Moisture-proof film coating materials In recent years, with the birth of various new high-molecular polymers and the successful development of high-efficiency coating pans, the film coating technology has been rapidly developed and there is a tendency to gradually replace the sugar coating process. Traditional Chinese medicine tablets, pills, and granules have the disadvantages of strong hygroscopicity, easy-splitting, and mildew due to the diversity of their ingredients. How to use film coating technology to make Chinese medicine full dip, semi-paste tablets, raw medicine powder, and even Chinese medicine particles and pellets have good moisture resistance and does not affect the disintegration is an important issue in the development of film coating materials. At the seminar, Professor Shen Pingniang of the National Institute of Chinese Medicine Pharmaceutical Engineering introduced their work on the development of a moisture-proof film coating material.
The factors influencing the moisture resistance of the film coating material include the formulation composition of the coating material and the preparation process of the material. A complete film coating material usually includes a film forming polymer material, a plasticizing type, a colorant, and an auxiliary agent (surfactant). In order to improve the moisture resistance of the material, one or more combinations of film-forming materials may be selected, and the ratio of the materials may be determined by calculation and verified by experiments to ensure uniform densification of the film and proper repulsion of moisture in the environment. The use of plasticizers and other auxiliaries was introduced to improve this effect. Researchers have used a new type of aqueous polymer in combination with other polymers to show stronger moisture resistance than other single-polymer coating materials, even for alcohol-soluble formulations. The superiority is that it has good disintegration performance, and by selecting an appropriate surfactant, the coating material process is smoother and the production operation time is shortened.
In addition, the scientific and reasonable preparation process is a guarantee that the material properties are fully embodied, such as the stable and even reproduction of the color of the material. In the preparation of a film coating material, it is critical to ensure that the components are fully and properly dispersed. The coating material is a compound formulation with insoluble particles. How to make these insoluble particles evenly dispersed into the colloidal solution to form a stable suspension so as to form an even and dense layer by spraying and drying. Continuous film is also a key factor affecting the final moisture resistance of the product. Researchers have achieved the above technical requirements by performing ultra-fine pulverization and modification of the coating materials on some materials, especially mineral fillers, which have improved the mineral powders and polymers through the refinement and surface modification of fillers. The compatibility also greatly increases the good optical and visual effects of the coated product.
Through careful consideration of the above two factors, researchers have developed two kinds of film coating materials with different moisture resistance capabilities - ordinary moisture-proof film coating materials TF-NMP and reinforced moisture-proof film coating materials TF-EMP. A variety of traditional Chinese medicine tablet varieties (Biyankang tablets, Huapian tablets, Sanjin tablets, and Coughing tablets) were tested under the same environment and packaging conditions of a plastic sealed bag, a temperature of 37°C and a relative humidity of 75%, and their moisture resistance properties were examined. . The results of application of the two moisture-proof film coating materials developed on the four varieties showed that the weight gain rate of both samples was slowed down to varying degrees compared with the control, especially on Sanjin tablets and cough tablets. obvious.
Formula composition and preparation process and other factors have a certain significance for guiding the development of moisture-proof film coating materials. The application of moisture-proof film coating materials is important for improving the moisture-proof ability of Chinese medicine solid preparations, improving their stability (directly related to the shelf life of drugs) and reducing the requirements for packaging conditions. However, the slowness of the moisture absorption rate and the quantitative data of the shelf life of the drug need to be verified by a complete stability inspection experiment. It should be noted that it is necessary to be cautious when comparing the results of different types of moisture-proof test results. Because the variety of Chinese herbs is different, the moisture absorption capacity of the cores of the Chinese herbs varies greatly, and the external surface area of ​​the cores also differs, making the data not have the same Comparative basis. This also suggests that when formulating a coating solution for a Chinese medicine preparation, it is first necessary to fully evaluate the properties of the core, and how to select appropriate film coating materials and process parameters so that the moisture-proof performance conforms to the corresponding technology. Requirements, but not the blind pursuit of the strongest moisture-proof ability.
The factors influencing the moisture resistance of the film coating material include the formulation composition of the coating material and the preparation process of the material. A complete film coating material usually includes a film forming polymer material, a plasticizing type, a colorant, and an auxiliary agent (surfactant). In order to improve the moisture resistance of the material, one or more combinations of film-forming materials may be selected, and the ratio of the materials may be determined by calculation and verified by experiments to ensure uniform densification of the film and proper repulsion of moisture in the environment. The use of plasticizers and other auxiliaries was introduced to improve this effect. Researchers have used a new type of aqueous polymer in combination with other polymers to show stronger moisture resistance than other single-polymer coating materials, even for alcohol-soluble formulations. The superiority is that it has good disintegration performance, and by selecting an appropriate surfactant, the coating material process is smoother and the production operation time is shortened.
In addition, the scientific and reasonable preparation process is a guarantee that the material properties are fully embodied, such as the stable and even reproduction of the color of the material. In the preparation of a film coating material, it is critical to ensure that the components are fully and properly dispersed. The coating material is a compound formulation with insoluble particles. How to make these insoluble particles evenly dispersed into the colloidal solution to form a stable suspension so as to form an even and dense layer by spraying and drying. Continuous film is also a key factor affecting the final moisture resistance of the product. Researchers have achieved the above technical requirements by performing ultra-fine pulverization and modification of the coating materials on some materials, especially mineral fillers, which have improved the mineral powders and polymers through the refinement and surface modification of fillers. The compatibility also greatly increases the good optical and visual effects of the coated product.
Through careful consideration of the above two factors, researchers have developed two kinds of film coating materials with different moisture resistance capabilities - ordinary moisture-proof film coating materials TF-NMP and reinforced moisture-proof film coating materials TF-EMP. A variety of traditional Chinese medicine tablet varieties (Biyankang tablets, Huapian tablets, Sanjin tablets, and Coughing tablets) were tested under the same environment and packaging conditions of a plastic sealed bag, a temperature of 37°C and a relative humidity of 75%, and their moisture resistance properties were examined. . The results of application of the two moisture-proof film coating materials developed on the four varieties showed that the weight gain rate of both samples was slowed down to varying degrees compared with the control, especially on Sanjin tablets and cough tablets. obvious.
Formula composition and preparation process and other factors have a certain significance for guiding the development of moisture-proof film coating materials. The application of moisture-proof film coating materials is important for improving the moisture-proof ability of Chinese medicine solid preparations, improving their stability (directly related to the shelf life of drugs) and reducing the requirements for packaging conditions. However, the slowness of the moisture absorption rate and the quantitative data of the shelf life of the drug need to be verified by a complete stability inspection experiment. It should be noted that it is necessary to be cautious when comparing the results of different types of moisture-proof test results. Because the variety of Chinese herbs is different, the moisture absorption capacity of the cores of the Chinese herbs varies greatly, and the external surface area of ​​the cores also differs, making the data not have the same Comparative basis. This also suggests that when formulating a coating solution for a Chinese medicine preparation, it is first necessary to fully evaluate the properties of the core, and how to select appropriate film coating materials and process parameters so that the moisture-proof performance conforms to the corresponding technology. Requirements, but not the blind pursuit of the strongest moisture-proof ability.
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