解毒抗白颗粒剂的含量测定及初步稳定性研究

李耀华; 蔡乐; 钟鸣; 卢森华; 陈勇; 辛华

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解毒抗白颗粒剂的含量测定及初步稳定性研究

更新时间：2024-09-23

- 解毒抗白颗粒剂的含量测定及初步稳定性研究
- Studies on the Content Determination and Preliminary Stability of Formulated Granules of Detoxification and Anti-Leukaemia
- 中国实验方剂学杂志 2013年19卷第3期页码：97-100
- 作者机构：
- 作者简介：
- 基金信息：
  
  广西科技攻关课题(桂科攻0718002-2-12)
- DOI：
  中图分类号：
- 纸质出版日期：2013
- 稿件说明：
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李耀华, 蔡乐, 钟鸣, 等. 解毒抗白颗粒剂的含量测定及初步稳定性研究[J]. 中国实验方剂学杂志, 2013,19(3):97-100.

LI Yao-hua, CAI Le, ZHONG Ming, et al. Studies on the Content Determination and Preliminary Stability of Formulated Granules of Detoxification and Anti-Leukaemia[J]. Chinese journal of experimental traditional medical formulae, 2013, 19(3): 97-100.
李耀华, 蔡乐, 钟鸣, 等. 解毒抗白颗粒剂的含量测定及初步稳定性研究[J]. 中国实验方剂学杂志, 2013,19(3):97-100. DOI：

LI Yao-hua, CAI Le, ZHONG Ming, et al. Studies on the Content Determination and Preliminary Stability of Formulated Granules of Detoxification and Anti-Leukaemia[J]. Chinese journal of experimental traditional medical formulae, 2013, 19(3): 97-100. DOI：

摘要

目的: 建立解毒抗白颗粒的含量测定方法

并考察制剂的稳定性。方法: 采用HPLC法对制剂中半枝莲有效成分野黄芩苷含量进行测定

色谱柱为C18柱(4.6 mm×250 mm

5 μm)

流动相为甲醇-0.1%磷酸溶液(34∶66)

检测波长为335 nm;同时对三批样品进行了初步稳定性试验考察。结果: 野黄芩苷进样量在0.260~2.60 μg之间与峰面积值呈线性关系

r=0.999 9

平均回收率为100.7%

RSD 2.6%(n=6);初步稳定性试验表明

制剂在性状、粒度、水分、装量差异、溶解度和含量测定等方面均符合规定。结论: 所建立的含量测定方法可行

制剂质量可控

稳定性良好。

Abstract

Objective:To create a determination method and to explore the preliminary stability of formulated granules of detoxification and anti-leukaemia. Method: HPLC was performed on a C18 column (4.6 mm×250 mm

5 μm) using methanol-0.1%H3PO4 (34∶66) as the mobile phase at the detection wavelength of 335 nm to determine scutellarin of barbata. The preliminary stability of three batches samples was also investigated. Result: The linear range of scutellarin was 0.260-2.60μg. The mean recovery was 100.7% with RSD 2.6% (n=6). The preliminary stability tests showed that formulated granules met the specification in the appearance

size

moisture content

load difference

solubility and determination of compliance. Conclusion: The method of determination is feasible

formulated granules could be controlled in quality with good stability.

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