商品白附片、黑顺片的质量分析

Quality analysis of the commodities Baifupian and Heishunpian

目的对商品白附片、黑顺片进行纯度分析,了解其质量现状。方法水分、灰分、总灰分、生物碱含量的测定采用《中国药典》2010年版附录方法;胆巴残留量的测定采用EDTA滴定法和银量法;各纯度指标间的相关性分析采用SPSS统计软件。结果通过分析50批样品,有19批水分含量高于现行药典规定的15%,最高为26.77%;总灰分最高为22.59%,最低为1.50%,平均8.23%;酸不溶性灰分最高为1.69%,最低为0.01%,平均0.18%;有13批单酯型生物碱的含量低于现行药典规定的0.01%,最低为0.004%;有12批双酯型生物碱的含量高于现行药典规定的0.02%,最高为0.11%。胆巴的残留量为0.64%～23.45%,正常加工的"清水片"为0.64%～4.64%,平均2.21%;"含胆片"为5.77%～23.45%,平均10.77%。样品的含水量与胆巴残留量有显著的相关性;总灰分与胆巴残留量有高度显著的相关性;酸不溶性灰分、单酯型生物碱、双酯型生物碱含量与胆巴残留量均无相关性。结论文中方法为附子纯度指标的选择及限量规定提供了参考依据。

OBJECTIVE To analyse the purity of the commodities Baifupian and Heishunpian,to know about their quanlity.METHODS The content of water,total ash,acid insoluble ash and alklodid were examined by the methods of Chinese Pharmacopoeia（edition 2010）.EDTA titration and argentometry were used to determine the residual content of danba.SPSS statistical software was utilized to analyse the correlation of impurities.RESULTS Though the analysis of 50 batches of samples,the water content of 19 baches were higher than the current phamacopoeia（15%）,with the highest value of 26.77%.The highest,minimum and average value of the total ash were 22.59%,1.50% and 8.23%,respectively.The highest,minimum and average value of the acid insoluble ash were 1.69%,0.01% and 0.18%,respectively.The content of the monoester-aconitum alkaloids in 13 batches were higher than the current phamacopoeia（0.01%）,with the lowest value of 0.004%.The content of the diester-aconitum alkaloids in 12 batches were higher than the current phamacopoeia（0.02%）,with the highest value of 0.11%.The residual content of danba was from 0.64% to 23.45%,and the qingshuipian（normal processing）contributed from 0.64% to 4.64% with the average of 2.21%.The handanpian contributed from 5.77% to 23.45% with the average of 10.77%.The content of water and danba had great correlation.The content of total ash and danba had highly great correlation.The content of acid insoluble ash,monoester-aconitum alkaloids,diester-aconitum alkaloids and danba had no correlation.CONCLUSION This research provides the reference for the quality evaluation of Aconitum carmichaeli.