预防流感颗粒(Ⅰ号)的制备及质量控制

Preparation and Quality Control of Granule No.1 for Preventing Influenza

目的:制备预防流感颗粒(Ⅰ号),并建立质量控制标准。方法:采用薄层色谱法(TLC)对黄芩和牛蒡子进行定性鉴别;采用高效液相色谱法(HPLC)对颗粒剂中黄芩苷进行含量测定。结果:制得的颗粒剂,在(TLC)色谱中均能明显的检出黄芩、牛蒡子;HPLC法测得黄芩苷在64～1280ng(r=0.9999)浓度范围内线性良好,平均回收率为99.00%,RSD为1.71%(n=6)。结论:该制剂制备工艺简单,合理可行;质量控制方法准确、可靠。

Objective： To prepare granule No. 1 for preventing influenza, and establish the quality control criteria for it. Method： Radix Scutellariae and Fructus Arctii were determined on the natures by thin-layer chromatography （TLC）. And baicalin in the granule was assayed by （HPLC）. Result ： The formulation was designed,Radix ScuteUariae and Fructus Arctii could be detected in the granule with TLC. The linear range of baicalin was in 64- 1 280 ng （r =0. 999 9） in TLC,and the average recovery was 99.00% with a RSD of 1.71% （n =6）. Conclu- sion： The preparation technology is rational and simple, and its quality control method is accurate and reliable.