CN112957335B - Acetyl glucosamine orally disintegrating tablet and preparation method thereof - Google Patents

Acetyl glucosamine orally disintegrating tablet and preparation method thereof Download PDF

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CN112957335B
CN112957335B CN202110204266.8A CN202110204266A CN112957335B CN 112957335 B CN112957335 B CN 112957335B CN 202110204266 A CN202110204266 A CN 202110204266A CN 112957335 B CN112957335 B CN 112957335B
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acetylglucosamine
disintegrating tablet
orally disintegrating
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CN112957335A (en
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刘丽媛
陈兵
张雪峰
庄贤韩
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Shanghai Bright Star Bio Pharmaceutical Co ltd
Shanghai Nawei Biotechnology Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7008—Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
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    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to an acetylglucosamine orally disintegrating tablet which comprises the following components in percentage by weight: 10-35% of acetylglucosamine, 10-35% of alcohol diluent, 10-30% of filler, 2-20% of disintegrating agent, 3-20% of adhesive, 0.5-5% of lubricant and 0.5-1.5% of flavoring agent. The invention also provides a preparation method of the orally disintegrating tablet. The use of the alcohol diluent in the invention not only plays a role in improving the taste of the preparation, but also improves the hardness of the tablet. The microcrystalline cellulose 90 is silicified by using the filler, so that the acetylglucosamine is uniformly dispersed in the mixed powder, the flowability is good, the powder can be directly tabletted, and the disintegration is good. The disintegrating tablet prepared by the invention has the hardness as high as 70-120N, is convenient to transport and can be quickly disintegrated in 30 seconds in the oral cavity.

Description

Acetyl glucosamine orally disintegrating tablet and preparation method thereof
Technical Field
The invention relates to the field of pharmaceutical preparations, in particular to an acetylglucosamine orally disintegrating tablet and a preparation method thereof.
Background
Acetylglucosamine is the smallest constitutional unit of chitin component in exoskeletons of insects and crustaceans, and is also the basic constitutional unit of many important polysaccharides in biological cells, and it has many important physiological functions in the organism. Pharmacodynamic tests, pharmacokinetic tests and the like show that the traditional Chinese medicine composition can be used for treating diarrhea-predominant irritable bowel syndrome, and has obvious effect and low toxic and side effects.
Chinese patent document CN107320456A discloses an N-acetyl-D-glucosamine capsule preparation and a preparation method thereof. However, no report is found about an acetylglucosamine tablet and a preparation method thereof.
Disclosure of Invention
In view of the above disadvantages of the prior art, the present invention aims to provide an acetylglucosamine orally disintegrating tablet, which comprises the following components in percentage by weight based on the total amount of the acetylglucosamine orally disintegrating tablet:
10 to 35 percent of acetyl glucosamine,
10-35% of alcohol diluent,
10-30% of filling agent,
2 to 20 percent of disintegrating agent,
3 to 20 percent of adhesive,
0.5 to 5 percent of lubricant,
0.5 to 1.5 percent of flavoring agent.
The second aspect of the present invention provides a method for preparing an orally disintegrating tablet of acetylglucosamine, comprising the steps of:
a. sieving the acetylglucosamine with a 80-mesh sieve;
b. mixing the acetylglucosamine with alcohol diluent, filler, disintegrating agent and adhesive to obtain premixed powder;
c. mixing the premixed powder with lubricant and correctant to obtain total mixed powder;
d. tabletting the total mixed powder to obtain the acetyl glucosamine orally disintegrating tablet.
The beneficial effects of the invention are as follows:
the formula of the orally disintegrating tablet of acetylglucosamine, particularly the specific component proportion, the comprehensive selection of silicified microcrystalline cellulose 90 and the like, generates excellent effects, particularly beneficial effects on the aspect of increasing the hardness of tablets. Generally, the hardness of the tablet is higher, so that the product is more favorably integrally formed and is not fragile, but the hardness is too high, so that the disintegration and the release of the tablet are influenced to a certain extent, and therefore, the hardness is controlled in the production process of the tablet. The invention can reach high hardness on the premise of ensuring the disintegration degree, and has excellent effect.
