Quality Control Of Mongolia Medicine Xiaoer Qingfei Bawei Pills

Objective(1)To establish the identification of Mongolian medicine Xiaoer Qingfei Bawei Pills;(2)To examine the items of Mongolian medicine Xiaoer Qingfei Bawei Pills;(3)To establish a method for the determination of Mongolian medicine Xiaoer Qingfei Bawei Pills;(4)To establish an HPLC fingerprint of Mongolian medicine Xiaoer Qingfei Bawei Pills.Method(1)Carthami flos ? Ophiopogonis radix ? Bistortae rhizoma ? Glehniae radix ?Picrorhizae rhizoma and Santali albi lignum in Xiaoer Qingfei Bawei Pills were legally identified by microscopic identification.Carthami flos ? Ophiopogonis radix ? Bistortae rhizoma?Bovis calculus artifactus and Picrorhizae rhizoma in Xiaoer Qingfei Bawei Pills were identified by TLC.(2)Water content,weight difference,disintegration time,heavy metals and arsenic salts were evaluated according to the 2015 edition of the Chinese Pharmacopoeia and relevant standards;(3)Determination of hydroxysafflower yellow A in Carthami flos and Picroside ??Picroside ? in Picrorhizae rhizoma by HPLC;(4)HPLC is used to study the fingerprint of 12 batches of Xiaoer Qingfei Bawei Pills.Results(1)The micro-differentiation method has achieved satisfactory results.The identification method was exclusive.The TLC spots were fairly clear,and the blank test showed no interference.(2)The measurement results of the inspection items showed that water content,weight difference,and dissolution time were in compliance with the pharmacopoeia;the plumbum,cadmium,chromium contents were0.14-2.95mg/kg,0.02-0.53mg/kg,0.01-3.96mg/kg;The arsenic spot is lighter than or consistent with the standard arsenic spot.(3)The hydroxysafflower yellow A showed a good linearity in the range of 0.01-0.2?g/?L(r=0.9999),the average recovery was 102.5%,and the RSD was1.52%.The Picroside ? showed a good linearity in the range of 3.8-76?g/m L(r=0.9999),the average recovery was 99.71%,and RSD was 1.03%.The Picroside ? showed a good linearity in the range of 8.40-168?g/m L(r=0.9999),the average recovery was 103.3%,and RSD was1.95%.(4)Established a fingerprint of 12 batches of Xiaoer Qingfei Bawei Pills,12 common peaks are identified,and 5 peaks are identified by comparison with the referencesubstance,which are gallic acid?chlorogenic acid?hydroxysafflower yellow A?Picroside ?and Picroside ?.The similarity of 12 batches of Xiaoer Qingfei Bawei Pills is compared with0.9.Conclusion In the paper,the established qualitative and quantitative methods are simple?accurate and sensitive,which can be used in the quality control of Xiaoer Qingfei Bawei Pills.