CN110934841A - Cefteram pivoxil tablet composition - Google Patents

Cefteram pivoxil tablet composition Download PDF

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Publication number
CN110934841A
CN110934841A CN201911413291.6A CN201911413291A CN110934841A CN 110934841 A CN110934841 A CN 110934841A CN 201911413291 A CN201911413291 A CN 201911413291A CN 110934841 A CN110934841 A CN 110934841A
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Prior art keywords
cefteram pivoxil
cefteram
tablet composition
acrylic resin
coating
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CN201911413291.6A
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Inventor
王作江
闫正伦
孙运贝
王飞
宋美云
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Shandong Luoxin Pharmaceutical Group Hengxin Pharmacy Co Ltd
Shandong Yu Xin Pharmaceutcal Corp Ltd
Shandong Luoxin Pharmaceutical Group Co Ltd
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Shandong Luoxin Pharmaceutical Group Hengxin Pharmacy Co Ltd
Shandong Yu Xin Pharmaceutcal Corp Ltd
Shandong Luoxin Pharmaceutical Group Co Ltd
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Priority to CN201911413291.6A priority Critical patent/CN110934841A/en
Publication of CN110934841A publication Critical patent/CN110934841A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/542Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/545Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
    • A61K31/546Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents

Abstract

The invention belongs to the technical field of medicines, and particularly relates to a cefteram pivoxil tablet and a preparation method thereof. The glyceryl behenate and the sodium carboxymethylcellulose are ground and mixed to be used as an inner coating, and the cefteram pivoxil is coated for the first layer, so that the bitter taste is effectively covered, and meanwhile, the decomposition of raw materials is greatly reduced; the sodium carboxymethyl starch is added to adjust the dissolution, and the quality of the raw materials is kept stable.

