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鉴于目前中药质量严重下降、药品质量标准缺乏客观指标控制的状况,笔者参考日本药局方第十一改正版生药部分,结合实际工作经验,通过理论分析认为,除增加杂质检查、灰分测定、比色控制及含量测定外,还应增加浸出物测定品种。为此拟定了某些药材做浸出物测定,供修订药材质量标准参考。
In view of the current serious decrease in the quality of Chinese medicines and the lack of objective indicators for the control of drug quality standards, the author refers to the 11th revision of the Japanese Herbal Pharmacy’s genuine crude drug, combined with practical work experience, and theoretical analysis, in addition to increasing impurity inspection, ash determination, and ratio In addition to color control and content determination, leachate determinations should also be added. For this purpose, certain medicinal materials were prepared for the determination of leachables for reference to the revised quality standards for medicinal materials.