Oral dosage form of lentinan and preparation method thereof

A technology of lentinan and dosage form, which is applied in the field of pharmaceutical dosage form research, can solve the problems of low oral utilization efficiency and large dosage, and achieve the effects of improving bioavailability, wide application, and reducing daily dosage

Active Publication Date: 2017-05-17
上海慈瑞医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Chinese patent CN101244093 has proposed a kind of oral liquid containing lentinan, and the molecular weight range of the lentinan contained in it is 2-1,000,000 Daltons, although this lentinan oral liquid has effect, its oral utilization efficiency is not high, needs Larger doses are required to achieve satisfactory therapeutic effect

Method used

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  • Oral dosage form of lentinan and preparation method thereof

Examples

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Effect test

Embodiment 1

[0025] An oral dosage form of lentinan, which contains pure β and triple-helical lentinan with a weight average molecular weight of 400,000 to 800,000 as shown in formula (1), the purity of which is 96.1 wt%, and the lentinan At 3500~3300cm -1 、2920-2800cm -1 、1100-1000cm -1 、890cm -1 With infrared absorption. Congo red reaction of lentinan was positive (+). The preparation method of the oral dosage form of the above-mentioned lentinan, the specific steps are: in a high-speed mixing granulator, add 99.7g of mannitol, dissolve 0.1g of the above-mentioned lentinan in 50mL water, add it into the mannitol under stirring, and Stir at 15 Hz for 12 minutes, pass through a 20-mesh sieve, and make granules. Dry the granules in a drying oven, add 0.2 g of magnesium stearate, mix evenly, transfer to a tablet machine for tableting, adjust the tablet weight to 0.1 g, and make 1000 tablets to obtain lentinan oral tablets. The obtained lentinan oral tablet has a smooth surface and good...

Embodiment 2

[0027] An oral dosage form of lentinan, which contains pure β and triple helix configuration lentinan with a weight average molecular weight of 400,000 to 800,000 as shown in formula (1), the purity of which is 96.1wt%, and the lentinan is in 3500~3300cm -1 、2920-2800cm -1 、1100-1000cm -1 、890cm -1 With infrared absorption. Congo red reaction of lentinan was positive (+). The preparation method of the oral dosage form of above-mentioned lentinan, concrete steps are: in high-speed mixing granulator, add microcrystalline cellulose 40g and mannitol 57.9g, above-mentioned lentinan 0.1g and glucose 2g are dissolved in 50mL water, in Add it into microcrystalline cellulose and mannitol under stirring, stir at 15 Hz for 15 minutes, pass through a 20-mesh sieve, and make granules. The granules are dried in a drying oven, sized through a 20-mesh sieve, mixed evenly, and then transferred into a capsule filling machine, and each capsule is filled with 0.1g to obtain 1000 lentinan ora...

Embodiment 3

[0029] An oral dosage form of lentinan, which contains pure β and triple-helical lentinan with a weight average molecular weight of 400,000 to 800,000 as shown in formula (1), the purity of which is 96.1 wt%, and the lentinan At 3500~3300cm -1 、2920-2800cm -1 、1100-1000cm -1 、890cm -1 With infrared absorption. Congo red reaction of lentinan was positive (+). The preparation method of the oral dosage form of the above-mentioned lentinan, the specific steps are: in the boiling granulator, add microcrystalline cellulose 2700g, open the compressed air, make the powder fluidization; Dissolve the above-mentioned lentinan 1g and glucose 299g in 500mL water , pumped into the fluidized granulator under stirring, added by top spray, boiled and granulated for 30 minutes, the air outlet was controlled at 70°C, dried for 5 minutes, the material was passed through a 40-mesh sieve to make granules, and transferred to the granule packaging machine for sub-packaging , 3g per pack, made in...

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Abstract

The invention provides a lentinan oral preparation, which is characterized by comprising lentinan, wherein the lentinan is a pure beta triple helix-forming single lentinan with specific infrared features, weight-average molecular weight of 400,000-800,000 and lentinan content of more than 94wt%. The lentinan oral preparation has effects on resisting tumors and enhancing immunomodulatory, being the same as a lentinan injection preparation, and the preparation method of the oral preparation is simpler and more convenient, shorter in production cycle, lower in cost and wider in application than that of the injection preparation.

Description

technical field [0001] The invention relates to an oral dosage form of lentinan and a preparation method thereof, which belongs to the field of biology and also belongs to the research of pharmaceutical dosage forms. Background technique [0002] As we all know, pure β, triple helix configuration, single lentinan is an immunomodulator widely used in radiotherapy and chemotherapy of tumors. For digestive system, lung, breast and other tumors, it can significantly enhance the curative effect and reduce toxic and side effects. Lentinan injection preparations (lentinan) are complicated in process, lengthy in cycle and high in manufacturing cost, especially injection is the only way of administration, which brings treatment risks and Trouble, but also increased treatment costs. [0003] Lentinan (C 6 h 10 o 5 ) n It is a pure β, triple helix configuration, single polysaccharide extracted from the fruiting body of Lentinus edodes. At present, everyone generally agrees that ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/715A61K9/20A61K9/48A61K9/16A23L2/02A23L33/125
Inventor 许洁陈林祥朱益锋
Owner 上海慈瑞医药科技股份有限公司
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