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Application of Methyl Silicone Oils in Pharmaceutical Preparations
1. Preparation of antacid capsules
The 22.02kg of glycerin, 34.13kg of distilled water, 10kg of dimethyl silicone fluid,added with 43.85kg of gelatin, dissolved under reduced pressure at 70-80°C, and made into capsules by the usual method. Formaldehyde/acetone (1/60) mixture is sprayed on capsules.
Due to the favourable hydrophobic effect of dimethicone, the prepared capsules do not dissolve in acidic gastric juice for 2 hours, but dissolve in alkaline intestinal solution for 200-620 seconds, are stable to enzymes and temperature, and have good mechanical strength.
2. Polishing of sugar-coated tablets (glazing agent)
During polishing operation, add Sichuan wax fine powder with 2% dimethyl silicone fluid to the color-coated tablets for polishing. Compared with those without dimethyl silicone fluid, sugar-coated tablets have brighter and more beautiful color and surface, and are moisture-proof. It can ensure that the sugar-coated tablets do not discolor and mildew during the storage period.
3. Film coating material
It is used as a plasticizer for film coating materials, using the hydrophobicity and oxygen resistance of dimethyl silicone fluid to isolate the core from the outside, so that the core is not affected by moisture and oxygen in the air, not absorb moisture and deteriorate, and the coating layer is firm and smooth.
The possible behaviors of droplet droplets in the condensate include spreading, droplet formation and mixing. Generally, when a liquid with a smaller surface tension is put into a liquid with a larger surface tension, the surface will spread, and on the contrary, it is easy to form droplets. Dimethicone is a common water-soluble drop pill condensing agent with the smallest surface energy (liquid paraffin 0.035 N/m, vegetable oil 0.035 N/m, dimethyl silicone fluid 0.021 N/m).
In addition, there are many types and specifications of dimethyl silicone fluid. By adjusting the temperature and selecting different types of dimethyl silicone fluid, the forming and precipitation speed of droplets in the condensing agent can be adjusted to achieve the best process conditions and quality conditions. And there is no hidden danger of polluting toxic substances in petrochemical products and water-based dripping pills, which cannot be guaranteed by liquid paraffin and vegetable oil.
In particular, the dropping pills using S-40 (polyoxyl 40 stearate) and poloxamer as the matrix must use dimethyl silicone fluid as the condensing agent. Because dimethyl silicone fluid can increase the dissolution of water-insoluble active drugs, which is beneficial to the absorption of drugs; but poloxamers can not use liquid paraffin as a condensing agent because of their hygroscopicity.
Dimethyl silicone fluidperiodic treatment technique in the production of dropping pills; Dimethyl silicone fluid should be recycled as much as possible in production because of the high price of it, and the used dimethyl silicone fluid will be mixed with foreign matter. One of the most common foreign matters is the broken pellets produced during the process of preparation of dropping pills, which can be removed by filtration, static precipitation or centrifugation; another common foreign matter is water. When using dimethyl silicone fluid mixed with water as the condensing agent, the dripping pellets may dissolve, deform or even it cannot be hardened by condensation. The method to remove the water in dimethicone oil is: freeze the dimethyl silicone fluid containing water at -4°C, take it out after the water condenses into ice, and filter it quickly to remove it.
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