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A production process and microcapsule technology, applied in the direction of organic active ingredients, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of large dosage and frequency, heavy burden on the kidneys, and difficult patient acceptance, etc. problem, to achieve the effect of small dosage, less adverse reactions and prolonging the residence time
Inactive Publication Date: 2020-11-24
南京康德祥医药科技有限公司
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[0004] The test found that fingolimod hydrochloride capsules are small-scale preparations, and after entering the human body, the drug effect is released quickly. To maintain the drug effect, the daily dosage and frequency are very large, which is a large burden on the kidneys and is not easy for patients to accept.
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Embodiment 1
[0032] A production process of fingolimod microcapsules, the following components in the weight-number ratio of each raw material of fingolimod microcapsule preparations: 10 parts of fingolimod bulk drug, 2 parts of surfactant, 1 part of solubilizer 1 part, 1 part of ethyl cellulose, 1 part of methyl cellulose, 5 parts of microcrystalline cellulose, 1 part of gum arabic, 1 part of gelatin, 1 part of fructooligosaccharide, 1 part of isomaltooligosaccharide;
[0033] The preparation method of fingolimod microcapsule preparation is as follows:
[0034] (1) Preparation of capsule material solution
[0035] Add 45-50% ethanol aqueous solution into the mixer, add ethyl cellulose, methyl cellulose, microcrystalline cellulose, gum arabic, gelatin, fructo-oligosaccharide and isomalto-oligosaccharide in turn while stirring, and stir to make capsules material solution a;
[0036] (2) Preparation of suspension
[0037] Adding the fingolimod raw material drug to peanut oil to obtain a f...
Embodiment 2
[0045] A production process of fingolimod microcapsules, the difference from Example 1 is: the following components of the ratio of the weight and number of each raw material of fingolimod microcapsule preparation: 20 parts of fingolimod bulk drug , 6 parts of surfactant, 2 parts of solubilizer, 5 parts of ethyl cellulose, 10 parts of methyl cellulose, 20 parts of microcrystalline cellulose, 5 parts of gum arabic, 10 parts of gelatin, 5 parts of fructooligosaccharide, oligosaccharide 5 parts of isomaltose.
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Abstract
The present invention discloses a production technology of fingolimod microcapsules. The fingolimod microcapsule preparation comprises the following raw material components in parts by weight: 10-20 parts of fingolimod crude drugs, 2-6 parts of a surfactant, 1-2 parts of a solubilizer, 1-5 parts of ethyl cellulose, 1-10 parts of methyl cellulose, 5-20 parts of microcrystalline cellulose, 1-5 partsof arabic gum, 1-10 parts of gelatin, 1-5 parts of fructooligosaccharides and 1-5 parts of isomaltooligosaccharides. The preparation method of the fingolimod microcapsule preparation is as follows: (1) preparation of a capsule material solution; (2) preparation of a suspension; (3) preparation of a sedimentation solvent; (4) sedimentation; and (5) vacuum drying. The polymer auxiliary material capsule material enables fingolimod to have sustained release, prolongs the retention time of the drug in body, and significantly improves drug absorption rate, thereby achieving advantages of small dosage, long action time, high bioavailability and fewer adverse reactions.
Description
technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a production process of fingolimod microcapsules. Background technique [0002] Multiple sclerosis is an autoimmune disease that specifically targets the white matter of the central nervous system, leading to its demyelination. Occurs more in young adults than men. It belongs to flaccidity. The disease is closely related to kidney and brain. The exact pathogenesis is unknown. Doctors believe it is an autoimmune disease. The disease is a debilitating neurological disorder that can cause loss of balance, muscle spasms and other movement impairments, and in severe cases, difficulty speaking, eating, and, in more severe cases, breathing. quality of life. [0003] Fingolimod, also known as Fingolimod, has a chemical name of 2-amino-2-[2-(4-octylphenyl)ethyl]-1,3-propanediol. Fingolimod hydrochloride is the first oral drug for the treatment of multiple sclero...
Claims
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