Montmorillonite properties
Montmorillonite, also known as microcrystalline kaolinite, is a silicate mineral with a layered structure and flake crystals. Its special structure gives it many excellent properties, including water absorption, expansion, and bonding. sex and thixotropy, etc. Therefore, it is widely used in cosmetics, papermaking, rubber and plastics, coatings, water treatment, animal husbandry and other industries. Its excellent adsorption capacity and cation exchange capacity make it important in the field of medical applications.
Pharmacopoeia regulations
Due to the wide application of montmorillonite in the pharmaceutical industry, advanced countries in the world have imposed strict specifications and quality standards on it. The United States Pharmacopoeia, British Pharmacopoeia and European Pharmacopoeia all contain and stipulate various indicators of montmorillonite. The second supplement of the 2010 edition of the "Pharmacopoeia of the People's Republic of China" has new and clear regulations on the composition, particle size, adsorption capacity, swelling degree, etc. of montmorillonite when used as raw materials and excipients. At present, the China Food and Drug Administration has officially announced that the second supplement to the 2010 edition of the Pharmacopoeia will come into effect on December 1, 2013.
Granularity index
The higher the montmorillonite content, the stronger its adsorption capacity. At the same content, the finer the particle size, the stronger the adsorption capacity. Among the new regulations on montmorillonite in the Chinese Pharmacopoeia, the most prominent one is the new regulations on its particle size. Particle size is an important indicator for measuring raw materials and excipients. When used to prepare raw materials for solid preparations or suspensions, the particle size has a great impact on bioavailability, dissolution and stability. Therefore, if necessary, it is necessary to measure the particle size, check the particle size distribution of the raw materials, and specify limits. . The particles of montmorillonite in medicinal montmorillonite raw materials or preparations can be single unit cells or agglomerates of many unit cells. Use a traditional medicinal sieve to check the particle size of montmorillonite. It is far from the actual particle size of montmorillonite. It is also inconsistent with the actual particle size of montmorillonite sold on the market. It cannot truly reflect the particles of medicinal montmorillonite. The fineness cannot achieve the purpose of controlling the quality of montmorillonite. The Pharmacopoeia, which came into effect on December 1, 2013, uses laser particle size analysis as the standard for testing montmorillonite. The laser particle size analyzer can perfectly realize the quality control of medicinal montmorillonite and ensure the stable efficacy of its finished products. In accordance with the provisions of the Pharmacopoeia and to meet the needs of the pharmaceutical industry for technological innovation, Jinan Winner Particle Instrument Co., Ltd. has developed a fully automatic intelligent laser particle size analyzer Winner2008 specially used for montmorillonite particle size testing.
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