中国药业
中國藥業
중국약업
China Pharmaceuticals
2015年
19期
41-43
,共3页
跌打片%质量控制%薄层色谱法%高效液相色谱法
跌打片%質量控製%薄層色譜法%高效液相色譜法
질타편%질량공제%박층색보법%고효액상색보법
Dieda Tablets%quality standard%TLC%HPLC
目的：建立跌打片成分定性、定量分析方法以提高其质量标准。方法采用薄层色谱（TLC）法，建立跌打片中三七、续断、血竭、白芍、赤芍、牡丹皮、枳实和骨碎补的定性分析方法；采用高效液相色谱（HPLC）法测定川续断皂苷Ⅵ的含量，色谱柱为KromasilTM C18柱(150 mm ×4.6 mm，5μm )，流动相为乙腈－水(梯度洗脱)，流速1.0 mL/min，检测波长212 nm，柱温35℃。结果 TLC鉴定组成斑点清晰，阴性无干扰；川续断皂苷Ⅵ进样量在0.3473~2.4308μg范围内与峰面积呈良好的线性关系（ r=0.9999），平均加样回收率为99.14%，RSD为1.34%（ n=9）。结论该法准确可靠、专属性强、重复性好，能有效地控制跌打片的内在质量。
目的：建立跌打片成分定性、定量分析方法以提高其質量標準。方法採用薄層色譜（TLC）法，建立跌打片中三七、續斷、血竭、白芍、赤芍、牡丹皮、枳實和骨碎補的定性分析方法；採用高效液相色譜（HPLC）法測定川續斷皂苷Ⅵ的含量，色譜柱為KromasilTM C18柱(150 mm ×4.6 mm，5μm )，流動相為乙腈－水(梯度洗脫)，流速1.0 mL/min，檢測波長212 nm，柱溫35℃。結果 TLC鑒定組成斑點清晰，陰性無榦擾；川續斷皂苷Ⅵ進樣量在0.3473~2.4308μg範圍內與峰麵積呈良好的線性關繫（ r=0.9999），平均加樣迴收率為99.14%，RSD為1.34%（ n=9）。結論該法準確可靠、專屬性彊、重複性好，能有效地控製跌打片的內在質量。
목적：건립질타편성분정성、정량분석방법이제고기질량표준。방법채용박층색보（TLC）법，건립질타편중삼칠、속단、혈갈、백작、적작、모단피、지실화골쇄보적정성분석방법；채용고효액상색보（HPLC）법측정천속단조감Ⅵ적함량，색보주위KromasilTM C18주(150 mm ×4.6 mm，5μm )，류동상위을정－수(제도세탈)，류속1.0 mL/min，검측파장212 nm，주온35℃。결과 TLC감정조성반점청석，음성무간우；천속단조감Ⅵ진양량재0.3473~2.4308μg범위내여봉면적정량호적선성관계（ r=0.9999），평균가양회수솔위99.14%，RSD위1.34%（ n=9）。결론해법준학가고、전속성강、중복성호，능유효지공제질타편적내재질량。
Objective To establish the qualitative and quantitative methods to improve its quality standard of Dieda Tablets. Methods TLC was applied to the identification of Notoginseng Radix et Rhizoma, Dipsaci Radix, Draconis Sanguis, Paeonia Radix Alba, Paeonia Radix Rubra, Moutan cortex, Aurantii Fructus ImmaTurus and Drynaria Rhizoma; HPLC was applied to determinte asperosaponin VI; the analytical column was KromasilTM C18 column ( 150 mm × 4. 6 mm, 5μm ); the mobile phase was acetonitrile-water at the flow rate of 1. 0 mL/min;the detection wavelength was 212 nm;and the column temperature was 35 ℃. Results The spots in the TLC were clear and could be well separated, the blank test showed that other medicine herbs had not interference with the main one;The calibra-tion curve of asperosaponin VI showed good linearity in the range of 0. 347 3-2. 430 8 μg ( r=0. 999 9 ) . The average recovery was 99. 14%, RSD was 1. 34%( n=9 ) . Conclusion The established methods are accurate, reliable, specific and with good reproducibility. It can be used for the quality control of the Dieda Tablets.
