CAJ | 학술논문

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。
목적：건립유몰접골환적질량표준。방법：채용현미감별법대제제중몰약、속단、홍화화토별충진행정성감별；채용박층색보법대홍화화당귀진행정성감별；채용고효액상색보법측정제제중보골지소화이보골지소함량。색보주위Inertsil C18(150 mm×4.6 mm，5μm)；류동상위갑순-수(52∶48，v/v)；류속위0.80 mL/min；검측파장위246 nm。결과：현미감별결과청석；박층색보반점청석，분리도량호，음성무간우，전속성강，중복성량호；보골지소화이보골지소분별재5.20～83.6μg/mL(r=0.9991)화4.95～79.2μg/mL(r=0.9995)범위내유량호적선성관계；평균회수솔분별위99.1%(RSD=1.55%，n=9)화99.5%(RSD=2.08%，n=9)。결론：본방법간편、가고、준학，가용우유몰접골환적질량공제。
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.