| Lycium barbarum L.,a traditional Chinese medicine,is rich in polysaccharides,flavonoids,phenolic acids,carotenoids and other natural active ingredients,which are widely used in clinical medicine and daily dietary supplements.In this paper,a compound capsule preparation with Lycium barbarum L.as the main raw material was selected to carry out relevant technical analysis and quality control method development,in order to provide new ideas and solutions for the construction of quality standards of traditional Chinese medicine.In this paper,a commercially available compound capsule preparation with Lycium barbarum L.as the main raw material was selected as the research object,and the difference of loading capacity and disintegration time under the capsule preparation were investigated,which met the requirements of Pharmacopoeia.Inductively coupled plasma mass spectrometry(ICP-MS)was used to detect the heavy metal impurities in three batches of compound Lycium barbarum L.capsules,and the results were all in line with the limits specified by ICH.In the aspect of stability investigation,the rapid spectral screening technology was established by using ultraviolet-visible spectrophotometry(UVs),which is simple,rapid and easy to popularize.Through the identification of this technology,it is determined that strong acid and alkali will obviously affect the ultraviolet absorption spectrum of capsule contents except high temperature and high humidity,which can be used as the daily quality control and monitoring technology of traditional Chinese medicine preparations.Ultra-high performance liquid chromatography-tandem mass spectrometry(UPLC Q-TOF)was used to optimize the extraction method of compound Lycium barbarum L.capsules.Based on the characteristic ultraviolet absorption peak area,the effects of ultrasound,solvent and its ratio,temperature and time on the extraction of active substances were investigated,and the optimum extraction conditions of compound Lycium barbarum L.capsules were established.Through the optimization of chromatographic method,the components of each substance in the extract were effectively separated,and the fingerprint of compound Lycium barbarum L.capsule was constructed by liquid chromatography-mass spectrometry.It is verified that the method has good specificity and high stability,and can effectively distinguish the capsule from other similar formulations on the market,and effectively indicate the different substance components in the deteriorated capsule.Using the original flavonoid LC-MS data in the laboratory and the newly added structural information of 3045 kinds of natural active substances,the 10 peaks in the fingerprint of compound Lycium barbarum L.capsules and other main substances were qualitatively analyzed,as well as the material composition analysis of Lycium barbarum L.granules and compound Lycium barbarum L.capsules damaged by high humidity.By tracing the source of active substances,the accuracy of the LC-MS database technology in the qualitative aspect of substances has been effectively verified.During the research process,through database identification,it was confirmed that the substance component that changed greatly in high-humidity damaged samples of compound Lycium barbarum L.capsules was sugar.An Amide column with better separation effect was used to develop a specific analysis method for polysaccharides,and the components of polysaccharides in Lycium barbarum L.polysaccharide,compound Lycium barbarum L.capsule sample,Lycium barbarum L.fruit sample and compound Lycium barbarum L.capsule high humidity damaged sample were analyzed.It was confirmed that the content of Lycium barbarum L.polysaccharide decreased under the condition of high humidity destruction,and the moisture intolerance of compound Lycium barbarum L.capsule contents was confirmed.Combined with the results of database analysis,Lycium barbarum L.polysaccharide and compound Lycium barbarum L.sample mainly contain polysaccharide components with hexose as structural unit.In order to confirm the monosaccharide structure,HPLC-ELSD combined with 9monosaccharide and disaccharide standards was used to establish a chromatographic analysis method,and Lycium barbarum L.polysaccharide in Lycium barbarum L.polysaccharide,Lycium barbarum L.fruit and compound Lycium barbarum L.capsule was analyzed.It was determined that the main monosaccharide components in Lycium barbarum L.polysaccharide were glucose,fructose and galactose,and the main monosaccharide components of Lycium barbarum L.polysaccharide in Lycium barbarum L.samples were glucose and fructose.To sum up,this paper takes compound compound Lycium barbarum L.capsule as the research object,and establishes rapid ultraviolet spectrum identification method,accurate quality control fingerprint method and polysaccharide analysis method in complex systems,all of which are simple,accurate and efficient.Modern analytical techniques,such as fingerprint,LC-MS database and LCMS polysaccharide analysis,can provide new research ideas and technical support for the research on the quality of traditional Chinese medicine and its detection methods and standards,and provide effective technical support for solving the core problems in the process of standardization of traditional Chinese medicine. |
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