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Lafutidine tablet and preparation method thereof

A technology for lafutidine tablets and futidine tablets, which is applied in the field of drug preparation, can solve the problems of dissimilar dissolution curves, poor stability and the like, achieves low toxicity and side effects, high stability, and ensures safety and effectiveness Effect

Active Publication Date: 2021-02-12
湖北舒邦药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Lafutidine is widely cited in the form of tablets, but lafutidine tablets in the prior art have poor stability and technical problems that the dissolution curve is not similar to the original research

Method used

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  • Lafutidine tablet and preparation method thereof
  • Lafutidine tablet and preparation method thereof

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preparation example Construction

[0012] A preparation method for lafutidine tablet, comprising the following steps:

[0013] S1, lafutidine raw material pretreatment;

[0014] The lafutidine raw material is pretreated so that the D10 of the pretreated lafutidine raw material is 1.015-2.16 μm; the D50 is 2.684-7.367 μm; and the D90 is 4.325-52.8 μm. In the prior art, the lafutidine tablet has poor stability, and the dissolution effect is not good. The inventors found that it is because the lafutidine raw material has a large electrostatic effect, and it is easy to agglomerate together, and then it is easy to cause uneven content of the main drug, which affects stability. Sexuality also leads to poor dissolution effect. The inventors found that by controlling the particle size of the lafutidine raw material, the aggregation of the lafutidine raw material can be effectively controlled to ensure that the prepared lafutidine tablet has good stability and dissolution effect. If during screening, the selected mesh...

Embodiment 1

[0043] The present embodiment provides a kind of preparation method of lafutidine tablet, comprises the following steps:

[0044] S1. Lafutidine raw material pretreatment——pass 50g of lafutidine raw material through a 120-mesh sieve, and after pretreatment, lafutidine raw material D 10 2.16μm, D 50 7.367μm, D 90 is 52.8 μm.

[0045] S2, preparing the main drug-containing granules;

[0046] 23.40 g of hydroxypropyl cellulose was dissolved in 444.6 g of water to obtain a binder with a concentration of 5% by mass.

[0047] The sieved lafutidine raw material was mixed with 14.98 g of corn starch, 319.64 g of lactose, 125.39 g of microcrystalline cellulose and 29.7 g of croscarmellose sodium to obtain a dry-blended material. Then the dry-blended material is mixed with the above-mentioned binder and sheared for 60 seconds, then granulated, and then dried and granulated through a 24-mesh sieve to obtain main drug-containing granules. The drying adopts fluidized bed drying, and t...

Embodiment 2-5

[0052] The preparation method of the lafutidine tablet provided by embodiment 2-5 is basically the same as the preparation method of the lafutidine tablet provided by embodiment 1. The difference is the specific operation of the preparation method provided by embodiment 2-5. Conditions vary and specific substances used vary.

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Abstract

The invention relates to the field of medicine preparation, in particular to a lafutidine tablet and a preparation method thereof. The preparation method of the lafutidine tablet comprises the following steps: enabling lafutidine raw materials subjected to pretreatment to be mixed with a binding agent, an internal disintegrant and a filling agent and then carrying out fluidized drying; and then mixing with an external disintegrant and a lubricant to carry out tabletting and coating. The particle size range D10 of the lafutidine raw materials subjected to the pretreatment is 1.015-2.16 mu m, D50 is 2.684-7.367 mu m, and D90 is 4.325-52.8 mu m. By the preparation method, the prepared lafutidine tablet can be guaranteed to have good stability, the dissolution curve is similar to that researched originally, and the preparation process is low in energy consumption and pollution, and is green and environmentally friendly.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a lafutidine tablet and a preparation method thereof. Background technique [0002] Lafutidine, the chemical name is (+ / one)-2-[(2-furylmethyl)sulfinyl]-N-[4-[4-(piperidinylmethyl)-2-pyridine Base] Oxygen-(Z)-2-butenyl]acetamide is a new generation of long-acting and potent H2-receptor antagonist developed by Japan Fuji and Dapeng Pharmaceutical Company, mainly used for the treatment of gastric ulcer and ten duodenal ulcer. Studies have shown that lafutidine can sustainably inhibit the basal and nocturnal secretion of human gastric acid and pepsin, and the secretion caused by stimulating factors such as tetrapeptide gastrin, and resist gastric mucosal damage caused by various gastric stimulating factors. Lafutidine is widely cited in the form of tablets, but the lafutidine tablets in the prior art have poor stability and the technical problems that the dissolution curve is n...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K47/38A61K47/36A61K47/12A61K47/04A61K31/4545A61P1/04
CPCA61K9/2009A61K9/2013A61K9/2054A61K9/2059A61K9/2077A61K9/2095A61K9/2866A61K31/4545A61P1/04
Inventor 杨刚江港黄晶王洪萍
Owner 湖北舒邦药业有限公司
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