Studies On Optimization Of Preparation Technology And Quality Standard Of Yiqi Tong Granular Particle

Objective: With the development of the society,constipation has become a high incidence of modern people,and presents the trend of increased incidence,seriously affecting the quality of people's lives,Chinese medicine treating constipation curative effect is unique.Based on this,this topic research and preparation of ease constipation of Yiqi tong granular particle,and optimized its preparation technology and quality standard was established.Methods:(1)According to function of the prescription and the nature of the drug ingredients,we draws up its preparation process route,during the soak process,we used the orthogonal matrix experiment method of Radix Astragali preparata,atractylodes and Cistanche by water extraction,The best process conditions were screened by using the index such as extracts rate and content of astragaloside;and using the orthogonal matrix experiment method of other four medicines by alcohol extraction,The best process conditions were screened by using the index such as the content of Emodin,astragaloside and neohesperidin;(2)TLC was used for the qualitative identification of Fleece-flower root,cohosh,astragalus root,bitter orange in Yiqi tong granular particle.The contents of Emodin,astragaloside,neohesperidin were determined by UPLC,established the quality control method of Yiqi tong granular particle.(3)we studied on its stability through the long-term experiments of three batch of pilot product.Results:(1)study on the preparation technology of Yiqi tong granular particle: confirm the water optimal extraction is acceding to eight times water to distill 2h,extracted time is 6 h,and extracting for 2 time;according to molding technics to confirm preparation.The alcohol extraction orthogonal experiment is acceding to 75% ethanol,extracting time is 2h,Eight times the amount of extraction solvent,and extracting for 2 time;(2)study on the quality standard of Yiqi tong granular particle: TLC indicated that four identified herbs could show that the Spot separation effect is good,and the negative control showed no interference.using the content of Emodin,astragaloside,neohesperidin as index,the average recovery was90%~110%,RSD was 1.16%(n=6).Based on the measured results of batch of samples,a preliminary content criterion was set up,for every 1g Yiqi tong granular particle contains Emodin,astragaloside,neohesperidin is not less than 2.22 mg.(3)study on the stability of Yiqi tong granular particle: Based on the long-term accelerated test results,the particle showed stable quality in 18 months,meetting the quality standard of the draft.Conclusion:(1)Using orthogonal experiment method,we screened the best extraction technology parameters,the results show that the preparation process is rational and feasible;(2)the results of Stability study further show that the quality of preparation is stable and the method is feasible;(3)using the content of Emodin,astragaloside,neohesperidin as index,the quality of the product is steady and controllable,and can be used as Yiqi tong granular particle control standard.