Research On The Quality Standard Of Huzhentongfeng Capsule

Huzhentongfeng capsule, is made by four flavour Chinese traditional medicine:Ligustrum and Plantain, Beehive and Polygonum Cuspidatum. PolygonumCuspidatum is monarch drug. Plantain is minister drug. Ligustrum is assistant drug.Beehive is the guide drug. And its main function mainly in the treatment of acutegouty arthritis, in Ⅱphase of clinical trial, the treatment effect is remarkable, and isnow preparing to enter Ⅲ phase of clinical trials.Because China pharmacopoeia for some of the medicinal material qualitystandard has been increasing, with2000edition pharmacopoeia as the foundation, thequality standards of Huzhentongfeng capsule and the new Chinese pharmacopoeialrequirements have some not consistent, the2010version of the first asked contentdetermination of Polydatin in Polygonum Cuspidatum and Specnuezhe in Ligustrum,and remove the determination of Oleanolic acid content, the reason may be Oleanolicacid and Ursolic acid separation degree is not high, the measurement of the resultshave a certain error. The extraction method of Emodin is2.5moL/L of sulfuric acidreflux two hours, again add50ml chloroform extraction equally four times, and in2005version after the extraction method is add50ml2.5moL/L sulfuric acid and50ml chloroform backflow two hours, the chloroform constant weight. So this topicresearch and improve the quality standard of the Huzhentongfeng capsule;determinethe content of Polydatin and Specnuezhe, and research extraction method of Emodinin Huzhentongfeng capsule Because the old TLC identification of Huzhentongfengcapsule with double negative medicinal materials, specificity is poor, and we alsostudied the TLC identification method.This topic was the first to be develop methods for determination ofPolydatin and Specnuezhe in the Huzhentongfeng capsule, the condition is usingXtimate C18column (4.6x250mm,5μ m), the column temperature is30℃,themethods for determination of Specnuezhe is acetonitrile:water (18∶82) as themobile phase at a flow rate of1ml/min and the detection wavelength was306nm. themethods for determination of Polydatin is acetonitrile: water (18∶82) as the the mobile phase at a flow rate of1ml/min and the detection wavelength was224nm.This method is easy to operate, repeatability and good stability, high accuracy.Also developed an extraction method of Emodin in Huzhentongfeng capsule for25ml chloroform and25ml2.5mol/L sulfuric acid solution, weighing,80℃reflow30min, chloroform fill heavy, take5ml of chloroform drying, in thecapacity of methanol to10ml. We determine the content of Emodin and Polydatin inthe Polygonum Cuspidatum of the eight different producing areas, and determine thecontent of Specnuezhe in the Ligustrum of the eight different producing areas.These research to establish and perfect the quality standard of Huzhentongfengcapsule.