Objective:To establish a quantitative analysis of multi-components by single marker(QAMS)method for determination of cephaeline,emetine,ipecoside in Xiao'er Huatan Zhike granules.Methods:The column was Agilent Eclipse C18(4.6 mm ×250 mm,5 μm).The mobile phase was acetonitrile-0.1％phosphoric acid solu-tion with gradient elution at the flowrate of 1.0 mL·min-1.The column temperature was 35 ℃,and the detection wavelength was 203 nm.Taking cephaeline as the internal reference,the relative correction factors of emetine and ipecoside were calculated,and then the content determination were carried out.Results:The three components showed good linear relationships within their own ranges(r＞0.999 0),and the average recoveries were 96.78％-105.01％with the RSDs of 2.20％-3.24％.There were no significant differences between the values obtained by QAMS and those obtained by an external standard method.Conclusion:The established QAMS method can be used for simultaneously determining the contents of 3 alkaloids in Xiao'er Huatan Zhike granules.

Objective To identify potential quality risks of Xiaoer Huatan Zhike Granules(Pediatric Phlegm-Resolving and Cough-Relieving Granules)through National Drug Sampling and Inspection,evaluate their overall quality,and propose improvements to the quality standards.Methods Samples from 34 manufacturers were tested using official standards.Exploratory methods were developed to enhance risk analysis,including thin-layer chromatography(TLC)identification,content uniformity testing,quantitative assays,and screening for unauthorized additives(e.g.,colorants).Results All batches met the official standards(100.0%compliance rate).However,deficiencies were observed:most manufacturers lacked controls for ephedrine hydrochloride content uniformity and quantification,omitted key ingredient identifications(e.g.,herbal components),and exhibited insufficient TLC specificity(e.g.,TLC of Ipecac tincture showed only one spot instead of multiple alkaloid-specific spots).Exploratory studies revealed risks in total emetine/cephaeline content,morroniside A/platycodin D content,ephedrine hydrochloride uniformity,and unauthorized colorant addition.Conclusions The overall quality of this variety is good,but the enterprise should improve the quality control measures throughout the entire process and establish stricter internal control standards;The official standards,unchanged for approximately 30 years,fail to address current regulatory requirements.The statutory quality standards need to be revised and improved.Qualitative or quantitative indicators for all drug flavors in the prescription should be added,and the content uniformity inspection of ephedrine hydrochloride should be increased.

Objective:To establish a quantitative analysis of multi-components by single marker(QAMS)method for determination of cephaeline,emetine,ipecoside in Xiao'er Huatan Zhike granules.Methods:The column was Agilent Eclipse C18(4.6 mm ×250 mm,5 μm).The mobile phase was acetonitrile-0.1％phosphoric acid solu-tion with gradient elution at the flowrate of 1.0 mL·min-1.The column temperature was 35 ℃,and the detection wavelength was 203 nm.Taking cephaeline as the internal reference,the relative correction factors of emetine and ipecoside were calculated,and then the content determination were carried out.Results:The three components showed good linear relationships within their own ranges(r＞0.999 0),and the average recoveries were 96.78％-105.01％with the RSDs of 2.20％-3.24％.There were no significant differences between the values obtained by QAMS and those obtained by an external standard method.Conclusion:The established QAMS method can be used for simultaneously determining the contents of 3 alkaloids in Xiao'er Huatan Zhike granules.

Objective To identify potential quality risks of Xiaoer Huatan Zhike Granules(Pediatric Phlegm-Resolving and Cough-Relieving Granules)through National Drug Sampling and Inspection,evaluate their overall quality,and propose improvements to the quality standards.Methods Samples from 34 manufacturers were tested using official standards.Exploratory methods were developed to enhance risk analysis,including thin-layer chromatography(TLC)identification,content uniformity testing,quantitative assays,and screening for unauthorized additives(e.g.,colorants).Results All batches met the official standards(100.0%compliance rate).However,deficiencies were observed:most manufacturers lacked controls for ephedrine hydrochloride content uniformity and quantification,omitted key ingredient identifications(e.g.,herbal components),and exhibited insufficient TLC specificity(e.g.,TLC of Ipecac tincture showed only one spot instead of multiple alkaloid-specific spots).Exploratory studies revealed risks in total emetine/cephaeline content,morroniside A/platycodin D content,ephedrine hydrochloride uniformity,and unauthorized colorant addition.Conclusions The overall quality of this variety is good,but the enterprise should improve the quality control measures throughout the entire process and establish stricter internal control standards;The official standards,unchanged for approximately 30 years,fail to address current regulatory requirements.The statutory quality standards need to be revised and improved.Qualitative or quantitative indicators for all drug flavors in the prescription should be added,and the content uniformity inspection of ephedrine hydrochloride should be increased.