CN110101675A - A kind of preparation method of Metronidazole Tablet - Google Patents
A kind of preparation method of Metronidazole Tablet Download PDFInfo
- Publication number
- CN110101675A CN110101675A CN201910374002.XA CN201910374002A CN110101675A CN 110101675 A CN110101675 A CN 110101675A CN 201910374002 A CN201910374002 A CN 201910374002A CN 110101675 A CN110101675 A CN 110101675A
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- China
- Prior art keywords
- parts
- metronidazole
- preparation
- cornstarch
- sodium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
Abstract
The present invention provides a kind of preparation method of Metronidazole Tablet, its contained component of the Metronidazole Tablet includes metronidazole, dextrin, cornstarch, the third methylcellulose of carboxylic, cross-linked carboxymethyl cellulose sodium, sucrose, carboxyrnethyl starch sodium, the microcrystalline cellulose, lauryl sodium sulfate, magnesium stearate of dose therapeutically effective.The application have passed through process optimization, the unilateral immaculate produced, and unilateral homogeneity is good.Present invention process is reproducible, and unilateral smooth in appearance is beautiful, and preparation method is easy to operate, quality controllable, is suitble to industrialized production.
Description
Technical field
The invention belongs to field of medicaments, and in particular to the preparation method of Metronidazole Tablet.
Background technique
Protostat is mainly used for infection caused by preventing and treating anaerobic bacteria, such as respiratory tract, alimentary canal, female reproduction
The anaerobic infection at the positions such as system, lower respiratory tract, skin and soft tissue, bone and joint, to septicemia, endocarditis, meninx sense
It contaminates and also effective using colitis caused by antibiotic；It is combined often with tetanus antitoxin (TAT) in treatment tetanus；Also
It can be used for oral cavity anaerobium infection.Current domestic most Metric 21 hardness, friability are lacking, there are easy sliver, loose pieces,
Unilateral spottiness sticking, the problems such as.Although having certain effect, effect is unobvious, and performance is unstable, and preparation process is multiple
Miscellaneous, process is more, at high cost.
Summary of the invention
The object of the invention is to remedy the disadvantages of known techniques, provides the preparation method of a kind of pair of Metronidazole Tablet, pressure
Tablet quality is high.
The present invention is achieved by the following technical solutions:
The invention has the advantages that
The preparation method of Metronidazole Tablet, it is characterised in that be prepared by the raw material of following parts by weight: metronidazole 75~85
Part, 5~9 parts of dextrin, 1~2 part of cornstarch, 0.3~0.8 part of the third methylcellulose of carboxylic, 2~4 parts of cross-linked carboxymethyl cellulose sodium, sugarcane
Sugared 10~15 parts, 3~7 parts of carboxyrnethyl starch sodium, 3~5 parts of microcrystalline cellulose, 0.2~0.7 part of lauryl sodium sulfate, stearic acid
1~2 part of magnesium；
Such as the preparation method of above-mentioned Metronidazole Tablet, comprising the following steps:
(1) sucrose, microcrystalline cellulose, cross-linked carboxymethyl cellulose sodium co-grinding are sieved with 100 mesh sieve into net；
(2) hydroxypropyl methylcellulose is added in purified water, is heated to boiling, dissolves hydroxypropyl methylcellulose, separately by corn
Starch is added in purified water, is poured into hydroxypropyl methylcellulose solution after mixing evenly, hydroxypropyl methylcellulose and cornstarch is made
Mixing slurry；
(3) it is matched by prescription and pours into metronidazole, dextrin, step (1) mixed powder in trough type mixing machine, be stirred 10-
20 minutes, mixing slurry stirring step (2) prepared is added, crosses 14 mesh nylon mesh wet granulations；
(4) wet granular made is 3~5 hours dry with heat-circulation oven, control drying temperature is 65~75 DEG C, then is used
12 mesh stainless steel mesh whole grains；
(5) movement is added in particle made from carboxyrnethyl starch sodium, lauryl sodium sulfate, magnesium stearate and step (4) to mix
It is mixed 30-60 minutes in conjunction machine；Tabletting；Packaging.
