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固体口服制剂溶出度测试的自动化

The automation of dissolution testing of solid oral dosage forms.

作者信息

Lamparter E, Lunkenheimer C H

机构信息

Department of Pharmaceutical Research and Development, Boehringer Ingelheim KG, Rhein, Germany.

出版信息

J Pharm Biomed Anal. 1992 Oct-Dec;10(10-12):727-33. doi: 10.1016/0731-7085(91)80072-h.

Abstract

Dissolution testing of solid oral dosage forms plays a very important part both in the development of new products and in quality control. A fully automated system for dissolution testing known as AUTO DISS is presented and its components are described. On-line determination of active ingredient concentration is possible with the aid of an integrated automatic sampler in combination with various measuring instruments (UV-vis spectrometry, liquid chromatography and flow injection analysis). The suitability of the system is demonstrated by determination of the dissolution of brotizolam from tablets by FIA and of bepafant from capsules by diode-array spectroscopy.

摘要

固体口服制剂的溶出度测试在新产品开发和质量控制中都起着非常重要的作用。本文介绍了一种名为AUTO DISS的全自动溶出度测试系统及其组件。借助集成自动进样器与各种测量仪器(紫外可见光谱法、液相色谱法和流动注射分析)相结合,可以在线测定活性成分浓度。通过流动注射分析法测定片剂中溴替唑仑的溶出度以及通过二极管阵列光谱法测定胶囊中贝帕芬特的溶出度,证明了该系统的适用性。

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