Study On Quality Detection And Stability Of Hydroxyethyl Starch130/0.4

Hydroxyethyl starch130/0.4is the major substitute for blood plasma in the medical market. With the growing demand of hydroxyethyl starch, to facilitate the comprehensive, effective and stable quality control of hydroxyethyl starch, this thesis analyzes such quality control method, thus contribute to the scientific support for the promotion of the quality of hydroxyethyl starch and related products. The mainly results are as follows:(1) Based on the test method stipulated in the appendix of People’s Republic of China Pharmacopoeia, a test on the quality of hydroxyethyl starch130/0.4API was made. It is found that raw hydroxyethyl starch130/0.4API is in the form of white powders, odorless, tasteless, with high hygroscopicity, and easy to dissolve in hot water, and almost insoluble in methanol, acetone and chloroform. Its specific rotation ranges between+185.64degrees and+188.18degrees, and its intrinsic viscosity number between15.4to15.7.(2) chemical identification experiments shows that the test article is starchy material. Such method is for qualitative identification only. Infrared identification method shows that the infrared spectroscopic test result of the test article and that of the reference substance are basically the same, with no significant difference. Thus it is concluded that the test article and the reference substance are identical.(3) Gas chromatography was adopted to establish analysis of the epoxy ethane and ethylene glycol in hydroxyethyl starch130/0.4. Epoxy ethane has a good lineal relation within the range of0.502μg/mL～1.506μg/mL; its repeatability test of RSD is2.4%; it maintains good stability after having been stored in a dark place for1hour, with the RSD being2.9%, which meets the requirements; Ethylene glycol has a good lineal relation within the range of0.01864mg/mL～0.04349mg/mL; its repeatability test RSD is2.9%; it maintains good stability after having been stored in a dark place for8hours, with the RSD being3%, which meets the requirements; neither epoxy ethane and ethylene glycol residues were detected in the test article. Through the silver nitrate titration method for the detection of sodium chloride, it is found that the percentage of sodium chloride is not more than0.21%. Through the UV visible spectrophotometric absorption degree examination, it is found that the absorption rate of none of samples of the solutions within400nm absorption is more than0.038. The clarity examination method shows that all of the test solutions are thinner than Turbidity Standard Solution Nol. HPGPC method was adopted for the determination of molecular weight and distribution of hydroxyethyl starch130/0.4. Epoxy ethane has a good lineal relation; its repeatability test of RSD is1.8%; it maintains good stability after having been stored for8hour, with the RSD being1.8%, which meets the requirements.(4)Through polarimetric analysis, the method for test of the content of hydroxyethyl starch130/0.4was established. Hydroxyethyl starch130/0.4within the concentration range of0.4014g/100mL～1.6007g/100mL has a good lineal relation. Its repeatability test RSD is2.9%; it maintains good stability after having been stored in a dark place for8hours, with the RSD being0.3%. The average percentage of hydroxyethyl starch130/0.4in the test article is99.56%..(5) Stability study of hydroxyethyl starch130/0.4shows that the goods should be stored in a hermetic, moisture-proof and dry place.