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Overview of the development and application of new processes in Chinese medicine
Powder injection process itself is not a new process, but used in traditional Chinese medicine injection is innovative. With the introduction of Shuanghuanglian powder injection, the study of traditional Chinese medicine injection has entered a new level, it effectively solves the problem of stability in storage.
Western medicine powder injection is mainly to prevent the degradation of heat-sensitive drugs and water-sensitive drugs. The former mostly use freeze-drying method, the latter generally use recrystallization or spray drying method. Shuanghuanglian powder injection of the initial process is to use spray drying method, and later used the freeze drying method, the two methods compared to the latter is better, that is, the freeze drying method from the dispersion, solubility, removal of pyrogens and so on is better than the spray drying method, but on the Shuanghuanglian powder injection of the pre-processing process is still hydroalcoholic method, with microporous membrane or ultrafiltration and then filtered again on the perfect.
2, fluidization drying process
Also known as boiling drying, that is, the use of negative pressure to make the particles jump up, was boiling, in the dynamics of heat exchange, and thus high efficiency, speed, drying yield, drying uniformity, low temperature, but the original boiling drying bed has some disadvantages. Therefore, in recent years, the fluidized bed has been transformed, such as return mixed flow fluidized bed, piston flow fluidized bed, vibration flow fluidized bed, contact fluidized bed and multi-layer fluidized bed.
Some fluidized bed is only suitable for drying and mixing of wet materials, and can not be used for granulation, with the continuous development of spray drying technology and new formulations and new types of spray devices in the fluidized bed, so that granulation, micro-pill making, coating process and drying process in the fluidized bed at a time to complete. Now the development of equipment has a fluidized bed atomization operating system and spray drying granulator.
3, film coating process
The traditional coating is sugar coating, the disadvantage is that the process time is long. Waste materials disintegrate and absorb slowly. In recent years the use of film coating technology or process, it is effective in overcoming the above shortcomings. The so-called film coating is a polymer solution into a dispersion uniformly coated in tablets, capsules, granules and micro-pills and other solid preparations on the surface, the formation of a number of micro-unoriginal integrative thin film layer, we call this process as film coating.
Film coating has many advantages: ① the process is generally in 1 ~ 2h short time to complete; ② the amount of material is greatly reduced, do not use too much such as talcum powder and other solid fillers; ③ can be used in a variety of automated mechanized equipment, such as boiling beds, spraying beds, etc., continuous operation; ④ thin layer, disintegration and absorption of fast. Because there are many points, so in the developed countries have long been commonly used. Has replaced sugar coating.
But the film coating process exists in the organic solvent volatilization problems, resulting in environmental pollution, and thus has been water-based coating technology research. Coating materials are mainly used for some of the polymers with nucleic acid genes dissolved in alkaline aqueous solution, such as cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate, etc.. Another new technology is the use of gel dispersion coating method, that is, water as a dispersing medium, polymers with a diameter of 50 nm ~ 0.2 μm of the gel particles suspended in the aqueous coating system, the outer transparent milky white color, so it is also known as latex.
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