中国中药杂志2025，Vol.50Issue(23)：6560-6570,11.DOI:10.19540/j.cnki.cjcmm.20250926.302
儿药传统散剂品质提升研究:羚珠散制剂口感改善及其质量标准优化
Quality improvement of traditional pediatric powder:taste enhancement and quality standard optimization of Lingzhu Powder
摘要
Abstract
Good taste of the preparation and strict quality control standards are key factors in ensuring patient compliance,guaranteeing drug safety and efficacy,and enhancing market competitiveness,significantly impacting the quality of the preparation.Lingzhu Powder has noticeable undesirable tastes such as bitterness,fishy odor,and a gritty texture,which can cause resistance in taste-sensitive children and thus makes it difficult for them to take the medication.This study made a comprehensive analysis through volunteer sensory evaluation and found that the undesirable tastes of Lingzhu Powder originated from Bovis Calculus Artifactus(bitterness and fishy odor),Saigae Tataricae Cornu powder(fishy odor),and amber powder(gritty texture).Therefore,functional components,including flavoring agents,were used to improve the taste of Lingzhu Powder.A systematic study was conducted on the types,dosages,and ratios of these functional components,ultimately determining that the addition levels of stevioside,L-malic acid,xanthan gum,and honey peach flavoring should be 7%,3%,3%,and 5%,respectively,of the average total mass of the mixed powder of Lingzhu Powder.Meanwhile,to enhance the quality of the flavored Lingzhu Powder preparation and achieve precise quality control,it was proposed to incorporate microscopic identification of medicinal ingredients such as Cinnabaris,amber,Saigae Tataricae Cornu,Margarita,and Bovis Calculus Artifactus,TLC identification of Bovis Calculus Artifactus,Acori Tatarinowii Rhizoma oil,and Borneolum Syntheticum,and content determination of key pharmacodynamic components such as cholic acid and hyodeoxycholic acid into the quality standards for the flavored Lingzhu Powder.This will address the inadequacy of the original quality standards,which only included simple identification items,and ensure the safety of medication for children.关键词
羚珠散/功能组分/口感优化/质量标准/制剂品质提升Key words
Lingzhu Powder/functional components/taste improvement/quality standard/enhancement of preparation quality引用本文复制引用
WANG Wei-lin,YANG Yan-jun,ZHU Mao-mao,QU Zhong-huan,QIAN Zhou-yang,ZHANG Wei-ye,SUN Lu,JIA Xiao-bin,FENG Liang..儿药传统散剂品质提升研究:羚珠散制剂口感改善及其质量标准优化[J].中国中药杂志,2025,50(23):6560-6570,11.基金项目
江苏省科技成果转化专项(BA2020077) （BA2020077）
国家重点研发计划中药现代化专项(2018YFC1706900) （2018YFC1706900）
