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目的确立血怡颗粒的制备工艺,制定质量控制方法。方法采用冰醋酸法提取血红素,将血红素成品粉碎成细粉加入适量的糊精、蔗糖制成颗粒,采用分光光度法575nm波长处测定该制剂的血红素含量,采用比色法测定铁含量。结果血怡颗粒的血红素含量各组分浓度与吸收度呈良好的线性关系,回归方程为A=3.47×10-3+1.044C,r=0.9996,平均回收率为98.8%,RSD=1.32%(n=6)。铁含量稳定,符合质量要求。结论血怡颗粒的制备工艺先进可行,质量稳定,可靠、可控。
Objective To establish the preparation process of Xueyi granule and establish the quality control method. Methods The hemoglobin was extracted by acetic acid method, the heme product was crushed into fine powder, dextrin was added into the powder, sucrose was made into granules, the heme content of the preparation was determined by spectrophotometry at 575 nm wavelength, and the content of iron was determined by colorimetry . Results The heme concentration of Xueyi granules showed a good linear relationship with the absorbance. The regression equation was A = 3.47 × 10-3 + 1.044C, r = 0.9996, the average recovery was 98.8%, RSD was 1.32% (n = 6). Iron content is stable, in line with quality requirements. Conclusion The preparation process of Xueyi granule is advanced and feasible, the quality is stable, reliable and controllable.