中药制剂含量均匀度的测定方法探究
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摘要
含量均匀度是评定制剂安全、稳定、有效、可控的重要前提,也是评定制剂工艺性和科学合理性的重要指标。中药制剂受原材料的影响,在制药过程中加工方法传统、药剂成分复杂,加之部分成分活性大,易变性,所以均匀度的控制是个难题。对制剂含量均匀度的检查是保证制剂产品质量的有效方法。本文通过讨论制剂均匀度的重要性开始,进而深入探讨检测药剂均匀度的方法,为提升中药制剂的品质起到借鉴作用。
Content uniformity was the essential prerequisites of evaluating preparation securely, stably, efficiently and effectively controlled, and it was the key indicator of evaluating technology capability and scientific rationality of preparation. Because of raw materials, traditional preparation and complexity of TCM medicines plus easy component activity and variability, thus content uniformity is a key question. The review of the preparation of content uniformity is the effective method to ensure the quality of the drug product.Starting with discussing the importance of the content uniformity and then the methods of detecting the content uniformity was investigated to enhance the quality of TCM preparation.
Content uniformity was the essential prerequisites of evaluating preparation securely, stably, efficiently and effectively controlled, and it was the key indicator of evaluating technology capability and scientific rationality of preparation. Because of raw materials, traditional preparation and complexity of TCM medicines plus easy component activity and variability, thus content uniformity is a key question. The review of the preparation of content uniformity is the effective method to ensure the quality of the drug product.Starting with discussing the importance of the content uniformity and then the methods of detecting the content uniformity was investigated to enhance the quality of TCM preparation.
引文
[1]李悦,芦晓彤,韦悦.HPLC法测定高乌甲素凝胶贴膏的含量及含量均匀度[J].现代中药研究与实践,2016,16(5):62-64.
[2]华小懿,龚建茜.HPLC法测定复方氨酚穿心莲片中三组分的含量和含量均匀度[J].海峡药学,2017,29(12):74-77.
[3]张越华,李荣,孙晓.复方肝浸膏胶囊(片)中维生素B1、B2的含量及含量均匀度测定[J].川北医学院学报,2016,31(4):483-485.
[4]相雨,钱碧坤,招嘉文.维C银翘片中马来酸氯苯那敏均匀度检查及其含量检测方法的改进[J].西北药学杂志,2017,32(3):304-307.
[5]章俊麟,何伍.低剂量固体药物制剂的质量控制要点[J].中国医药工业杂志,2016,47(12):1604-1608.
[2]华小懿,龚建茜.HPLC法测定复方氨酚穿心莲片中三组分的含量和含量均匀度[J].海峡药学,2017,29(12):74-77.
[3]张越华,李荣,孙晓.复方肝浸膏胶囊(片)中维生素B1、B2的含量及含量均匀度测定[J].川北医学院学报,2016,31(4):483-485.
[4]相雨,钱碧坤,招嘉文.维C银翘片中马来酸氯苯那敏均匀度检查及其含量检测方法的改进[J].西北药学杂志,2017,32(3):304-307.
[5]章俊麟,何伍.低剂量固体药物制剂的质量控制要点[J].中国医药工业杂志,2016,47(12):1604-1608.