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硫酸羟氯喹啉片剂处理后在口服液体制剂中的临时混悬液稳定性数据。

Stability data of extemporaneous suspensions of hydroxychloroquine sulphate in oral liquid bases after tablet manipulation.

作者信息

Perrone Mara, Laquintana Valentino, Lopedota Angela Assunta, Cutrignelli Annalisa, Lopalco Antonio, Franco Massimo, Pepe Antonio, Fontana Sergio, Denora Nunzio

机构信息

Centro Studi e Ricerche "Dr. S. Fontana 1900-1982", Farmalabor s.r.l., Via Piano S. Giovanni, 47, 76012 Canosa di Puglia (BT), Italy.

Department of Pharmacy - Pharmaceutical Sciences, University of Bari "Aldo Moro", Via E. Orabona, 4, 70125 Bari, Italy.

出版信息

Data Brief. 2020 Nov 30;33:106575. doi: 10.1016/j.dib.2020.106575. eCollection 2020 Dec.

Abstract

Hydroxychloroquine is a well-known anti-malarial and anti-rheumatic drug that has garnered recently unprecedented attention as potential therapeutic agent against virus infections. Hydroxychloroquine sulphate is authorized in the EU as film-coated tablets (i.e. Plaquenil®), which cannot be administered to non-cooperative patients, such as those in intensive care units or, more in general, unable to swallow solid dosage forms. Therefore, the hospital pharmacist must manipulate the solid dosage form for the preparation of suspension, even if it can strongly affect the product quality. In this scenario, it is crucial to offer useful information and advice to assist hospital pharmacists in their activity. The data presented in this article suggest that extemporaneous suspensions of hydroxychloroquine sulphate in oral liquid bases after tablet manipulation are stable for at least 30 days.

摘要

羟氯喹是一种知名的抗疟疾和抗风湿药物,最近作为一种潜在的抗病毒感染治疗药物受到了前所未有的关注。硫酸羟氯喹在欧盟被批准为薄膜包衣片(即羟氯喹片),不能用于不配合的患者,如重症监护病房的患者,或者更普遍地说,不能吞咽固体剂型的患者。因此,医院药剂师必须对固体剂型进行处理以制备混悬液,即使这可能会严重影响产品质量。在这种情况下,提供有用的信息和建议以协助医院药剂师开展工作至关重要。本文提供的数据表明,片剂处理后在口服液体制剂中临时制备的硫酸羟氯喹混悬液至少30天内稳定。

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