首乌生发颗粒的制备与质量控制

Preparation and quality control of Shouwu shengfa granules

目的研究首乌生发颗粒的制备工艺，并对其进行质量控制和安全性考察。方法拟定制剂的生产工艺流程，采用薄层层析对何首乌、当归进行定性分析，高效液相色谱法对制剂主要成分芍药苷进行定量分析，以小鼠进行急性毒性试验。结果该制备工艺简单可行，制剂性质稳定，薄层定性斑点清晰，高效液相色谱法测定芍药苷在浓度2．05－41．00μg·mL^-1与峰面积有良好的线性关系（r=0．9999），平均回收率为97．0％，RSD=0．9％（n=6）。小鼠耐药量按制剂生药量为186g·kg^-1，未见明显毒性反应。结论首乌生发颗粒工艺合理，质量控制方法可行，制剂安全。

Objective To study the preparation of Shouwu shengfa granules, their quality control and safety inspection. Methods The production process of the preparation had been designed. Polygonurn multi f forum Thunb and Angelica were indentified by TLC. Paecniflorin was determined by HPLC. Acute toxicity testing was carried out with mice. Results The preparation was stable, Qualitative TLC spots were clear, and paeoniflorin had a good linearity at 2.05-41.00μg·mL^-1 （r=0. 999 9）. The average recovery was 97.0%, RSD=0. 9% （n=6）, tolerance in mice was 186 g·kg^-1 by agents of pharmacognosy, and obvious toxicity was not found. Conclusion The preparation process is simple and feasible, The technology for Shouwu shengfa granules is reasonable, the quality control method is feasible, and the agents are secure.