The preparation method of the Metronidazole Tablet, it is characterised in that be prepared by the raw material of following parts by weight: metronidazole
80 parts, 7 parts of dextrin, 1.6 parts of cornstarch, 0.6 part of the third methylcellulose of carboxylic, 3 parts of cross-linked carboxymethyl cellulose sodium, 12 parts of sucrose, carboxylic
4.8 parts of first sodium starch, 4 parts of microcrystalline cellulose, 0.4 part of lauryl sodium sulfate, 1.2 parts of magnesium stearate.
Metronidazole Tablet provided by the invention, using sucrose, microcrystalline cellulose, cross-linked carboxymethyl cellulose sodium co-grinding, benefit
With the water suction point disintegration of microcrystalline cellulose and bonding characteristic, merely in the case where mixing after microcrystalline cellulose, what is easily occurred is unilateral
White point situation is merged using more material and is crushed, and unilateral complete colour mixture is uniform, and without white point spot situation, unilateral quality is high, due to sugarcane
The caking property of sugar, by being blended, the case where overcoming easy sticking, meets high speed into the needs of punching, improves production capacity, and unilateral
It is smooth, good brightness, hardness height.It is eventually adding carboxyrnethyl starch sodium, lauryl sodium sulfate, magnesium stearate mixing, due to three kinds of originals
Expect that dosage is smaller, has substantially no effect on unilateral, to produce unilateral immaculate, unilateral homogeneity is good.Present invention process is reproducible, piece
Face smooth in appearance is beautiful, and preparation method is easy to operate, quality controllable, is suitble to industrialized production.
Specific embodiment
A kind of preparation method of Metronidazole Tablet, comprising the following steps:
A kind of Metronidazole Tablet, to prepare in terms of Metronidazole Tablet 100,000, the raw material components of the Metronidazole Tablet be metronidazole 20kg,
Dextrin 1.75kg, cornstarch 0.4kg, the third methylcellulose of carboxylic 0.15kg, cross-linked carboxymethyl cellulose sodium 0.75kg, sucrose 3kg, carboxylic
First sodium starch 1.2kg, microcrystalline cellulose 1kg, lauryl sodium sulfate 0.1kg, magnesium stearate 0.3kg.
(1) sucrose, microcrystalline cellulose, cross-linked carboxymethyl cellulose sodium co-grinding are sieved with 100 mesh sieve into net；
(2) 0.15kg hydroxypropyl methylcellulose is added in 2.5kg purified water, is heated to boiling, keep hydroxypropyl methylcellulose molten
0.4kg cornstarch is separately added in 1.2kg purified water, pours into hydroxypropyl methylcellulose solution, be made dense after mixing evenly by solution
Hydroxypropyl methylcellulose and cornstarch mixing slurry of the degree for 13%；
(3) it is matched by prescription and pours into metronidazole, dextrin, step (1) mixed powder in trough type mixing machine, be stirred 10-
20 minutes, the mixing slurry that step (2) are prepared is added and stirs 5 minutes, crosses 14 mesh nylon mesh wet granulations；
(4) wet granular made is uniformly spread out in stainless steel disc, wet granular thickness 3-5cm, it is dry with heat-circulation oven
Dry 3~5 hours, control drying temperature was 65~75 DEG C, then with 12 mesh stainless steel mesh whole grains；
(5) movement is added in particle made from carboxyrnethyl starch sodium, lauryl sodium sulfate, magnesium stearate and step (4) to mix
It is mixed 30-60 minutes in conjunction machine；Oscillating motor, revolving speed motor working frequency are set as 40Hz, is mixed 60 minutes；With φ 9.0mm
Shallow concave punch tabletting；Packaging.
Dissolution rate, friability and the content for detecting the Metronidazole Tablet of embodiment, as a result see the table below.