Description

Cefteram pivoxil tablet composition
The technical field is as follows:
the invention belongs to the field of pharmaceutical preparations, and particularly relates to a cefteram pivoxil tablet composition.
Background art:
cefteram pivoxil, chemical name (6R, 7R) -7- [ (Z) -2- (2-amino-4-thiazolyl) -2- (methoxyimino) acetamido ] -3- [2- (5-methyl-2H-tetrazol-2-yl) methyl ] -8-oxo-5-thia-1-azabicyclo [4,2,0] oct-2-ene-2-carboxylic acid pivaloyloxymethyl ester. The cefteram pivoxil belongs to oral third-generation cephalosporin, is a prodrug of the cefteram modified by an ester group structure, has weaker self activity, and generates active cefteram by esterase hydrolysis after oral absorption to generate antibacterial activity. Has spectrum antibacterial effect on gram negative and positive bacteria such as Citrobacter, Serratia and Enterobacter. The medicine is mainly used for treating infections caused by streptococcus, pneumococcus, escherichia coli, klebsiella, proteus and haemophilus influenzae, such as sphagitis, tonsillitis, bronchitis, pneumonia, pyelonephritis, cystitis, gonococcal urethritis, cholecystitis, otitis media, scarlet fever and the like.
The cefteram pivoxil has poor water solubility, almost is insoluble in water, has good fat solubility, is easily soluble in solvents such as methanol and the like, has better photo-thermal stability in a solid state, is not stable in a solution, and is easily decomposed when meeting acid and alkali. Therefore, the existing cefteram pivalol preparation has slow dissolution, absorption and distribution in vivo and relatively low bioavailability.
Patent CN108113972A discloses a pharmaceutical composition containing cefteram pivoxil, wherein sodium propionate is added into the composition as a gel inhibitor, so as to effectively inhibit the solid preparation from gelling in an aqueous solution, effectively improve the dissolution performance of the solid preparation, and further improve the bioavailability. And the problem of bitter taste of the granular preparation is solved by utilizing the synergistic flavoring effect of the sodium propionate and the aspartame.
Patent CN103919744A discloses a cefteram pivoxil tablet, which comprises the following components in parts by weight: 80-120 parts of cefteram pivoxil; 80-100 parts of starch; 5-15 parts of lactose; 5-15 parts by weight of microcrystalline cellulose; 15-30 parts by weight of croscarmellose sodium; 0.5-2 parts by weight of magnesium stearate; and (4) a proper amount of adhesive. The tablet adopts the croscarmellose sodium to match with the microcrystalline cellulose, so that the disintegration time limit and the release effect of the tablet are unexpectedly improved, the drug effect is more obvious, but the impurity content is higher, and the stability of the preparation needs to be improved.
Patent CN1709262A discloses a cefteram composition for injection, which comprises the following components: cefteram or a pharmaceutically acceptable salt thereof as an active ingredient and a cosolvent as a cosolvent ingredient; the cosolvent is basic amino acid, or inorganic acid salt of alkali metal, or organic acid salt of alkali metal, or inorganic acid salt of alkaline earth metal, or organic acid salt of alkaline earth metal; the proportion of the cefteram or the medicinal salt thereof to the cosolvent is 1: 0.05-20 in parts by weight. Due to the addition of a proper amount of cosolvent, the cefteram composition becomes a soluble medicament, has good water solubility, can fully exert the antibacterial action of the active cefteram when used as an injection medicament, and overcomes the defect of the existing cefteram ester oral preparation and can be used for all indications of the cefteram ester.
Patent CN100998595A provides a pharmaceutical composition of a cyclodextrin inclusion compound of cefteram pivoxil, which comprises the following basic components: A) cefteram pivoxil, and B) a pharmaceutically acceptable cyclodextrin; the cyclodextrin is selected from B-cyclodextrin or one or more of derivatives thereof. The clathrate compound of the invention obviously increases the solubility and stability of the drug, and simultaneously has lower hemolysis stimulation and high activity.
The method adopts a method of adding pharmaceutical excipients to improve the solubility and stability of the cefditoren pivoxil.
Patent CN102351886A discloses a cefteram pivoxil crystal and a composition tablet of the crystal, starting from a cefteram pivoxil raw material drug, a cefteram pivoxil crystal with a small particle size is prepared by an ultrasonic method, and the obtained cefteram pivoxil crystal is added with pharmaceutically acceptable auxiliary materials to prepare the cefteram pivoxil composition tablet.
