文档介绍：ANNEX 10 附件 10 MANUFACTURE OF PRESSURISED METERED DOSE AEROSOL PREPARATIONS FOR INHALATION 吸入式压力型带计量阀的气雾剂的生产 Principle 原则 The manufacture of pressurised aerosol products for inhalation with metering valves requires special consideration because of the particular nature of this form of product. It should be done under conditions which minimise microbial and particulate contamination. Assurance of the quality of the ponents and, in the case of suspensions, of uniformity is also of particular importance. 吸入式压力型带计量阀的气雾剂产品的生产,由于该产品的特殊性质,要予以特别注意。应在减少微生物和尘埃粒子污染的环境下进行生产。要保证阀门部件的质量,如果是混悬液制剂,保证其均匀性也特别重要。 General 一般要求 1. There are presently mon manufacturing and filling methods as follows: a. Two-shot system (pressure filling). The active ingredient is suspended ina high boiling point propellant, the dose is put into the container, the valve is crimped on and the lower boiling point propellant is injected through the valve stem to make up the finished product. The suspension of active ingredient in propellant is kept cool to reduce evaporation loss. 常用的生产方法有如下两种: a. 二次注入法( 压力灌装)。活性成分混悬在高沸点推动剂中, 药物放入容器, 装上阀门, 然后通过阀门注入低沸点推动剂,从而制成终产品。在推动剂里面的活性成分保持低温状态,防止蒸发的损失。 b. One-shot process (cold filling). The active ingredient is suspended ina mixture of propellants and held either under high pressure or ata low temperature, or both. The suspension is then filled directly into the container in one sho