Nizatidine composition tablet

A technology for nizatidine and a composition, which is applied in the field of medicine and medicine manufacturing, can solve the problems of inconvenient use, carrying and transportation, storage inconvenience, restrictions on clinical use and promotion, affecting the absorption effect of patients, etc., and achieves low cost and accurate dosage. , easy-to-control effects

Inactive Publication Date: 2014-01-29
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Existing nizatidine preparations have dosage forms such as ordinary tablets, capsules, injections, etc., but are subject to certain restrictions in clinical use and promotion
Due to the poor water solubility of nizatidine, ordinary tablets and capsules have the problems of slow disintegration and slow dissolution rate, which affects the absorption effect of patients: although injections have high bioavailability, they are difficult to use, carry, transport and store. inconvenient

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Nizatidine was used as the raw material to investigate the effects of the dosage of various excipients on the angle of repose, hardness, appearance, disintegration, friability and dissolution of the drug. The dosage of excipients in each prescription is shown in Table 1.

[0038] Sieve the raw materials and auxiliary materials separately, and set aside: Nizatidine, chitosan nanoparticles, hypromellose, pregelatinized starch, croscarmellose sodium, carboxymethyl starch sodium, stearic acid Magnesium was mixed according to the prescription amount, the angle of repose was measured, and the hardness, appearance, weight difference, disintegration, friability, and dissolution were measured after tableting. The results are shown in Table 2. Among them, the determination methods of hardness, appearance, weight difference, disintegration, friability and dissolution refer to the second appendix of "Chinese Pharmacopoeia" 2005 edition. Appearance: visual inspection; hardness, dis...

Embodiment 2

[0045] Prepare nizatidine granules with prescription 4 of Example 1, take three parts and place each in a weighed flat weighing bottle, place them under the conditions of RH43%, RH59%, and RH70% respectively, place 1, 3, After 5 days, they were weighed separately to investigate the influence of different humidity on the drug, and the absorption rate of the particles was calculated. The results are shown in Table 3.

[0046] Table 3 moisture absorption rate test results

[0047] condition

[0048] It can be seen from the results in Table 3 that under the humidity condition of RH70%, the moisture absorption weight gain increases significantly, and under the condition of RH59% humidity, the moisture absorption weight gain does not change significantly. Therefore, the space humidity must be controlled below RH59% during the preparation process.

Embodiment 3

[0049] Embodiment 3: Nizatidine composition tablet of the present invention

[0050]

[0051]Preparation method: respectively pass nizatidine, chitosan nanoparticles, croscarmellose sodium and carboxymethyl starch sodium through 80 mesh sieves, then 200g of nizatidine, 72g of chitosan nanoparticles Mix evenly with 13g of croscarmellose sodium, add 100g of 4% hypromellose 50% ethanol soft material, pass through a 20-mesh sieve and make granules, control the humidity below RH59%, will make The granules are dried at 50-60°C, passed through a 18-mesh sieve, added with 22g of sodium carboxymethyl starch and 3g of magnesium stearate, mixed evenly, punched and pressed into tablets with a Φ11mm shallow arc surface, and obtained.

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Abstract

The invention provides a nizatidine composition tablet, and belongs to the field of medicine and medicine production technology. The nizatidine composition tablet comprises following raw materials, by weight, 200 parts of nizatidine, 72 parts of chitosan nanoparticle, 13 parts of croscarmellose sodium, 100 parts of 4% hydroxypropyl methylcellulose 50% ethanol, 22 parts of sodium carboxymethyl starch and 3 parts of magnesium stearate. The thin tablet coating of the nizatidine composition tablet is capable of increasing stability of the nizatidine composition tablet, and the increase of tablet weight is less, so that influence on disintegration speed is less. The nizatidine composition thin-film tablet is simple in preparation method operation, short in production period, high in production yield, and is suitable for industrialized production.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a nizatidine composition tablet. Background technique: [0002] Pharmacological studies have shown that nizatidine is an H2 receptor blocking drug, which can reversibly compete with histamine for H2 receptors and inhibit the increase of gastric acid secretion caused by various reasons. Existing nizatidine preparations have dosage forms such as common tablets, capsules, injections, etc., but are subject to certain restrictions on clinical use and popularization. Due to the poor water solubility of nizatidine, ordinary tablets and capsules have the problems of slow disintegration and slow dissolution rate, which affects the absorption effect of patients: although injections have high bioavailability, they are difficult to use, carry, transport and store. inconvenient. Tablets made of chitosan nanoparticles can be used as diluents for chewable tablets, s...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K31/426A61K47/36A61K47/38A61P1/04A61K31/722
Inventor 汪六一汪金灿肖群
Owner HAINAN WEI KANG PHARMA QIANSHAN
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