达比加群酯胶囊处方工艺研究的一般考虑

陈思, 石靖, 王璐

中国药学杂志 ›› 2020, Vol. 55 ›› Issue (21) : 1824-1828.

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中国药学杂志
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中国药学杂志 ›› 2020, Vol. 55 ›› Issue (21) : 1824-1828. DOI: 10.11669/cpj.2020.21.013
论著

达比加群酯胶囊处方工艺研究的一般考虑

  • 陈思, 石靖, 王璐
作者信息 +

General Consideration on Preparation Study of Dabigatran Etexilate Capsules

  • CHEN Si, SHI Jing, WANG Lu
Author information +
文章历史 +

摘要

目的 对达比加群酯胶囊处方研究及制备工艺控制要点进行讨论。方法 分析了相关文献及专利,在此基础上提出达比加群酯胶囊处方工艺研究的一般考虑。结果与结论 达比加群酯是新一代口服直接凝血酶抑制剂,是目前仿制药申报较为热门的品种,其仿制药研发应深入进行处方工艺研究,提出质量控制策略。

Abstract

OBJECTIVE To discuss the key points of the preparation process control of dabigatran etexilate capsules. METHODS Based on the analysis of relevant literatures and patents, the general consideration on preparation study of dabigatran etexilate capsules was proposed. RESULTS AND CONCLUSION Dabigatran etexilate is a new synthetic, rapidly acting oral direct thrombin inhibitor, which is a hot point in application of generic drugs in recent years.Generic drugs should conduct in-depth prescription study and put forward the quality control strategy.

关键词

达比加群酯 / 处方研究 / 工艺参数研究 / 控制要点

Key words

dabigatran etexilate / prescription study / preparation process parameter study / control points

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陈思, 石靖, 王璐. 达比加群酯胶囊处方工艺研究的一般考虑[J]. 中国药学杂志, 2020, 55(21): 1824-1828 https://doi.org/10.11669/cpj.2020.21.013
CHEN Si, SHI Jing, WANG Lu. General Consideration on Preparation Study of Dabigatran Etexilate Capsules[J]. Chinese Pharmaceutical Journal, 2020, 55(21): 1824-1828 https://doi.org/10.11669/cpj.2020.21.013
中图分类号： R944   

参考文献

[1] MENG H G, JIAO S Q, ZHANG L Y, et al. Progress in research on dabigatran etexilat[J]. China Pharm(中国药业). 2017, 26(2):4-7.
[2] LI J L, ZHAO L. Rationality and safety evaluation of dabigatran etexilate[J]. Chin J Hosp Pharm (中国医院药学杂志),2019, 39(21):2179-2180.
[3] FDA.APPLICATION NUMBER: 22-512 CHEMISTRY REVIEW[EB/OL]. (2010-10-19). https://www. accessdata. fda. gov/drugsatfda_docs/nda/2010/022512Orig1s000ChemR_Corrrected%203. 11. 2011. pdf.
[4] EMA. CHMP ASSESSMENT REPORT FOR Pradaxa[EB/OL]. (2008-4-23). https://www. ema. europa. eu/en/documents/assessment-report/pradaxa-epar-public-assessment-report_en. pdf.
[5] Boehringer Ingelheim Pharma GmbH & Co. KG. Form of presentation for 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1h-benzimidazol-5-carbonyl)-pyridin-2-yl-amino] propionic acid ethyl ester to be administered oral:China, 100528157C [P]. 2009-08-19.
[6] HE X X, DONG P, CAI J H, et al. Pharmaceutical Composition Comprising Dabigatran Etexilate:China, 105640909 B [P]. 2019-09-20.
[7] TANG Y, XU Y R, SHENG X X. Dosing preparation of dabigatran etexilate or a salt thereof and a preparation method thereof:WO, 2016070696 A1[P]. 2016-05-12.
[8] PILGAONKAR P S, RUSTOMJEE M T, GANDHI A S. Oral Pharmaceutical Compositions of Dabigatran Etexilate:China, 110123774 A [P]. 2019-08-16.
[9] WANG Y, WU X, NIE Y. A dabigatran etexilate mesylate capsule pharmaceutical composition and a preparing method thereof:China, 104784147 A [P]. 2018-01-23.
[10] YAN J, LI X. Composition of Pradaxa and preparation method thereof:China, 104434867A [P]. 2015-03-25.
[11] KONG S T, LAN Y, ZHAO L J, et al. A review of factors influencing coating quality in fluidized bed based on particle characteristics[J]. Chin J Pharm(中国医药工业杂志),2020, 51(3):325-333.
[12] CHANG E H, GUO F, CHEN Y L, et al. Application of process analytical technology in fluidized bed granulation and pellet coating process[J]. Pharm Today(今日药学), 2019, 29(12):857-860.
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