| Detection project | Dissolution rate (%) | Friability (%) | Content (%) |
| Testing result | 93,95,92,94,94,92 | 0.2 | 97.3 |
Claims (2)
1. the preparation method of Metronidazole Tablet, it is characterised in that be prepared by the raw material of following parts by weight: 75 ~ 85 parts of metronidazole,
5 ~ 9 parts of dextrin, 1 ~ 2 part of cornstarch, 0.3 ~ 0.8 part of the third methylcellulose of carboxylic, 2 ~ 4 parts of cross-linked carboxymethyl cellulose sodium, sucrose 10 ~ 15
Part, 3 ~ 7 parts of carboxyrnethyl starch sodium, 3 ~ 5 parts of microcrystalline cellulose, 0.2 ~ 0.7 part of lauryl sodium sulfate, 1 ~ 2 part of magnesium stearate；
Such as the preparation method of above-mentioned Metronidazole Tablet, comprising the following steps:
(1) sucrose, microcrystalline cellulose, cross-linked carboxymethyl cellulose sodium co-grinding are sieved with 100 mesh sieve into net；
(2) hydroxypropyl methylcellulose is added in purified water, is heated to boiling, dissolves hydroxypropyl methylcellulose, separately by cornstarch
It is added in purified water, is poured into hydroxypropyl methylcellulose solution after mixing evenly, hydroxypropyl methylcellulose and cornstarch mixing is made
Slurry；
(3) it is matched by prescription and pours into metronidazole, dextrin, step (1) mixed powder in trough type mixing machine, be stirred 10-20 points
Clock is added mixing slurry stirring step (2) prepared, crosses 14 mesh nylon mesh wet granulations；
(4) wet granular made is 3 ~ 5 hours dry with heat-circulation oven, control drying temperature is 65 ~ 75 DEG C, then not with 12 mesh
Rust steel sieve whole grain；
(5) movement mixer is added in particle made from carboxyrnethyl starch sodium, lauryl sodium sulfate, magnesium stearate and step (4)
Middle mixing 30-60 minutes；Tabletting；Packaging.
2. the preparation method of Metronidazole Tablet as described in claim 1, it is characterised in that by the raw material preparation of following parts by weight
At: 80 parts of metronidazole, 7 parts of dextrin, 1.6 parts of cornstarch, 0.6 part of the third methylcellulose of carboxylic, 3 parts of cross-linked carboxymethyl cellulose sodium, sugarcane
Sugared 12 parts, 4.8 parts of carboxyrnethyl starch sodium, 4 parts of microcrystalline cellulose, 0.4 part of lauryl sodium sulfate, 1.2 parts of magnesium stearate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910374002.XA CN110101675A (en) | 2019-05-07 | 2019-05-07 | A kind of preparation method of Metronidazole Tablet |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910374002.XA CN110101675A (en) | 2019-05-07 | 2019-05-07 | A kind of preparation method of Metronidazole Tablet |
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| Publication Number | Publication Date |
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| CN110101675A true CN110101675A (en) | 2019-08-09 |
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| CN201910374002.XA Pending CN110101675A (en) | 2019-05-07 | 2019-05-07 | A kind of preparation method of Metronidazole Tablet |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112007002A (en) * | 2020-08-05 | 2020-12-01 | 河北君临药业有限公司 | Metronidazole tablet composition with stable quality and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007079082A2 (en) * | 2005-12-30 | 2007-07-12 | Advancis Pharmaceutical Corporation | Gastric release pulse system for drug delivery |
| WO2012075015A2 (en) * | 2010-11-29 | 2012-06-07 | Dr. Reddy's Laboratories Ltd. | Oral metronidazole pharmaceutical compositions |
| CN106137988A (en) * | 2016-01-14 | 2016-11-23 | 上海信谊万象药业股份有限公司 | A kind of metronidazole solid preparation and preparation method thereof |
-
2019
- 2019-05-07 CN CN201910374002.XA patent/CN110101675A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007079082A2 (en) * | 2005-12-30 | 2007-07-12 | Advancis Pharmaceutical Corporation | Gastric release pulse system for drug delivery |
| WO2012075015A2 (en) * | 2010-11-29 | 2012-06-07 | Dr. Reddy's Laboratories Ltd. | Oral metronidazole pharmaceutical compositions |
| CN106137988A (en) * | 2016-01-14 | 2016-11-23 | 上海信谊万象药业股份有限公司 | A kind of metronidazole solid preparation and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 姜玉明: "浅析片剂脆碎度与崩解时限的影响因素", 《中外健康文摘》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112007002A (en) * | 2020-08-05 | 2020-12-01 | 河北君临药业有限公司 | Metronidazole tablet composition with stable quality and preparation method thereof |
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Application publication date: 20190809 |
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