关键词: 益脑心片, 制备工艺, 质量标准, 丹酚酸B

Abstract: The orthogonal design was used to optimize the water extraction process of Yinaoxin Tablets, and the single factor method was used to screen the molding process. After refining, concentration, granulation, drying, pressing and coating, Yinaoxin Tablet was prepared. The Polygoni multiflori Praeparata and Gastrodiae rhizoma in Yinaoxin Tablet were qualitatively identified by the thin layer chromatography （TLC）, and the content of salvianolic acid B was determined by the high-performance liquid chromatography （HPLC）. The preparation process was as follows： Gastrodiae rhizoma was crushed into fine powder, and the rest herbs were decocted with 8-folds water for 1 hour. After filtration and standing for 4 hours, the supernatant was filtered, and concentrated under reduced pressure to the thick paste with a relative density of 1.25~1.30 （80 ℃）. Then Gastrodiae rhizoma powder was added, mixed, dried to dry paste, and then crushed into the fine powder. Talcum powder was added, mixed, and granulated with 70% ethanol solution. Then drying, granule sieving, adding magnesium stearate, mixing, compressing to the tablet, and sugar-coating were conducted to obtain the Yinaoxin Tablet. In the TLC identification, the main spots of Polygoni multiflori Praeparata and Gastrodiae rhizoma in Yinaoxin Tablet were clear, and the negative control had no interference. The average content of Salvianolic acid B in the test solution of Yinaoxin Tablet was 2.36 mg/tablet. The optimized preparation process of Yinaoxin tablets in this study was stable, and the quality control method was accurate and reliable, which provided a basis for the secondary development of Yinaoxin Granules.

Key words: Yinaoxin Tablet, preparation technology, quality standards, salvianolic acid B