Study On Quality Standard Of Total Saponins Sustained - Release Pellets

JM is the root of Potentilla anserina L.It is neutral in nature,sweet flavor,and it can invigorate the spleen,promote the production of body fluid to quench thirst,stop coughing,damp elimination. JM saponin sustained-release pellets are based on active compounds（JMS）of Potentilla anserine, and the sustained-release preparation can lasted for 24 hours.Pharmacological study found that JMS can anti-hepatitis virus,protect liver and lower biocatalyst,elevate immunity,enhance liver’s detoxication and metabolism effect.This study which based on JM saponin sustained-release pellets,established the quality control method of the medicine.1.Studies on quality control of JM saponin sustained-release pellets（1）The TLC was used for qualitative analysis.The spots in TLC are clear and distinguishable.The result was reproducible and accurate.According to this method,the qualitative analysis of JM saponin sustained-release pellets can be achieved.（2）The UV was used for quantitative analysis of JM saponin.The HPLC was used for the quantitative analysis of JMGâ… and JMGâ…¡,mobile phase was water（A）- acetonitrile（B）;gradient elution program was 0～25 min（20%B～36%B）;column temperature was 30℃;flow rate was 1.0 mL·min^-1;detection wavelength was 208 nm.The linear ranges of JMGâ… and JMGâ…¡were 0.0400～0.400 mg·mL^-1（r=0.999 5）and 0.0640～0.640 mg·mL^-1（r=0.999 4）,with average recovery rates at 103.4%（RSD=2.5%）and 102.1%（RSD=1.8%）,respectively.This method was simple and accurate.According to this method,the quantitative analysis of JM saponin sustained-release pellets can be achieved.2.Studies on dissolution of JM saponin sustained-release pellets.After referring to China Pharmacopoeia（2005）,Appendix X D,250 mL 0.5%SDS was used as dissolution medium and apparatus of 100 r·min^-1.We used HPLC method to determine the dissolution of JM saponin sustained-release pellets.In this HPLC method Pinnacle DB C₁₈（4.6 mm×200 mm,5μm）was used as the stationary phase,methanol-water solution（64:36,v/v）as the mobile phase and the detection wavelength of 208 nm were adopted.Release dynamics process meet Higuchi equations.This method was simple and accurate,and can be used for monitoring release behavior of JM saponin sustained-release pellets.3.Studies on stability of JM saponin sustained-release pellets.6 months accelerated test and 12 months room temperature test were carried out.This study provide evidence for JM saponin sustained-release pellets’ delivery,package,storage, transportation.4.Studies on Potentilla anserine finger printing.The HPLC was used for Potentilla anserina L finger printing.The HPLC chromatographic fingerprints of Potentilla anserina L showed 9 Peaks with good resolution and chemical data was obtained.Similarity analysis was carried out using cosine as measure.