基于玉屏风煎剂的玉屏风制剂质量评价研究

Quality Evaluation of Yupingfeng Preparation Based on Yupingfeng Decoction

目的:测定玉屏风制剂中毛蕊异黄酮苷、升麻素苷、5-O-甲基维斯阿米醇苷的含量并分析其高效液相色谱(HPLC)指纹图谱,以玉屏风煎剂的内在质量评价不同厂家、不同剂型玉屏风制剂的质量。方法:采用HPLC法测定3种成分的含量,色谱柱为Hypersil ODS(250mm×4.6mm,5μm),流动相为乙腈-水(梯度洗脱),检测波长为254nm,流速为1mL·min-1,柱温为30℃。采用HPLC法分析指纹图谱,色谱柱为Hypersil ODS(250mm×4.6mm,5μm),流动相为乙腈-水(梯度洗脱),检测波长为220nm,流速为1mL·min-1,柱温为30℃。结果:按日用量计,颗粒剂中3种成分的含量均>口服液的含量,提示玉屏风不同剂型因工艺不同,其有效成分的保留有较大差异;颗粒剂含量基本高于煎剂含量,与煎剂煎煮2次提取率不高的结果基本相符。3个不同厂家口服液指纹图谱共有模式的相似度只在0.830～0.942之间,表明同剂型不同厂家之间产品质量有较大差异;颗粒剂共有模式与口服液共有模式之间的相似度仅为0.899;与煎剂指纹图谱相比,颗粒剂共有模式的相似度为0.964,3个药厂口服液模式的相似度分别为0.929、0.799、0.935,提示颗粒剂的质量与传统煎剂质量较为接近,与含量测定结果基本相符。结论:玉屏风制剂水提工艺基本能保留原煎剂的化学物质基础;基于玉屏风煎剂质量的玉屏风制剂质量评价的方法,可以为制剂工艺合理性与临床用药指导提供一定的参考。

OBJECTIVE： To determine the content of calycosin-7-O-β-D-glucoside, prim-O-glucosylcimifugin and 4＇-O-β-D-glucosyl-5-O-methylvisammin in the Yupingfeng preparation, to analyze their HPLC fingerprints, and to evaluate the quality of different dosage form of Yupingfeng preparation from different manufactures by internal quality evaluation of Yupingfeng decoction. METHODS： The content of calycosin-7-O-β-D-glucoside, prim-O-glucosylcimifugin and 4＇-O-β-D-glucosyl-5- O-methylvisammin were determined by HPLC. Hypersil ODS （250mm×4.6mm,5μm）column was used using acetonitrile-water （gradient elution）as mobile phase at detection wavelength of 254 nm. The flow rate was 1mL·min^-1 and column temperature was set at 30℃. HPLC fingerprints was analyzed with Hypersil ODS （250mm×4.6mm,5μm）column with acetonitrile-water（gradient elution）as a mobile phase at detection wavelength of 220 nm. The flow rate was 1 mL.min- and column temperature was set at 30℃. RESULTS ： By the daily dose, the content of the three components in granule were higher than in oral liquid, which indicat- ed the remaining effective constituent had large difference among different dosage forms resulted from extraction techonlogy. The content of three components in granule was higher than in decoction, which matched with low extraction percentage for 2 times of decoction. The similarity of oral solutions from three manufactures were 0.830-0.942, which meant there was significant difference in quality of same dosage form among different manufactures. The similarity between granule and oral solution was 0.899 and the similarity between granule and decoction was 0.964. The similarities of oral solutions from three manufactures were 0.929, 0.799, 0.935 respectively. This indicated the quality of granule was near to that of decoction, which matched with results of content determination. CONCLUSIONS： The chemical constituents of Yupingfeng decoction can be remained by aqueous extraction technology. The quality evaluation of Yupingfeng preparation based on the quality evaluation of decoction can provide reference for technical rationality and clinical use of drugs.