中国执业药师
中國執業藥師
중국집업약사
CHINA LICENSED PHARMACIST
2014年
2期
8-11,15
,共5页
续断壮骨胶囊%川续断皂苷遇%高效液相色谱法%含量测定
續斷壯骨膠囊%川續斷皂苷遇%高效液相色譜法%含量測定
속단장골효낭%천속단조감우%고효액상색보법%함량측정
Xuduanzhuanggu Capsules%AsperosaponinⅥ%HPLC%Content Determination
目的：建立续断壮骨胶囊中总皂苷和川续断皂苷遇的含量测定方法。方法：采用高氯酸显色，紫外-可见分光光度法测定总皂苷含量。采用高效液相色谱法测定川续断皂苷遇含量，Agilent C18柱（250 mm ×4.6 mm，5μm），乙腈-0.15%三氟乙酸水溶液（29∶71）为流动相，检测波长215 nm ，流量1.0 mL/min。结果：总皂苷平均含量为86.3%，平均加样回收率为99.88%， RSD =1.52%；川续断皂苷遇在64～320μg/mL 范围内呈良好线性关系（r =0.9995），平均加样回收率为100.4%， RSD =0.77%。结论：所建方法准确，能快速测定续断壮骨胶囊总皂苷和川续断皂苷遇的含量，可用于该制剂的质量控制。
目的：建立續斷壯骨膠囊中總皂苷和川續斷皂苷遇的含量測定方法。方法：採用高氯痠顯色，紫外-可見分光光度法測定總皂苷含量。採用高效液相色譜法測定川續斷皂苷遇含量，Agilent C18柱（250 mm ×4.6 mm，5μm），乙腈-0.15%三氟乙痠水溶液（29∶71）為流動相，檢測波長215 nm ，流量1.0 mL/min。結果：總皂苷平均含量為86.3%，平均加樣迴收率為99.88%， RSD =1.52%；川續斷皂苷遇在64～320μg/mL 範圍內呈良好線性關繫（r =0.9995），平均加樣迴收率為100.4%， RSD =0.77%。結論：所建方法準確，能快速測定續斷壯骨膠囊總皂苷和川續斷皂苷遇的含量，可用于該製劑的質量控製。
목적：건립속단장골효낭중총조감화천속단조감우적함량측정방법。방법：채용고록산현색，자외-가견분광광도법측정총조감함량。채용고효액상색보법측정천속단조감우함량，Agilent C18주（250 mm ×4.6 mm，5μm），을정-0.15%삼불을산수용액（29∶71）위류동상，검측파장215 nm ，류량1.0 mL/min。결과：총조감평균함량위86.3%，평균가양회수솔위99.88%， RSD =1.52%；천속단조감우재64～320μg/mL 범위내정량호선성관계（r =0.9995），평균가양회수솔위100.4%， RSD =0.77%。결론：소건방법준학，능쾌속측정속단장골효낭총조감화천속단조감우적함량，가용우해제제적질량공제。
Objective:To establish a method for the content determination of total saponins and asperosaponin Ⅵ in xuduanzhuanggu capsules. Methods:The content of total saponins was determined by ultraviolet visible spectrophotomet-ric method using perchloric acid as the chromogenic reagent. The content of asperosaponin Ⅵ was determined by HPLC, using Agilent C18 column (250 mm × 4.6 mm, 5 um) with acetonitrile -0.15% trifluoroacetic acid solution (29:71) as mobile phase, the detection wavelength was at 215 nm and the flow rate was 1.0 mL/min. Results: The av-erage content of total saponins was 86.3% and the average recovery was 99.88% (RSD = 1.52%). Asperosaponin Ⅵ showed a good linear relationship in the range of 64~320 μg/mL (r=0.9995) and the average recovery was 100.4%(RSD=0.771%). Conclusion: The established method is accurate and applicable to the rapid determination of the con-tents of total saponins and asperosaponinⅥin xuduanzhuanggu capsules , and can be used for the quality control of the preparation.
