柴黄咀嚼片的制备及质量标准

Preparation and Quality Standard of Chaihuang Chewable Tablets

目的：建立柴黄咀嚼片的制备方法与质量标准.方法：TLC法同时鉴别柴胡和黄芩;HPLC法测定黄芩苷和柴胡皂苷a的含量.结果：TLC法能同时检出柴胡皂苷d与黄芩苷,斑点清晰;黄芩苷、柴胡皂苷a分别在0.180 8～0.723 2 μg（r=1.000 0）,0.226～9.024 μg（r=0.999 8）范围内与峰面积呈良好线性关系,平均回收率分别为97.71%（RSD=0.92%,n=9）,98.83%（RSD=1.12%,n=9）.结论：本制剂处方合理,工艺稳定,质量控制方法简便、准确、可靠,可有效控制柴黄咀嚼片的质量.

Objective： To establish the preparation method and quality standard of Chaihuang chewable tablets. Method： A TLC method was used to identify Bupleurum and Radix scutellariae, and an HPLC method was used to determine baiealin and saikosaponin a. Result： The TLC method could detect saikosaponin a and baicalin, and the spots were clear. Baicalin and saikosaponin a showed good linear relationship within the range of 0. 180 8-0. 723 2 p,g（r = 1. 000 0） and 0. 226-9. 024 μg（r =0.999 8） with the average re covery of 97.71% （RSD =0.92% ,n =9） and 98.83% （RSD = 1.12% ,n =9） , respectively. Conclusion： The formula is reasonable and the preparation technology is stable. The quality control method is simple, accurate and reliable, and can control the quality of Chaihuang chewable tablets effectively.