乳痛宁颗粒的质量标准研究

Quality control of granules for relieving breast pain

目的:建立乳痛宁颗粒的质量标准。方法:用薄层色谱法对乳痛宁颗粒中的淫羊藿和柴胡进行鉴别;用高效液相色谱法测定制剂中芍药苷含量。结果:在薄层色谱中均能鉴别出制荆中的淫羊藿和柴胡;芍药苷进样量在0．212～0．636μg范围内呈良好线性关系(r=0．9997);平均回收率分别为100．5％,100．0％和99．8％,RSD分别为0．55％,0．20％和0．85％(n=3)。结论:本方法可用于乳痛宁颗粒的质量控制。

Objective：To establish the quality criteria of granules for relieving breast pain （Rutongning granules）. Methods： The raw materials of the herbal formulation were examined by TLC; the paeonoside was quantified by HPLC. Results： The active principles from Herba Epimedii and Radix Bupleuri were identified by TLC. Linearity of paeonoside concentration curve was in the range of 0.212-0. 636μg （r=0. 9997 ）. The average recovery of three batches of paeonoside quantifications was 100.5%, 100.0% and 99.8% with RSD of 0. 55% quality control of Rutongning granules was achieved 0.20% and 0.85% , respectively. Conclusion：A quality control of Rutongning granules was achieved.