白癜灵颗粒质量标准研究

【摘要】  　　目的 提高白癜灵颗粒的质量标准。方法 采用薄层色谱法鉴别紫草、地榆；高效液相色谱(HPLC)法测定制何首乌中2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷的含量，色谱条件：使用C18柱(250 mm×4.6 mm，5 μm)，乙腈-水(1∶4)为流动相，检测波长为320 nm。结果 薄层色谱斑点清晰，易于识别；HPLC法测定2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷的含量在26.84～134.20 μg/mL范围内呈现良好的线性关系，r=0.999 8，平均回收率为101.2%，RSD=1.3%。结论 所建立的标准方法简单，专属性强，结果准确可靠，可以用作白癜灵颗粒的质量控制方法。

【关键词】  紫草 地榆 HPLC 回收率 苯乙烯类 葡糖苷类 薄层色谱法 颗粒剂 质量控制

　　Study on quality standard for Baidianling granules 

　　SONG Erying, CUI Zhihai Langfang Institute for Drug Control, Hebei, Langfang 065000

　　【Abstract】  Objective  To improve the standard of quality of Baidianling Granules.Methods  Radix Arnebiae and Radix Sanguisorbae were distinguished by thin layer chromatogrphy (TLC). 2,3,5,4′-tetrahydroxystilbene-2-O-β-D-glucoside in Prepared Radix Polygoni Multiflori was determined by HPLC. The C18 column (250×4.6mm, 5μm) was used.The mobile phase was acetonitrile- water (1∶4). The wavelength of detector was set at 320nm.Results  The spots were clear in TLC and could be identified easily. The linear detection range of 2,3,5,4′-tetrahydroxystilbene-2-O-β-D-glucoside was in 26.84～134.20 μg/mL,r=0.9998.The average recovery was 101.2% and RSD was 1.3%.Conclusion  This method is simple and accurate with a good reproducibility and can be used for the quality control of Baidianling Granules.

　　【Key words】  Radix Arnebiae;Radix Sanguisorbae;HPLC;Recovery;Styrene class;Glucose glucoside class;Thin layer chromatography；Granular formulation；Quality control

　　白癜灵颗粒是河北省廊坊市中医医院研制的制剂(冀药制字Z20051453)，由制何首乌、当归、红花、丹参、紫草、地榆、墨旱莲、郁金、牡丹皮、石决明、刺蒺藜、陈皮等12味中药经提取制成，具有养血活血、调补肝肾的功效，用于白癜风的治疗。方中制何首乌具有补肝肾、益精血的功效［1］，为君药；紫草、地榆具有凉血、活血、解毒的功效［1］，共为臣药。原质量标准只有丹参及陈皮的理化鉴别，不能有效地控制白癜灵颗粒的内在质量。本研究建立了白癜灵颗粒中制何首乌的有效成分2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷的含量测定方法，增加了紫草、地榆的薄层鉴别，为进一步完善白癜灵颗粒的质量标准提供了科学的依据。

　　1  仪器与

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