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1.
Article in Chinese | WPRIM | ID: wpr-828396

ABSTRACT

Forsythiae Fructus is divided into Qingqiao and Laoqiao due to different harvesting periods. So far, the accumulation of heavy metals in the two types of Forsythiae Fructus has not been reported. In this study, the residual levels of copper(Cu), lead(Pb), chromium(Cr), arsenic(As), cadmium(Cd) and mercury(Hg) in 29 batches of Laoqiao and 60 batches of Qingqiao were determined by inductively coupled plasma mass spectrometry(ICP-MS). The samples were collected from Shanxi, Shaanxi, Henan, and Hebei Provinces. In addition, the diversity and correlation of harmful elements in Qingqiao and Laoqiao were analyzed by multivariate statistical method. Furthermore, principal component analysis(PCA) was used to analyze the harmful elements concentrations of Qingqiao and Laoqiao. The results showed that there was a significant difference on the residual levels of heavy metals and harmful elements between Qingqiao and Laoqiao. Among them, the content of Pb in Laoqiao is significantly higher than that in Qingqiao(P<0.01), while the content of Cu is significantly lower than that in Qingqiao. However, the difference in harmful elements among different producing areas of Forsythiae Fructus is not significant. PCA analysis showed that Qingqiao and Laoqiao were successfully grouped into two categories. This study suggests significant difference in the residual levels of heavy metals and harmful elements between Qingqiao and Laoqiao. Besides, Forsythiae Fructus has a certain enrichment of Pb in the fruit ripening stage(Laoqiao). This study provides a reference for the quality classification and safety of Forsythiae Fructus.


Subject(s)
Arsenic , Copper , Drugs, Chinese Herbal , Metals, Heavy
2.
Article in Chinese | WPRIM | ID: wpr-773177

ABSTRACT

This study aims to explore the evaluation model for the proficiency testing of heavy metal and harmful element residues in pharmaceuticals,and to provide reference for the proficiency testing program and proficiency testing result in the field of residue analysis. The proficiency test result of cadmium determination in honeysuckle as an example. The algorithm A,NIQR,and Horwitz function are used to calculate the assigned value and the standard deviation. Z was obtained at the same time. If | Z | ≤2,the result is satisfactory. If 2< | Z | <3,the result is questionable. If | Z | ≥3,the result is unsatisfactory. In addition,the median value is the assigned value,and deviation(D%) is used. If D% is not more than 16%,the result is satisfactory; if D% is more than 16%,the result is unsatisfactory. After analysis,in the results of questionable or dissatisfied laboratories calculated by algorithm A and NIQR,the deviation error of some data is within the scope of the standard. In the results of the satisfactory laboratory evaluated by the Horwitz function,some data deviation errors far exceed the standard range. The evaluation result of the D% meets the requirements. According to heavy metal and harmful element trace analysis methods,this study is the first to apply D% to the evaluation of the detection ability of heavy metals and harmful elements in pharmaceuticals. This method makes the evaluation result more reasonable,and has important reference significance for the evaluation of other proficiency test results.


Subject(s)
Cadmium , Laboratories , Laboratory Proficiency Testing , Lonicera , Chemistry , Pharmaceutical Preparations , Reference Standards , Plant Preparations , Reference Standards , Trace Elements
3.
Article in Chinese | WPRIM | ID: wpr-771514

ABSTRACT

To achieve a comprehensive understanding of heavy metals and harmful elements residues in Niuhuang Qingwei Pills,49 samples from 18 manufactures were collected from 31 provinces in China.Risk assessment and control preparations were applied innovatively in evaluation of exogenous pollution in traditional Chinese Medicine.Determination methods for Pb,Cd,As,Hg and Cu were established by inductively coupled plasma mass spectrometry(ICP-MS).Based on the procedures including hazard identification,hazard characterization,exposure assessment and risk characterization,risk assessment was performed and residual limits for Pb,Cd,As,Hg and Cu in the drug were formulated.The results showed that the hazardous quotients(HQ) of the elements were decreased in the following order:Pb>As>Cu>Hg>Cd,and the total hazardous index(HI) of heavy metals and harmful elements in Niuhuang Qingwei Pills was above 1,implying health risk of the drug.Under the proposed limits,5 elements in the control preparation as well as Cd and Cu in the samples were within the limits range,but the excess rates of Pb,As and Hg in the samples were 12%,12% and 14%,respectively.For the first time,basic steps for risk assessment of Chinese patent medicine were established,which provided model and reference for risk assessment and limit formulation of other drugs.


