Study Of Quality Control Methods For Ningxinbao Capsule

Fermented cordyceps mycelium powder is a kind of medicinal material produced by fermentation of sellected Cordyceps strains,the most common ones including Cs-C-Q80,Cs-4,Artificial Cordyceps mycelium powder,Cordyceps Mortierella powder and Cordyceps mycelium powder.Ningxinbao is a preparation of Cordyceps mycelium powder and widely used for the treatment of arrhythmia,premature ventricular contraction,and kidney injury caused by hyperlipemia and diabetes.There are many manufacturers for this preparation,of which the production processes and excipients are significant different,leading to uneven qualities of the products.On the other hand,there are also several quality standards of Ningxinbao,and the test items between each standard are not uniform,bringing a lot of problems for the quality control.Considering the problems above,this paper carried out the following experiment study to comprehensively evaluate the quality of Ningxinbao preparations from different manufacturers and improve its quality standards.TLC identification:By comparing the thin layer chromatogram(TLC)of Ningxinbao from different manufactures,it was found that ergosterol could be obviously detected in all samples,which might be used as chemical marker for identification of this preparation.For other constituents,the location and strength of spots were significant different among samples from different manufacturers,while those were much more consistent among samples from the same manufacturer.Characteristic chromotogram analysis:HPLC fingerprints for Ningxinbao from different manufacturers were separatly established,as well as their common patterns.The common peaks were identified and the similar degree were calculated.As a result,the common peak of samples from different manufacturers were consistent,which were identified as nucleosides.However,their contents were obviously different.Furthermore,the similar degrees of samples from different manufacturers were much lower than those from the same manufacturer.Quantification of five nucleosides:An HPLC-UV method was developed and validated for simultaneous determination of five nucleosides(uracil,urdine,guanosine,adenosine and Cordycepin)in Ningxinbao preparations.The contents were compared with those in other four related preparations,Cordyceps,and Cordyceps militaris.Among the five investigated compounds,cordycepin could only be detected in Cordyceps militaris samples.uracil,urdine,guanosine,adenosine were abundantly present in Ningxinbao preparations,but their contents varied greatly.In general,there were no significant differences in the distribution of the five nucleosides between Ningxinbao and other four related preparations.However,their contents were much higher than those in Cordyceps and Cordyceps militaris.Identification of Adulteration:Analyzed and compared with the methanol extract of ningxinbao capsule,other four related preparations and Cordyceps,using QTOF-MS and MarkerLynx date processing software,serch and found marker ingredient of ningxinbao capsule(m/z732.6),and determinated all the samples,proven after Methodology,This mothed is foolproof,Convenience and reliable,This method can be used for ningxinbao capsule identifying.After study of above four sections,develop a method of quality control of TLC identification,determination and identifying,By analyzing the characteristics chromotogram of Ningxinbao capsule could evaluate overall quality.