Optimization of Molding Process and Determination of Volatile Components Assay in Compound Shexiang Huangqi Dropping Pills by A Central Composite Design-Response Surface Method
10.3870/j.issn.1004-0781.2025.01.011
- VernacularTitle:复方麝香黄芪滴丸成型工艺优选及挥发性成分含量测定
- Author:
Mengdi SHAO
1
;
Shuyan ZHANG
;
Qi ZHENG
;
Chunhui CHANG
;
Jiahao LI
;
Yunke ZHANG
;
Yongyan JIA
Author Information
1. 河南中医药大学药学院,郑州 450046
- Publication Type:Journal Article
- Keywords:
Compound Shexiang Huangqi dropping pills;
Central composite design and response surface method;
Molding process;
Gas chromatography;
Content determination
- From:
Herald of Medicine
2025;44(1):88-95
- CountryChina
- Language:Chinese
-
Abstract:
Objective The molding process of compound Shexiang Huangqi dropping pills was optimized by central composite design and response surface method,the determination of volatile components in the compound by gas chromatography was established in order to improve the quality standard of the compound.Methods Single factor method was used to select the optimum range of matrix type,the ratio of matrix to liquid,and drop distance of compound Shexiang Huangqi dropping pills;Appearance traits,a difference of pill weight,and dissolution time were used as evaluation indexes,the optimum forming process conditions of compound Shexiang Huangqi dropping pills were optimized by central composite design and response surface method;Three batches of compound Shexiang Huangqi dropping pills were taken as test samples and determined by gas chromatography;The gas chromatographic column was HP-5 sillica capillary column,the inlet temperature was 260 ℃,the temperature was programmed,and the detector temperature was 300 ℃,the split ratio was 10∶1,nitrogen was selected as the carrier gas with a flow rate of 1.0 mL·min-1.Results The optimum forming process conditions of compound Shexiang Huangqi dropping pills were selected by central composite design and response surface method as a matrix:matrix=0.99,drug:matrix=0.55,drop distance=6.00,and the comprehensive score were 0.845 2.Under these conditions,the quality of the prepared dropping pills was the best;The chromatographic peaks of borneol,muscone,and ligustilide reached the baseline separation;the linear ranges of the three components were 0.327-1.962,0.140-0.840,0.710 5-4.263 μg(all r＞0.999);The average recoveries were 92.30％(RSD=1.65％,n=6),101.28％(RSD=0.81％,n=6)and 98.99％(RSD=0.65％,n=6);The average contents of the three components were 0.201 7,0.084 7 and 1.382 9 mg·g-1,respectively.Conclusions The forming process is stable and feasible,which can provide a reference for the development and application of compound Shexiang Huangqi dropping pills;The gas chromatography method established can simultaneously determine the contents of borneol,muscone,and ligustilide in compound Shexiang Huangqi dropping pills,which can be used for quality control of compound Shexiang Huangqi dropping pills.
