Study On Preparation Process And Quality Standard Of Xiao’er Kesouting Granules

Xiao’er Kesouting Granules, composed of Citri Grandis Exocarpium, Herba Colei Forskohlii,Perillae Folium, Platycodonis Radix and Glycyrrhizae Radix Et Rhizoma, is a empirical Chinese herbal medicine compound preparation which is used for the treatment of children cold cough clinically in hospital for many years with the efficacy of ventilating lung, relieving exterior syndrome, dispelling cold, regulating vital energy, preventing phlegm from forming and stopping coughing. The systematic experimental study and preliminary pharmacodynamics research of the preparation process and quality standards of Xiao’er Kesouting Granules were conducted, according to the requirements of traditional Chinese medicine and natural medicine new drug registration classification 6.1, guided by traditional Chinese medicine theory, using modern scientific technology and methods, to ensure the scientific and reasonable preparation process, stable and controllable quality and safe medication. 1.Study on PreparationExtraction process:Taking the transfer rates of the main effective constituents which are isoforskolin, naringin, liquiritin and ammonium glycyrrhetate as evaluating indexes, selecting optimum extraction process through preliminary test and orthogonal design test and combining the results of pharmacodynamic test, the extraction process of Xiao’er Kesouting Granules is finally determined as follows: Add 12 times the amount water in Citri Grandis Exocarpium, Perillae Folium, Platycodonis Radix and Glycyrrhizae Radix Et Rhizoma for 3 times of decoction(each decoction takes 1.5 hours), filter, gather filtrate, concentrate the filtrate under reduced pressure to the cream with the relative density of 1.20(60℃), add alcohol to 70%, stand for 24 hours, take the supernate, ready for use; add 10 times the amount 70% alcohol for 3 times of extraction(each extraction takes 1.5 hours),filter, gather filtrate, ready for use.Concentration process: Taking the transfer rates of isoforskolin, naringin and liquiritin as evaluating indexes, through the study of the concentration method, degree and temperature, combining alcohol precipitation and alcohol extract and concentrating under reduced pressure, the thick cream with the relative density of 1.30(70℃) is finally determined.Preparation forming process: Through the researching the influence of the excipients, sweetening agent and their dosage to the granulation and by many batches of lab-scale test, the preparation forming process of Xiao’er Kesouting Granules is finally determined as follows: Mix the thick cream from the concentration process and sucrose-dextrin(1:3), add 1% Aspartame(APM), mix well, make into soft material, use 20 mesh sieve for granulation, dry, use 18 mesh sieve for straightening granules, package and obtain. 2. Study on quality standardTLC qualitative research: Qualitative discrimination of Herba Colei Forskohlii, Herba Colei Forskohlii and Glycyrrhizae Radix Et Rhizoma in the Xiao’er Kesouting Granules is conducted by using TLC. The result shows that the spots with the same color are shown in the related place of reference medical material or reference substance in the sample chromatogram and they are negative and without interference.Assay determination study: Assay determination of naringin in Citri Grandis Exocarpium in Xiao’er Kesouting Granules is conducted. The chromatographic conditions are as follows: Filling agent octadecy- lsilane chemically bonded silica; mobile phrase-methanol and 2.2% acetic acid(35:65); test wave length-283nm;column temperature-30℃; flow rate-1.0ml·min-1. Through 10 batches of lab-scale test, the naringin assay in final product is not less than 26.0mg/bag.