Subject(s)
China , Drug Contamination , Drugs, Chinese Herbal , Reference Standards , Metals, Heavy , Risk Assessment
4.
Article in Chinese | WPRIM | ID: wpr-850630

ABSTRACT

Objective: To establish a method for the determination of 17 heavy metals and harmful elements in Xiyanping Injection (XI). Methods: The samples were digested and determined by inductively coupled plasma mass spectrometry (ICP-MS). The RF power was 1 550 W; The peristaltic pump speed was 0.3 r/s; The plasma gas velocity was 15 L/min; The auxiliary gas velocity was 0.2 L/min; The carrier gas velocity was 1 L/min; The sampling depth was 10 mm and the signal was measured for three times. Results: The detection limits of Li, Al, V, Cr, Fe, Co, Ni, Cu, As, Ag, Cd, Sn, Sb, Ba, Hg, Pb, Bi were 9.584, 49.858, 0.504, 3.016, 51.209, 0.142, 1.116, 0.675, 0.924, 1.421, 0.403, 2.770, 0.711, 3.584, 0.590, 0.411, 0.169 ng/mL, and the quantitative limits were 28.933, 151.085, 1.528, 9.139, 155.179, 0.429, 3.381, 2.046, 2.799, 4.312, 1.220, 8.394, 2.155, 10.861, 1.965, 1.244, and 0.513 ng/mL within a certain concentration range, respectively. The response value had a good linear relationship with the concentration (r > 0.999 1); The RSDs (n = 12) of the injection precision test were in the range of 0.8%-3.8%, the RSDs (n = 6) of the repeatability were in the range of 0.7%-2.0%, and the average recoveries of 17 elements were in the range of 95.7%-104.8%. Detection results of 20 batches of mass production samples: Ag was not detected, Li and V were detected but lower than the quantitative limit, the maximum mass concentration of Al, Ni, Cu, As, Ba, Hg and Pb were 0.685, 0.013, 0.007, 0.006, 0.208, 0.070 and 0.027 μg/ml respectively, Cr, Fe, Co, Cd, Sn, Sb, and Bi were not detected or lower than the quantitative limit. Conclusion: The specificity, linearity, sensitivity, precision, accuracy and durability of the method were all good. It can be used to determine 17 elements of Li, Al, V, Cr, Fe, Co, Ni, Cu, As, Ag, Cd, Sn, Sb, Ba, Hg, Pb and Bi in XI. The test results of 17 elements in 20 batches of mass production samples were less than the limit requirements, meeting the requirements.

5.
China Pharmacist ; (12): 1723-1727, 2017.
Article in Chinese | WPRIM | ID: wpr-661209

ABSTRACT

Objective:To study the safety factors of Fuyanyu mixture. Methods: The contents of antiseptic and residual ethanol were determined by HPLC and GC, respectively, and those of heavy metals and harmful elements were detected by ICP-MS. Results:The contents of benzoic acid in 6 batches of samples were less than 0. 3%. In two thirds of samples, ethanol residue was more than 0. 5%. The total mercury exceeded 15μg/day in one of the samples, and the contents of Pb, Ge, Gr, As, Ni and Cu met the limits described in USP<232> in all of the last samples. Conclusion: The methods are accurate and reliable. It is urgent to improve the preparation process so as to reduce the residual amount of ethanol according to the detection results. It is recommended to increase the testing items that affect the safety of the preparation so as to control the preparation quality strictly.

6.
China Pharmacist ; (12): 1723-1727, 2017.
Article in Chinese | WPRIM | ID: wpr-658298

ABSTRACT

Objective:To study the safety factors of Fuyanyu mixture. Methods: The contents of antiseptic and residual ethanol were determined by HPLC and GC, respectively, and those of heavy metals and harmful elements were detected by ICP-MS. Results:The contents of benzoic acid in 6 batches of samples were less than 0. 3%. In two thirds of samples, ethanol residue was more than 0. 5%. The total mercury exceeded 15μg/day in one of the samples, and the contents of Pb, Ge, Gr, As, Ni and Cu met the limits described in USP<232> in all of the last samples. Conclusion: The methods are accurate and reliable. It is urgent to improve the preparation process so as to reduce the residual amount of ethanol according to the detection results. It is recommended to increase the testing items that affect the safety of the preparation so as to control the preparation quality strictly.

7.
Article in Chinese | WPRIM | ID: wpr-486498

ABSTRACT

Objective To determine the content of heavy metals and harmful elements in commercially available Yuanhu Zhitong Capsule. Methods The determination of lead, cadmium, arsenic, mercury, copper and chromium by atomic absorption spectrometry and atomic fluorescence spectrometry was established.Results The recovery rate of the method was between 91.2% and 111.2%, and the precision of the experiment was less than 5%, and the range of each element was good.The stability and reproducibility of the method were good.Lead and cadmium and copper of Yuanhu zhitong capsule in different degree exceeded the standard, while the content of arsenic, mercury and chromium was in accordance with the requirements. Conclusion The method is simple and easy to operate, convenient and quick.The content of the current limit of Yuanhu zhitong capsule still need to establish the quality standard of lead and cadmium, arsenic, mercury, copper and chromium.In this paper, the establishment of the heavy metals and harmful elements determination method of Yuanhu zhitong capsule provide quality control and safety evaluation of reference.

