| Thymalfasin is a polypeptide compound which is composed of 28 kinds of amino acids linked by manual.immune regulation often used in clinical medicine.It is mainly used for the treatment of hepatitis,chronic bronchitis and various cellular immune dysfunction diseases.In order to control the quality of the products,the thymalfasin performed a series of experiments,.Including the character,identification,clarity and colour of solution,moisture,specific rotation and acetonitrile residue content,respectively,by using chemical method,HPLC,solution clarity inspection method,determination of moisture content and polarimetry of thymalfasin detection.Where thymalfasin acetonitrile residual amount determined by gas chromatography method.To see whether these test items to meet the specified standard on thymalfasin method in the 2010 edition of pharmacopoeia.In addition,Study on related substances of thymalfasin,to determine the separation effect of main components and impurities.In the quantitative analysis,high performance liquid chromatographic method for the content determination,the establishment of a verification methodology to determine the quality standards.The experimental results are as follows:(1)Identification:The chromatogram with HPLC to determine the content of the display,the main peak retention times of the test solution are consistent with the main peak retention times of the reference solution.(2)In the control items,thymalfasin quality testing in line with the Pharmacopoeia;test results clarity and color of the solution indicates that the solution colorless turbid,the turbidity shallower than the 1st turbidity standard solution;result of determination of moisture content:Thymalfasin moisture content was 2.6%;The specific rotation test results measured value is-106°,conforms to the Pharmacopoeia.Gas chromatographic determination of acetonitrile residue test results:the samples failed to detect the content of acetonitrile,the provisions of the Pharmacopoeia Drug acetonitrile containing not more than 0.041%,so the results meet the requirements;HPLC method for the determination of related substances test results show that,containing impurity chromatogram of the test solution.blank solvent had no interference on the peak,in addition to the solvent peak and peak of acetate,the single impurity peak area is less than the control solution peak area(1.0%),the peak area of each impurity peak area is less than the sum of the peak area of the control solution 3 times(3.0%);Description of the main components of the thymalfasin and impurities can be well separated;above the detection projects are in line with Pharmacopoeia requirements.(3)Determination of the content of research methods,have good repeatability,thymalfasin at 4.887?g/ml?48.87?g/ml concentration range,there is a good linear relationship between concentration and peak area.The average recovery was 99.06%,RSD was 0.16%(n=6),a better description of the recovery;same sample precision is also very good;sample solution was stable within 8 hours.In the determination,the anhydrous acetic acid and no matter calculations thymalfasin content is 98.1%,relative to the average deviation of 0.6%.Comply with the pharmacopoeia.Final conclusion:In related substances,this method can make the main components and more impurities can be separated very well,and can effectively control the quality of products;content was determined by high performance liquid chromatography,the result was 98.1%.Specificity test result analysis,the main component peak and impurity peaks can be well separated,and the separation was more than 1.5,indicating highly specific;through systematic tests,the quality research of the thymalfasin that the method is feasible,specificity,repeatability,accuracy,and ease of testing,product quality can be more effectively controlled. |
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