中国执业药师
中國執業藥師
중국집업약사
China Licensed Pharmacist
2015年
11期
31-34
,共4页
参龙散结丸(浓缩丸)%质量标准%高效液相色谱%薄层色谱
參龍散結汍(濃縮汍)%質量標準%高效液相色譜%薄層色譜
삼룡산결환(농축환)%질량표준%고효액상색보%박층색보
Shenlong Sanjie Pills%Quality Standard%HPLC%TLC
目的：制定参龙散结丸（浓缩丸）的质量控制标准。方法：采用薄层色谱定性鉴别参龙散结丸方中的白术、菝葜、夏枯草；采用高效液相色谱测定参龙散结丸方中橙皮苷成分的含量。色谱柱：YMC-Pack ODS-A C18（150 mm ×4.6 mm，5μm），流动相：甲醇-乙酸-水（35∶4∶61），柱温：30℃，流速：1.0 mL/min，检测波长：283 nm。结果：白术、菝葜、夏枯草的薄层色谱斑点清晰，阴性对照无干扰。橙皮苷对照品进样量在0.04434～1.1085μg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96.88%， RSD =1.49%（n =6）。结论：参龙散结丸方中药材白术、菝葜、夏枯草的薄层色谱定性鉴别专属性强；方中橙皮苷的高效液相色谱定量测定，方法准确，重现性好，适用于参龙散结丸的质量控制标准。
目的：製定參龍散結汍（濃縮汍）的質量控製標準。方法：採用薄層色譜定性鑒彆參龍散結汍方中的白術、菝葜、夏枯草；採用高效液相色譜測定參龍散結汍方中橙皮苷成分的含量。色譜柱：YMC-Pack ODS-A C18（150 mm ×4.6 mm，5μm），流動相：甲醇-乙痠-水（35∶4∶61），柱溫：30℃，流速：1.0 mL/min，檢測波長：283 nm。結果：白術、菝葜、夏枯草的薄層色譜斑點清晰，陰性對照無榦擾。橙皮苷對照品進樣量在0.04434～1.1085μg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96.88%， RSD =1.49%（n =6）。結論：參龍散結汍方中藥材白術、菝葜、夏枯草的薄層色譜定性鑒彆專屬性彊；方中橙皮苷的高效液相色譜定量測定，方法準確，重現性好，適用于參龍散結汍的質量控製標準。
목적：제정삼룡산결환（농축환）적질량공제표준。방법：채용박층색보정성감별삼룡산결환방중적백술、발계、하고초；채용고효액상색보측정삼룡산결환방중등피감성분적함량。색보주：YMC-Pack ODS-A C18（150 mm ×4.6 mm，5μm），류동상：갑순-을산-수（35∶4∶61），주온：30℃，류속：1.0 mL/min，검측파장：283 nm。결과：백술、발계、하고초적박층색보반점청석，음성대조무간우。등피감대조품진양량재0.04434～1.1085μg범위내여봉면적정량호적선성관계（r =0.9999）；평균가양회수솔위96.88%， RSD =1.49%（n =6）。결론：삼룡산결환방중약재백술、발계、하고초적박층색보정성감별전속성강；방중등피감적고효액상색보정량측정，방법준학，중현성호，괄용우삼룡산결환적질량공제표준。
Objective: To establish the quality standards for shenlong sanjie pills . Methods: rhizoma atractylodis macrocephalae , chinaroot greenbrier and spica prunellae in shenlong sanjie pills were identified by TLC and the content of hesperidin in shenlong sanjie pills was determined by HPLC. The column of YMC-Pack ODS-A C18 (150 mm × 4.6 mm,5 μm)was used with a mobile phase of methanol-acetic acid-water (35∶4∶61), the column temperature was at 30 ℃, the flow rate was 1 . 0 mL/min and the detection wavelength was at 283 nm . Results: Rhizoma atracty-lodis macrocephalae , chinaroot greenbrier and spica prunellae were tested and the TLC spots were clear , there was no interference in negative control . A good linear relationship was showed between the peak area and hesperidin reference sample size in the range of 0.044 34~1.108 5 μg, (r = 0.999 9). The average recovery was 96.88%, RSD = 1 . 49% ( n = 6 ) . Conclusion: TLC qualitative identification of rhizoma atractylodis macrocephalae , china-root greenbrier and spica prunellae in shenlong sanjie pills was specific . The method for the quantitative determina-tion of hesperidin by HPLC is accurate , reproducible and applicable to the quality control of shenlong sanjie pills .
