One step granulation and application is the hope of modern preparation of traditional Chinese Medicine

Changzhou fengneng drying is an enterprise with unique design and continuous innovation in drying industry in China! One step granulator produced by Changzhou fengneng drying equipment Engineering Co., Ltd (also known as fluidized bed control and boiling granulation) the system uses clean hot air to boil the solid powder particles in the closed container from the bottom The powder particles flow up and down from the fixed bed to the fluidized bed in a regular and complex way to achieve the purpose of mixing Then the wetting and adhesion agent is injected by the spray gun to form small particles, which are dried in the fluidized bed It combines the mixing, wetting, soft material making, particle scraping, drying and other processes in the traditional granulation in the same container to complete the granulation production in the ideal GMP environment, so it is called one-step granulation Its equipment was developed and applied abroad in 1980s At present, many enterprises in China have equipped such equipment, which is widely used in the production of Western medicine preparations, and the report on the successful production of traditional Chinese medicine preparations is rare The new one-step granulator improved by fengneng drying company on the basis of absorbing advanced technology at home and abroad is an ideal drying equipment for traditional Chinese medicine preparation The equipment meets GMP specifications through powder granulation, improvement of fluidity and reduction of dust flying Due to the different physical properties of the powder raw materials (including crude drug powder, crude extract and powder, standardized extract, monomer compound, etc., the same below), it will be difficult to mix homogeneity In particular, the components of traditional Chinese medicine compound (including monomer compounds and soluble components that can be dissolved in wetting agent) have the phenomenon of migration of soluble components (referring to the fact that the wet particles themselves have been mixed evenly, but the content of each effective component is uneven after drying) This is a new problem in the process of modernization of traditional Chinese medicine, that is, the "particularity" of traditional Chinese medicine, which is still used by enterprises With the traditional method of production, the enterprise GMP certification allows to retain the traditional process production line of traditional Chinese medicine solid preparation The so-called "particularity" is actually a persistent disease in the production of traditional Chinese medicine and an obstacle to the modernization of traditional Chinese medicine Therefore, we are afraid of new equipment and technology In fact, enterprises call for modern preparation of traditional Chinese medicine, which requires innovative production, production and Realization of technological level in line with international standards This is the renewal of thinking and concept, and the driving force for the renewal of traditional technology Our pharmaceutical workers have the responsibility and obligation to complete the promotion and application of new equipment and new technology, so as to promote the secondary development of traditional Chinese medicine products and the design and development of modern preparation production We have the responsibility to formulate one-step standard operation procedure SOP and technical measures and conditions for granulation of water sensitive and thermal sensitive powder raw materials This time, we focus on the influence of mixing and content uniformity, preventing the migration of soluble components, selection and use of wetting adhesive, process prescription factors, technical measures and other factors on the one-step granulation particle forming and particle quality 1、 It is the basis of content uniformity for the application of mixed engineering and the prevention of the migration of soluble components For more than species, not only the proportion of materials varies greatly, but also the main components are considered as small dosage components in the prescription The quantitative component and qualitative three components have the phenomenon of soluble component migration, so it is easy to cause the problems of unstable mixed uneven content, which is a big obstacle for the modern preparation of traditional Chinese medicine For the drugs with small content in the preparation, due to the addition of many excipients, it is objective that the drugs and excipients are not easy to mix evenly Modern production of one-step granulation can not ignore it The difference of the specific gravity of each component is another important problem In the process of fluidization, the fluidization height of the material with small specific gravity is higher than that of the material with large specific gravity, and the distance between them is widened Even the small dose components are concentrated in the dust bag, which can not guarantee the even mixing and even the loss of effective components The migration of effective components runs through the whole process from the beginning of mixing to the end of granulation and drying, especially the migration within the particle itself after forming The effective components are higher in the outer layer than in the inner layer of the particle Due to the collision and grinding between fluidizing particles, the fine powder with high effective components is easily ground off from the particle surface, so the particle content is low Therefore, it is necessary to pay attention to mixing as a system engineering and take comprehensive measures for one-step granulation and mixing For example, the materials