降脂复肝胶囊质量标准的研究.docVIP

降脂复肝胶囊质量标准的研究 　　摘要：目的 建立降脂复肝胶囊的质量标准。方法 采用薄层色谱法对制剂中赤芍、丹参进行薄层定性鉴别。采用高效液相色谱法，Phenomenex C18色谱柱，以甲醇-0.1%磷酸水溶液（31∶69、75∶25）为流动相，流速1.0 mL/min，分别对制剂中芍药苷和丹参酮ⅡA的含量进行分析测定。结果 薄层鉴别图谱斑点清晰，阴性对照无干扰。芍药苷和丹参酮ⅡA进样量分别在0.448～4.48 μg和0.057 6～0.576 μg范围内线性关系良好，相关系数分别为0.999 4、0.999 5，平均加样回收率分别为99.93%（RSD=1.98%，n=9）、99.75%（RSD=1.70%，n=9）。结论 本试验定性定量检测方法准确、可靠、稳定、快速，重复性好，可用于降脂复肝胶囊的质量控制及评价。 　　关键词：降脂复肝胶囊；质量标准；薄层色谱法；高效液相色谱法 　　DOI：10.3969/j.issn.1005-5304.2015.04.026 　　中图分类号：R284.1 文献标识码：A 文章编号：1005-5304（2015）04-0094-04 　　Study on Quality Standard of Jiangzhi Fugan Capules LI Cai-dong， PAN Xin-bo， ZHANG Wei， WANG Xin （The Second People’s Hospital of Lanzhou， Lanzhou 730046， China） 　　Abstract：Objective To establish the quality standard of Jiangzhi Fugan Capules. Methods TLC was used to the qualitative identification of Paeoniae Radix Rubra and Salviae Miltiorrhizae Radix et Rhizoma. The contents of Paeoniflorin and Tanshinone ⅡA were determined by HPLC. The HPLC separation was performed on Phenomenex C18 column （4.6 mm×250 mm， 5 μm）， with methanol- 0.1% phsophonic acid （31∶69， 75∶25） as mobile phase， and the flow rate was 1.0 mL/min. Results The results of TLC showed that relevant spots were clear without interference against the negative sample. The calibration curves for Paeoniflorin and Tanshinone ⅡA were found to be liner within the range of 0.448-4.48 μg， 0.057 6-0.576 μg， respectively. The correlation coefficients were 0.999 4 and 0.999 5， respectively. The average recoveries were 99.93% and 99.75%， with RSD of 1.98% （n=9） and 1.70% （n=9）， respectively. Conclusion The method is accurate， reliable， stable， rapid， and reproducible， and can be used for the quality control and evaluation of Jiangzhi Fugan Capules. 　　Key words：Jiangzhi Fugan Capules；quality standard；TLC；HPLC 　　降脂复肝胶囊由赤芍、丹参、山楂、制何首乌等9味中药提取加工而成，具有疏肝健脾、降脂化瘀、活血软坚等功效，临床用于脂肪肝、高脂血症的治疗，为本院院内制剂。本研究对处方中赤芍、丹参进行薄层色谱鉴别，采用高效液相色谱法（HPLC）对处方中芍药苷、丹参酮ⅡA进行含量测定，并对其进行方法学验证，建立降脂复肝胶囊的质量控制方法，为该制剂的质量控制提供依据。 　　1 仪器与试药 　　HPLC-20A高效液相色谱仪：PDA紫外检测器（日本