The alcohol diluent is used for improving the taste of the preparation and improving the hardness of the tablet. The microcrystalline cellulose 90 is silicified by using the filler, so that the acetylglucosamine is uniformly dispersed in the mixed powder, the flowability is good, the powder can be directly tabletted, and the disintegration is good. The disintegrating tablet prepared by the invention has the hardness as high as 70-120N, is convenient to transport and can be quickly disintegrated in 30 seconds in the oral cavity.
Drawings
FIG. 1: the compression-hardness curve of the disintegrating tablets of each formulation in example 2 of the present invention.
FIG. 2 is a schematic diagram: the tablet hardness-disintegration time curve of the disintegrating tablet of each formulation in example 3 of the present invention.
Detailed Description
The following embodiments of the present invention are provided by way of specific examples, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention.
Before the present embodiments are further described, it is to be understood that the scope of the invention is not limited to the particular embodiments described below; it is also to be understood that the terminology used in the examples is for the purpose of describing particular embodiments, and is not intended to limit the scope of the present invention; in the description and claims of the present application, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise.
When numerical ranges are given in the examples, it is understood that both endpoints of each of the numerical ranges and any number between the two endpoints are optional unless otherwise specified in the invention. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In addition to the specific methods, devices, and materials used in the examples, the invention may be practiced using any method, device, and material that is similar or equivalent to the methods, devices, and materials described in examples herein, in addition to those described in prior art practice and the description herein.
Unless otherwise indicated, the experimental methods, detection methods and preparation methods disclosed in the present invention all employ conventional techniques in the art.
The orally disintegrating tablet of acetylglucosamine of an embodiment of the invention is based on the total amount of the orally disintegrating tablet of acetylglucosamine, and comprises the following components by weight percent:
10 to 35 percent of acetyl glucosamine,
10-35% of alcohol diluent,
10 to 30 percent of filling agent,
2 to 20 percent of disintegrating agent,
3 to 20 percent of adhesive,
0.5 to 5 percent of lubricant,
0.5-1.5% of flavoring agent.
In a preferred embodiment, the alcoholic diluent is a physical mixture of mannitol and sorbitol.
In a preferred embodiment, the mass ratio of mannitol to sorbitol is 4.
In a preferred embodiment, the filler is selected from silicified microcrystalline cellulose 90.
In one embodiment, the disintegrant is selected from the group consisting of physical mixtures of crospovidone and sodium carboxymethyl starch.
In a preferred embodiment, the mass ratio of crospovidone to sodium carboxymethyl starch is 1.
In one embodiment, the binder is selected from povidone K30.
Optionally, the lubricant is selected from magnesium stearate.
Optionally, the flavoring agent is selected from aspartame.
In one embodiment, based on the total amount of the orally disintegrating tablet, the orally disintegrating tablet comprises the following components in percentage by weight:
15-30% of acetyl glucosamine,
15-30% of alcohol diluent,
15 to 30 percent of filling agent,
5 to 15 percent of disintegrating agent,
3 to 15 percent of adhesive,
0.5 to 3 percent of lubricant,
0.5 to 1.5 percent of flavoring agent.
The preparation method of the acetylglucosamine orally disintegrating tablet comprises the following steps:
a. sieving acetylglucosamine with 80 mesh sieve;
b. mixing the acetylglucosamine with an alcohol diluent, a filler, a disintegrating agent and an adhesive to obtain premixed powder;
c. mixing the premixed powder with a lubricant and a flavoring agent to obtain total mixed powder;
d. tabletting the total mixed powder to obtain the acetyl glucosamine orally disintegrating tablet.
Specifically, the components may be mixed using a mixer.
Example 1:
preparing an orally disintegrating tablet of acetylglucosamine of the following formula:
recipe 1:
35 percent of acetyl glucosamine,
10 percent of mannitol and sorbitol (4),
silicified microcrystalline cellulose 50 (SMCC 50) 30%,
3 percent of cross-linked polyvidone and sodium carboxymethyl starch,
30 percent of polyvidone K,
0.5 percent of magnesium stearate,
1.5 percent of aspartame.
