Establishment Of Characteristic Chromatogram Of The Compound Phellodendron Gel And Its Quality Evaluation

The compound Phellodendron liquid coating(Fufang Huangbaiye Tuji)is an exclusive product of Shandong Hanfang Pharmaceutical Co.,Ltd..It is good effective in the field of post-ulcer treatment for many years,and has been widely used in dermatology,gynecology,proctology and pediatrics for many years,especially in children eczematosis,impetigo,atopic dermatitis treatment.Moreover,the expert consensus was formed in a compound Phellodendron liquid coating treatment of children eczematosis,impetigo,atopic dermatitis in 2016[1].However,there are some defects in the application of compound Phellodendron liquid coating in pediatrics.Firstly,the compound Phellodendron liquid coating is liquid,which is inconvenient for children to apply with a wet dressing.In order to improve the above-mentioned defects of the compound Phellodendron liquid coating,we improved the formulation of the compound Phellodendron liquid coating and developed the compound Phellodendron Gel preparation.In this paper,the quality standard of the compound Phellodendron Gel was studied on the basis of the quality standard of the compound Phellodendron liquid coating.The standard of the compound Phellodendron liquid coating refers to the corresponding standard of the compound Phellodendron liquid coating in Chinese Pharmacopoeia 2020 edition,in which the qualitative identification of forsythia suspense and forsythin,Phellodendron chinensis cortex,berberine hydrochloride,Lonicerae jappnicae flos and Taraxaci herba are carried out by using thin layer chromatography(TLC),and the contents of phillyrin and berberine hydrochloride were determined by high performance liquid chromatography(HPLC).There is no characteristic chromatogram for its quality control in the current quality standard,which could not fully reflect the quality of the compound Phellodendron liquid coating.Additionally,there is no quantitative method for the determination of the target components in Lonicerae jappnicae flos and Taraxaci herba,and no qualitative identification or quantitative determination method was established for the ScolopendraIn order to improve the quality standard of the compound Phellodendron liquid coating,the quality standard of compound Phellodendron gel was studied as follows:(1)Scolopendra has been proved to play an indispensable role in the pharmacodynamics study of the compound Phellodendron liquid coating in the treatment of eczema.In the screening process of the compound Phellodendron gel,we compared the pharmacodynamics of Scolopendra,Bombyx Batryticatus and Pheretima,and found that the efficacy of Scolopendra is obviously better than other animal drugs.But there is no quality control of Scolopendra in the standard of the compound Phellodendron liquid coating.In view of this defect,during the establishment of the quality standard of the compound Phellodendron gel,we focused on the exclusive identification of Scolopendra,and the purpose of identifying the specificity of centipedes is realized by the identification of peptide components in the preparation;(2)The method of HPLC characteristic chromatogram of the compound Phellodendron gel was studied and established,and 14 common characteristic peaks were determined at 278nm and 325nm by "fingerprint similarity Evaluation System 2012 edition",the characteristic peaks of the compound Phellodendron gel were identified,and the chromatographic chromatograms of 10 batches of the compound Phellodendron gel were analyzed and discussed.Using dual-wavelength to study the characteristic chromatogram of the compound Phellodendron gel,the chromatographic peak separation and characterization effect can be better realized,the more comprehensive and richer component’s information can be indicated,and the effective quality control and evaluation of the compound Phellodendron gel can be achieved.(3)A method of characteristic chromatogram of the compound Phellodendron gel was also used for the determination of phillyrin,berberine hydrochloride and chlorogenic acid,and the contents of three components in three batches of samples were determined.The corresponding method validation was also carried out.In the compound Phellodendron liquid,only forsythin in Forsythiae fructus and berberine hydrochloride in Phellodendron were quantified,and phenolic acids in Lonicerae jappnicae flos and Taraxaci herba were not quantitatively analyzed.We achieved the purpose of determining the contents of forsythin,berberine hydrochloride and chlorogenic acid in the preparation under the same chromatographic conditions used in the characteristic chromatogram of the compound Phellodendron gel,and realized the quality control of the four medicinal materials in the prescription.Compared with the compound Phellodendron liquid,the safety,effectiveness and quality controllability of the compound Phellodendron gel has been significantly improved.