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中成药质量标准,历来多依靠形、色、气、味等外观性状和经验来进行评定,对于内在质量一直缺乏科学的分析和必要的控制标准。为了提高药品质量,保障用药的安全有效,我们对清音丸的质量标准进行了研究,根据方药分析对其中主要药物以及含量高、有效成分明确的药物进行定性定量分析,初步提出以甘草,河子,葛根,贝母的薄层层析作为定性指标,并以甘草酸,鞣质,葛根素,贝母总生物硷以及灰分,水份的含量作为定量标准,可供生产和药检部门制定质量标准时参考。
The quality standards of traditional Chinese medicines have traditionally depended on the appearance and experience of shape, color, gas, taste, etc., and have always lacked scientific analysis and necessary control standards for internal quality. In order to improve the quality of medicines and ensure the safe and effective use of medicines, we conducted research on the quality standards of Qingyin Pills. Based on the analysis of traditional Chinese medicines, the main medicines and the medicines with high contents and effective ingredients were qualitatively and quantitatively analyzed, and the licorice and river were initially proposed. The thin-layer chromatography of Pueraria lobata, Pueraria lobata and Fritillaria was used as a qualitative indicator, and glycyrrhizic acid, tannins, puerarin, total biological glycosides, and ash and moisture contents were used as quantitative standards for production and drug testing departments to establish quality standards. reference.