糯稻根颗粒剂制备及其游离氨基酸的鉴别与含量测定

Preparation and quality standard of Nuodaogen granules

目的制备糯稻根颗粒剂,并建立其质量标准。方法将糯稻根水煎液加ZTC 1+1天然澄清剂处理后,浓缩至稠膏,并制成颗粒剂。用TLC对游离氨基酸定性,用氨基酸分析仪测定其总含量。结果糯稻根颗粒剂中含有15种游离氨基酸,且总含量≥2.23 mg.g-1。连续3个批号产品的各项指标均符合中国药典2005版一部附录颗粒剂项下的规定。结论糯稻根颗粒剂制备工艺合理,所建立的方法简便、准确、可靠。该制剂也是首次研制。

Objective To develop the preparation and quality standard for nuodaogen granules. Methods Decoctions were concentrated to thick paste after being processed by ZTC 1＋1 natural precipitator, and were used to make granules. Then thin-layer chromatograph was used to identify the amino acid, and amino acid analyzer was used to determine the content of amino acid. Results Fifteen free amino acids were detected, and the total free amino acid was no less than 2.23 mg · g ^-1. The indexes of 3 consecutive products accorded with the China Pharmacopoeia （CHP.）. 2005. Conclusion The preparation technique of nuodaogen granules is rational, and the method is convenient and accurate. It is suitable for the quality standard of the preparation.