固态制剂制粒过程控制

Solid preparation granulation process control

随着我国医疗卫生水平的不断提高,我国对于各类药品的需求量也不断加大,对于制药工程的要求也越来越高。目前应用最为广泛的是固体制剂,固体制剂与其他形态的制剂相比,有着诸多优点,比如:制造成本低、便于储存、运输、药物起效快等。但是,要想真正做好固体制剂的研发和生产工作,需要诸多努力。对于固体制剂来说,制粒的生产过程是关键的环节。如果制粒过程出现问题,就很难生产出合格的固体制剂。因此,应对固态制剂制粒过程进行严格控制。分析固态制剂制粒过程控制的几个方面,分析如何做好固态制剂制粒过程控制工作,提出相应的控制措施,希望可以为相关部门和人员提供一定的帮助。

With the continuous improvement of China’s medical and health level,China’s demand for all kinds of drugs is also increasing,and the requirements for pharmaceutical engineering are also increasing.At present,solid preparations are widely used.Compared with other forms of preparations,solid preparations have many advantages,such as low manufacturing cost,easy storage,transportation,rapid onset of drugs and so on.However,many efforts are needed to make solid preparations for research and production.For solid preparations,the production process of granulation is a key step.If there is a problem in granulation process,it is difficult to produce qualified solid preparations.Therefore,the solid granulation process should be strictly controlled.This paper analyzes several aspects of solid preparation granulation process control,analyzes how to do a good job in solid preparation granulation process control,and puts forward corresponding control measures,hoping to provide some help for relevant departments and personnel.