CN102579378A - Child cefdinir composition freeze-dried oral disintegrating tablet and preparation method thereof - Google Patents
Child cefdinir composition freeze-dried oral disintegrating tablet and preparation method thereof Download PDFInfo
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- CN102579378A CN102579378A CN2012100290344A CN201210029034A CN102579378A CN 102579378 A CN102579378 A CN 102579378A CN 2012100290344 A CN2012100290344 A CN 2012100290344A CN 201210029034 A CN201210029034 A CN 201210029034A CN 102579378 A CN102579378 A CN 102579378A
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Abstract
A child cefdinir composition freeze-dried oral disintegrating tablet and a preparation method thereof relate to the technical field of medicine and preparation methods for medicine. The child cefdinir composition comprises, by weight, 24% to 49% of cefdinir, 49% to 72% of mannitol, 2% to 4% of gelatin and 0.1% to o.15% of sucralose. A tert butyl alcohol- water cosolvent is used as a menstruum. The freeze-dried oral disintegrating tablet has the advantages that components are simple, water is not required when a user takes the freeze-dried oral disintegrating tablet, chewing is not required, disintegrating time in human mouths is no more than two seconds, absorption is quick, bioavailability is high, intestinal canal residue is few, side effect is low, hepatic first pass effect is small, and the freeze-dried oral disintegrating tablet tastes good and is particularly suitable for infant patients.
Description
Technical field:
The present invention relates to the method for preparing technical field of medicine and medicine, relate in particular to a kind of children's's cefdinir composition freeze-drying oral cavity disintegration tablet and preparation method thereof.
Background technology:
Cefdinir is a kind of third generation cephalo-type antibiotics, and another name: generation is held up Buddhist nun, FK-482, CFDN, FK-482.Its chemical name is: (6R, 7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-hydroxyl imide base acetylamino]-8-oxo-3-vinyl-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid.Structural formula is as follows:
Cefdinir is applicable to skin and soft tissue infection due to the sensitive organism, acute bronchitis, urinary system infection, genital system infection etc.Cefdinir has broad spectrum antibiotic activity to Grain-positive, negative aerobe and anaerobe.Antibacterial activity to staphylococcus aureus, Hemolytic streptococcus, peptostreptococcus, propionibacterium is strong, and is stronger than cefixime, cefaclor and cefalexin to staphylococcus aureus and the streptococcic external activity that produces enzyme staphylococcus, methicillin-sensitivity.There is certain activity that most negative bacterium are had powerful activity to methicillin-resistant staphylococcus aureus and fecal bacteria.
Although the cefdinir indication is extensive, be limited to its dosage form, its actual use receives certain restriction.Mostly common cefdinir is capsule and granula subtilis at present, and people generally must use warm water delivery service when taking medicine, and this is for the patient, and particularly pediatric patient is inconvenient.
Summary of the invention:
The object of the invention is to overcome the defective of prior art; Need not water when a kind of taking is provided, need not to chew, fast children's's cefdinir composition freeze-drying oral cavity disintegration tablet of disintegration rate and preparation method thereof in the oral cavity; This method preparation is easy to control, is fit to suitability for industrialized production.The said composition composition is simple: principal agent is a cefdinir, as solvent, also includes skeleton agent (mannitol) with the tertiary butanol and water cosolvent, forming agent (gelatin), correctives (sucralose).
For realizing the object of the invention, technical scheme realizes through following mode:
A kind of children's's cefdinir compositions is characterized in that: said composition comprises following component and component quantity ratio:
The preferred ingredient quantity ratio of said each component of children's's cefdinir compositions is:
A kind of children's's cefdinir composition freeze-drying oral cavity disintegration tablet that contains children's's cefdinir compositions is characterized in that, is prepared from following component and component quantity ratio:
The preferred ingredient quantity ratio of each component of children's's cefdinir composition freeze-drying oral cavity disintegration tablet is:
A kind of method for preparing of children's's cefdinir composition freeze-drying oral cavity disintegration tablet is characterized in that the concrete steps of this method for preparing are:
A) cefdinir with group component is dissolved in the tert-butyl alcohol of amounts of components, under 25 ℃-30 ℃, and the insulation of stirring and dissolving continued;
B) gelatin with group component is dissolved in the purified water of component water consumption 20%-30%, is heated to dissolving fully;
C) mannitol and the sucralose with group component is dissolved in the purified water of component water consumption 70%-80% stirring and dissolving;
D) merging three kinds of solution that above-mentioned steps a, step b, step c obtain merges and stirs;
E) regulate pH value to 6.5-7.0 with sodium bicarbonate;
F) according to children's's cefdinir composition freeze-drying oral cavity disintegration tablet specification; After confirming loading amount, the medicinal liquid after merging is moved in the drug-containing dish by loading amount, and put into freeze drying box; Medicinal liquid is carried out freezing (cryogenic temperature is-20 ℃--50 ℃); Evacuation dry (baking temperature is at+5 ℃-+20 ℃, and vacuum is 0.1 handkerchief-20 handkerchief), the control moisture is no more than 1.0%;
G) treat children's's cefdinir composition freeze-drying oral cavity disintegration tablet drying after, in freeze drying box, seal;
H) cut drug-containing dish after the medicament that freezes is taken out freeze drying box, and carry out finished product packing.
