论文部分内容阅读
采用传统的加热或化学方法对片剂灭菌都不理想,因为会使片剂发生变色、花斑、裂口等外观性状变化或有效成份改变等。本试验用~(60)钴-γ射线辐照肝血宁糖衣片观察对杂菌的灭菌效果,探讨其最适辐射剂量,并对灭菌前后糖衣片进行质量对比分析。内容及方法一、受试物选经杂菌检验不合格的肝血宁糖衣片作受试物。二、灭菌方法采用~(60)钴-γ射线辐照灭菌,以3、5、7、9 KGY不同总辐射剂量射照灭菌(采用PTW两用仪(西德)测定剂量)。三、细菌检验对不同辐射剂量辐照前后的受试物均进行细菌培养并计算其杂菌数(个/克)。采用卫生部药品卫生检验方法。四、质量分析对辐照前后受试物均进行
The use of traditional heating or chemical methods are not ideal for tablet sterilization because of the appearance of discoloration, speckles, rips and other changes in appearance or changes in active ingredients. In this experiment, the effect of sterilization on the bacteria was observed with ~ (60) Co-γ-ray irradiation on the Hepatic blood sugar-coated tablets, and the optimum radiation dose was explored. The quality comparison of sugar-coated tablets before and after sterilization was carried out. Content and methods First, the test material selected by miscellaneous bacteria test Hepang Ning sugar-coated tablets for the test substance. Second, the sterilization method using ~ (60) cobalt-gamma irradiation sterilization, with 3,5,7,9 KGY different total radiation dose sterilization (PTW dual-use instrument (West Germany) to measure the dose). Third, bacterial test Radiation before and after irradiation at different doses of bacteria were cultured and calculate the number of bacteria (a / g). Using the Ministry of Health drug testing methods. Fourth, quality analysis Before and after irradiation of the test substance are carried out