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Journal of Spectroscopy
Volume 2019, Article ID 4139762, 10 pages
https://doi.org/10.1155/2019/4139762
Research Article

Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits

1Research Center of TCM Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, China
2Beijing Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine, Beijing 100029, China
3TianJin Children’s Hospital, TianJin 300204, China
4School of Pharmacy, Hebei Medical University, Shijiazhuang 050017, China

Correspondence should be addressed to Bing Xu; nc.ude.mcub@gnibux and Yanjiang Qiao; ten.362@oaiqjy

Received 5 October 2018; Revised 15 January 2019; Accepted 23 January 2019; Published 3 March 2019

Academic Editor: Alessandra Durazzo

Copyright © 2019 Guolin Shi et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The concept of real-time release testing (RTRT) has recently been adopted by the production of pharmaceuticals in order to provide high-level guarantee of product quality. Process analytical technology (PAT) is an attractive and efficient way for realizing RTRT. In this paper, near-infrared (NIR) determination of cryptotanshinone and tanshinoneIIA content in tanshinone extract powders was taken as the research object. The aim of NIR analysis is to reliably declare the extract product as compliant with its specification limits or not. First, the NIR quantification method was developed and the parameters of the multivariate calibration model were optimized. The reliable concentration ranges covering the specification limits of two APIs were successfully verified by the accuracy profile (AP) methodology. Then, with the designed validation data from AP, the unreliability graph as the decision tool was built. Innovatively, the β-content, γ-confidence tolerance intervals (β-CTIs) around the specification limits were estimated. During routine use, the boundary of β-CTIs could help decide whether the NIR prediction results are acceptable. The proposed method quantified the analysis risk near the specification limits and confirmed that the unreliable region was useful to release the product quality in a real-time way. Such release strategy could be extended for other PAT applications to improve the reliability of results.