with small specific gravity, the ingredients with small dosage in the prescription and the components that can be migrated should be protected; then, the materials can be mixed in the fluidized bed with low temperature, low humidity and low fluidization for a certain period of time, which can better complete the mixing engineering of different traditional Chinese medicine compounds Taking protective measures, three low operating states of fluidization, proper time and other factors are the basis of uniform content Of course, in the production practice, in order to give full play to the advantages of one-step granulation, the operation should be simplified According to the equipment configuration of the enterprise, it is more appropriate to use three-dimensional mixing equipment and its supporting equipment first 2、 It is the key to the quality of granules that wetting and adhesion agents are well used In the process of modernization, it has been reported that the raw materials of traditional Chinese medicine preparation are changed into crude extracts or effective ingredients, and PVP is used as wetting agent Because of the mechanical force of the trough mixing and swing granulation, the granulation is easy to form Using one-step granulation is quite different It is a granulation method which uses the solution of wetting adhesive with the same substance as the drug powder and sprays it on the powder by the spray gun to agglomerate and grow up Its mechanism is impact, wetting, spreading, penetration and adhesion The powder is connected by the wetting adhesive bridge During fluidization, the particles and the wall of the fluidized bed tank rub to form round particles If necessary, adopt curing measures And then dried into particles Therefore, the selection and use of wetting adhesive is the key to granulation In the pilot test, ethanol, soluble starch, dextrin, syrup and other wetting and adhesion agents have been selected, including those used in the original production line or the ingredients of the auxiliary materials in the prescription, which should be regarded as homogeneous with the materials But according to the formation time, hardness, fluidity, bulk density, particle size distribution, abrasion test, particle solubility, particle instant solubility and other indexes, four kinds of wetting adhesion agents are optimized Their excellent order is: 0.8% sodium alginate > 0.3% ~ 0.6% CMC Na > 3-6% PVP > the main raw material solution in the prescription Although sodium alginate used in this variety has the advantages of fast granulation and good particle quality, it has not been widely used because of its complex effect on the solubility index with calcium in the prescription The other three kinds of wetting adhesion agents are combined to form three process plans according to the measures of film coating and particle solidification After the experiment of scale-up production, it is successful 3、 One step granulation and application is the hope of modern preparation of traditional Chinese Medicine It is the only way for the modernization of traditional Chinese medicine to gradually improve the traditional Chinese medicine dosage form into a more advanced one It is undoubtedly one of the contents of the modernization of traditional Chinese medicine to adopt one-step granulation technology, which is not only a question of the level of preparation, but also a direct impact on the bioavailability of drugs in vivo Select the pharmaceutical excipients and improve the preparation level In the process of modernization of traditional Chinese medicine, the use of crude extracts or effective compounds to produce preparation products, there is a one-sided pursuit of good solubility of granules, improper selection of excipients, resulting in the migration of soluble components, seriously affecting the quality of products One step granulation of fengneng drying production With the development of technology, the possibility of uneven content caused by migration is small (compared with the particles in the drying box), but the migration in the particles cannot be prevented The content in the outer layer is higher than that in the inner layer The fine powder is ground on the surface of the particles, and the effective ingredients are also lost The solution is to select new pharmaceutical excipients, improve the affinity to the soluble ingredients, prevent or reduce migration CMS Na is added in after selection and use CMC Na, the former rapidly forms expansion body to prevent component migration when wetting, the latter forms film coated particles, solidified particles, a great stable quality index There are experimental data to verify that the content of the whole fine powder is reduced to prevent the loss of effective ingredients and improve the level of the preparation Reasonable process and technical measures and conditions, improve SOP level The unstable ingredients in the prescription can be used when outsourcing, which is an effective process Other technical measures, such as temperature and spray speed, pressure and droplet size, fluidization height and throttle size, can be designed according to the requirements of material properties and granulation time The technical parameters can be detected and controlled on line to realize the one-step granulation production of heat sensitive and water sensitive materials such as compound granules of traditional Chinese medicine Changzhou fengneng's one-step granulation lays a solid foundation for the realization of modern production, production, innovative production and international integration of traditional Chinese medicine preparations, and also creates conditions for reducing costs and enhancing the level of enterprise competition Welcome new and old customers, negotiate!