8.
Article in Chinese | WPRIM | ID: wpr-853244

ABSTRACT

Objective: In this study, the feasibility of hot air-microwave combination drying method for processing Angelicae Sinensis Radix (ASR) was investigated and evaluated. Methods: Hot air temperature, drying time, microwave electric current, and microwave time were taken into consideration. The combined drying method was optimized based on the standards of ASR documented in Chinese Pharmacopoeia (2015 version). After that, microorganisms, heavy metals, harmful elements, and active ingredients (ferulic acid, coniferyl ferulate, senkyunolide I, senkyunolide H, senkyunolide A, E-ligustilide, Z-ligustilide, n-butylidenephthalide, riligustilide, and levistilide A) were detected to evaluate the quality of processed samples. Results: The optimal method was that samples were dried in hot air (70℃) for 20 h, then heated in microwave (100 mA) for 6 min. The number of microorganisms in processed samples equaled to sulfur-fumigated samples; Heavy metals and harmful elements were qualified after this processing; The new drying method for processing ASR had no significant effect on the active ingredient. Conclusion: After this process, the physical and chemical indicators of ASR are in line with the criteria of Chinese Pharmacopoeia. This hot air-microwave combination drying method should be a fast drying method for post-harvest handling of ASR.

9.
China Pharmacist ; (12): 1798-1802, 2015.
Article in Chinese | WPRIM | ID: wpr-670084

ABSTRACT

Objective: To discuss the quality control method and index of traditional She medicine -Melastoma dodecandrum. Methods:The contents of gallic acid , ellagic acid and total flavonoids ( the total amount of quercetin and kaempferol) were deter-mined by HPLC. Water content, acid insoluble ash content, extract, heavy metals and harmful elements in 26 batches of herbs were also detected. Results:The content range of gallic acid, ellagic acid and total flavonoids was 9. 84-26. 31 mg·g-1 , 4. 13-16. 11 mg· g-1 and 1. 31-38. 28 mg · g-1 , respectively. The content range of water, acid insoluble ash and extract was 6. 70%-13. 90%, 1. 05%-6. 20% and 18. 00%-40. 80%, respectively. The content of Pb in all the samples was more than 5 ppm, the number of sam-ples with the content of Cd above ten thousand three was 7, and the content of As, Hg and Cu in all the samples was less than 1 ppm, ten thousand one and 20 ppm, respectively. Conclusion:The contents of gallic acid, ellagic acid and total flavonoids can comprehen-sively reflect the content of active ingredients in Melastoma dodecandrum. The contents of acid insoluble ash, Pb and Cd in Melastoma dodecandrum are relative high, which should be studied further to draw up reasonable limit.

10.
China Pharmacist ; (12): 1788-1790, 2015.
Article in Chinese | WPRIM | ID: wpr-670058

ABSTRACT

Objective:To analyze the content of Pb, Cd, Cu, As and Hg in freeze-dried Rehmannia from different habitats by FAAS and double channels AFS. Methods:The contents of Pb,Cd and Cu in Rehmannia from different habitats were directly deter-mined by FAAS, while the contents of As and Hg were determined by double channels AFS after pretreated with HNO3-HClO4 . Re-sults:It was shown that each element had good linear relationship with the correlation coefficient above 0. 997 4. The average recovery was 97. 88%-100. 90% with RSD of 0. 019% -4. 20% (n=6). Meanwhile, the concentrations of 5 harmful elements and heavy met-als in 4 batches of 10 samples were higher than the limits described in Chinese pharmacopoeia. Conclusion:The results measured by the method are considered to be accurate, quick and easy to be operated. It can be used to determine heavy metals and harmful ele-ments in freeze-dried Rehmannia from different habitats.

11.
Article in Chinese | WPRIM | ID: wpr-853983

ABSTRACT

In recent years, it is a hot spot of research on detecting heavy metals such as Pb (II), Cu (II), and Hg (II) and harmful element As (III) based on novel fluorescence probe quantum dots (QDs). This review introduced the preponderance optical properties and advantages of QDs. In addition, the principles of fluorescence quenching concerning ion complexing reaction, electron transfer, fluorescence resonance energy transfer and others, fluorescence enhancement and methods combined with rolling circle amplification of DNA, redshift of emission wavelength, fluorescence ratio and others were presented. Finally, the paper summarized the applications and took prospect to provide the basis for the detections of heavy metals and harmful elements in Chinese materia medica based on fluorescence probes QDs.

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