人参茸芝胶囊的制备工艺及质量控制
Preparation Process and Quality Control of Renshen Rongzhi Capsules
目的：建立人参茸芝胶囊的定性鉴别和含量测定的方法。方法：采用薄层色谱法定性鉴别人参茸芝胶囊中人参、灵芝孢子粉；采用高效液相色谱法测定人参皂苷和灵芝酸A的含量。人参皂苷色谱条件：流速1.0 mLomin-1，柱温35 ℃，检测波长203 nm，流动相为乙腈（A）?水（B），梯度洗脱；灵芝酸A：流速0.8 mLomin-1，柱温25 ℃，检测波长254 nm，流动相为乙腈（B）?0.1%醋酸水（A）溶液，梯度洗脱。结果：薄层鉴别荧光斑点清晰，分离度好，阴性对照无干扰；人参皂苷在0.5～50 μg范围内呈良好的线性关系，平均回收率在98.53%～102.53%之间，相对标准偏差（RSD）在0.84%～1.83%之间；灵芝酸A的线性范围0.02～0.6 mgomL-1（R2=0.9998），平均回收率为98.80%，RSD为0.88%。结论：所建立的定性、含量测定分析方法可用于人参茸芝胶囊的质量控制。
Objective: To prepare Renshen Rongzhi Capsules and to establish its quality control method. Method: Qualitative identification of ginseng, ganoderma spore in Renshen Rongzhi Capsules was carried out by thin layer chromatograhy; Ginsenosides and Ganoderma acid A were determined by HPLC. Chromatography: LC 3000-C18 column, Ginsenosides: the flow rate was 1.0 mLomin-1, the column temperature was 25 ℃ and the measurement wavelength was 203 nm, the moving phase was acetonitrile (A) and water (B), Gradient elute; Ganoderma acid A: the flow rate was 0.8 mLomin-1, the column temperature was 25 ℃ and the measurement wavelength was 254 nm, the moving phase was acetonitrile (B) and 0.1% glacial acetic acid-water (A), Gradient elute. Results: The TLC spots were clear with high resolution, and the blank test showed no interference; Ginsenosides linear range was 0.5-50 μg, the average recovery was between 98.53%-102.53%, and the relative standard deviation (RSD) was between 0.84%-1.83%; Ganoderma acid A linear range was 0.02-0.6 mgomL-1 (R2=0.9998), the average recovery was 98.80%, and the RSD was 0.88%. Conclusion: The established qualitative and quantitative analysis method is applicable for the quality control of Renshen Rongzhi Capsules.
妙志岩、蔡恩博、杨鹤、刘双利、张连学、赵岩
药学
人参茸芝胶囊薄层色谱法高效液相色谱法质量控制
Renshen Rongzhi CapsulesTLCHPLCquality control
妙志岩,蔡恩博,杨鹤,刘双利,张连学,赵岩.人参茸芝胶囊的制备工艺及质量控制[EB/OL].(2014-07-16)[2025-07-21].http://www.paper.edu.cn/releasepaper/content/201407-196.点此复制
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