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[Application of quantitative fingerprint technique for in-process quality control of Guizhi Fuling capsules]
Jiachun Li1, Na Liang, Wei Xiao
1Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China. ljclyg2010@163.com
Objective:
To investigate an evaluation mode FOR in-process quality control for traditional Chinese medicines by adopting quantitative fingerprint technique as the main mean.
Method:
Regarding Guizhi Fuling capsules as an example, the stability and repeatability were observed by tests of quantitative fingerprint of 90% ethanol extract, aqueous extract, the final mixing extract, soft material and products during the production process.
Result:
The fingerprint similarities of four kinds of intermediates and products from 10 batches of Guizhi Fuling capsules were in the range of 0.966-0.999, respectively. The RSD of quantitative results of marked components, which included gallic acid, paeoniflorin, benzoic acid, cinnamic acid, benzoyl paeoniflorin, cinnamic aldehyde, paeonol, etc, were less than 15% in the products.
Conclusion:
This method is accurate, feasible and could be an effective way to be applied to in-process quality control of traditional Chinese medicine.
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