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目的分析市售补骨脂指标成分的含量,为保证用药安全有效提供依据。方法采用高效液相色谱法,Hypersil ODS2 C18色谱柱;流动相:甲醇∶水(55∶45);柱温:30℃,流速:1.0 ml/min,检测波长:246 nm。结果 40批样品中12批质量分数低于0.30%,21批为0.30%~0.50%,6批为0.50%~0.61%,1批高于0.70%,共39批不符合《中华人民共和国药典》。结论市场流通的补骨脂指标成分大多低于《中华人民共和国药典》的规定,是否近年来补骨脂药材质量有所下降,尚有待于进一步考查。
Objective To analyze the contents of the index components of commercially available psoralen in order to provide a basis for the safe and effective use of drugs. Methods The column was Hypersil ODS2 C18. The mobile phase was methanol: water (55:45). The column temperature was 30 ℃, the flow rate was 1.0 ml / min and the detection wavelength was 246 nm. Results 12 batches of batches of batches of batches of batches of 12 batches were 0.30% ~ 0.50%, 0.50% ~ 0.61% of 6 batches, 0.70% of batches of batches of batches of batches of batches, and 39 batches of batches of batches of 40 batches were inconsistent with “Pharmacopoeia of People’s Republic of China” . Conclusion Most of the constituents of psoralen circulating in the market are lower than those stipulated in the “Pharmacopoeia of the People’s Republic of China”. Whether the quality of psoralen medicinal materials has declined in recent years remains to be further examined.