Quality Studies On The Extracts And Tablets Of Panax Notoginseng And Herba Epimedii

There is a long history of herbal medicine in far Eastern countries,in particular Chinese people have utilized herbs and plants to treat various diseases for more than 8000 years.Panax Notoginseng and Herba Epimedii are traditional Chinese medicine. Modern pharmacological experiments indicate that Herba Epimedii use compatibility with Panax Notoginseng,in the prevention and treatment of Alzheimer's disease(AD) is of positive significance.In this work,tablets were completed under the guidance of the development.In order to meet the drug research and development,in accordance with the new medicine five declaration requirements,we studied the quality of the extracts and tablets of Panax Notoginseng and Herba Epimedii.1.Quality studies on the extracts of Panax Notoginseng and Herba EpimediiObjective To study the quality of the extracts of Panax Notoginseng and Herba Epimedii.Method 1)We developed a HPLC method for the determination the contents of notoginsenoside R₁,ginsenoside Rg₁,ginsenoside Re and ginsenoside Rb₁ in Panax Notoginseng extracts.Agilent Extend-C18 column(250×4.6mm,5μm)and gradient elution were used with acetonitrile-water as the mobile phase.The flow rate was 1.0mL·min^-1.Sample volume was 10μL.Diode array detector was set at 203nm. The content of total saponins was determinated by vanillin colorimetry with 550nm as wavelength.The reference substance was ginsenoside Re.We referenced to the Chinese Pharmacopoeia,moisture,ignition residues,heavy metals and arsenic salt were investigated.We choiced chloroform-ethyl acetate-methanol-water(32:1:16: 4)and silica gel G plate to identify the Panax Notoginseng extracts.We developed a headspace gas chromatography method for the determination of 7 residual organic solvents in the Panax Notoginseng extracts.The samples were injected into HP-INNOWAX capillary column by headspace sampler and analysed with FID detector using standard addition method.With the definitive method,we investigated the stress test of the Panax Notoginseng extracts.2)We developed a HPLC method for the determination the content of icariin in the Herba Epimedii extracts.Agilent SB-C18 column(250×4.6mm,5μm)and acetonitrile-water(26:74)were used.The flow rate was 1.0mL·min^-1.Sample volume was 10μL.Diode array detector was set at 270nm.The content of total flavones in extracts was determinated by UV with 270nm as wavelength.The reference substance was icariin.We referenced to the Chinese Pharmacopoeia,moisture,ignition residues,heavy metals and arsenic salt were investigated.We choiced Ethyl-butanone-acid-water(10:1:1:1)and silica gel H plate to identify the Herba Epimedii extracts.With the definitive method,we investigated the stress test of the Herba Epimedii extracts.Result 1)HPLC:Several saponins(including notoginsenoside R1,ginsenoside Rg1,ginsenoside Re and ginsenoside Rb1)in the Panax Notoginseng extracts got a very good separation.It showed a good linear relationship(notoginsenoside R₁ r=0.9997,ginsenoside Rg₁ r=0.9999,ginsenoside Re r=0.9997 and ginsenoside Rb₁ r=0.9999).Different concentrations of recovery were 95.29%～104.0%.The intra-day precision did not exceed 4.4%RSD,and inter-day precision did not exceed 6.8%RSD.Vanillin colorimetry:The regression equation was Y=4.1135X-0.0127,r=0.9993.Different concentrations of recovery were 96.88%～101.8%.The intra- and inter-day precision did not exceed 5.0%RSD.The moisture contents of three batches of the Panax Notoginseng extracts were 3.236%,4.501%and 3.266%.Ignition residue were 0.2262%,0.2696%and 0.2409%,heavy metals＜10ppm and arsenic salt＜3.3ppm. TLC:Several saponins in the Panax Notoginseng extracts got a good separation.GC: During the inspection concentration,it appears a good linearity in the experimental concentration(r:0.9932～0.9999).The rate of recovery were in the rang of 81.74%～111.2%.The RSD of precision and accuracy were all less than 10.0%.The results from stress test showed the Panax Notoginseng extracts is not stable when exposed to high humidity(RH75±5%and RH90±5%)and light(4500±5001x)but stable when exposed to high temperature(40℃and 60℃)for 10 days.2)HPLC:The regression equation was Y=12085X-24.245,r=0.9998.Different concentrations of recovery were 96.22%～101.0%.The intra- and inter-day precision did not exceed 2.0%RSD.UV: The regression equation was Y=34.876X+0.0083,r=0.9996.Different concentrations of recovery were 95.81%～97.70%.The intra- and inter-day precision did not exceed 2.0%RSD.The moisture contents of three batches of Herba Epimedii extracts were 4.438%,4.428 and 4.423%.Ignition residue were 1.266%,1.330%and 1.282%, heavy metals＜20ppm and arsenic salt＜1ppm.TLC:Several flavones in the Herba Epimedii extracts got a good segregation.The results from stress test showed the Herba Epimedii extracts is not stable when exposed to high humidity(RH75±5% and RH90±5%)but stable when exposed to high temperature(60℃)and light (4500±5001x)for 10 days.Conclusion All the method we established could study the quality of the extracts of Panax Notoginseng and Herba Epimedii,and provide a basis for the quality standard of the extracts of Panax Notoginseng and Herba Epimedii.2.Quality studies on the tablets of Panax Notoginseng and Herba Epimedii Object To establish the method to determine the contents of 4 saponins,icariin,total saponins and total flavones in the tablets,and establish the method to determine the dissolution of the tablets.Method 1)We developed a HPLC method for the determination the contents of notoginsenoside R₁,ginsenoside Rg₁,ginsenoside Re, ginsenoside Rb₁ and icariin in the tablets.Agilent SB-C18 column(250×4.6mm,5μm) and gradient elution were used with acetonitrile-water as the mobile phase.The flow rate was 1.0mL·min^-1.Sample volume was 50μL.Diode array detector was set at 203nm and 207nm.The content of total saponins in the tablets was determinated by the vanillin colorimetry.Sepctrometry was set at 550nm with ginsenoside Re as reference substance.The content of total flavones in the tablets was determinated by...