Preparation Technology and Quality Standard of Swertia patens Burk.Standard Decoction Based on the Quality by Design Concept
10.3870/j.issn.1004-0781.2024.06.016
- VernacularTitle:基于质量源于设计理念的小儿腹痛草标准汤剂的制备工艺及质量标准
- Author:
Sicheng HUANG
1
,
2
,
3
;
Junshan LI
;
Yanyan ZHANG
;
Yuntao ZHOU
;
Anguo HOU
;
Long HUANG
Author Information
1. 云南中医药大学中药学院,昆明 650500
2. 云南省高校外用给药系统与制剂技术研究重点实验室,昆明 650500
3. 云南省南药可持续利用研究重点实验室,昆明 650500
- Keywords:
Swertia patens Burk.;
Standard decoction;
Swertiamarin;
Gentiopicrin;
Quality by design;
Design space
- From:
Herald of Medicine
2024;43(6):941-948
- CountryChina
- Language:Chinese
-
Abstract:
Objective To optimize the preparation process of Swertia patens,Burk.standard decoction and establish its quality standard by using the quality by design(QbD)concept.Methods Critical Quality Attributes(CQAs)were predicted and analyzed according to the quality marker(Q-marker)theory of traditional Chinese medicine;Failure mode and effects analysis(FMEA)was used to screen critical process parameters(CPPs);The measurement method of key quality attributes was established;The extraction process was optimized by Box Behnken test after the preliminary range was determined according to the single factor test;The entropy method was used for comprehensive scoring;The design space was established and the optimal operation space for process validation was selected;Standard decoction of Swertia patens Burk in fifteen batches with different habitats were prepared with the best technology,and the quality standards for the extraction rate,extract,thin layer chromatography,fingerprint,content,and the content transfer rate were established finally.Results The key quality attributes were swertiamarin content,gentiopicrin content,and paste yield;The key process parameters were soaking time,water amount,and decocting time;The established model had statistical significance;The optimum conditions were as follows:soaking time 90 min,adding water 15 times,decocting time 30 min(second decocting 20 min);The paste yield was 21.13％-30.73％;The extract was 82.00％-88.00％;The spot of swertiamarin was clear in TLC;The similarity between each samples in 15 batches and reference atlas were＞0.85％;The content of swertiamarin was 250.64-385.21 mg·g-1,and the transfer rate was 43.76％-77.73％;The content of gentiopicrin was 0.69-2.70 mg·g-1,and the transfer rate was 56.02％-105.29％.Conclusion Based on the above methods and techniques,the preparation process of Swertia patens Burk.The standard decoction was screened,which provides a reference for the preparation development and quality control of its formula granules.
