Real-time release control of alcohol precipitation about Artemisiae Annuae Herbaand Lonicerae Flos based on statistical process control technology
10.7501/j.issn.0253-2670.2016.09.009
- Author:
Yong-Xiang WANG
1
Author Information
1. Jiangsu Kanion Pharmaceutical Co., Ltd.
- Publication Type:Journal Article
- Keywords:
Alcohol precipitation process;
Artemisiae Annuae Herba;
Central composite design;
Chlorogenic acid;
Cryptochlorogenic acid;
Lonicerae Flos;
Neochlorogenicacid;
Real-time release criteria;
Solid content;
Statistical process control;
Univariate statistical process control
- From:
Chinese Traditional and Herbal Drugs
2016;47(9):1501-1507
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To study the application of statistical process control technology to establish the real-time release criteria of alcohol precipitation process of ArtemisiaeAnnuae Herba and Lonicerae Flos. Methods: Twenty-ninebatches of samples came from alcohol precipitation process of ArtemisiaeAnnuae Herba and Lonicerae Flos were collected as the calibration set. The contents of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, and solid content were determined to establish the quantitative real-timerelease criteria based on statistical process control technology. Thirteenbatches of alcohol precipitation process of ArtemisiaeAnnuae Herba and Lonicerae Flos were prepared under the different process conditions by the central composite design. They were regarded as the validation set to test the dependability of the real-time release criteria. Results: The established quantitative release ranges were neochlorogenic acid 0.279-0.541 mg/g, chlorogenic acid 1.941-2.610 mg/g, cryptochlorogenic acid 0.453-0.570 mg/g, and solid content3.565%-4.925%. The four index component contentsof the samples 1, 4, 8, 9, and 10 from the validation set werewithin the range of the real-time release criteria. Conclusion: Univariate statistical process control could be well monitored and understood of production process for Chinses materiamedica.They are used to achieve the purpose of real-time release.
