金沙排石冲剂的制备及质量标准研究

Preparation Method and Quality Standards Research of Jinshapaishi Granules

目的:制备金沙排石冲剂并建立其质量标准。方法:采用水提醇沉工艺制成颗粒剂,采用薄层色谱法对广金钱草、泽泻、白芍、穿破石、炙甘草进行定性鉴别,采用高效液相色谱法进行白芍苷的含量测定。结果:采用薄层色谱法对广金钱草、泽泻、白芍、穿破石、炙甘草进行定性鉴别,特征性强,重现性好。白芍苷的进样量在2.5~200.0μg(r=0.9992)的线性范围良好,加样回收率为98.05%,RSD=1.65%(n=6)。结论:该制剂制备方法合理、简便、可行,所建立的质量标准可为金沙排石冲剂的临床应用疗效提供保证。

ObjectiveTo establish the preparation method and the quanlity standards of Jinshapaishi granules. Methods Jinshapaishi granules were prepared with the water decoction and alcohol precipitation technique. Alisma plantago - aquatica Linn, radices paeoniae alba , Cudrania cochin chinensis , Glycyrrhiza uralensis Fisch were identified by thin layer chromatography （TLC）. The contents of Albiflorin were determined bu high performance liquid chromatography （HPLC）. Results The TLC method used in the identification of Alisma plantago - aquatica Linn, radices paeoniae alba , Cudrania cochin chinensis , Glycyrrhiza uralensis Fisch was highly specific with good reproducibility. Using the HPLC method to determinate the albiflorin in the granules, the linear range of it was from 2. 5 μg to 200 μg （r = 0. 9992） and the average recovery rates was 98.05% , RSD = 1.65% （ n = 6）. Conclusion The preparation method was reasonable, simple and feasible, and the estabilished quality standards can provide the guarantee for clinical efficacy.