丹参颗粒剂的制备及质量考察

Salvia preparation and quality inspection granules

通过丹参颗粒剂的制备及质量考察来对比颗粒剂与其他剂型的不同与优势,并说明湿法制粒与高效液相色谱法的优点.本实验采用湿法制粒,并用高效液相色谱法对丹参酮IIA进行质量考察,色谱柱为Optimusil C_(18)(250 mm×4.6 mm,5μL),已腈-0.2%乙酸为流动相,流动速度大约为0.6 mL/min,检测波长为270 nm.丹参酮IIA在0.1 mg/m L至0.5 mg/mL的范围内呈良好的线性关系(R=0.999 6),丹参酮IIA的平均回收率为99.67%,RSD值为0.665%,3个批号的丹参颗粒剂中丹参酮IIA的平均质量比为8.305 mg/g.湿法制粒方便快捷,效果好,高效液相色谱法检测丹参酮IIA质量比重现性好,简单易行,准确可靠.

This paper mainly through the preparation and quality of Danshen granules to compare granules and other formulations of different and advantages,and discussed the advantages of wet granulation and high performance liquid chromatography. The experiment was carried out by wet granulation and the quality of tanshinone IIA was determined by HPLC. The chromatographic column was Optimusil C_（18）（ 250 mm × 4. 6 mm,5 μL） and nitrile was 0.2% acetic acid as the mobile phase. The flow rate was about 0. 6 mL/min,detection wavelength of 270 nm. Tanshinone IIA showed a good linearity in the range of 0. 1 mg/mL to 0.5 mg/mL,（ R = 0. 9998）,the average recovery of tanshinone IIA was 99. 67%,RSD was0. 665%,and 3 batches of salvia miltiorrhiza. The average content of tanshinone IIA in the granules was 8. 305 mg/g. The wet granulation method was convenient and quick,and the method has the advantages of good reproducibility,simple,accurate and reliable.