The Research And Development Of Cihang Granules(Sugar-free)

Objective:To change the formulation of Cihang tablets into Sugarless granules based on the prescription and production process of Cihang tablets.The study focused on the extraction process and quality control of the Angelica liquid extract and the Angelica&Leonurus liquid extract,the preparation process and quality control of Cihang granules,and established the quality standard draft to provide basis for follow-up study and development of Cihang granules.Methods:① A HPLC method was used to determine the content of ferulic acid in the Angelica liquid extract.Single factor and orthogonal experiments were employed to determine the optimum extraction technology of this liquid extract with the content of ferulic acid as the index.TCL were used to identify this liquid extract.The liquid extract were inspected with the indexes of insoluble substance,relative density and dry extract yield.② A HPLC method was used to determine the content of Leonurine hydrochloride in the Angelica&Leonurus liquid extract.Single factor and orthogonal experiments were employed to determine the optimum extraction technology of this liquid extract with the content of Leonurine hydrochloride as the index.This liquid extract were inspected with the indexes of insoluble substance,relative density and dry extract yield.③ The forming technology was optimized by single factor and orthogonal experiments using comprehensive score of many indexes.④ TCL were used to identify Cihang granules.The products were inspected with the indexes of appearance,granularity,moisture content and dissolubility.A HPLC method was used to determine the content of ferulic acid in the products.Results:①The optimum extraction technology of the Angelica liquid extract were chosen.The Angelica power(assed through the 10 mesh screen)were soaked for 12 hours with 70%ethanol,the amount of percolation extract is determined to be 8 times more than the medicinal materials,percolation speed 2ml· min-1.This liquid extract displayed the same spots in the TLC graphs as ferulic acid reference substance and the Angelica control herbs in the same position.A HPLC method for determining the content of ferulic acid in this liquid extract was established.The methodological evaluation showed that the precision,repeatability,stability and accuracy met all the requirements.The methods were simple,accurate and reliable.A draft quality control standard of this extract was established.②The optimum extraction technology of the Angelica&Leonurus liquid extract is:adding 10 times amount of water,extracting 2 times and every time with 1 hour.A HPLC method for determining the content of Leonurine hydrochloride in this liquid extract was established.The methodological evaluation showed that the precision,repeatability,stability and accuracy met all the requirements.The methods were simple,accurate and reliable.A draft quality control standard of this liquid extract was established.③The prescription was composed of Leonurus 1500g,Angelica 1000g,Chuanxiong 750g,dextrin 3080g,water 950g,which produced a total of 1,000 bags.④ Cihang granules displayed the same spots in the TLC graphs as the Angelica and Chuanxiong control herbs in the same position.All of the basic performance conformed to the requirements of Chinese pharmacopoeia.A HPLC method for determining the content of ferulic acid in the products was established.The methodological evaluation showed that the precision,repeatability,stability and accuracy met all the requirements.The methods were simple,accurate and reliable.A draft quality control standard of the products was established.Conclusion:The study established the extraction process and preparation process of Cihang granules.The products conformed to the pharmacopoeia of China.A draft quality control standard of the products was established based on the experiments,which could provide a reliable basis for follow-up study and development.