摘要
目的：建立乳没接骨丸的质量标准。方法：采用显微鉴别法对制剂中没药、续断、红花和土鳖虫进行定性鉴别；采用薄层色谱法对红花和当归进行定性鉴别；采用高效液相色谱法测定制剂中补骨脂素和异补骨脂素含量。色谱柱为Inertsil C18（150 mm×4.6 mm，5μm）；流动相为甲醇-水（52∶48，v/v）；流速为0.80 mL/min；检测波长为246 nm。结果：显微鉴别结果清晰；薄层色谱斑点清晰，分离度良好，阴性无干扰，专属性强，重复性良好；补骨脂素和异补骨脂素分别在5.20～83.6μg/mL（r=0.9991）和4.95～79.2μg/mL（r=0.9995）范围内有良好的线性关系；平均回收率分别为99.1%（RSD=1.55%，n=9）和99.5%（RSD=2.08%，n=9）。结论：本方法简便、可靠、准确，可用于乳没接骨丸的质量控制。
Objective： To formulate the quality standard forRuMoJieGupills. Methods： The qualities of Moyao（CommiphoramyrrhaEng1.）,Xuduan（Radix Dipsaci）,Honghua（CarthamustinctoriusL.）, andTubiechong （Eupolyphaga seu Steleophaga） in the pills were identified by microscopic examination; the natures ofHonghuaand Dangguiwere detected by thin layer chromatography （TLC）; the contents of psoralen and isopsoralen were measured by high performance liquid chromatography （HPLC）. The operating conditions by HPLC were Inertsil C18 column （150 mm×4.6 mm, 5μm）, v （methanol）/v （water）= 52/48 as mobile phase, 0.80 mL/min as flow speed and wave-length 246 nm. Results： The results observed by microscopy were obvious; the TLC spots developed were clear with efficient separating ability, which were negative noninterference with the characteristics of high specificity and satis-factory reproducibility; the linear relation between psoralen among 5.20 and 83.6μg/mL （r=0.999 1） and the isopso-ralen from 4.95 to 79.2μg/mL （r=0.999 5） was excellent; the average recoveries of psoralen and isopsoralen were 99.1% （RSD=1.55%,n=9） and 99.5% （RSD=2.08%,n=9）, respectively. Conclusion： Microscopy, TLC and HPLC are handy, safe and accurate forRuMoJieGupills to determine the quality.
出处
《西部中医药》
2015年第1期18-22,共5页
Western Journal of Traditional Chinese Medicine
基金
江苏省介入医疗器械研究重点实验室开放基金资助项目(编号jrl209)
