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Pridinol methanesulfonate matrix sustained-release tablet and preparation method thereof

A technology of pridinol and methanesulfonic acid, which is applied in bone diseases, medical formulas, medical preparations with non-active ingredients, etc., can solve the problems that there are no related reports on sustained-release tablets, and achieve easy control of the quality of the preparations and the production process. Simple, Prescription Advanced Results

Active Publication Date: 2015-03-25
SOUTHWEST UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, preparations such as ordinary tablets, enteric-coated tablets, injections, and injection powders of pridinol mesylate have been listed in Japan, South Korea, Argentina and Taiwan, but its sustained-release tablets are not available at home and abroad. see related reports

Method used

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  • Pridinol methanesulfonate matrix sustained-release tablet and preparation method thereof
  • Pridinol methanesulfonate matrix sustained-release tablet and preparation method thereof
  • Pridinol methanesulfonate matrix sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1, prescription and process screening of pridinol mesylate matrix sustained-release tablet

[0027] 1. Single factor test

[0028] Taking the in vitro release rate as the index, the influence of matrix materials, fillers, binders, blockers and tableting pressure on the release rate of pridinol mesylate matrix sustained-release tablets was mainly investigated.

[0029] 1. Skeleton material screening

[0030] Under the condition that other conditions remained unchanged, the effects of HPMC with different molecular weights (ie K4M, K15M and K100M) as matrix materials on the in vitro release of ppridinol mesylate matrix sustained-release tablets were investigated. see results figure 1 , HPMC K15M and HPMC K100M as the framework materials have obvious burst release phenomenon in the early stage, but the late release is very slow, and the effect of releasing more than 80% at 12 hours is not achieved. Relatively speaking, it is better to choose HPMC K4M as the fra...

Embodiment 2

[0047] Embodiment 2, the preparation of pridinol mesylate matrix sustained-release tablet

[0048] The optimal prescription screened out by Example 1 is used to prepare pridinol mesylate matrix sustained-release tablets, and the preparation method is as follows:

[0049] a. Raw material pretreatment: dry the starch at 100-105°C to keep the water content below 8%; pulverize pridinol mesylate, HPMCK4M, EC, starch, CMC-Na and magnesium stearate through 100 meshes respectively screen;

[0050] b. Preparation: Take the prescribed amount of HPMC K4M, starch, EC and CMC-Na, mix well, add the prescribed amount of pridinol mesylate by equal increment method, mix well, add 50% (v / v) ethanol Make soft material from solution, make wet granules with 24-mesh sieve, dry at 50°C for 50 minutes, pass through 24-mesh sieve for granulation, then add the prescribed amount of magnesium stearate, mix well, and compress with 35N pressure to obtain primidyl mesylate Nuo matrix sustained-release tab...

Embodiment 3

[0053] Embodiment 3, the in vitro release degree investigation of pridinol mesylate matrix sustained-release tablet

[0054] Take commercially available pridinol mesylate ordinary tablets and 6 tablets of pridinol mesylate matrix sustained-release tablets prepared in Example 2 respectively, and measure the cumulative release rate. see results Figure 6 , compared with ordinary pridinol mesylate tablets, the pridinol mesylate matrix sustained-release tablets prepared by the present invention have obvious sustained-release effects.

[0055] Get respectively 3 batches of pridinol mesylate matrix sustained-release tablets prepared in Example 2, and measure its cumulative release rate. see results Figure 7 , 3 batches of pridinol mesylate matrix sustained-release tablets have regular drug release in vitro, which shows that the prescription and process of pridinol mesylate matrix sustained-release tablets of the present invention are reasonable.

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Abstract

The invention discloses a pridinol methanesulfonate matrix sustained-release tablet which is composed of the following components in percentage by mass: 6% of pridinol methanesulfonate, 20-30% of hydroxypropyl methylcellulose K4M, 10-30% of ethyl cellulose, 35-50% of starch, 1-2% of sodium carboxymethyl cellulose and 0.5-3% of magnesium stearate. After being orally taken, the sustained-release tablet is subjected to aquation to generate gel when meeting digestive juice, and the medicines are released in a dispersion or gel matrix corrosion mode. The sustained-release tablet has the advantages of advanced prescription, stable product quality, sustained medicine release, enduring drug effect and smooth blood concentration; and the wet-process granulating preparation method has the advantages of simple production technique, low cost and controllable preparation quality, and is suitable for industrialized large-scale production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a primidinol mesylate preparation and a preparation method thereof. Background technique [0002] Low back pain and neck, shoulder and wrist syndrome have become the most common musculoskeletal pain syndromes in modern times. Almost everyone has to face the health problem of low back, neck and wrist pain. The overall prevalence of low back pain in Western countries is about 15% to 30%, and the prevalence of office workers is as high as 60% to 85%. This not only seriously affects the health and quality of life of patients, but also leads to a decrease or even loss of production and labor capacity. Parkinson's syndrome is a neurodegenerative disease commonly seen in middle-aged and elderly people. According to statistics, the prevalence of Parkinson's syndrome is about 0.5% among people over 50 years old, and the prevalence rate increases to 1% among people over ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4453A61K47/38A61P29/00A61P21/02A61P25/16A61P19/08A61P19/02A61K9/22
Inventor 罗永煌王翠园罗敏罗雷龙飞谭明国王帅曾海春骆晓宏
Owner SOUTHWEST UNIV
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