Batch release control of Gardenia jasminoides intermediate purification process based on statistical process control and near-infrared spectroscopy technology
10.7501/j.issn.0253-2670.2015.14.008
- Author:
Sha WU
1
Author Information
1. Beijing University of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
Batch release;
Chlorogenic acid;
Deacetyl asperulosidic acid methyl ester;
Genipin-1-β-D-gentiobioside;
Geniposide;
Geniposidic acid;
Near-infrared spectroscopy;
Reduning Injection;
Shanzhiside;
Statistical process control;
Total acid
- From:
Chinese Traditional and Herbal Drugs
2015;46(14):2062-2069
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To establish the batch release criteria of Gardenia jasminoides intermediate purification process based on statistical process control technology in order to ensure the batch-to-batch consistency and stability. Methods: Forty-eight batches of G. jasminoides intermediate purified solution were collected as the calibration set. The content of chlorogenic acid, shanzhiside, geniposidic acid, deacetyl asperulosidic acid methyl ester, genipin-1-β-D-gentiobioside, geniposide, and total acid were determined to establish the quantitative release criteria. Near-infrared spectra (NIRS) were acquired to establish the qualitative release criteria. Seventeen batches of G. jasminoides intermediate purified solution were prepared under different process conditions by the Box-Behnken experimental design. They were regarded as the validation set to verify the feasibility of the established quantitative and qualitative release criteria. Results: The established quantitative release ranges were: chlorogenic acid 5.753-6.713 mg/g, shanzhiside 9.456-10.723 mg/g, geniposidic acid 3.313-4.401 mg/g, deacetyl asperulosidic acid methyl ester 15.260-16.419 mg/g, genipin-1-β-D-gentiobioside 30.529-33.473 mg/g, geniposide 165.17-175.16 mg/g, and total acid 45.028-53.118 mg/g, respectively. The established qualitative release upper limits were: Hotelling T2 = 4.067 8 and DModX = 1.218 8. For sample 1, 5, 7, 9, 10, 14-17 from the validation set, the content of quality control indicators satisfied the quantitative release criteria and NIRS satisfied the qualitative release criteria. Conclusion: Based on NIRS and statistical process control technology, the developed quantitative and qualitative release criteria are simple and feasible. They could be used for the production quality control of G. jasminoides intermediate purification process.
