Study On Quality Control Of Realgar And Chinese Traditional Medicine Containing Realgar

Background:This study was part of the research of National Science and Technology Major Project of the Ministry of Science and Technology of China?2014ZX09304307001?.Realgar,also known as Gold stone,Cocktail stone,is a kind of mineral drugs commonly used in clinic,which has the efficacy of insecticide detoxification,dampness expectorant,anti-malaria,clinically to treat abscesses,snake bites.At present,there are still controversies about the main constituents of realgar.The 2015 edition of the Pharmacopoeia records that the main component of realgar is As2S2,but the relevant research shows that the main components of realgar are As4S4 and AsS.Realgar is toxic,improper processing or improper use are easy to cause human poisoning.On the one hand,the toxicity of realgar is related to the soluble arsenic contained in it,on the other hand,realgar is often associated with orpiment,cinnabar,antimony.These impurities have certain toxicity.At the same time,the trace elements contained in realgar and its proprietary medicines may promote or inhibit the dissolution of soluble arsenic in realgar,and then have a certain impact on the pharmacological activity and toxicity of realgar.So it is necessary to study the quality control of realgar and realgar containing Chinese patent medicines.This research using XRD,ICP-MS,ICP-AES,polarizing microscope and other advanced technology to study realgar and Chinese patent medicine containing realgar,so as to provide references for its rational and safe use in clinic.Research target:1.To study the configuration of realgar and impurity types in realgar and Chinese patent medicines containing realgar,and to compare the quality of realgar from different habitats.2.To study the kinds and contents of trace elements in realgar and Chinese patent medicines containing realgar,and whether heavy metal elements in them exceed the standard.3.To investigate the dissolution of total soluble arsenic in realgar and the compound realgar natural indigo tablets,and to compare the effects of different conditions on the dissolution of total soluble arsenic in realgar and the compound realgar natural indigo tablets.Research results:1.In this paper,X-ray diffraction?XRD?was used to analyze realgar from different places,symbiotic minerals of realgar,associated minerals of realgar and Chinese patent medicine containing realgar.Results shows that realgar from Shimen,Hunan,the genuine production area of realgar contains less impurities.And which after processing is suitable for clinical use.The quality of realgar in Hechi,Guangxi is not as good as Shimen.There were two or more kinds of impurities in 7 batches of realgar collected in Hechi,Guangxi.The experiment also analyzed different batches of realgar purchased in different hospitals and pharmacies,and a certain amount of orpiment were detectd.The quality of different batches varies,suggesting that different hospitals and pharmacies have different purchasing channels.The quality of these realgar are uneven.A total of 8 different Chinese patent medicines containing realgar were detected,orpiments were not detected in these realgar,but SiO₂,CaCO₃ and other impurities have been found.CaCO₃ is the main component of calcite,SiO₂ is possible for the preparation of accessories.2.In this study,we used polarized light microscopy to identify realgar and Chinese patent medicines containing realgar.In this paper,realgar and its patent medicine were added into absolute alcohol,made into granular carriers and observed under polarized microscope.The result shows that both orpiment and calcite were detected both in the genuine production area and non-authentic production areas,and orpiment,calcite and other impurities have also been detected in 6 batches of Chinese patent medicines containing realgar in the experiment.This is not inconsistent with the results of XRD,because XRD can only detect the impurity which content is higher than 1%.3.Study on the trace elements in realgar and its compound.In this paper,the contents of trace elements in realgar and its compound tablets were studied by ICP-MS.The results showed that the contents of Sb,Pb,Hg and other trace elements were high in realgar.The content control of Hg and Pb elements in Chinese patent medicines containing realgar should be further strengthened.The content of different trace elements in the Chinese Patent Medicine Containing Realgar is obviously related to the dosage form of the medicine,and has certain relevance with the manufacturer of the medicine at the same time.4.In this experiment,we studied the dissolution of soluble total arsenic in realgar and the compound realgar natural indigo tablets.Four different dissolution media were selected to dissolve the total soluble arsenic in the samples,and the samples were sampled at 9 different time points,and ICP-AES was used for detection.The result shows that the dissolution rate of soluble total arsenic in realgar varies in different dissolutions.The rate of 50%ethanol dissolution was significantly higher than other three dissolution mediums.This suggests that when the patients were treated with realgar,they should be forbidden to drink alcohol and alcoholic beverages,because the dissolution of soluble total arsenic in realgar can be increased in human body.The dissolution rate of soluble total arsenic in compound realgar natural indigo tablets is the lowest in 50%ethanol at the begining,as time went on,the dissolution rate increases gradually.It was speculated that the coating or other components of this Chinese patent medicine which containing realgar had a certain inhibitory effect on the dissolution of total soluble arsenic.Research conclusion:1.The common impurities in realgar are orpiment,calcite,quartz,gypsum and etc.Hunan,Shimen is the genuine production area of realgar,and realgar produced in it is of better quality.Refining realgar with water or acid can't remove impurities such as orpiment.It is still necessary to further strengthen the quality control of realgar in the manufacturers of Chinese patent medicine containing realgar.2.Polarized light microscopy can be effectively combined with XRD technology to analyze impurities in realgar and Chinese patent medicines containing realgar.Through the combination of several observation methods,the content of impurities in realgar and Chinese patent medicine containing realgar can be accurately detected.3.The quality control of trace elements in Chinese patent medicines containing realgar still need to be further strengthened,and the contents of heavy metals in some medicines are beyond standard.At the same time,the content of different trace elements in the medicines mentioned above is obviously related to the dosage form of the medicines,and has certain relevance with the manufacturers of the medicines at the same time.4.The dissolution of soluble total arsenic in realgar and the compound realgar natural indigo tablets is different in different dissolution medium.It suggests that alcohol should be avoided after taking realgar.The other components in the compound realgar natural indigo tablets have certain influence on the dissolution behavior of soluble total arsenic in realgar.Innovation:1.At present,there are few studies on mineral drugs in china.In this paper,the quality control of realgar and its patent medicines were studied by using XRD,polarizing microscopy,ICP-MS,etc.This experiment is advanced in ideology and technology.2.Polarized light microscopy method and XRD were used to detect the impurities contained in realgar,and these methods were seldom used to study the mineral before.This study provides an innovative idea for the analysis of impurities in realgar and Chinese patent medicines containing realgar,and it also provides a reference value for the rational and safe use of realgar in clinical.