Study On Quality Standard Of Paiduyangyan Capsules

Objective:Used research methods that were based on pharmacopoeia such as TLC and HPLC to establish a new quality standard for PYC.This standard could evaluate and monitor the safety and effectiveness of products better.At the same time,reasons for the difference in quality of different batches of products could be discover.This move could provide new ideas for manufacturers to improve product quality.Methods:?1?Part of Rhubarb,American ginseng and Atractylodis Macrocephalae were added in as the form of fine powder in the standard method.Therefore,it was necessary to update the method of microscopic identification.?2?Used TLC research methods.The new standard was based on the original one.Revised the new standard for Rhubarb and increased determination method for American ginseng,Fructus aurantii immaturus and Lotus leaf in the prescription.Also had done some research for Cistanche deserticola and Atractylodis Macrocephalae and Two other ethnic medicines,Qingyangshen and Xiaohongshen.?3?Employed HPLC research methods.The content determination of rhubarb was added to the standard.This measure established a general detection method for content ten determinations of Rhubarb.Through research,a method for simultaneously determining the content of main active ingredients of rhubarb,Fructus aurantii immaturus and Cistanche deserticola was obtained.This results could be used to initially evaluate the levels of three herbs in the prescription.And combined with chemical pattern recognition to evaluate the reasons for the differences in the quality of different batches of drugs.The contents of the three ginsenosides of American ginseng were also studied.?4?Because the drug contains Glauber's salt,the content of Glauber's salt was determined,and the research on the content of heavy metals and Arsenic salts were also done to ensure the safety of the drug.Results?1?Microscopic research results were very good.The calcium oxalate cluster crystal of rhubarb,the calcium oxalate needle crystal of Atractylodes chinensis,and the resin tract fragments of American ginseng could be clearly detected.?2?In the chromatogram of the test sample,the sample showed the same color of spots at the cprresponding positions to Rhubarb,Emodin and Chrysophanol;American ginseng,Ginsenoside F₁₁,Ginsenoside Rg₁,Ginsenoside Re and Ginsenoside Rb_1;Fructus aurantii immaturus;Lotus leaf and Nuciferine,and the negative control had no interference.The spots of the sample were not clear with the corresponding positions of Atractylodis Macrocephalae,Cistanche deserticola,Qingyangshen and Xiaohongshen,and the interference was serious.?3?Through preliminary evaluation tests,combined with chemical mode analysis,the reasons for the difference in quality of multi-batch products were mainly caused by different Rhubarb feeds.Finally,the content of Rhubarb was added to control the effectiveness of drugs by determining the content of total anthraquinones in rhubarb.Aloe-emodin,Rhein,Emodin,Chrysophanol and Rheochrysidin ether showed a good linear relationship in their linear range?r=1?.The average recovery of PYC were 101.26%,99.91%,101.15%,97.30%,and99.22%?RSD<2.0%?.And the RSD values were less than 2.0%in stability,precision and repeatability tests.In the HPLC study of American ginseng,the accuracy of the measurement was not high due to poor specificity and repeatability so it was not included in the standard.?4?The limit of heavy metal and arsenic salt in the sample was detected.The heavy metal content in the multi-batch sample was much lower than10 mg/kg,and the arsenic content was less than 1 mg/kg,so there was no need to increase the determination of heavy metal arsenic salt.The content of Glauber's salt was higher than the theoretical value,which might be caused by the influence of other drugs in the compound preparation.The experimental results were not specific,so they were not included in the standard.Conclusion:In this study,the microscopic identification of Rhubarb and Atractylodes macrocephala was added.The TLC method of Rhubarb had been modified.The TLC method of American ginseng,Fructus aurantii immaturus and lotus leaves had been increased and also updated the content of rhubarb in the prescription.The experimental results clarified the reasons for the differences in the quality of PYC,it was suggested that the manufacturer should strengthen the quality control of rhubarb in the preparation process,and provided reference for the follow-up study of PYC.