Study On Quality Control Method Of Mongolian Medicine Qingxue Bawei Tablets

Objective Qingxue bawei Tablets contain gypsum rubrum(cold processing),arnebiae radix,inulae radix,bovis calculus artifactus,gardeniae fructus,dianthi herba,gypsum fibrosum,and glycyrrhizae radix et rhizoma.It is commonly used in Traditional Mongolian medicine prescriptions for clinical,and has significant effect on treating blood disease.Basic research of Qingxue bawei Tablets is weak,and the existed quality standard is not very perfect,so the level of quality control is urgently needed to improve.This research plans to establish HPLC fingerprint of Qingxue Bawei Tablets,to study the content determination method of multi-components,and to qualitatively and quantitatively analyze the inorganic elements.This research would study the quality control method of Qingxue bawei Tablets from many aspects,and more fully control product quality.Methods 1.Fingerprint of Qingxue bawei Tablets was established with high performance liquid chromatography and photo-diode array detector(HPLC-PDA)technology.The chromatograms of eighteen batches samples were processed by similarity evaluation system,and the fingerprint and its technical parameters were analyzed.The single herbs spectra was used to make attribution of common peak,and part of the characteristic peak was identified by the reference substance.2.The samples with nitric acid and hydrogen peroxide system as digestion reagents,digested via microwave,were inlet into inductively coupled plasma mass spectrometry to analyze the contents of the 32 inorganic elements,including Be,B,Na,Mg,Al,P,K,Ca,Ti,V,Cr,Mn,Fe,Co,Ni,Cu,Zn,Ga,As,Se,Rb,Sr,Mo,Ag,Cd,Sn,Sb,Cs,Ba,Hg,Tl,and Pb.The content distribution curve and the fingerprint chromatogram of inorganic elements were plotted.The principal components were analyzed with the SPSS 19.0,and the characteristic elements were screened.3.Calcium salt and sulfate were detected by the physical and chemical identification test.The conditions of samples processing and test were studied respectively.Samples were carbonized and incinerated to ash,and the content of calcium was determined by EDTA-2Na complexometric titration method.4.Genipin-l-gentiobioside,gardenoside,liquiritin,glycyrrhizic acid,alantolactone and isoalantolactone of Qingxue bawei Tablets were chosen as index components.Through the single factor investigation to choose the best extraction method,and to optimize the chromatographic detection conditions.The contents of 6 kinds of index components in 18 batches of samples were determined by HPLC method.Results 1.The fingerprint of Qingxue Bawei Tablets established had good separation effect,obtained twenty-one common peaks,and clarified the source of common peaks and part of peaks qualitatively.The chromatogram of samples matches the reference fingerprint,the average similarity was 0.974,RSD was 1.54%.Fingerprint of 18 batches of samples generated were of high similarity and smaller difference.The fingerprint method has good feasibility.2.The 32 inorganic elements showed good linearity in the selected concentration ranges,with the correlation coefficients more than 0.9995.The detection limits were in the range of 0.001?6.390 ?g/L.The recovery was 94.36%?105.47%,while their RSD was 1.53%?4.56%.The fingerprint was established by the content distribution curve of inorganic elements.Different batches of samples were similar peak shape,and the amount of inorganic elements content in different order was tend to be more consistent.The results of principal component analysis showed that Co,As,Ba,Ca,Sb,Ti,Ni,Fe,Cs,Se,P,Al,K and Tl may be the characteristic elements in Qingxue Bawei Tablets.The content of heavy metals,such as Pb,Cd,As,Hg and Cu,was below the limit requirements of the Chinese Pharmacopoeia(2015).3.The optimal processing condition was 2-step heating:samples was carbonized one hour on the electric stove,and incinerated six hours under the 700?800? in the muffle furnace.The RSD value of the repeatability was 0.32%,the recovery was 98.67%?101.25%with RSD of 0.97%.They all met the demands of quantitative analysis.4.The 6 kinds of main active components separation by HPLC method was good.In the certain concentration range the linear relationship of six compositions was good,and the correlation coefficient was more than 0.9998.Its precision,repeatability,stability,and recovery all met the demands of quantitative analysis.The contents of six compositions was stable in 18 batches of samples,there was no significant difference.Conclusion With the fingerprint study,inorganic elements analysis,and the component content determination on Qingxue bawei Tablets,this research provides the technical reference to promote the product quality standard and totally control the product quality,and also provides the scientific basis for the production,processing,market circulation,research on pharmacodynamic material basis and clinical application.