骨质疏松治疗药物艾尔地骨糖醇软胶囊体外溶出行为的研究

IF 0.4 4区医学 Q4 PHARMACOLOGY & PHARMACY

Acta poloniae pharmaceutica Pub Date : 2023-01-20 DOI:10.32383/appdr/154948

Dan Liang, Zelian Chen, Jian Zhang, Lan Su, Zhifeng Chen

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引用次数: 0

摘要

目的：建立接骨木醇软胶囊的溶出度测定方法，评价国产接骨木糖醇软胶囊与原制剂的体外溶出行为方法：考察不同搅拌装置、不同溶出介质、不同搅拌速度对接骨木醇软胶囊溶出行为的影响，采用HPLC-MS/MS法测定溶出样品的累积溶出度。结果：采用转篮法，搅拌速度75rpm，温度37℃，在四种介质中进行了接骨木醇软胶囊的溶出度测定结论：该方法可有效应用于接骨木醇软胶囊的溶出度测定。所选仿制药与原研药具有良好的溶出一致性。关键词：接骨木醇软胶囊溶解方法解散行为一致性评价

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Study on dissolution behavior in vitro of an osteoporosis treatment drug: eldecalcitol soft capsule

Objective：To establish a method for the dissolutions profile determination of Eldecalcitol softgels, evaluate the in vitro dissolutions behavior between domestic Eldecalcitol soft capsules and the original preparation。Methods：The effects of different stirring apparatus, different dissolutions medium, different agitation speeds on the dissolutions behavior of Eldecalcitol soft capsules were investigated, cumulative dissolutions were calculated by measuring the dissolutions samples with HPLC-MS/MS method. Results：The dissolutions test of Eldecalcitol soft capsules was carried out by rotating basket method, agitation speed of 75 rpm, temperature of 37℃ in four mediums。Conclusion：This dissolutions method can be effectively applied to the dissolutions test of soft Eldecalcitol capsules. and the selected generics have good dissolution consistency with the original drugs. Keywords：Eldecalcitol soft capsules；dissolutions method；dissolutions behavior；consistency evaluation

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来源期刊

Acta poloniae pharmaceutica 医学-药学

CiteScore

0.80

自引率

0.00%

发文量

审稿时长

6-12 weeks

期刊介绍： The international journal of the Polish Pharmaceutical Society is published in 6 issues a year. The journal offers Open Access publication of original research papers, short communications and reviews written in English, in all areas of pharmaceutical sciences. The following areas of pharmaceutical sciences are covered: Analysis, Biopharmacy, Drug Biochemistry, Drug Synthesis, Natural Drugs, Pharmaceutical Technology, Pharmacology and General. A bimonthly appearing in English since 1994, which continues “Acta Poloniae Pharmaceutica”, whose first issue appeared in December 1937. The war halted the activity of the journal’s creators. Issuance of “Acta Poloniae Pharmaceutica” was resumed in 1947. From 1947 the journal appeared irregularly, initially as a quarterly, then a bimonthly. In the years 1963 – 1973 alongside the Polish version appeared the English edition of the journal. Starting from 1974 only works in English are published in the journal. Since 1995 the journal has been appearing very regularly in two-month intervals (six books a year). The journal publishes original works from all fields of pharmacy, summaries of postdoctoral dissertations and laboratory notes.