摘要
目的:建立顺势康胶囊的薄层鉴别和含量测定的方法。方法:建立顺势康胶囊中黄芪、麻黄和甘草3味中药的薄层定性鉴别;以HPLC-ELSD法测定黄芪中黄芪甲苷的含量。结果:薄层色谱斑点清晰,分离良好,阴性对照制剂无干扰;高效液相色谱法测定黄芪甲苷的线性范围在50.24~251.2μg·mL^-1,r=0.9993(n=5),线性关系良好;平均加样回收率为97.76%,RSD为2.35%,3批次胶囊中每粒胶囊黄芪甲苷平均含量在每粒0.081 2~0.092 8 mg,本样品中黄芪甲苷的含量最低不得低于每粒0.050 mg。结论:本文建立的方法准确可靠,可控制该制剂的质量。
Objective: To establish a method for the identification and content determination of Shunshikang capsules. Methods: Radix Astragali, Ephedra and Liquorice were identified by TLC qualitatively. The content of astragaloside iv in Radix Astragali was determined by HPLC-ELSD. Results:The spots in TLC were clear, the separation was good, and the negative control preparation had no interference. The linear range of astragaloside iv in HPLC determination was 50.24-251.2 μg·mL^-1, r=0.999 3(n=5), the average recovery rate was 97.76% and the RSD was 2.35%. The average content of astragaloside iv was between 0.081 2 mg/pill and 0.092 8 mg/pill in three batches of capsules. The minimum content of astragaloside iv in this product should not be less than 0.050 mg/pill. Conclusion: The method established in this paper is accurate and reliable, and can effectively control the quality of this preparation.
作者
杭娟
金丽
张心悦
卜莹
张晓丹
HANG Juan;JIN Li;ZHANG Xinyue;BU Ying;ZHANG Xiaodan(Wuxi Joint Logistics Support Centre,Drug Instrument Supervision and Inspection Station,Nanjing 210002)
出处
《药学与临床研究》
2020年第4期266-269,共4页
Pharmaceutical and Clinical Research
作者简介
杭娟,女,主管药师,E-mail:quanquan3003@126.com;通讯作者:张晓丹,女,主任药师,E-mail:zxd0610@163.com。