Recipe 2:
35 percent of acetyl glucosamine,
mannitol and sorbitol (4),
silicified microcrystalline cellulose 90 (SMCC 90) 30%,
3 percent of cross-linked polyvidone and sodium carboxymethyl starch,
30 percent of polyvidone K,
0.5 percent of magnesium stearate,
1.5 percent of aspartame.
Recipe 3:
35 percent of acetyl glucosamine,
10 percent of mannitol and sorbitol (4),
microcrystalline cellulose and silicon dioxide (MCC + SiO) 2 )30％，
3% of crospovidone and sodium carboxymethyl starch (1,
30 percent of polyvidone K,
0.5 percent of magnesium stearate,
1.5 percent of aspartame.
Prescription 4:
35 percent of acetyl glucosamine,
10 percent of mannitol and sorbitol (4),
30% of microcrystalline cellulose (MCC),
3 percent of cross-linked polyvidone and sodium carboxymethyl starch,
30 percent of polyvidone K,
0.5 percent of magnesium stearate,
1.5 percent of aspartame.
The flowability, tablet hardness and disintegration time of the powder were measured according to the chinese pharmacopoeia method, and the results are shown in table 1, in this example, the formula was prepared under the same conditions of the component ratios:
(1) In terms of flowability, the total powder blend prepared from the formulations containing SMCC50 and SMCC90 has comparable flowability, better than the powder blend prepared from the formulation containing MCC + SiO 2 (98).
(2) In terms of tablet hardness, the formula containing SMCC90 can prepare tablets with the best hardness and the smallest friability which are better than those containing SMCC50, MCC + SiO 2 (98.
(3) In thatIn terms of disintegration time, the disintegration time of the prescription (containing SMCC 90) with the highest hardness is basically the same as that of the prescription containing SMCC50 and is better than that of the prescription containing MCC + SiO 2 (98.
TABLE 1
Figure BDA0002949223050000051
Example 2:
preparing an orally disintegrating tablet of acetylglucosamine of the following formula:
prescription 5:
35 percent of acetyl glucosamine,
30 percent of mannitol,
silicified microcrystalline cellulose 90 (SMCC 90) 10%,
20% of crospovidone and sodium carboxymethyl starch (1,
30 percent of polyvidone K,
1.5 percent of magnesium stearate,
aspartame 0.5 percent.
Prescription 6:
35 percent of acetyl glucosamine,
30 percent of sorbitol,
silicified microcrystalline cellulose 90 (SMCC 90) 10%,
20% of crospovidone and sodium carboxymethyl starch (1,
30 percent of polyvidone K,
1.5 percent of magnesium stearate,
aspartame 0.5 percent.
Prescription 7:
35 percent of acetyl glucosamine,
mannitol and sorbitol (3,
silicified microcrystalline cellulose 90 (SMCC 90) 10%,
20% of crospovidone and sodium carboxymethyl starch (1,
30 percent of polyvidone K,
1.5 percent of magnesium stearate,
aspartame 0.5 percent.
Recipe 8:
35 percent of acetyl glucosamine,
mannitol and sorbitol (4),
silicified microcrystalline cellulose 90 (SMCC 90) 10%,
20% of crospovidone and sodium carboxymethyl starch (1,
30 percent of polyvidone K,
1.5 percent of magnesium stearate,
0.5 percent of aspartame.
Prescription 9:
35 percent of acetyl glucosamine,
mannitol and sorbitol (5),
silicified microcrystalline cellulose 90 (SMCC 90) 10%,
20% of crospovidone and sodium carboxymethyl starch (1,
30 percent of polyvidone K,
1.5 percent of magnesium stearate,
aspartame 0.5 percent.
Hardness test was performed according to the chinese pharmacopoeia method, as shown in table 2 and fig. 1, each prescription of this example was performed under the same pressure:
(1) Contains mannitol: sorbitol (4.
