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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。
Purposes of the goods white tablets, black tablets for purity analysis to understand the quality of the status quo. Methods Determination of moisture, ash, total ash, alkaloids content using the “Chinese Pharmacopoeia” 2010 edition appendix method; Determination of gall bladder residue by EDTA titration and silver method; The purity of the correlation between the analysis using SPSS statistical software . Results By analyzing 50 batches of samples, 19 batches of water were higher than the 15% and 26.77%, respectively, of the current Pharmacopoeia. The highest total ash was 22.59%, the lowest was 1.50% and the average was 8.23% The minimum is 0.01% and the average is 0.18%. The content of 13 monoester alkaloids is less than 0.01% of the current Pharmacopoeia and the minimum is 0.004%. The content of 12 diesters of diphenylacetic alkaloids is higher than 0.02 %, Up to 0.11%. The residues of gallbladder were 0.64% ~ 23.45%. The normal processed “Qingshui Pian” was 0.64% ~ 4.64% with an average of 2.21%. The content of gallbladder was 5.77% ~ 23.45% with an average of 10.77%. There was a significant correlation between the water content of the sample and the residual volume of gall bladder. The total ash content was highly correlated with the residual volume of gall bladder. The contents of acid-insoluble ash, monoester alkaloids and diester alkaloids were No correlation. Conclusion The method provided a reference for the selection of aconite purity index and the limited provisions.