Methodological Study Of The Bacterial Endotoxins In The Matrine & Glucose Injection

The current quality control standard of Matrine and Glucose Injection is the one standard approved by State Food and Drug Administration. According to the standard, the pyrogen is determined in rabbit pyrogen test. Matrine and Glucose Injection composed of matrine and glucose sterile aqueous solution is applied to improve the abnormality of aminopherase and bilirubin caused by chronic hepatitis.There is some irritation of Matrine and Glucose Injection. When carrying out the experiment in rabbit pyrogen test, the rabbit will be restlessness, so the result tends to be affected. Thus, the objective of the research is to study the feasibility that replace the bacterial endotoxin test with the pyrogen test. In addition, we will establish a method to test the bacterial endotoxin in Matrine and Glucose Injection. Therefore , we can get the reasonable data to regularize the quality control standard.Bacterial endotoxin test is a method that is used to detect or quantitatively determine the bacterial endotoxin produced by Gram-negative bacteria with tachypleus amebocyte lysate, so that we can judge if the quantitative limitation of bacterial endotoxin in the simple products accords with the standard. Bacterial endotoxin test includes two methods: microcolumn gel assay and spectrophotometry. The latter also includes turbidimetric method and chromogenic substrate method. Bacterial endotoxin test has aroused the interest of drug administration in many countries, and has been extensively applied and developed in quantitative limitation of pyrogen. Especially, since the bacterial endotoxin test was recorded in Pharmacopoeia of the People's Republic of China (2005 Edition), the test has been assured, applied and extended as well as its future development in China.The research is based on the knowledge of the bacterial endotoxin, introducing the concept, chemical constitution and ingredient, bioactivity, pathopoiesis mechanism. By referring to the bacterial endotoxin test in the appendix XI E of the second section of Pharmacopoeia of the People's Republic of China (2005 Edition), the experimental condition was formulated, namely, there was no interference from bacterial endotoxin test using the microcolumn gel assay when the product was diluted two times. Also, there was no interference using the turbidimetric method when the product was diluted eight times. For the reasons, the method used to detect the bacterial endotoxin in Matrine and Glucose Injection was established. Meanwhile, we exploited the possible influential factors on the test, and took the correlated means to analyze and resolve them.The bacterial endotoxin test that we established according to the experimental results is fast, simple, practical with good repeatability and high sensitivity. Replacing the bacterial endotoxin test with the pyrogen test is practical and it can be applied to quantitative determination of the bacterial endotoxin.