第三章 灭菌与无菌制剂.ppt

第三章 灭菌与无菌制剂 Preparations of sterilization and sterility 第一节 概 述 By definition, a sterile preparation is described as the absolute absence of microbial contaminants. Certain pharmaceutical preparations, medical devices and items for which usage involves contact with broken skin, mucosal surfaces or internal organs are required to be sterile. Microbiological materials, such as soiled dressings and other contaminated items, also need to be sterilized before disposal or reuse. Sterilization is the process by which a product is rendered sterile, i.e. the destruction or removal of microorganisms. Most preparations can be sterilized in their final container or packaging. Certain processes will achieve terminal sterilization through the destruction of the microorganisms, for example by physical means such as heat and radiation or a combination of physical and chemical means (e.g. gaseous sterilization). However, such processes can be detrimental for the chemical composition of certain preparations. For these sensitive preparations or for preparations to which an additional component is added aseptically, the process of non-terminal sterilization, which is based on aseptic filtration, is used. NEED FOR STERILITY Certain pharmaceutical preparations, medical products and devices are required to be sterile. Briefly, these include: Injections - intravenous infusion, total parenteral nutrition (TPN), small-volume injections and small-volume oily injections non-injectable sterile fluids - non-injectable water, urological irrigation solutions, peritoneal dialysis and haemodialysis solutions, inhaler solutions ophthalmic preparations - eye drops, lotions and ointments and some contact lens solutions dressings implants absorbable haemostats surgical ligatures and sutures (absorbable and non-absorbable) instruments and equipment - syringes, metal instruments, respirator parts. 灭菌与无菌制剂主要是指直接注入体内或直接接触创伤面、粘膜等的一类制剂。 这类制剂直接作用于人体血液系统，在使用前必须保证处于无菌状态。 基本概念： (1)灭菌