防风饮片标准汤剂

Standard Decoction of Saposhnikoviae Radix Pieces

目的:制备防风饮片标准汤剂,并进行质量标准的研究,为其临床应用及其他饮片标准汤剂的研究提供科学参考。方法:采用传统水煎煮方法,制备11批防风饮片标准汤剂,进行p H,升麻素苷及5-O-甲基维斯阿米醇苷含量的测定,计算其出膏率与转移率,并对测定方法可行性进行考察。建立HPLC指纹图谱分析方法,采用Hypersil ODS2色谱柱(4. 6 mm×250 mm,5μm),流动相甲醇-进行梯度洗脱,检测波长254 nm,流速1 m L·min^-1,柱温25℃,并进行相似度评价。结果:11批防风饮片标准汤剂的p H均为5. 5,出膏率在34. 3%~46. 3%,平均出膏率为41. 4%,标准偏差为3. 7%;升麻素苷的转移率在66. 8%~93. 5%,平均转移率为79. 4%,标准偏差为12. 1%;5-O-甲基维斯阿米醇苷的转移率在70. 4%~98. 2%,平均转移率为83. 4%,标准偏差为10. 8%。各项方法学考察结果 RSD均符合要求。指纹图谱中确定了9个主要共有峰,其相似度> 0. 9。结论:该研究建立的质量评价方法稳定性、精密度和重复性良好,指纹图谱的相似度高,适用于防风饮片标准汤剂的质量评价,并且可为其他相关制剂的质量评价提供科学依据。

Objective: To prepare standard decoction of Saposhnikoviae Radix pieces,and conduct a study on the quality standards,in order to provide the scientific reference for the study of clinical application and other decoction standard decoctions. Method: By the traditional water decocting method,11 batches of standard decoction of Saposhnikoviae Radix pieces were prepared to determine pH,prim-O-glucosylcimifugin and 4'-O-β-Dglucosyl- 5-O-methylvisamminol content,calculate the paste rate and transfer rate,and investigate the feasibility of the measurement method. An analytical method for HPLC fingerprint was established. Hypersil ODS2 column ( 4.6 mm × 250 mm,5 μm) was adopted and eluted with methanol-water as the mobile phase in a gradient mode. The detection wavelength was 254 nm,the flow rate was 1 mL·min ^- 1,and the column temperature was 25 ℃. The fingerprint analysis method was used to evaluate the similarity of the 11 batches of standard decoction of Saposhnikoviae Radix pieces. Result: Through the determination of 11 batches of standard decoctions of Saposhnikoviae Radix pieces,the average pH value was 5.5,the paste-out rates were between 34.3% and 46.3%,and the average paste-out rate was 41.4%,the standard deviation was 3.7%,the transfer rate of prim- O-glucosylcimifugin was 66.8%-93.5%,the average metastasis rate was 79.4%,the standard deviation was 12.1%,the transfer rate of 4'-O-β-D-glucosyl-5-O-methylvisamminol was 70.4%-98.2%,the average transfer rate was 83.40%,the standard deviation of 10.8%. The results of various methodological studies were consistent with the requirements of RSD. The fingerprinting analysis was performed using similarity evaluation software for traditional Chinese medicine fingerprints,and 9 principal common peaks were identified. The similarity was higher than 0.9.Conclusion: The quality evaluation method established in this study has a good stability,precision and repeatability. The fingerprints have a high similarity,which is suitable for the quality evaluation of standard decoctions of Saposhnikoviae Radix pieces,and can provide the scientific basis for the quality evaluation of other related preparations.