Patent CN108143723A discloses a cefoperan pivoxil tablet, which is mainly composed of cefoperan pivoxil micropowder with the particle size of 35-50 μm, and is assisted by ultrafine powder with the particle size of 3-6 μm, so that the cefoperan pivoxil tablet has a good space scale effect, and meanwhile, mannitol with poor fluidity and microcrystalline cellulose with good fluidity are matched according to a certain proportion to be used as a disintegrating agent.
Patent CN102091039A discloses a solid preparation of cefteram pivoxil liposome, which is prepared from the following raw and auxiliary materials in parts by weight: 1 part of cefteram pivoxil, 4-25 parts of soybean lecithin, 1-12 parts of cholesterol, 0.5-20 parts of tween 80, 1-4 parts of soyasterol and 5-40 parts of a pharmaceutically acceptable carrier. The liposome solid preparation has high entrapment rate, uniform particle size and long retention time of the drug in blood circulation, but the production control requirement of the liposome solid preparation is higher, so that the clinical application is greatly limited.
Summarizing the preparation of the cefteram pivoxil in the prior art, the tablet is a common preparation form, and a wetting agent water or alcohol is required to be added in the wet granulation process, so that gelation is easy to cause, and the bonding phenomenon is serious; although the dry granulation can avoid the problem of gelation, the problem of dissolution reduction caused by gelation when meeting water in the medication process still exists; the direct tabletting effect of the powder is poor, so a large amount of filler is generally required to be added, and the requirement on the filler is high, so that the preparation cost is greatly increased, and the medicine is not dissolved well.
The invention content is as follows:
in order to overcome the defects in the prior art, the invention provides a cefteram pivoxil tablet composition.
The invention provides a cefteram pivoxil tablet composition which is prepared from the following raw and auxiliary materials:
Figure BDA0002350532660000021
Figure BDA0002350532660000031
wherein, the coating material comprises acrylic resin No. 2, acrylic resin No. 3, castor oil, talcum powder and 85% ethanol, and the mass ratio is that acrylic resin No. 2: acrylic resin No. 3: castor oil: talc powder: 15% ethanol: 5:3:2: 25.
the preparation method of the cefteram pivoxil tablet composition provided by the invention comprises the following steps:
(1) respectively grinding the cefteram pivoxil and the sodium carboxymethyl starch, sieving with a 80-mesh sieve, and mixing for later use;
(2) grinding glyceryl behenate and sieving with 100 mesh sieve, grinding sodium carboxymethylcellulose and sieving with 200 mesh sieve, mixing, heating and melting;
(3) adjusting proper air volume in a fluidized bed to ensure that the mixture of the cefteram pivoxil and the sodium carboxymethyl starch obtained in the step (1) is fully fluidized, adjusting the temperature to 40-50 ℃, forming atomized liquid drops from the mixed melt in the step (2) under the action of compressed air, and slowly spraying the atomized liquid drops on the surface of the fully fluidized mixture of the cefteram pivoxil and the sodium carboxymethyl starch to uniformly coat the mixture;
(4) adding compressible starch into the tundish coating obtained in the step (3), stirring and mixing uniformly, and tabletting;
(5) adding acrylic resin No. 2, acrylic resin No. 3, castor oil and talcum powder into 85% ethanol, and stirring for 8 hours at 35-45 ℃ to form a coating solution;
(6) and (4) putting the plain tablets obtained in the step (4) into a coating pan, atomizing the coating solution into small liquid drops through a spray gun, attaching the small liquid drops to the surface of the plain tablets for coating, and drying to obtain the cefteram pivoxil tablets.
Compared with the prior art, the invention has the following beneficial technical effects:
(1) the glyceryl behenate and the sodium carboxymethylcellulose are ground and mixed to be used as an inner coating, and the cefteram pivoxil is coated for the first layer, so that the bitter taste is effectively covered, and meanwhile, the decomposition of raw materials is greatly reduced; the sodium carboxymethyl starch is added to adjust the dissolution, and the quality of the raw materials is kept stable.
(2) The two layers of coatings are matched with auxiliary materials for adjusting dissolution, so that the cefotetan pivoxil tablet can be maintained for a longer time in vivo while keeping faster and higher dissolution.
The specific implementation mode is as follows:
the following examples are intended to illustrate the present invention without limiting its scope.
Example 1
A cefteram pivoxil tablet composition is prepared into 1000 tablets by the following raw and auxiliary materials
