Acute Bronchitis Syrup Quality Control Of Key Technologies And The Evaluation Criteria

Jizhi Syrup,one of well-sold Traditional Chinese Medicine for treating respiratory infection,cough,acute tracheitis and bronch,etc.It was recorded in the China pharmacopoeia(2000,2005 edition),in which the identifications of protocatechuic acid, ephedrine and naringin were established by TLC,and the content of naringin was tested by an HPLC method.But the working standard can't control the whole quality of Jizhi Syrup from materials to end products.In order to solve the problem,we studied the method of HPLC fingerprint and simultaneous analysis of active compounds in Folium Ilicis Purpurea,one of the main ingredients of cough syrup,and the syrup itself.A HPLC fingerprint and simultaneous determination of four phenolic acid from Folium Ilicis Purpurea was established.The method is sensitive,accurate and stable.The contents of protocatechuic acid,protocatechualdehyde,chlorogenic acid and caffeic acid were suggested to be more than 0.45%,0.24%,0.19%and 0.20%,respectively.14 peaks were suggested as the common peaks of Folium Ilicis Purpurea,the relative retention times of the 14 common peaks,contrasted with the Peak of protocatechuic acid,should be 0.640,0.680,0.915,1,1.662,1.875,2.165,2.372,2.445,3.471,4.088,5.015,5.475 and 5.620, respectively,the range of relative deviation should be±10%,and the area of uncommon peaks should be less than 10%.20 batches of samples were divided into two groups by hierarchical clustering analysesthe superior and the fake according to their qualities.By the correlation analysis of the materials-interrnediat-end products' HPLC-FPC of Jizhi Syrup,original attribute was confirmed.Compared the similarity of showed well dependability.Based on the chemical data can be applied to the on-line control in workshop to ensure the products' quality of all batches.A HPLC fingerprint and simultaneous determination of active constituents from Jizhi Syrup was established.The method is sensitive,accurate and stable.The contents of protocatechuic acid,protocatechualdehydc,chlorogenic acid,caffeic acid,naringin,ncohesperidin were suggested to be more than 0.47mg.ml^-1,0.24 mg.ml^-1,0.10 mg.ml^-1,0.09 mg.ml^-1,1.03 mg.ml^-1 and 0.51 mg.ml^-1 respectively.21 peaks were suggested as the common peaks of Jizhi Syrup,the relative retention times of the 21common peaks,contrasted with the peak of protocatechuic acid,should be 0.525,0.639,0.909,1,1.330,1.670,1.879,2.166,2.213,2.383,2.455,3.481,4.069,4.280, 4.515,4.615,4.697,5.024,5.309,5.494 and 5.919 respectively,the range of relative deviation should be±10%,and the area of uncommon peaks should be less than 10%.The method effectively established the correlativity between FP and its relevant fractions, which would contribute to deduce the chemical components or sources of effective fraction of TCM.Manufacturing technique and quality standard were optimized and established.In conclusion,more powerful technical supports for Jizhi Syrup in effectiveriess,stability and control will be provided.At the Same time,it will be a model for other compound preparation studies on the quality standardization.