Study On Quality Standard Of Shufeng Jiedu Capsule

The Shufeng Jiedu Capsule is a large variety of Chinese materia medica(CMM),which is produced by Anhui Jiren Pharmaceutical Co.,Ltd.The preparation is made up of Polygoni cuspidati rhizoma et radix,Forsythiae fructus,Isatidis radix,Verbenae herba,Dahurian patrinia herba,Bupleuri radix,Phragmitis rhizome and Glycyrrhizae radix et rhizome,are used for the treatment of fever,nausea,sore throat,headache,stuffy nose,turbid nasal discharge and cough because of the wind heat syndrome of acute upper respiratory tract infection.The current quality standard of Shufeng Jiedu Capsule only contains the character,identification and TLC scanning method for the determination of emodin.It is difficult to effectively control the quality of the product.In view of the existing problem of Shufeng Jiedu Capsule quality standard system,this paper carried out the study on the quality standard of Shufeng Jiedu Capsule on promoting.Specific researches are as follows:1.The identification of main herbal medicines: According to the current quality standard of Shufeng Jiedu Capsule and other relevant literatures,we improved the TLC identification methods of Forsythia suspense and Verbena in the original standard of Shufeng Jiedu Capsule,and added the TLC identification method of Licorice.The established TLC identification methods have good repeatability and specificity,the spot color is clear,and the result is easy to judge.The methods can be used for the qualitative identification of Forsythia suspense,Verbena and Licorice in Shufeng Jiedu Capsule.2.The screening of anti-inflammatory active substances: we studied on the anti-inflammatory effects of each part in the UPLC fingerprint of Shufeng Jiedu Capsule and ascertained the anti-inflammatory active components.This provided the basis for the choice of quality control index.3.The determination of multi components’ content: We established a method for the determination of multi components in Shufeng Jiedu Capsule for the first time.The method can do the simultaneous determination of hastatoside,verbenalin,polydatin,ofrsytlloside A,verbascoside,ammonium glycyrrhizinate and emodin in the Shufeng Jiedu Capsule at the same chromatographic condition.This method is of high sensitivity and good repeatability,reliable,simple and easy to operation.We established a comprehensive and effective method for the quality control of the product.The 7 components in 14 batches of Shufeng Jiedu Capsules was determined by this method.4.The study on fingerprint: We studied on the fingerprints of 14 batches of Shufeng Jiedu Capsule by using the method of HPLC.A total of 22 common peaks were identified.The relative retention time and relative peak area of the common peaks were used to calculate the method’s precision,repeatability and stability.The standard fingerprint and technical parameters of Shufeng Jiedu Capsule were also established.We evaluated the fingerprint of Shufeng Jiedu Capsule by using principal analysis.We also found out the origins of 22 common peaks by means of the control study on the fingerprints of Shufeng Jiedu Capsule,the medicinal materials and the corresponding negative samples.The results showed that eight components are from Polygoni cuspidati rhizoma et radix,six components are from Forsythiae fructus,three components are from Verbenae herba,two components are from Glycyrrhizae radix et rhizome,and one component is from Dahurian patrinia herba.The experiment identified the common chromatographic peaks of the fingerprint throughing the method of Liquid chromatography-mass spectrometry.In summary,from the quality control aspect,the study comprehensively improved the quality standard of Shufeng Jiedu Capsule by the methods and technologies of TLC,Screening of anti-inflammatory active substances,determination of multi index content,fingerprint.This is benefit to ensure the stable uniformity,safety and effectiveness of Shufeng Jiedu Capsule.