Reasearch On Methond To Identify The Chemical Drugs Added Illegally To Chinese Patent Medicine And Health Care Products

ObjectiveWith the improvement of people's living conditions and health awareness,the Chinese patent medicines and health care products which are less side effects are more and more popular.However,in order to seek exorbitant profits,some unscrupulous businessmen illegally added some Chemical drugs to Chinese patent medicine and health care products so that the products have specific benefits or change the product fea-tures.Illegal additives are not only bad for public health,but also for medical development and social stability.In order to combat these illegal acts,the CFDA(China food and drug administration)issued a series of standards and complementary methods.However,in order to avoid legal detection,some unscrupulous businessmen add other kinds drugs to the products,which brings great challenges to regulators.Therefore,the establishment of a more reliable,more efficient and more comprehensive detection methods is of great practical significance to combat these illegal adding behaviors and protect people's health-MethodsIn this study,a database of 121 compounds illegally added to Chinese patent medicines and health care products were established by UPLC-Q-TOF/MSE and UNIFI.The database includes the chromatograph retention time and characteristic fragment ions of the 121 compounds.A large number of Chinese patent medicines and health care products samples were screened by using the compound database and UNIFI software.Qualitative screening of 9 chemicals illegally added into antiasthmatic and anti tussive Chinese patent medicine was firstly performed by UPLC-Q-TOF.The quantitative detection of positive sample detected by UPLC-Q-TOF was used by HPLC,Chromatographic separation was achieved on a Kromasil C18 column(1250 mm X 4.6 mm,5 ?m)with the mobile phase of acetonitrile and ammonium formate buffer(PH 3.65)by gradient elution.The flow rate was 1.0 mL/min and the detection wavelengths were 225 nm and 360 nm.As the situation illegal adding behaviors about anti-impotence Chinese Patent Medicine and health care products is relatively serious,the study focused on 12 kinds of chemical components which were illegally added to anti-impotence Chinese Patent Medicine and health care products and collected their characteristic fragment ions by using the(TQ-MS)triple quadrupole tandem mass spectrometry and(Q-TOF-MS)quadrupole time-of-flight tandem mass spectrometry in order to establish a mass spectrometry database with some versatility.At the same time,by analyzing the relationship between the fragment ions and the structure of the compounds,the typical fragments of the structure analogues were summarized and the MS fragment pathways was deduced.In addition,with the information of the database,a rapid screening method on anti-impotence Chinese patent medicines and health care products was established.ResultsIn this study,a database of 121 compounds which are illegally added Chinese patent medicines and health care products was established by UPLC-Q-TOF/MSEand UNIFI.42 batches of positive samples were screened by the database established in the study and UNIFI software.The results were consistent with the standards and complementary methods issued by the China food and drug administration(CFDA).In this study,9 chemicals illegally added into antiasthmatic and antitussive Chinese patent medicine was separated in a very short period of time(about 3 min)by UPLC-Q-TOF.Meanwhile,the chromatograph retention time and characteristic fragment ions of the 9 compounds were obtained.Codeine phosphate was founded in one sample by screening and the content was 0.84 mg/mL by HPLC.A mass spectrometry database with some versatility of 12 compounds illegally added in anti-impotence Chinese patent medicines and health care products was established.In addition,A rapid screening method on anti-impotence Chinese patent medicines and health care products was established.In the rapid screening method,the mass spectral information of the sample can be obtained in a very short time(about 0.1 min).ConclusionIn this study,a database of 121 compounds which are illegally added Chinese patent medicines and health care products was established by UPLC-Q-TOF/MSEand UNIFI by using the established database and UNIFI software.Using the established database and UNIFI software to realize the automatic extraction of chromatographic peak and the automatic determination of molecular formula,which greatly improves the efficiency and accuracy of sample analysis and detection..A qualitative and quantitative method for the detection of 9 chemicals illegally added into antiasthmatic and antitussive Chinese patent medicine were established in this study.Compared with the standards and complementary methods(NO.2009031)by the China food and drug administration(CFDA),The method established in this study detected more components and costed less analyzing time.In this study,a mass spectrometry database with some versatility of 12 compounds illegally added in anti-impotence Chinese patent medicines and health care products was established.Compounds or a structural analogues in the mass spectrometry database can be rapidly screened by typical fragment ions of analogues in the mass spectrometry database.Quality inspectors in the case of no reference substance,still can use the database information carries on the preliminary screening of the sample.