(2) Contains mannitol: the formulation of sorbitol (4. In the other four formulas, when the pressure reaches a certain condition, the hardness of the tablet does not increase along with the increase of the pressure.
TABLE 2
Figure BDA0002949223050000071
Example 3:
preparing an orally disintegrating tablet of acetylglucosamine of the formula in table 3:
TABLE 3
Figure BDA0002949223050000072
Figure BDA0002949223050000081
The hardness test is carried out by using a Chinese pharmacopoeia method, and the results are shown in table 4 and figure 2, which show that the formula of the invention can know that the hardness of the alloy is as follows:
(1) Containing crospovidone: the formulation of sodium carboxymethyl starch (1.
(2) Containing crospovidone: the formulation of sodium carboxymethyl starch (1. While the disintegration times for the other four formulations increased significantly with increasing hardness.
TABLE 4
Figure BDA0002949223050000082
The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Those skilled in the art can modify or change the above-described embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims (5)

1. The orally disintegrating tablet of acetylglucosamine is characterized in that the orally disintegrating tablet of acetylglucosamine is composed of the following components by weight percent based on the total amount of the orally disintegrating tablet of acetylglucosamine:
10 to 35 percent of acetyl glucosamine,
10-35% of alcohol diluent,
10-30% of filling agent,
2 to 20 percent of disintegrating agent,
3 to 20 percent of adhesive,
0.5 to 5 percent of lubricant,
0.5-1.5% of flavoring agent;
the alcohol diluent is a physical mixture of mannitol and sorbitol;
the mass ratio of the mannitol to the sorbitol is 4;
the filler is selected from silicified microcrystalline cellulose 90;
the disintegrant is selected from a physical mixture of crospovidone and sodium carboxymethyl starch;
the mass ratio of the crospovidone to the sodium carboxymethyl starch is 1.
2. The orally disintegrating tablet of acetylglucosamine of claim 1, wherein said binder is selected from povidone K30.
3. The orally disintegrating tablet of acetylglucosamine of claim 1, further comprising one or more of the following characteristics:
1) The lubricant is selected from magnesium stearate;
2) The flavoring agent is selected from aspartame.
4. The orally disintegrating tablet of acetylglucosamine of claim 1, wherein based on the total amount of the orally disintegrating tablet of acetylglucosamine, the orally disintegrating tablet of acetylglucosamine comprises the following components by weight percent:
15 to 30 percent of acetyl glucosamine,
15-30% of alcohol diluent,
15 to 30 percent of filling agent,
5 to 15 percent of disintegrating agent,
3 to 15 percent of adhesive,
0.5 to 3 percent of lubricant,
0.5-1.5% of flavoring agent.
5. The process for preparing an orally disintegrating tablet of acetylglucosamine of any one of claims 1 to 4, which comprises the steps of:
a. sieving acetylglucosamine with 80 mesh sieve;
b. mixing the acetylglucosamine with an alcohol diluent, a filler, a disintegrating agent and an adhesive to obtain premixed powder;
c. mixing the premixed powder with lubricant and correctant to obtain total mixed powder;
d. tabletting the total mixed powder to obtain the orally disintegrating tablet of acetylglucosamine.
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US20070122473A1 (en) * 2005-11-12 2007-05-31 Felton Linda A Aminosugar and/or glycosaminoglycan composition having therapeutic use
WO2008119659A2 (en) * 2007-03-29 2008-10-09 F. Hoffmann-La Roche Ag Pharmaceutical composition and process
CN102512393A (en) * 2011-12-19 2012-06-27 浙江华海药业股份有限公司 Oral disintegrated tablet containing tolvaptan
CN104258411A (en) * 2014-09-19 2015-01-07 安徽山河药用辅料股份有限公司 Silicified microcrystalline cellulose composite auxiliary material and preparation method thereof
CN110507620B (en) * 2019-09-09 2021-05-11 山东润德生物科技有限公司 Compound glucosamine sulfate dispersible tablet and preparation method thereof

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