Figure BDA0002350532660000032
Figure BDA0002350532660000041
The preparation method comprises the following steps:
(1) respectively grinding the cefteram pivoxil and the sodium carboxymethyl starch, sieving with a 80-mesh sieve, and mixing for later use;
(2) grinding glyceryl behenate and sieving with 100 mesh sieve, grinding sodium carboxymethylcellulose and sieving with 200 mesh sieve, mixing, heating and melting;
(3) adjusting proper air quantity in a fluidized bed to ensure that the mixture of the cefteram pivoxil and the sodium carboxymethyl starch obtained in the step (1) is fully fluidized, adjusting the temperature to 40 ℃, forming atomized liquid drops from the mixed melt in the step (2) under the action of compressed air, and slowly spraying the atomized liquid drops on the surface of the fully fluidized mixture of the cefteram pivoxil and the sodium carboxymethyl starch to uniformly coat the mixture;
(4) adding compressible starch into the tundish coating obtained in the step (3), stirring and mixing uniformly, and tabletting;
(5) adding acrylic resin No. 2, acrylic resin No. 3, castor oil and talcum powder into 85% ethanol, and stirring for 8h at 35 ℃ to form a coating solution;
(6) and (4) putting the plain tablets obtained in the step (4) into a coating pan, atomizing the coating solution into small liquid drops through a spray gun, attaching the small liquid drops to the surface of the plain tablets for coating, and drying to obtain the cefteram pivoxil tablets.
Example 2
A cefteram pivoxil tablet composition is prepared into 1000 tablets by the following raw and auxiliary materials
Figure BDA0002350532660000042
The preparation method comprises the following steps:
(1) respectively grinding the cefteram pivoxil and the sodium carboxymethyl starch, sieving with a 80-mesh sieve, and mixing for later use;
(2) grinding glyceryl behenate and sieving with 100 mesh sieve, grinding sodium carboxymethylcellulose and sieving with 200 mesh sieve, mixing, heating and melting;
(3) adjusting proper air quantity in a fluidized bed to ensure that the mixture of the cefteram pivoxil and the sodium carboxymethyl starch obtained in the step (1) is fully fluidized, adjusting the temperature to 50 ℃, forming atomized liquid drops from the mixed melt in the step (2) under the action of compressed air, and slowly spraying the atomized liquid drops on the surface of the fully fluidized mixture of the cefteram pivoxil and the sodium carboxymethyl starch to uniformly coat the mixture;
(4) adding compressible starch into the tundish coating obtained in the step (3), stirring and mixing uniformly, and tabletting;
(5) adding acrylic resin No. 2, acrylic resin No. 3, castor oil and talcum powder into 85% ethanol, and stirring for 8h at 45 ℃ to form a coating solution;
(6) and (4) putting the plain tablets obtained in the step (4) into a coating pan, atomizing the coating solution into small liquid drops through a spray gun, attaching the small liquid drops to the surface of the plain tablets for coating, and drying to obtain the cefteram pivoxil tablets.
Example 3:
a cefteram pivoxil tablet composition is prepared into 1000 tablets by the following raw and auxiliary materials
Figure BDA0002350532660000051
The preparation method comprises the following steps:
(1) respectively grinding the cefteram pivoxil and the sodium carboxymethyl starch, sieving with a 80-mesh sieve, and mixing for later use;
(2) grinding glyceryl behenate and sieving with 100 mesh sieve, grinding sodium carboxymethylcellulose and sieving with 200 mesh sieve, mixing, heating and melting;
(3) adjusting proper air quantity in a fluidized bed to ensure that the mixture of the cefteram pivoxil and the sodium carboxymethyl starch obtained in the step (1) is fully fluidized, adjusting the temperature to 45 ℃, forming atomized liquid drops from the mixed melt in the step (2) under the action of compressed air, and slowly spraying the atomized liquid drops on the surface of the fully fluidized mixture of the cefteram pivoxil and the sodium carboxymethyl starch to uniformly coat the mixture;
(4) adding compressible starch into the tundish coating obtained in the step (3), stirring and mixing uniformly, and tabletting;
(5) adding acrylic resin No. 2, acrylic resin No. 3, castor oil and talcum powder into 85% ethanol, and stirring for 8h at 40 ℃ to form a coating solution;
(6) and (4) putting the plain tablets obtained in the step (4) into a coating pan, atomizing the coating solution into small liquid drops through a spray gun, attaching the small liquid drops to the surface of the plain tablets for coating, and drying to obtain the cefteram pivoxil tablets.
Experimental example 1 dissolution measurement
