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Ranitidine bismuth citrate intra-gastric floating sustained-release tablet and preparation method thereof

A technology of bismuth citrate ranitidine and gastric flotation, which is applied in the directions of pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of patients taking medicines frequently, poor compliance, etc. , to achieve the effect of lasting blood drug concentration, good stability, and reducing the number of times of medication

Active Publication Date: 2014-12-03
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are mainly two pharmaceutical manufacturers of RBC common dosage form products that have been listed in my country, Livzon Pharmaceutical and Changzhou Lanling Pharmaceutical. Not listed at home and abroad

Method used

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  • Ranitidine bismuth citrate intra-gastric floating sustained-release tablet and preparation method thereof
  • Ranitidine bismuth citrate intra-gastric floating sustained-release tablet and preparation method thereof
  • Ranitidine bismuth citrate intra-gastric floating sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] The preparation of embodiment 1RBC gastric floating tablet

[0045] Tablet core formula: RBC raw material 228g, stearyl alcohol 240g, HPMC 15000SR 60g, HPMC 100000SR 30g, NaHCO 3 12g, micronized silica gel 2g, magnesium stearate 2g, absolute ethanol 10g.

[0046] Coating film coating material: Eudragit RS100, RL100 30g each, triethyl citrate 6g, talcum powder 15g, ethanol 919g.

[0047] Preparation:

[0048] Pass the raw material and auxiliary materials through a 100-mesh sieve for later use; weigh the prescribed amount of raw materials and auxiliary materials in equal amounts and mix them uniformly, add an appropriate amount of binder, and make a soft material. Granulate through a 30-mesh sieve, and dry in an oven at 45°C for 2-3 hours. Sieve through a 24-mesh sieve, add a lubricant (the same amount of micro-powder silica gel and magnesium stearate) and mix well; control the tablet hardness at 40-50N, punch the tablet with a 12mm shallow concave; that is, the table...

Embodiment 2

[0051] The preparation of embodiment 2RBC gastric floating tablet

[0052] Tablet core formula: RBC raw material 228g, stearyl alcohol 240g, HPMC 15000SR 40g, HPMC 100000SR 20g, NaHCO 3 12g, magnesium stearate 4g, absolute ethanol 10g.

[0053] Coating film coating material: Eudragit RS100, RL100 30g each, triethyl citrate 6g, talcum powder 15g, ethanol 919g.

[0054] Preparation:

[0055] Pass the raw material and auxiliary materials through an 80-mesh sieve for later use; weigh the prescribed amount of raw materials and auxiliary materials in equal amounts and mix them uniformly, add an appropriate amount of binder, and make a soft material. Pass through a 30-mesh sieve to granulate, and dry in an oven at 50°C for 2 hours. Sieve with a 24-mesh sieve, add a lubricant and mix evenly; control the tablet hardness at 40-50N, punch the tablet with a 12mm shallow concave; that is, the tablet core.

[0056] Weigh the coating material in proportion and dissolve it in 500g of eth...

Embodiment 3

[0058] The preparation of embodiment 3RBC gastric floating tablet

[0059] Tablet core formula: RBC raw material 228g, stearyl alcohol 240g, HPMC 15000SR 80g, HPMC 100000SR 40g, NaHCO 3 12g, magnesium stearate 4g, absolute ethanol 10g.

[0060] Coating film coating material: Eudragit RS100, RL100 30g each, triethyl citrate 6g, talcum powder 15g, ethanol 919g.

[0061] Preparation:

[0062] Pass the raw material and auxiliary materials through a 120-mesh sieve for later use; weigh the prescribed amount of raw materials and auxiliary materials in equal amounts and mix them uniformly, add an appropriate amount of binder, and make a soft material. Granulate through a 30-mesh sieve, and dry in an oven at 40°C for 3 hours. Sieve with a 24-mesh sieve, add a lubricant and mix evenly; control the tablet hardness at 40-50N, punch the tablet with a 12mm shallow concave; that is, the tablet core.

[0063] Weigh the coating material in proportion and dissolve it in 500g of ethanol, ad...

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Abstract

The invention relates to a ranitidine bismuth citrate intra-gastric floating sustained-release tablet which is composed of a tablet core containing ranitidine bismuth citrate and a coating film wrapped over the tablet core. The tablet core is prepared from raw materials at least containing, by weight, 110 to 120 parts of ranitidine bismuth citrate, 30 to 60 parts of a skeletal material, 5 to 20 parts of a foaming agent and 45 to 130 parts of a bleaching assistant. The coating film accounts for 1 to 5% of the weight of the tablet. The tablet provided by the invention can effectively adjust the rate of constant speed release of the drug ranitidine bismuth citrate and enables a steady and lasting effective plasma concentration to be obtained, so side effects of the drug, frequency of administration and influence of the drug on an in-vivo environment are reduced, and compliance of a patient is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a drug for treating peptic ulcer, that is, bismuth ranitidine gastric floating sustained-release tablet and a preparation method thereof. Background technique [0002] Peptic ulcer (peptic ulcer, PU) is a chronic disease that easily recurs. Due to the increasing pace of modern life and work pressure, as well as the abuse of corticosteroids, the incidence of PU is increasing. The incidence of digestive system in the world accounts for 10% to 12% of human beings, and the incidence of digestive system in cities and towns in my country is about 11.43%, which is basically similar to many developed countries in Europe and America. At present, there is no effective method to completely cure it, which has become one of the key topics in the field of medical research. Current treatment drugs mainly include antacids, anticholinergics, histamine H 2 Recept...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K9/32A61K9/22A61K31/341A61K47/38A61K47/32A61P1/04
Inventor 吕美红鞠岚岚王艳郑嫣然
Owner 蚌埠丰原涂山制药有限公司
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