Study On The Quality Standard Of Fuyankangfu Tablets

The modernization of traditional Chinese medicine quality standards is an important part of the modernization of traditional Chinese medicine, and it is a important way to ensure Chinese patent medicine safe and effective. Fuyankangfu tablets are posted by the standards of Ministry of Health for standards Volume IV of new drug(1994 version). It's made of China Ixeris, Semen Coicis, Fructus Toosendan, Radix Bupleuri, Pericarpium Citri, Reticulatae, Radix Scutellariae, Radix paeoniae Rubra, and it is a Chinese patent medicine for the clinical treatment of chronic pelvic inflammatory disease. The Ministerial Standard listed microscopic identification, TLC identification of Pericarpium Citri Reticulatae and Radix Scutellariae, but haven't Content determination. Now the standards of Ministry of Health and the China Pharmacopoeia (2005 version) have some reformulation, and the products have been improved too.The study on the quality standards of Fuyankangfu tablets, including research of heavy metal check, arsenic salt check, identify improving and effective component's content determination, to ensure the medicine safe and effective. Fuyankangfu tablets profit from the roles of China Ixeris, Semen Coicis, Fructus Toosendan, Radix Bupleuri, Pericarpium Citri Reticulatae, Radix Scutellariae, Radix paeoniae Rubra, can clearing heat and draining dampness, remove blood stasis and correct the pain. There are Baicalin, hesperidin and baicalin from Radix Scutellariae, Pericarpium Citri Reticulatae and Radix paeoniae Rubra have significant effect of anti-inflammatory and antimicrobial. In order to ensure the quality of Fuyankangfu tablets, the experiment selected hesperidin, baicalin and paeoniflorin as the main active ingredients of this preparation for determining in same time. In accordance with sets of Chinese herbal medicine research, we have made reseaches above heavy metal check, arsenic salt check, identify by TLC, the same-time-determination of baicalin, hesperidin and paeoniflorin by high performance liquid chromatography, the results show that with baicalin, hesperidin, paeoniflorin as a reference substance, with acetonitrile-0.05mol/L potassium dihydrogen phosphate as the mobile phase and detection wavelength 231nm, using gradient elution method, with external standard method, by different manufacturers and different batches of samples determining and analysis, constructed a effective methods for the component's content determination.The methods of the component's content determination has been constructed, in the items, baicalin, hesperidin and paeoniflorin were determined by simply and fast at the same time. For the quality control, to ensure this medicine be used in a safe and effective way, and to promote the modernization of this medicine, there is a great significance.