三子胶囊的制备及质量标准研究

目的:制备三子胶囊并建立其质量标准。方法:采用水煎煮法提取药液;以薄层色谱(TLC)法进行定性鉴别,以高效液相色谱(HPLC)法对制剂中栀子苷进行含量测定。结果:在TLC中可检出栀子、诃子、川楝子的特征斑点,阴性对照无干扰;栀子苷线性范围为3.0～30μg.mL-1(r=0.9999),平均回收率为100.06%(RSD=1.17%)。结论:本制备方法合理;定性鉴别和定量方法专属性强、重现性好、准确、可靠,所建标准可用于质量控制。

Study on Preparation and Quality Standard of Sanzi Capsules

OBJECTIVE:To prepare Sanzi capsules and establish the Standard of its quality.METHODS:Water decocting method was applied to extract physic liquor,thin-layer chromatography(TLC)was used for qualitative identification,and high efficiency liquid chromatography(HPLC)was used to determine the content of Jasminoidin in the preparation.RESULTS:Feature spots of Fructus Gardeniae,Fructus Chebulae,Fructus Toosendan were identified by TLC,with no sensible interference seen in the negative control.The linear range for Jasminoidin was 3.0～ 30μ g· mL-1(r=0.999 9)with average recovery rate at 100.06%(RSD=1.17%).CONCLUSION:The preparation method is well-grounded,highly-specific and reproducible in property identification,accurate and reliable in content determination,and can be used for the quality control of Sanzi capsules.