目的:对全国不同地区市售麻黄药材中盐酸麻黄碱、盐酸伪麻黄碱和总生物碱的含量进行测定,从化学成分的角度对其质量进行评估。方法:收集了28个批次来源于全国7个不同产地、21个不同地区的麻黄药材,按照2010版《中国药典》的方法测定其中盐酸麻黄碱、盐酸伪麻黄碱的含量;建立酸性染料比色法测定药材中的总生物碱。结果:有10个批次的麻黄药材(占全部批次的35.7%)达不到2010版《中国药典》的要求(盐酸麻黄碱和盐酸伪麻黄碱的总质量分数不得少于0.80%),且28个批次的样品中两种生物碱的总质量分数最高与最低相差45倍,总生物碱的质量分数最高与最低相差33倍。结论:所建立的酸性染料比色法测定麻黄总生物碱的含量方法简便、重复性好。市售麻黄药材以草麻黄为主,有效成分生物碱的含量差异较大,劣质情况较为严重。有必要加强麻黄药材的市场监管,保证其临床应用的安全、有效。
OBJECTIVE:To determine the content of ephedrine hydrochloride,pseudoephedrine hydrochloride and total alkaloids from commercial Herbal ephedrae from different areas,and evaluate the quality from chemical aspects. METHODS:28 batches of commercial H. ephedrae were collected from 7 producing areas and 21 areas. The content of ephedrine hydrochloride and pseudoephedrine hydrochloride of H. ephedrae was determined according to Chinese Pharmacopoeia(2010 edition);the content of total alkaloids was tested by the established acid dye colorimetry method. RESULTS:10 batches of H. ephedrae(35.7%)did not come up to the standard of Chinese Pharmacopoeia(2010 edition)(the total mass fraction of ephedrine hydrochloride and pseudoephedrine hydrochloride must not be less than 0.80%). Among 28 batches of H. ephedrae samples,the highest of total mass fraction of ephedrine hydrochloride and pseudoephedrine hydrochloride was 45 times than the lowest and the highest of mass fraction of total alkaloids was 33 times than the lowest. CONCLUSIONS:The established acid dye colorimetry is simple and repeatable for the content determination of total alkaloids from H. ephedrae. H. ephedrae on markets is mainly Ephedra sinica,there was big difference in the content of effective components alkaloids and inferior situation is serious. It is necessary to strengthen the market monitoring of H. ephedrae to ensure the safety and effectiveness of H. ephedrae in clinic.