Study on Quality Standard of Mongolian Medicine Compound Preparation Mengen Vos-18 Pills
Objective To establish the quality standard of the Mongolian medicine compound preparation Mengen Vos-18 Pills.Methods The microscopic identification was performed on the preparation,and the thin-layer chromatography(TLC)method was used to qualitatively identify Liquidambaris Resina in the preparation.The titration method was used to determine the thermal mercury.The high-performance liquid chromatography(HPLC)method was used to determine six alkaloids;the chromatographic column was the Agilent Eclipse Plus C18 column(250 mm X 4.6 mm,5 μm),the mobile phase was acetonitrile-0.2％phosphoric acid aqueous solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 232 nm,the column temperature was 40℃,and the injection volume was 10 μL.Results The microscopic identification characteristics of the preparation were obvious.The TLC chromatogram of Liquidambaris Resina showed clear spots,good resolution,with no interference from the negative reference.The RSDs of the repeatability test for thermal mercury was 1.63％,and its average recovery rate was 100.50％with an RSD of 1.99％(n=9).The linear ranges of benzoylmesaconine,benzoylhypaconine,benzoylaconine,mesaconitine,hypaconitine,and aconitine were 45.19-293.72 μg,4.73-30.73 μg,6.33-41.17 μg,9.28-60.33 μg,8.78-57.09 μg,9.31-60.52 μg(r=0.999 9)respectively;the RSDs of precision,stability and repeatability tests were all lower than 3.0％;the average recovery rates of the above six components were 93.24％,95.68％,92.13％,89.59％,88.30％,89.82％,with the RSDs of 2.34％,2.45％,3.13％,2.61％,2.69％,3.22％(n=9),respectively.The thermal mercury content in the 10 batches of preparations was in the range of 9.42％-13.83％,with a transfer rate of 96.97％.The total amount of monoester-alkaloids(benzoylmesaconine,benzoylhypaconine,benzoylaconine)was in the range of 7.7-62.0 μg/g,and the total amount of diester-alkaloids(mesaconitine,hypaconitine,aconitine)was in the range of 9.0-49.0 μg/g.Conclusion The established method is easy and specific,which can provide a reference for the establishment of standards for Chinese and Mongolian medicine preparations containing Aconiti Kusnezoffii Radix.
Mengen Vos-18 Pillsthermal mercuryAconiti Kusnezoffii Radix CoctaAconiti Kusnezoffii Radix processed with Hezi Decoctionmonoester-alkaloiddiester-alkaloidquality standard
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