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.