In the development of traditional Chinese medicine, the modernization of traditional Chinese medicine has always been the goal pursued by the industry. To achieve modernization, gradually improving the traditional Chinese medicine dosage forms into more advanced dosage forms is the only way for the industry. The adoption of one-step granulation high-tech is undoubtedly one of the modernization contents of traditional Chinese medicine preparations.
The so-called one-step granulation (also known as fluidized bed control and boiling granulation) uses clean hot air to blow the solid particles in a closed container from the bottom, and the powder particles are regularly and complicatedly flowed up and down from the fixed bed to the fluidized bed. After the mixing and mixing are achieved, the wetting and adhesive agent is sprayed by a spray gun to form small particles and dried in a fluidized bed.
One-step granulation equipment was developed and applied abroad in the 1980s. At present, many domestic enterprises have equipped such equipment for the production of western medicines, and it is still rare to report on the successful production of traditional Chinese medicine preparations.
With the advancement of one-step granulation technology, it is less likely that the migration will cause uneven content (relative to the dry box particles) but it cannot prevent the migration within the particles. The outer layer content is higher than the inner layer, and the particles are ground to a fine powder, which also loses the active ingredient. The solution to the problem is to select new pharmaceutical excipients, increase the affinity for soluble components, and prevent or reduce migration. After screening, the use of CMS-Na and outsourced CMC-Na is used. The former quickly forms swelling when wet to prevent component migration. The latter forms film-wrapped particles, solidifies the particles, and greatly stabilizes the quality index. Experimental data verify that the content of whole fine powder is reduced to prevent the loss of effective ingredients and improve the level of preparations.
Reasonable process and technical measures to improve the SOP level. The use of the most unstable ingredients in prescriptions can be outsourced, which is an effective process. Other technical measures Conditions, temperature and spray speed, pressure and droplet size, fluidization height, and flap size, etc., can be balanced according to the material properties and the granulation time requirements, and the parameters are balanced to achieve stable operation. Technical parameters can be detected and controlled online to realize one-step granulation production of heat-sensitive and water-sensitive materials such as traditional Chinese medicine compound particles.
The one-step granulation technology not only reflects the level of preparation, but also directly affects the bioavailability of the drug in vivo. One-step granulation lays a solid foundation for the modern production, high-quality production, innovative production and international integration of traditional Chinese medicine preparations, and at the same time, it also creates conditions for reducing costs and enhancing the level of competition among enterprises.
The so-called one-step granulation (also known as fluidized bed control and boiling granulation) uses clean hot air to blow the solid particles in a closed container from the bottom, and the powder particles are regularly and complicatedly flowed up and down from the fixed bed to the fluidized bed. After the mixing and mixing are achieved, the wetting and adhesive agent is sprayed by a spray gun to form small particles and dried in a fluidized bed.
One-step granulation equipment was developed and applied abroad in the 1980s. At present, many domestic enterprises have equipped such equipment for the production of western medicines, and it is still rare to report on the successful production of traditional Chinese medicine preparations.
With the advancement of one-step granulation technology, it is less likely that the migration will cause uneven content (relative to the dry box particles) but it cannot prevent the migration within the particles. The outer layer content is higher than the inner layer, and the particles are ground to a fine powder, which also loses the active ingredient. The solution to the problem is to select new pharmaceutical excipients, increase the affinity for soluble components, and prevent or reduce migration. After screening, the use of CMS-Na and outsourced CMC-Na is used. The former quickly forms swelling when wet to prevent component migration. The latter forms film-wrapped particles, solidifies the particles, and greatly stabilizes the quality index. Experimental data verify that the content of whole fine powder is reduced to prevent the loss of effective ingredients and improve the level of preparations.
Reasonable process and technical measures to improve the SOP level. The use of the most unstable ingredients in prescriptions can be outsourced, which is an effective process. Other technical measures Conditions, temperature and spray speed, pressure and droplet size, fluidization height, and flap size, etc., can be balanced according to the material properties and the granulation time requirements, and the parameters are balanced to achieve stable operation. Technical parameters can be detected and controlled online to realize one-step granulation production of heat-sensitive and water-sensitive materials such as traditional Chinese medicine compound particles.
The one-step granulation technology not only reflects the level of preparation, but also directly affects the bioavailability of the drug in vivo. One-step granulation lays a solid foundation for the modern production, high-quality production, innovative production and international integration of traditional Chinese medicine preparations, and at the same time, it also creates conditions for reducing costs and enhancing the level of competition among enterprises.
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Xinxiang Zhenying Mechanical Equipment Co., Ltd , https://www.beltconveyor.nl