There are many kinds of drugs, which can be divided into solid, semi-solid, liquid and gas dosage forms. Among them, solid preparation accounts for about 70% of all drugs, which is the main dosage form of drugs. It has the advantages of good physical and chemical stability, low production cost, easy to take and carry, so it is welcomed by patients.
Drug solid preparation is based on drug powder as the starting material. In order to ensure the product quality and smooth production process of solid preparation, it is often necessary to process and treat drugs, such as crushing, grading, mixing, granulation, drying, tablet pressing, etc. In the production process of solid pharmaceutical preparations, granulation is a very important process.
According to the understanding of the traditional granulation process, it is easy to use the mixing drying oven to affect the product quality. In order to strengthen the supervision and management of drug production and drug quality, and ensure the safety of patients, China has implemented the GMP certification system. Under this system, the design of plant and equipment configuration, water, ventilation and air conditioning system, warehouse conditions, production management and quality management file system, organization and other aspects are facing more stringent requirements It also includes the requirement to prevent cross contamination.
In this context, the traditional granulation process obviously can not meet the requirements of certification enterprises, and gradually become unpopular, and a new "efficient wet granulation boiling drying" production process was born, its obvious characteristics are: high production efficiency, short cycle, and in line with GMP requirements, at present this new granulation process is widely recognized and applied by pharmaceutical enterprises.
The production process of "high efficiency wet granulation boiling drying" includes two parts: high efficiency wet granulation and boiling drying. The high efficiency wet granulation refers to the granulation process of mixing humidifying stirring high speed cutting granulation in the same equipment container, which is characterized by avoiding cross pollution, convenient operation, reducing labor intensity and meeting the GMP requirements. The boiling drying is the best process The dried granular material is in boiling state in the clean hot air flow. Through the heat exchange between the hot air and the material, the rapid drying of the material is realized.
It is worth mentioning that although the advantages of the new pelletizing process are prominent, the key to the normal use of the new process equipment is the success of debugging. Many users report that the quality problems such as "too many material heads" often appear in the commissioning process of the wet granulation and boiling drying equipment, which seriously affect the granulation effect.