According to the dissolution determination method under the item of the cefditoren pivoxil tablet of the 17 th edition of the Japanese pharmacopoeia, according to the paddle method, 900mL of purified water is used as a dissolution medium, the rotating speed is 75 revolutions per minute, the operation is carried out according to the method, when 30 minutes pass, a proper amount of solution is taken, filtered, a proper amount of subsequent filtrate is precisely taken, the solution containing about 20 mu g of cefditoren pivoxil in each 1mL is prepared by quantitative dilution with the dissolution medium, the absorbance is determined at the wavelength of 300nm, a proper amount of cefditoren pivoxil reference substance is precisely weighed, the solution containing about 20 mu g of cefditoren pivoxil in each 1mL is prepared by dissolution medium dissolution and quantitative dilution, and the determination is carried out by the same method. The amount of elution was calculated for each tablet. The results of the examination of example 3 of the present invention and 100mg of cefteram pivoxil tablet commercially available from Fushan chemical industries, Ltd are as follows:
sample (I) Dissolution rate%
Example 1 97.8
Example 2 96.9
Example 3 98.3
Is commercially available 98.5
Experimental example 2 stability test
And (4) investigating items: properties, dissolution rate, content, related substances and water. The test is carried out according to the guiding principle of 9001 raw material medicaments and preparation stability test in the fourth pharmacopoeia 2015 edition.
(1) Test for influencing factor
High-temperature test: taking the cefditoren pivoxil tablet obtained in the embodiment 1 of the invention, placing the tablet at the temperature of 60 ℃ for 10 days, sampling on the 5 th day and the 10 th day, and detecting according to a stability focus examination item.
High humidity test: taking the cefteram pivoxil tablet obtained in the embodiment 1 of the invention, placing the cefteram pivoxil tablet in a constant-humidity closed container, placing the cefteram pivoxil tablet in a relative humidity RH 90% +/-5% condition for 10 days at 25 ℃, sampling on the 5 th day and the 10 th day, and detecting according to the requirements of important stability investigation projects.
Strong light irradiation test: the cefteram pivoxil tablet obtained in the embodiment 3 of the invention is put in a lighting box provided with a fluorescent lamp, is placed for 10 days under the condition that the illumination is 4500lx +/-500 lx, and is sampled on the 5 th day and the 10 th day, and is detected according to the key stability investigation items.
The results of taking and examining example 3 of the present invention and a 100mg tablet of cefteram pivoxil commercially available from Fushan chemical industries, Ltd., were as follows:
the results of the influence factor test in example 3 of the present invention are shown in the following table:
Figure BDA0002350532660000061
Figure BDA0002350532660000071
the results of the influence factor test of commercially available cefteram pivoxil tablets are shown in the following table:
Figure BDA0002350532660000072
(2) accelerated test
100mg of cefteram pivoxil tablets commercially available from example 3 of the present invention and Fushan chemical industry Co., Ltd were taken and left at 40. + -. 2 ℃ and 75. + -. 5% relative humidity for 6 months, respectively. Samples were taken at the end of 1 month, 2 months, 3 months and 6 months during the test period, and were tested according to stability focus test items.
The results of the accelerated testing are shown in the following table:
Figure BDA0002350532660000073
(3) long term test
The method comprises the steps of respectively taking 100mg of cefteram pivoxil tablets sold in example 3 of the invention and Fushan chemical industry Co., Ltd, placing the tablets for 12 months under the conditions of 25 ℃ plus or minus 2 ℃ and 60% plus or minus 10% of relative humidity, sampling every 3 months, respectively sampling for 0 month, 3 months, 6 months, 9 months and 12 months, and detecting according to the stability key examination item.
Figure BDA0002350532660000081
Experimental example 3 blood concentration test
10 subjects orally administered 100mg of the cefteram pivoxil tablet prepared in example 3 to obtain the cefteram mean blood concentration data (ug/mL), and 10 subjects orally administered 100mg of the cefteram pivoxil tablet sold by Fushan chemical industries, Ltd to obtain the cefteram mean blood concentration data (ug/mL), and the results are as follows.
Figure BDA0002350532660000082
The experimental results show that compared with the commercially available preparation, the cefteram pivoxil tablet prepared by the invention can maintain higher blood concentration for a longer time.

