文档介绍：复方酸枣仁颗粒质量标准研究
[摘要] 目的对复方酸枣仁颗粒的质量标准进行研究。方法采用薄层色谱法(TLC)对制剂中的酸枣仁、知母、甘草三味药材进行专属性鉴别;采用高效液相色谱法(HPLC)对处方中药材知母的有效成分芒果苷进行含量测定。色谱柱为Welchrom C18 HPLC Column( mm×200 mm,5 μm);流动相为甲醇-乙***-%的乙酸水(7∶7∶86),检测波长为258 nm,进样量为10 μL, mL/min,柱温为30℃。结果酸枣仁、知母、甘草三味药材的TLC特征斑点清晰,分离度好,阴性没有干扰。~ μg/mL的浓度范围内呈良好的线性关系,回归方程为Y=42 888X-30 400,r = 9。%,RSD=%(n = 6)。、、 mg/g,符合要求。结论所建立的质量标准准确、重复性良好,可用于?头剿嵩嫒士帕5闹柿靠刂啤?
[关键词] 复方酸枣仁颗粒;芒果苷;高效液相色谱法;薄层色谱法;质量控制
[中图分类号] R927 [文献标识码] A [文章编号] 1673-7210(2017)05(c)-0144-05
[Abstract] Objective To establish the quality standard for Fufang Suanzaoren Granules. Methods Ziziphi spinosae semen, Anemarrhenae rhizome, Glycyrrhizae radix et rhizoma were identified by TLC. The contents of mangiferin were determined by HPLC. HPLC method on mangiferin was adopted on a Welchrom C18 ( mm×200 mm, 5 μm) column with Methanol-acetonitrile-% acetic acid (7∶7∶86) as the mobile phase, the flow rate was mL/min, the detection wavelength was 258 nm, the column temperature was 30℃ and the injection volum was 10 μL. Results TLC spots of Ziziphi spinosae semen, Anemarrhenae rhizome, Glycyrrhizae radix et rhizoma were clear with good resolution and without interference of negative samples. There was a good linearity within the range of - μg/mL, with the linear equation of Y=42 888X-30 400, r = 9. The average recovery of berberine hydrochloride was % and the RSD was % (n = 6). The content of Mangiferin in three batchs samples were satisfactory. Conclusion The method is simple, accurate and reproducible. It can be used as the quality control method of Fufang Suanzaoren Granules.
[Key words] Fufang Suanzaoren Granules; Mangiferin; HPLC; TLC; Quality standard
复方酸枣仁颗粒含有川芎、知母、酸枣仁、甘草、茯苓五味中药,具有养肝血,安心神,调血养肝,清热除烦的功效,用于治疗虚劳烦不得眠、心悸、盗汗、头晕目眩、咽干口燥、脉弦或细数所致的心烦失眠等症,临床应用中疗效确切,效果较好。复方酸枣仁颗粒是由沈阳军区总医院(以下简称“我院”)生产的,根据总后勤部卫生部下发的“军队医疗机构制剂标准提高计划”中对医院制剂标准研究项目的提高的要求,对复方酸枣仁颗粒的质量标准进行了再提高和进一步完善[1]。复