再造浓缩丸的质量控制研究

Study on the Quality Control of Zaizao Nongsuo Wan

目的建立再造浓缩丸的质量标准。方法采用薄层色谱法鉴别人工牛黄、赤芍、黄连和麻黄,采用气相色谱法测定本制剂中麝香酮的含量。结果在选定的薄层色谱条件下,层析斑点清晰,分离效果较好。气相色谱法测定麝香酮的线性范围为0.1012μg～1.012μg,r=0.9999。平均回收率为99.11%,RSD为3.59%(n=5)。结论该方法简便可行、专属性强、重现性好,可较好地控制该制剂的质量。

Objective To establish the quality standard for Zaizao Nongsuo Wan. Methods Artificial Calculus Bovis, Radix Paeoniae Rubra, Rhizoma Coptidis and Herba Ephedrae were identified by TLC. The content of Muscone was determined by GC. Results Under the selected conditions, the clear and distinguished spots were obtained. For content determination, the linear range of Muscone was 0. 101 2 μg - 1. 012 μg, r = 0. 999 9, the average recovery was 99. 11% （ n = 5） and RSD was 3.59 %. Conclusion The methods are proved to be simple, specialization with a good reproducibility, and can be used to control the quality of Zaizao Nongsuo Wan.