The Key Issuess Of Quality Control Of Two Traditional Chinese Medicine Injections

Quality control of traditional Chinese medicine injection is one of the core problems facing the modernization of traditional Chinese medicine.In this study,the commonly used Kumu Injection and Xiyanping Injection were used as research objects,and the blanks and defects of the current quality standards of the two traditional chinese medicine injections were supplemented and improved.In this paper,based on the color reaction of polyethoxy group and cobalt thiocyanate in Tween 80 to form blue complex soluble in organic solvent,the key conditions such as color reaction temperature,time and extraction of organic solvent were optimized.A colorimetric method for the rapid and accurate quantitative determination of Tween 80 in Kumu injection was established.Under the optimized conditions,the Tween 80 content in the range of 0.8³.0 mg showed a good linear relationship with the absorbance?y=0.258x-0.047,r=0.9996?,RSD<2%,and the average recovery rate was 99.7%.The method can quickly and accurately determine the content of Tween 80 in the pharmaceutical preparation,and provides a reliable technical means for the quality control of the traditional Chinese medicine injection.To establish a method for the determination of total sulfonate content of andrographolide in Xiyanping injection.The content of andrographolide total sulfonate in the sample was determined by UV with andrographolide sulfonate E as the control at 262nm.Andrographolide sulfonate E has a good linear relationship?r=0.9998?in the range of0.02⁰.2 mg/mL,the average recovery rate is 99.8%,and the RSD is 2.5%?n=9?.The method is suitable for the determination of total sulfonate of andrographolide in Xiyanping injection.A headspace capillary GC method was established for the determination of the residualsolvents in Xiyanping injection.The Chromatographic conditions adopted were ZB-1 capillary column,with nitrogen as carrier gas and FID as detector.The temperature programand split injection mode were used.The calibration curves of ethanol was had a good linear relationship in 40¹60?g/mL?r=0.9989?.The average recovery was 100.3%?RSD=3.2%,n=9?.The detection limit was 2.0?g/mL,the limit of quantification was 8.0?g/mL.The established method is accurate,rapid and sensitive.The determination results reflect the residual amount of organic solvents in Xiyanping injection,which provides a basis for its quality evaluation.A method for rapid determination of sodium sulfate in Xiyanping injection by ion chromatography was established.Anion column Metrosep A Supp 5-250/4.0 and eluent1.0 mM NaHCO₃;3.2 mM Na₂CO₃;5%acetone for SO₄^2-detection;The linear relationship is good in the 4⁴0ppm concentration range.The method was applied to the determination of Na₂SO₄ in Xiyanping.The average recovery rate was 103.8%and RSD=2.0%.The method is simple and rapid,and the sample has good precision.The molecular docking software of Autodock and Ligplus were used to evaluate the interaction between allergenic proteins and components of Xiyanping injection.The four potential allergenic components of Xiyanping injection were screened according to the binding mode and binding energy of the compound with Fc?RI receptor by cell membrane chromatography,which provided a preliminary reference for the study of allergenic substances of Xiyanping injection.In summary,this paper systematically studies the gaps and defects of a series of key problems in the quality standards of two traditional Chinese medicine injections.In order to improve the Tween 80 content determination method based on literature research,a rapid and efficient colorimetric method was applied to the quantitative determination of Tween 80 for pharmaceutical excipients.For the defects of the original determination method of the total sulfonate content of the anti-andrographolide injection,the UV-visible spectrophotometry was established to determine the total sulfonate content of andrographolide.A headspace capillary gas chromatographic method was established for the determination of residual organic solvents in Xiyanping injection.The method is simple and accurate.An ion chromatography method was established to determine the content of sodium sulfate by-product in Xiyanping injection.The above establishment method was tested for multiple batches of products.According to the analysis results of multi-batch products,the quality control limits of each project were formulated to provide reliable technical means for the production and quality control of the two traditional Chinese medicine injections.