Process Optimization and Health Risk Assessment of Calcined Haematitum Based on QbD Concept
10.13422/j.cnki.syfjx.20251466
- VernacularTitle:基于QbD理念的煅赭石炮制工艺优化及健康风险评估
- Author:
Yue YANG
1
;
Jingwei ZHOU
1
;
Jialiang ZOU
1
;
Guorong MEI
2
;
Yifan SHI
1
;
Lei ZHONG
2
;
Jiaojiao WANG
1
;
Xuelian GAN
1
;
Dewen ZENG
1
;
Xin CHEN
1
;
Lin CHEN
1
;
Hongping CHEN
1
;
Shilin CHEN
1
;
Yuan HU
1
;
Youping LIU
1
Author Information
1. State Key Laboratory of Southwestern Chinese Medicine Resources，School of Pharmacy， Chengdu University of Traditional Chinese Medicine，Chengdu 611137，China
2. Sichuan Neo-green Pharmaceutical Technology Development Co. Ltd.，Pengzhou 611930，China
- Publication Type:Journal Article
- Keywords:
quality by design（QbD）;
Haematitum;
processing technology;
analytic hierarchy process（AHP）;
criteria importance through intercriteria correlation（CRITIC）;
electron scanning microscopy;
inductively coupled plasma mass spectrometry（ICP-MS）;
health risk assessment
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2025;31(13):187-196
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo investigate the processing technology of calcined Haematitum based on the concept of quality by design（QbD） and to assess its health risk. MethodsTaking whole iron content， Fe2+ dissolution content and looseness as critical quality attributes（CQAs）， and calcination temperature， calcination time， spreading thickness and particle size as critical process parameters（CPPs） determined by the failure mode and effect analysis（FMEA）， the processing technology of calcined Haematitum was optimized by orthogonal test combined with analytic hierarchy process-criteria importance through intercriteria correlation（AHP-CRITIC） hybrid weighting method. The contents of heavy metals and harmful elements were determined by inductively coupled plasma mass spectrometry， and the health risk assessment was carried out by daily exposure（EXP）， target hazard quotient（THQ） and lifetime cancer risk（LCR）， and the theoretical value of the maximum limit was deduced. ResultsThe optimal processing technology for calcined Haematitum was calcination at 650 ℃， calcination time of 1 h， particle size of 0.2-0.5 cm， spreading thickness of 1 cm， and vinegar quenching for 1 time［Haematitum-vinegar（10：3）］. The contents of 5 heavy metals and harmful elements in 13 batches of calcined Haematitum were all decreased with reductions of up to 5-fold. The cumulative THQ of 2 batches of samples was>1， while the cumulative THQ of all batches of Haematitum was>1. The LCR of As in 1 batches of Haematitum was 1×10-6-1×10-4， and the LCR of the rest was<1×10-6， and the LCRs of calcined Haematitum were all<1×10-6， indicating that the carcinogenic risk of calcined Haematitum was low， but special attention should still be paid to Haematitum medicinal materials. Preliminary theoretical values of the maximum limits of Cu， As， Cd， Pb and Hg were formulated as 1 014， 25， 17， 27， 7 mg·kg-1. ConclusionThe optimized processing technology of calcined Haematitum is stable and feasible， and the contents of heavy metals and harmful elements are reduced after processing. Preliminary theoretical values of the maximum limits of Cu， As， Cd， Pb and Hg are formulated to provide a scientific basis for the formulation of standards for the limits of harmful elements in Haematitum.
