排石Ⅱ号颗粒的制备及质量控制

Preparation and Quality Control of Paishi Ⅱ Granules

目的:制备排石Ⅱ号颗粒并建立其质量控制方法。方法:药材用水煎煮法提取。采用薄层色谱(TLC)法对处方中的广金钱草、泽泻、赤芍进行定性鉴别;采用高效液相色谱法对绿原酸、芍药苷进行含量测定。结果:TLC斑点清晰,阴性对照无干扰;绿原酸、芍药苷的进样量分别在0.2064～2.064μg(r=0.9997)、0.3736～2.2416μg(r=0.9999)范围内与各自峰面积积分值呈良好的线性关系;二者平均回收率分别为99.8%和100.1%,RSD分别为0.91%(n=6)和1.01%(n=6)。结论:该制备工艺简单;质量控制方法简便、快速、准确。

OBJECTIVE：To prepare Paishi Ⅱ granules and to establish a method for its quality control .METHODS： Water decoction method was used to extract physic liquor from all medical materials.Desrnodiurn styracifolium, Alisrna orientalis and Radix Paeoniae Rubra were indentified by TLC.The contents of Chlorogenic acid and Paeoniflorin in the mixture were determined by HPLC.RESULTS： The TLC spots were clear and free from interference of negative control.The linear ranges of Chlorogenic acid and Paeoniflorin were 0.206 4μg- 2.064μg（ r = 0. 999 7） and 0. 373 6μg- 2. 241 6 μg, respectively （ r = 0.999 9） .The average recoveries were 99.8% （RSD = 0.91% , n = 6） and 100.1% （RSD = 1.01% , n = 6）, respectively. CONCLUSION：The preparation technology is simple, and the quality control method is simple, rapid and accurate.