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目的研究和提高茵杞复肝丸的质量标准。方法采用显微鉴别法对巴戟天、枸杞子、连翘进行显微鉴别;采用薄层鉴别(TLC)法对连翘进行薄层鉴别;采用高效液相色谱(HPLC)法对茵杞复肝丸中连翘的有效成分连翘苷进行含量测定,并确定含量限度。结果显微鉴别专属性好;薄层鉴别斑点清晰,且阴性对照无干扰;连翘苷含量在0.030~0.900μg范围内呈良好的线性关系(r=0.999 5),加样回收率为97.55%(n=6),RSD值为0.49%。结论该方法能有效地控制茵杞复肝丸的药品质量,有利于医院制剂质量标准的提升。
Objective To study and improve Yinqi Fugan pill quality standards. Methods Microscopic identification was used to identify Morinda officinalis, Lycium chinense and Forsythia suspense. The thin layer identification (TLC) method was used to identify Forsythia suspensa. TLC and HPLC were used to determine the content of Yinqi complex Liver pills Forsythia active ingredient forsythin content determination, and to determine the content limit. The results showed that the micro-identification had good specificity. The TLC spots were clear and there was no interference with the negative control. The felinin content showed a good linearity (r = 0.999 5) in the range of 0.030-0.900 μg, and the recovery rate was 97.55% (n = 6) with a RSD value of 0.49%. Conclusion The method can effectively control the quality of Yinqi Fugan Pills and improve the quality standard of the hospital preparations.