Study On The Improvement And Stability Of Yinhua Ganmao Granules

Object: In this project,the improvement of the quality standard of yinhua Ganmao granules was studied,including qualitative identification by TLC,and determination of main components,determination of its quality standard and study of its stability.Methods: 1.Quality standard improvement:(1)Qualitative identification has been carried out for two monarch drugs including honeysuckle and forsythia in the preparation,wind-proof and platycodon grandiflora with the use of thin-layer chromatography.Meanwhile,comparison has also been carried out for the active constituents of chlorogenic acid,forsythin,cimicifugoside,cimicifugin,5-O-methylvisamminol,platycodon grandiflora in honeysuckle Ganmao granules produced by five different manufacturers.(2)Content determination has been carried out for the chlorogenic acid(the active constituent of honeysuckle),forsythin(the active constituent of forsythia),and cimicifugoside,cimicifugin and 5-O-methylvisamminol(three active constituents of Chinese parsnip root)in the preparation with the use of high-performance liquid chromatography.Stability research: According to the relevant regulations under the item of granules of the “Chinese Pharmacopoeia(2015 edition)”,the characteristics test of honeysuckle Ganmao granules was carried out,including traits,moisture,particle size,solubility,volume difference and microbial limit.And then,the stability of the preparation was studied,including long-term stability test and accelerated stability test.Samples need to be inspected for 6 months.Results: 1.Quality standard improvement:(1)In the thin-layer chromatogram,the spots are clear and easy to distinguish,with good reproducibility,and the negative control has no interference.Therefore,the thin-layer qualitative identification of the honeysuckle and forsythia can be included in the quality standard of honeysuckle Ganmao granules.(2)Content determination has been carried out for the chlorogenic acid(the active constituent of honeysuckle),forsythin(the active constituent of forsythia),and cimicifugoside,cimicifugin and 5-O-methylvisamminol(three active constituents of Chinese parsnip root).After content determination,it can be found that the injection amount of the two monarch drugs was 0.03mg～0.06 mg and 0.03mg～0.12 mg respectively.After further testing,it can be found that the regression equations were Y=30000000X – 19576 and Y= 20000000 X – 25604,the correlation coefficients were 0.99996 and 0.9998,the recovery rates were 101.10% and 99.51%,and the RSD were 1.55% and 1.23%(n=9)respectively.For cimicifugoside,cimicifugin and 5-O-methylvisamminol,the regression equations were Y = 30900X-42136,Y = 20392X-27173,Y = 22866 X – 56662,the correlation coefficients were all 0.999,the recovery rates were 99.92%,97.90% and 99.60%,respectively,and the RSD was 1.78%,2.19%,and 1.08% respectively.2.Stability research: All the inspection items of the granule characteristics of the three different manufacturers under the conditions of commercial drug packaging and storage were in compliance with the Pharmacopoeia regulations.After 6 months of long-term stability test and accelerated stability test,there was no significant change in the indexes of the samples compared with that of 0 month.Conclusion: Through the establishment of TLC and HPLC identification methods,as well as the quantitative analysis methods of the main active components of different medicinal materials,the qualitative and quantitative evaluation methods and quality evaluation indexes of yinhua ganmao granules were optimized,in order to establish a better quality standard and control the quality of yinhu ganmao granules more effectively.