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 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 simultaneously determine six components ( paeoniflorin, rosmarinic acid, salvianolic acid B, ligustilide, clyptotanshinone and tanshinone ⅡA ) in refined coronary tablets by UHPLC-DAD. Methods: A Dikma Endevaorsil C18 column (2. 1 mm × 100 mm,1. 8 μm) was used to perform the determination, which was maintained at 30℃ during the analysis. The mobile phase was composed of acetonitrile and 0. 05% phosphoric acid at a flow rate of 0. 3 ml·min-1 with gradient elution. The detection wavelength was respectively set at 230,270,288 and 321 nm. Results:Paeoniflorin, rosmarinic acid, salvianolic acid B, ligustilide, clyptotanshinone and tanshinone ⅡA showed good linearity within the range of 0. 001 0-0. 010 2 μg ( r = 0. 999 8 ), 0. 005 7-0.056 9 μg(r =1.000 0), 0.005 3-0.052 7 μg(r = 1.000 0),0.002 1-0.020 6 μg(r = 1.000 0),0.001 1-0.011 2 μg(r =1. 000 0) and 0. 001 4-0. 014 4 μg(r=0. 999 8),respectively. The average recovery was 98. 78%(RSD=0. 50%), 97. 99%(RSD=0. 76%),98. 44%(RSD=0. 85%),99. 12%(RSD=0. 66%), 98. 82%(RSD=0. 81%) and 97. 80%(RSD=0. 80%), respec-tively. Conclusion:The method is simple, rapid and accurate, which can be used for the quality control of refined coronary tablets.

Objective: To study the relationship between insulin resistance (IR) and coronary collateral circulation in patients with impaired glucose tolerance (IGT). Methods: A total of 227 patients with coronary angiography (CAG) were studied. There were 131 patients with male gender and the average patient’s age was (53.2 ± 11.0) years. IR (HOMA2-IR) index was measured by HOMA2 method, the severity level of coronary stenosis was assessed by Gensini scoring system, collateral circulation condition was determined by Rentrop classiifcation. 187 IGT patients were divided into 4 groups: Rentrop 0 group,n=55, Rentrop 1 group,n=42, Rentrop 2 group,n=39 and Rentrop 3 group,n=51; in addition, Control group,n=40 patients with normal glucose tolerance and coronary stenosis<50%. Results: Compared with Control group, all patients in 4 Rentrop groups had increased 2h-PBG, HbA1c, HOMA2-IR and Gensini score, while decreased fasting insulin (FINS), allP<0.05. Compared with Rentrop 3 group and Rentrop 2 group, the patients in Rentrop 1 group and Rentrop 0 group had elevated 2h-PBG, HbA1c, HOMA2-IR and Gensini score, while Rentrop 0 group had reduced FINS, allP<0.05. Multivariable regression analysis showed that HOMA2-IR index (R=0.518,P<0.05), HbA1c (R=1.916, P<0.05), 2h-PBG (R=2.130,P<0.05) and FINS (R=1.547,P<0.05) might be related to the severity of coronary stenosis. Binary regression analysis indicated that poor collateral circulation (the patients in Rentrop 0 group and Rentrop 1 group) was related to HOMA2-IR index (OR=1.679, 95% CI 1.101-2.558,P=0.016). Conclusion: HOMA2-IR index could be signiifcantly higher in patients with IGT combining chronic coronary occlusion. IR was the independent risk factor for the severity of coronary stenosis and coronary collateral formation.

Objective:To determine the content of lead, cadmium, arsenic, mercury and copper in Xiaohuoluo pills produced by 34 enterprises. Methods:Using microwave digestion, the contents of lead, cadmium and arsenic were determined by graphite furnace atomic absorption spectrometry;the content of mercury was determined by hydride generation atomic absorption spectrophotometry;the content of copper was determined by air-acetylene flame atomic absorption. Results: Lead, cadmium, arsenic and mercury in Xiao-huoluo pills from 34 different manufacturers were beyond the limits in various degrees. Conclusion: The method is simple and accu-rate, and can be used in the heavy metal determination of Xiaohuoluo pills.