Studies on Quality Control Standard of Modified Xileisan Suppository

DING Xiao-yu; CHEN Jun; LIU Yi-dan; GUO Dan-zhao; YANG Xue-juan

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Studies on Quality Control Standard of Modified Xileisan Suppository

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- Studies on Quality Control Standard of Modified Xileisan Suppository
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 17, Issue 17, Pages: 97-99(2011)
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- Published：2011
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DING Xiao-yu, CHEN Jun, LIU Yi-dan, et al. Studies on Quality Control Standard of Modified Xileisan Suppository[J]. Chinese journal of experimental traditional medical formulae, 2011, 17(17): 97-99.
DOI：

DING Xiao-yu, CHEN Jun, LIU Yi-dan, et al. Studies on Quality Control Standard of Modified Xileisan Suppository[J]. Chinese journal of experimental traditional medical formulae, 2011, 17(17): 97-99. DOI：

摘要

目的: 建立减味锡类散栓剂的质量标准。方法: 采用TLC法对制剂中的青黛、牛黄、冰片进行定性鉴别。用HPLC对制剂中的靛玉红进行含量测定。色谱柱为SinoChrom ODS-AP C18 (4.6 mm×250 mm

5 μm)

流动相为甲醇-1%醋酸水溶液(81 ∶19)

流速0.8 mL ·min-1

检测波长288 nm

柱温为室温。结果: 定性鉴别薄层色谱特征明显。靛玉红在0.2~10.8 mg ·L-1线性关系良好(r=0.999 5)

平均回收率为100.95%(RSD 1.12%

n=6)。结论: 该方法简单、准确、重复性好

可作为减味锡类散栓的质量控制方法。

Abstract

Objective: To eatablish the quality standard of modified xileisan suppository. Method: Indigo Naturalis

Calculus Bovis

and borneol in this preparation were identified by TLC. The content of indirubin in Modified Xileisan Suppository was determined by HPLC which was performed on a Sino Chrom ODS-AP C18 (4.6 mm×250 mm

5 μm) column with a mobile phase of methanol-1% acetic acid solution (81:19) at a flaw rate of 0.8 mL ·min-1. The UV detection wavelength was 288 nm

and the column temperature was room temperature. Result: Characteristics of identification were very obviously. The linear ranged from 0.2 mg ·L -1 to 10.8 mg ·L-1 (r=0.999 5) and the average recovery was 100.95% (RSD 1.12%

n=6). Conclusion: The method is simple

accurate

good reproducibility

and can be used as quality control for Modified Xileisan Suppository.

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Related Institution

Hubei Institute for Food and Drug Control

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Shanxi University of Traditional Chinese Medicine

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