茵杞复肝丸质量标准研究  

Quality Standard Study for Yinqifugan Pills

作　　者：宋增炫 邓映明 蓝红梅 

机构地区：[1]梅州市食品药品监督检验所,广东梅州514071

出　　处：《今日药学》2017年第7期457-459,共3页Pharmacy Today

摘　　要：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 promote the qualtity standard for Yinqi Fugan pills. METHODS Microscopic identification method was performed to identify Morinda officinalis,Lycii Fructusand Forsythiae Fructus. TLC was performed to identify Forsythiae Fructus.HPLC was used to determine the content of Forsythin in the active ingredients of Forsythiae Fructus,and the lower limitation of the content was determined. RESULTS The mincroscopic identification method was simple. The spot of TLC was distinct.And the negative control had no interference. Forsythin had good linear range of 0.030-0.900 μg（ r = 0.999 5）. The average recovery was 97. 55%,and RSD was 0. 49%（ n = 6）. CONCLUSION The method can be used in the quality control of Yinqifugan pills effectively. And this is good at the promotion for the quality standard of hospital preparations.

关 键 词：茵杞复肝丸 质量标准 高效液相色谱 薄层鉴别 

分 类 号：R927.11[医药卫生—药学]