Claims (7)

1. The cefteram pivoxil tablet composition is characterized by being prepared from the following raw and auxiliary materials:
Figure FDA0002350532650000011
2. the cefteram pivoxil tablet composition according to claim 1, which is characterized by being prepared from the following raw and auxiliary materials:
Figure FDA0002350532650000012
3. the cefteram pivoxil tablet composition of any of claims 1 or 2, wherein the coating material consists of acrylic resin No. 2, acrylic resin No. 3, castor oil, talc, 85% ethanol.
4. The cefteram pivoxil tablet composition according to claim 3, wherein the mass ratio of the auxiliary materials constituting the coating material is acrylic resin No. 2: acrylic resin No. 3: castor oil: talc powder: 85% ethanol-15: 5:3:2: 25.
5. The process for the preparation of a cefteram pivoxil tablet composition according to claim 4, characterized by comprising the steps of:
(1) respectively grinding the cefteram pivoxil and the sodium carboxymethyl starch, sieving with a 80-mesh sieve, and mixing for later use;
(2) grinding glyceryl behenate and sieving with 100 mesh sieve, grinding sodium carboxymethylcellulose and sieving with 200 mesh sieve, mixing, heating and melting;
(3) adjusting proper air quantity in a fluidized bed to ensure that the mixture of the cefteram pivoxil and the sodium carboxymethyl starch obtained in the step (1) is fully fluidized, adjusting proper temperature, forming atomized liquid drops from the mixed melt in the step (2) under the action of compressed air, and slowly spraying the atomized liquid drops on the surface of the fully fluidized mixture of the cefteram pivoxil and the sodium carboxymethyl starch to uniformly coat the mixture;
(4) adding compressible starch into the tundish coating obtained in the step (3), stirring and mixing uniformly, and tabletting;
(5) adding acrylic resin No. 2, acrylic resin No. 3, castor oil and talcum powder into 85% ethanol, heating and stirring for 8 hours to form a coating solution;
(6) and (4) putting the plain tablets obtained in the step (4) into a coating pan, atomizing the coating solution into small liquid drops through a spray gun, attaching the small liquid drops to the surface of the plain tablets for coating, and drying to obtain the cefteram pivoxil tablets.
6. The process for preparing a cefteram pivoxil tablet composition according to claim 5, wherein the temperature in the step (3) is 40-50 ℃.
7. The process for preparing a cefteram pivoxil tablet composition according to claim 5, wherein the mixing temperature in the step (5) is 35-45 ℃.
CN201911413291.6A 2019-12-31 2019-12-31 Cefteram pivoxil tablet composition Pending CN110934841A (en)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101103965A (en) * 2006-05-02 2008-01-16 兰贝克赛实验室有限公司 Stable solid preparation containing amorphous cefditoren pivoxil and preparation method thereof
CN103565770A (en) * 2012-07-31 2014-02-12 北京阜康仁生物制药科技有限公司 Dexlansoprazole enteric-coated slow controlled-release pellet tablets
CN103877027A (en) * 2014-03-17 2014-06-25 广东药学院 Cefuroxime axetil hot-melt coating composition and preparation method of composition
CN103919744A (en) * 2014-04-25 2014-07-16 优胜美特制药有限公司 Cefteram pivoxil tablet and preparation process thereof
CN108113972A (en) * 2018-03-08 2018-06-05 董贵雨 A kind of pharmaceutical composition containing cefteram pivoxil
CN108143723A (en) * 2018-01-04 2018-06-12 清远华能制药有限公司 A kind of Cefteram Pivoxil Tablets and preparation method thereof and purposes

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101103965A (en) * 2006-05-02 2008-01-16 兰贝克赛实验室有限公司 Stable solid preparation containing amorphous cefditoren pivoxil and preparation method thereof
CN103565770A (en) * 2012-07-31 2014-02-12 北京阜康仁生物制药科技有限公司 Dexlansoprazole enteric-coated slow controlled-release pellet tablets
CN103877027A (en) * 2014-03-17 2014-06-25 广东药学院 Cefuroxime axetil hot-melt coating composition and preparation method of composition
CN103919744A (en) * 2014-04-25 2014-07-16 优胜美特制药有限公司 Cefteram pivoxil tablet and preparation process thereof
CN108143723A (en) * 2018-01-04 2018-06-12 清远华能制药有限公司 A kind of Cefteram Pivoxil Tablets and preparation method thereof and purposes
CN108113972A (en) * 2018-03-08 2018-06-05 董贵雨 A kind of pharmaceutical composition containing cefteram pivoxil

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
罗杰英,王玉蓉,张自然等编著: "《现代物理药剂学理论与实践》", 30 April 2005, 上海科学技术文献出版社 *

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