The Study Of Quality Consistency Of Yuanhu Zhitong Prescription

Yuanhu Zhitong Prescription (YZP) is a typical and relatively simple traditional Chinese medicine.It contains Angelicae Dahuricae Radix and Corydalis Rhizoma and is widely used in the clinical treatment of headache, gastralgia, and dysmenorrhea.The main content of the paper is the quality consistency study of YZP.lt is divided into three parts, which are the content determination of multicomponent of YZP, fingerprint of High Performance Liquid Chromatography (HPLC) and dissolution experiment.The study aims at the research of general standard of YZP and the establishment of quality consistency evaluation system of YZP.The maker compounds for assay are Protopine, Dehydrocorydaline, Tetrahydropalmatine, Imperatorin and isoimperatorin.17 batches of Yuanhu Zhitong Tablet (YZT),17 batches of Yuanhu Zhitong soft capsule (YZSC),Yuanhu Zhitong dripping pill and Yuanhu Zhitong capsule samples respectively were determined respectively.The results showed that all the samples meet the requirement of content determination standard of YZP in the Chinese Pharmacopoeia 2010 edition.But there are significant differences in content of the other four components.Fingerprint was established by analyzing 10 different manufactories of YZT and 17 batches of YZSC.Data from chromatographic fingerprints were processed using similarity analysis, principal component analysis (PCA) and hierarchical cluster analysis (HCA). There were 15 common peaks in which 12 components were from Corydalis Rhizoma and 3 from Angelica Dahuricae Radix. The similarity values of YZT were in the range of 0.505-0.988. Based on the value, they could fall into three groups. The result of HCA showed that 10 batches of samples could be divided into 3 classes. The results of PCA indicated the first three principal components (PCs) could represent the 15 common peaks. According to the scores of 3 PCs,10 batches of samples could be divided into four categories. The classification result was mainly affected by the components of Corydalis Rhizoma. The classification results of three methods were basically the same. Based on the combination of the three methods 10 samples can be divided into three grades in the aspect of quality. The quality differences of YZT from different manufacturers were obvious. The similarity values of YZSC were in the range of 0.963-0.967, which meant all samples were greater than 0.95, and had high similarity.But the HCA and PCA methods still showed differences between batches.The dissolution media was studied in the dissolution test, and the dissolution media of pH5.0 was appropriate.The results of dissolution curve similarity showed that samples from different manufacturers had significant difference.Comparing the dissolution of different batches from the same manufacturer showed that one manufacturer had a good dissolution of three batches, and the other two had a poor dissolution of one batch respectively.6 batches of YZSC showed that one batch had poor dissolution.The test showed that different batches of YZP had significant difference in dissolution and most batches of YZSC were constant in dissolution curve similarity.The above results indicate that the quality standard of only one indicator can’t control the quality of YZP effectively at present. Determination of multicomponent can be more comprehensive for different samples in quality evaluation. Similarity evaluation combined with HCA and PCA methods are more explicit for evaluating the fingerprint chromatogram similarity.The dissolution test illustrates that different manufacturers and batches of YZP still remain nonconformity.The manufacturers should improve the quality of products further in the preparation stability.