偏瘫康胶囊的质量标准研究

目的:建立偏瘫康胶囊的质量标准.方法:采用薄层色谱法(TLC)对处方中的石菖蒲、丹参、赤芍、郁金、冰片进行定性鉴别;采用高效液相色谱法测定制剂中丹参酮ⅡA和丹酚酸B的含量.结果:TLC法可检出石菖蒲、丹参、赤芍、郁金、冰片的特征斑点;丹参酮ⅡA的线性范围为0.032 ～ 0.32 μg(r ＝ 0.999 9),平均回收率为99.28%(RSD = 1.37%,n ＝ 6);丹酚酸B的线性范围为0.56 ～ 5.6 μg (r ＝ 0.999 9),平均回收率为99.02%(RSD = 1.74%,n ＝ 6).结论:该质量标准可有效控制偏瘫康胶囊的质量.

Study on the Quality Standards of Piantankang Capsules

To establish the quality standards of Piantankang capsules. Methods： Acori Tatarinowii Rhizoma, Salviae Miltiorrhizae Radix Et Rhizoma,Paeoniae Radix Rubra, Curcurnae Radix and Borneolum Syntheticum were identified by TLC. The contents of tanshinone 11 A and salvianolic acid B in the preparation were determined by HPLC.Results： Acori Tatarinowii Rhizoma,Salviae Miltiorrhizae Radix Et Rhizoma,Paeoniae Radix Rubra,Curcumae Radix and Bomeolum Syntheticum could be identified by TLC.The linear range of tanshinone I1 A was 0.032 - 0.32 Ixg （r ---- 0.999 9）, and the average recovery was 99.28% （RSD = 1.37%, n ： 6）. The linear range of salvianolic acid B was 0.56 - 5.6 Ixg （r=0.999 9）, and the average recovery was 99.02% （RSD = 1.74%, n ： 6）. Conclusion： The quality of piantankang capsules could be controlled effectively with the established quality standards.