Focusing on the production of solid pharmaceutical preparations, granulation is an important process

There are many kinds of medicines, and if they are classified by physical state, they can be divided into solid, semi-solid, liquid and gas dosage forms. Among them, solid preparations account for about 70% of all medicines, and are the main dosage forms of medicines. They have the advantages of good physical and chemical stability, low production and manufacturing costs, and easy to take and carry. Therefore, they are well received by patients.

Pharmaceutical solid preparations use medicinal powder as the starting material. In order to ensure the product quality of solid preparations and the smooth progress of the production process, it is often necessary to process and process the medicines, such as crushing, grading, mixing, granulating, drying, and tablet pressing. Among them, granulation is a very important process in the production process of pharmaceutical solid preparations.

It is understood that in the past, the traditional granulation process generally used "mixing and stirring-swing granulation-oven drying". The disadvantages of this process are weak production capacity, cumbersome operation, and prone to cross-contamination, which affects the quality of products. Safety. In order to strengthen the supervision and management of drug production and drug quality and ensure the safety of patients' medication, my country has implemented the Good Manufacturing Practice (GMP) certification system. Systems, warehouse conditions, production management and quality management documentation systems, and organizational structures are all facing stricter requirements, including requirements to prevent cross-contamination.

In this context, the traditional granulation process obviously cannot meet the conditions of certified enterprises, and gradually becomes unpopular, and a new production process of "high-efficiency wet granulation-boiling drying" was born. Its obvious characteristics are that : High production efficiency, short cycle, and compliance with GMP requirements. At present, this new granulation process is being widely recognized and applied by pharmaceutical companies.

The production process of "high-efficiency wet granulation-boiling drying" includes two parts: high-efficiency wet granulation and boiling drying. Among them, high-efficiency wet granulation refers to the simultaneous mixing-humidification-stirring-high-speed cutting granulation and other processes in the same equipment container. The granulation method is characterized by avoiding cross-contamination, easy operation, reducing labor intensity, and meeting GMP requirements; boiling drying means that the dried granular material is in a boiling state in a clean hot air flow, and the hot air and the material are in a boiling state. Heat exchange to achieve rapid drying of materials.

It is worth mentioning that although the advantages of the new granulation process are prominent, the key to whether the new process equipment can be used normally is the key to the success or failure of debugging. Many users reported that the above-mentioned wet granulation and boiling drying equipment often have quality problems such as "too many feeds" during the debugging process, which seriously affects the granulation effect.

In order to solve the quality problems such as "too many feeds" in the trial production and commissioning, some domestic manufacturers have also started from the working principles of wet granulation and boiling drying, combined with the traditional granulation process, and carried out experimental analysis and discussion on boiling drying. Commissioning of the new wet granulation and boiling drying equipment, and improvements were made to the problems that occurred during the commissioning of the equipment.

There are also companies that have designed a wet granulation boiling and drying in-line unit through extensive absorption and combination of domestic and foreign solid preparation production process characteristics, which are wet granulator, boiling dryer, dry granulator, The material conveying, mixer, etc. are effectively combined, and the new model is developed according to the actual production demand worldwide. The structure is reasonable and the performance is stable. It also avoids the problem of "too many materials", and is suitable for the previous process such as tablets and capsules. and the production of granules

In general, under the background of increasing aging and consumption upgrading, the market demand for solid pharmaceutical preparations will also continue to grow. Pharmaceutical equipment also needs to keep pace with the times and constantly upgrade to meet the production requirements of higher quality products.