerugolian tablet imitation medicine process are influenced is solved.
本发明属于药物分析技术领域，提供了一种耐用性和重现性良好、具有区分力的瑞卢戈利片的溶出曲线测定方法，该溶出曲线方法以pH5.6磷酸盐缓冲液为溶出介质，解决了现有技术中溶出方法不能满足《普通口服固体制剂溶出曲线测定与比较指导原则》指导原则中关于采用相似因子(f2)法比较溶出曲线相似性的要求，因而影响瑞卢戈利片仿制药工艺筛选和体外一致性评价的问题。 |
| format | Patent |
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本发明属于药物分析技术领域，提供了一种耐用性和重现性良好、具有区分力的瑞卢戈利片的溶出曲线测定方法，该溶出曲线方法以pH5.6磷酸盐缓冲液为溶出介质，解决了现有技术中溶出方法不能满足《普通口服固体制剂溶出曲线测定与比较指导原则》指导原则中关于采用相似因子(f2)法比较溶出曲线相似性的要求，因而影响瑞卢戈利片仿制药工艺筛选和体外一致性评价的问题。</description><language>chi ; eng</language><subject>CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOIDCHEMISTRY ; INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES ; MEASURING ; PERFORMING OPERATIONS ; PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL ; PHYSICS ; TESTING ; THEIR RELEVANT APPARATUS ; TRANSPORTING</subject><creationdate>2022</creationdate><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://worldwide.espacenet.com/publicationDetails/biblio?FT=D&date=20221220&DB=EPODOC&CC=CN&NR=115493917A$$EHTML$$P50$$Gepo$$Hfree_for_read</linktohtml><link.rule.ids>230,308,780,885,25564,76547</link.rule.ids><linktorsrc>$$Uhttps://worldwide.espacenet.com/publicationDetails/biblio?FT=D&date=20221220&DB=EPODOC&CC=CN&NR=115493917A$$EView_record_in_European_Patent_Office$$FView_record_in_$$GEuropean_Patent_Office$$Hfree_for_read</linktorsrc></links><search><creatorcontrib>WANG YING</creatorcontrib><creatorcontrib>XIONG LING</creatorcontrib><creatorcontrib>CHEN HONG</creatorcontrib><creatorcontrib>QIAO ZHITAO</creatorcontrib><creatorcontrib>WANG YINGJIAO</creatorcontrib><creatorcontrib>PANG XIAOXING</creatorcontrib><title>Method for determining dissolution curve of Rurugolix tablet</title><description>The invention belongs to the technical field of drug analysis, and provides a method for determining a dissolution curve of a Rurugolix tablet, which has good durability and reproducibility and distinguishing power, and adopts a phosphate buffer solution with pH of 5.6 as a dissolution medium; the problem that in the prior art, a dissolution method cannot meet the requirement for comparing the similarity of dissolution curves by adopting a similarity factor (f2) method in the guidance principle of Dissolution Curve Determination and Comparative Guiding Principles of Common Oral Solid Preparation, so that the screening and in-vitro consistency evaluation of a rerugolian tablet imitation medicine process are influenced is solved.
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本发明属于药物分析技术领域，提供了一种耐用性和重现性良好、具有区分力的瑞卢戈利片的溶出曲线测定方法，该溶出曲线方法以pH5.6磷酸盐缓冲液为溶出介质，解决了现有技术中溶出方法不能满足《普通口服固体制剂溶出曲线测定与比较指导原则》指导原则中关于采用相似因子(f2)法比较溶出曲线相似性的要求，因而影响瑞卢戈利片仿制药工艺筛选和体外一致性评价的问题。</abstract><oa>free_for_read</oa></addata></record> |
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| subjects | CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOIDCHEMISTRY INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES MEASURING PERFORMING OPERATIONS PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL PHYSICS TESTING THEIR RELEVANT APPARATUS TRANSPORTING |
| title | Method for determining dissolution curve of Rurugolix tablet |
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