Study On Improving The Quality Standard Of Xieliguchang Pills

Objective: The current quality standard of Xieliguchang Pills is very simple.In order to evaluate scientifically and effectively control the quality of the preparation,the subject was improved from three aspects: the improvement of quality standards,the safety and quality evaluation.To ensure the quality of the preparation is effective,safe and controllable.Methods: Improvement of quality standards: Using the TLC method has a qualitative research on 7 herbs such as Radices paeoniae alba,Myrobalan,Atractylodes,Poppy capsule and so on.Using the HPLC method has a quantitative study on Morphine,Codeine,Papaverine and Paeoniflorin.Drug safety: Using the GC-MS method to detect the residues of 28 pesticides.The contents of 18 heavy metal elements such as lead,arsenic,mercury,copper and cadmium were determined by ICP-MS method.Establishing methods to detect contents of Aflatoxin and Sulfur dioxide.Quality evaluation: To establish the HPLC fingerprint of Xiliguchang pills.To establish an HPLC method for the determination of gallic acid,paeoniflorin,liquiritin and hesperidin in the preparation.Establishing an HPLC method to determine the dissolution rate of paeoniflorin in the preparation.Results: The establishment of TLC identifacation method on Ginseng,Licorice,Pericarpium citri reticulatae,Radices paeoniae,alba and Myrobalan.The TLC method of Atractylodes and Poppy capsule was improved in the original standard.All samples of Manufacturers A and B can detect the corresponding components.The establishment of HPLC conditions on morphine,codeine,papaverine and paeoniflorin.The paeoniflorin content of 2 samples was not qualified in Manufacturer B.The methods are simple and feasible that determine the residues of pesticide residues,heavy metal elements,sulfur dioxide and aflatoxin.The 28 kinds of pesticide residues and aflatoxin were not detected in all the samples.The contents of 5 heavy metals were all in accordance with the regulations.There is 1 sample of high sulfur dioxide residue in Manufacturer B.The HPLC fingerprint of Xieliguchang pills was established.The similarity between simples of Manufacturer B and control preparations was poor.A HPLC method was established for the determination of multi-components.The content of main components in Manufacturer A samples was higher.HPLC method was established for the determination of the dissolution of paeoniflorin.There were 2 samples from the manufacturer B which were not similar to those in the control preparation.Conclusion: The quality standard of the preparation was developed by the above studies.Its quality was analyzed and evaluated.