N-acetyl-D-glucosamine capsule preparation and preparation method thereof

A technology of glucosamine and acetyl, which is applied in the field of N-acetyl-D-glucosamine capsule preparations and its preparation, can solve problems such as poor fluidity, low particle bulk density, and easy discoloration, and achieve improved compliance, simple process, and production low cost effect

Active Publication Date: 2017-11-07
SHANGHAI BRIGHT STAR BIO-PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The raw material of N-acetyl-D-glucosamine is needle-like crystal, which is easy to change color when it meets water after bei

Method used

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  • N-acetyl-D-glucosamine capsule preparation and preparation method thereof
  • N-acetyl-D-glucosamine capsule preparation and preparation method thereof
  • N-acetyl-D-glucosamine capsule preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1: the selection of auxiliary material

[0034] The main drug is N-acetyl-D-glucosamine, and the auxiliary materials are selected from diluents, binders, disintegrants, lubricants such as starch, carboxymethyl starch, pregelatinized starch, hydroxypropyl methylcellulose, low Substitute hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, micronized silica gel, etc. According to the present invention, the auxiliary materials can also be various combinations of the above ingredients.

[0035] Mix the main ingredient: excipients at a ratio of 1:1, and then place them under conditions of strong light (4500±500lx), high temperature (60°C) or high humidity (25°C, relative humidity of 90±5%) for 10 Take a sample after 1 day, and check the changes of content and related substances before and after placing by HPLC method, and observe the changes of drug conditions such as appearance color, weight loss on drying, etc. at the same time. The test re...

Embodiment 2

[0040] Embodiment 2: the research of preparation technology

[0041] The raw material of this product, N-acetyl-D-glucosamine, is a needle-like crystal with poor fluidity and compressibility, so the raw material needs to be crushed. Two pulverizers were used to carry out the pulverization test, and the results are shown in Table 2. Bulk density measurement method: Weigh the weight (g) of the material filled with a 100ml measuring cylinder, and the value obtained is the bulk density value, which needs to be weighed to an accuracy of 0.1g.

[0042] Table 2 shows the bulk density under different crushing methods

[0043]

[0044] The test results show that the pulverization effect by ball mill is the most ideal, not only the bulk density is high, but also the granules are uniform after granulation, the dispersibility is good, and it is easy to put into No. 2 capsules, which improves the patient's compliance. However, after the turbine crushing, the particles are uneve...

Embodiment 3

[0046] Take 1.5kg of N-acetyl-D-glucosamine crystals and grind them by ball milling. After 16 minutes of grinding, raw material particles with a bulk density of 69g / 100mL are obtained and sieved.

[0047] Weigh 1.188kg of crushed and sieved qualified N-acetyl-D-glucosamine, 0.959kg of microcrystalline cellulose, and 115g of low-substituted hydroxypropyl cellulose according to the prescription quantity, put them into the mixer and mix for 15 minutes, take them out, and use dry The French granulator performs dry granulation, the main pressure is 1.7Mpa, the side pressure is 0.55Mpa, the feeding current is 1A, and the rotating speed of the roller is 300 rpm. After sizing with a 14-mesh nylon sieve, sieve and weigh the granules. Add 1% micropowder silica gel therein by particle weight, mix for 15 minutes, take out, fill in No. 2 capsules, and adjust the punch to make the particle weight suitable, and suck off the fine powder on the surface of the capsule. After passing the inspec...

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Abstract

The invention discloses an N-acetyl-D-glucosamine capsule preparation and a preparation method thereof. The capsule preparation comprises the following components in percentage by weight: 40 to 60% of N-acetyl-D-glucosamine, 40 to 60% of microcrystalline cellulose, 5 to 15% of cellulose derivatives, and 1 to 5% of lubricant. Raw materials are ball-grinded, the bulk density is greatly increased, raw materials are reasonably compounded with a few of auxiliary materials, after dry process granulation, the fluidity and dispersing property are improved, the granules can be filled into No.2 capsules, and the compliance of patients is improved. Dry process granulation also has the advantage that the color of N-acetyl-D-glucosamine changes after N-acetyl-D-glucosamine is compounded with auxiliary materials and water. The technological conditions are researched to ensure that there is no weight difference among different batches of capsules. The content and related substances all meet the quality requirements. Other indexes all meet the pharmacopeia standards.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to N-acetyl-D-glucosamine capsule preparations and a preparation method thereof. Background technique [0002] Irritable bowel syndrome (IBS) is a functional bowel disorder characterized by abdominal pain or discomfort associated with bowel movements or changes in bowel habits. The disease lacks the evidence of morphological and biochemical abnormalities, and the etiology and pathogenesis are not yet fully understood. At present, most of them are classified by etiology, mainly divided into three categories: mental factors, dietary factors and other incentives (such as intestinal flora disorder). . [0003] N-acetyl-D-glucosamine is the smallest constituent unit of chitin in the exoskeleton of insects and crustaceans, and is also the basic constituent unit of many important polysaccharides in biological cells, which have many important physiological functions in ...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/7008A61K47/38A61P1/00A61P1/12
CPCA61K9/4866A61K31/7008
Inventor 王健陈晓丹
Owner SHANGHAI BRIGHT STAR BIO-PHARM CO LTD
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