散结明目颗粒的制备及质量标准研究

Study on Preparation and Quality Standards of Sanjie Mingmu Granules

目的:制备散结明目颗粒,并建立其质量标准。方法:采用湿法制粒制备散结明目颗粒,薄层色谱(TLC)法对方中夏枯草、赤芍、槐花、川芎进行定性鉴别,高效液相色谱法对制剂中丹酚酸B进行含量测定。结果:制备的颗粒干燥、均匀;TLC斑点清晰、分离度较好,阴性对照无干扰。丹酚酸B的检测浓度在0.062～1.054mg·mL-1范围内与峰面积积分值呈良好线性关系(r=0.9999),平均回收率为100.3%(RSD=1.52%,n=6)。结论:所建标准可用于散结明目颗粒的质量控制。

OBJECTIVE： To prepare Sanjie mingmu granules, and to establish the quality standard of it. METHODS： Sanjie mingmu granules were prepared by wet granulation, Prunella vulgaris, Paeoniae Radix Rubra, Sophora japonica and Ligusticum chuanxiong in prescription were identified with the method of TLC. The contents of salvianolic acid B were determined by HPLC. RESULTS：Prepared granulationes were dry and uniform.TLC spots were clear and well-separated without interference from negative sample. The linear range of salvianolic acid B was 0.062-1.054 mg·mL^-1 （r=0.999 9） with an average recovery of 100.3% （RSD= 1.52 %, n= 6）. CONCLUSIONS：Established standard is suitable for the quality control of Sanjie mingmu granules.