| Traditional Chinese medicines are complex in composition.At present,most of the literature on detecting synthetic dyes at home and abroad have reported the detection of synthetic dyes in foods,while the literature on detecting synthetic dyes in traditional Chinese medicines are relatively few.In the "Approval of Supplementary Inspection Methods and Inspection Items for Inspection of Chinese Herbal Medicines and Chinese Herbal Medicines" issued by the State Food and Drug Administration,there are a few inspection items for each medicinal material,and some unscrupulous manufacturers and traders have illegally used other types of dyes other than the inspection items in order to meet their national drug inspection standards.Therefore,it is necessary to establish systemic detection method of multi-component dye or dye series.Kidney-impotence Chinese proprietary medicines and dietary supplements are most often illegally added sildenafil citrate(commercial name:Viagra,commonly known as "Viagra"),tadalafil(commercial name:Cialis),vardenafil(commercial name:Alida),acetildenafil,etc.Among them,illegal addition of sildenafil citrate is most common.Since these drugs are prescription drugs,they must be purchased on prescription,and the production and sales requirements for dietary supplements are much lower.Therefore,most of these aphrodisiac ingredients are illegally added to the so-called "fatigue-resistance","relief of physical fatigue" or "enhance immunity"in dietary supplements.Without the guidance of a doctor,long-term use of a large number of dietary supplements that have illegally added "aphrodisiac" ingredients may cause great damage to the body.If taken too much,it can easily cause toxic side effects.Dizziness,fainting,and even glaucoma can cause severe damage to kidney function,heart function,and cardiovascular disease.Taking it for a long period of time can also cause the erector to lose his erection,injure the musculature of his genitals,even increase the impotence,and even become permanent impotence.There is no doubt that Orbitrap is the most important invention of mass spectrometry in the last 20 years.Q-Orbitrap high-resolution mass spectrometry is one of the latest high-resolution mass spectrometry technologies developed in recent years.It is a quadrupole-electrostatic field orbitrap high resolution mass spectrometer with high mass resolution and capable of providing accurate relative molecular mass.Qualitative analysis was performed by multi-stage mass spectrometry fragment ions.We applied Q-Orbitrap high-resolution mass spectrometry to the screening and qualitative quantitative analysis of synthetic dyes illegally added in Chinese herbal medicines and Chinese Herbal Medicine Pieces as well as illegally added chemical medicines for proprietary Chinese medicines and dietary supplements,and to increase the intensity and efficiency of regulatory work,safeguard people's drug safety.The first chapter of this article is the introduction part,summarizes the dyes,clarifies their concepts and classifications,introduces the current status and harms of synthetic dyes,summarizes the analysis methods of synthetic dyes,and then introduces the illegal addition of undeclared synthetic chemicals in Kidney-impotence Chinese proprietary medicines and dietary supplements,including the types of chemical drugs,and the current status and harm of illegal additions,focused on the introduction of methods for the detection of added chemical drugs in traditional Chinese medicines and health supplements for kidney-inspiring and impotence-type products;finally,the principle of Q-Orbitrap high-resolution mass spectrometry and the application in detecting proprietary Chinese medicines were introduced.The second chapter of this article systematically introduces the screening,qualitative and quantitative analysis of 21 synthetic dyes using Q-Orbitrap high resolution mass spectrometry.By optimizing the chromatographic conditions and mass spectrometry conditions,rapid(10 min),highly accurate(resolution 70 000 FWHM),and highly sensitive(LOD:0.05-0.50 ng/mL)detection methods were obtained.All analytes showed excellent linear relationships.In a wide range of linearity(for example,sunset yellow 1-500 ng/mL),r2 is>0.9978.Among the 54 batches of Chinese herbs tested,9.26%of samples were positive.In the third chapter of this article,the qualitative and quantitative analysis of 11 PDE-5 inhibitors using Q-Orbitrap high resolution mass spectrometry is systematically described.By optimizing the chromatographic conditions and mass spectrometry conditions,the shortcomings of the existing national standard detection methods are improved,and the experimental efficiency is significantly improved. |
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