Said sucralose consumption is the 0.2%-0.6% of cefdinir quality in the component.
Said children's's cefdinir composition freeze-drying oral cavity disintegration tablet specification is 80mg/ sheet or 160mg/ sheet.
We have formulated relevant detection method for the disintegration rate of children's's cefdinir composition freeze-drying oral cavity disintegration tablet:
Disintegration
According to inspection technique disintegration (two appendix x of Chinese Pharmacopoeia version in 2010 A); The stainless steel shaft of hanging basket through the upper end hung on the metal rack; Immerse in the 1000ml beaker; And screen cloth fills temperature and is 37 ℃ ± 1 ℃ water apart from beaker bottom 25mm in the beaker when regulating the hanging basket position it being descended, when regulating height of water level hanging basket being risen screen cloth in the underwater 15mm place.
Except as otherwise herein provided, get 5 groups of test samples (every group of dosage is 200mg), put respectively in the glass tubing of above-mentioned hanging basket, add baffle plate, start disintegration tester and check, each sheet all should all disintegrates in 1.1 seconds.Result such as following table:
Dosage equates, the disintegration time of different cefdinir tablets
The disintegration rate that can find out children's's cefdinir composition freeze-drying oral cavity disintegration tablet of the present invention from above experimental result is faster than the Cefdinir oral disintegration tablet of cefdinir ordinary tablet, the manufacturing of traditional pressing.
Advantage of the present invention:
The first, the tablet disintegrate is rapid, and drug effect is fast.Children's's cefdinir composition freeze-drying oral cavity disintegration tablet of the present invention is disintegrate rapidly in 2 seconds in mouth, is beneficial to the rapid stripping of medicine, shortens dissolution time, accelerates to absorb, and liver first-pass effect is little, makes its performance curative effect fast.
The second, drug absorption is abundant.Children's's cefdinir composition freeze-drying oral cavity disintegration tablet of the present invention is disintegrate fully in the oral cavity, makes the absorption of medicine more abundant, helps improving bioavailability of medicament like this.
Three, taking convenience, mouthfeel is good.Children's's cefdinir composition freeze-drying oral cavity disintegration tablet of the present invention needn't be used water delivery service, and saliva can make its complete disintegrate, and no foreign body sensation in mouthful is owing to wherein add the compliance that the sweet child of helping of suitable correctives cool taste flavor takes medicine.Compare with liquid preparation and dosage advantage accurately arranged.
The principal agent of children's's cefdinir composition freeze-drying oral cavity disintegration tablet is a cefdinir, and cefdinir is water insoluble basically, so we select with the tertiary butanol and water cosolvent as solvent, strengthens the dissolubility of cefdinir, strengthens stability of drug.In freezing process, can change the crystalline state of water with the tertiary butanol and water cosolvent as solvent, help the volatilization of water, accelerate the mass transport process in the freezing dry process.In addition, another purpose that we select the tert-butyl alcohol be because tert-butyl alcohol toxicity low, and after the lyophilizing residual quantity seldom, the safety of the drug use that can guarantee.
The selected adjuvant of children's's cefdinir composition freeze-drying oral cavity disintegration tablet all is the adjuvants that are suitable for this tablet of preparation.In prescription, add the correctives sucralose, so not only can improve the compliance of pediatric pharmaceuticals, more be of value to children's's growth.In traditional production application, aspartame flavour mouthfeel is pretty good, but is prone to decompose instability; Cyclamate, glucide safety receive dispute to a certain degree, and are prone to produce the back bitterness.And the sucralose sweet feel is very near sucrose, and is very stable, safe to heat, acid, alkali.Simultaneously, sucralose is not utilized by the dental caries pathogenic bacteria, can reduce pathogenic bacteria in the oral cavity, and the acid amount of generation and streptococcus cell effectively play the dental caries effect in the adhesion of dental surface, and useful especially teenager teeth is healthy; The sucralose good stability can long term storage, and in freezing dry process, can not be damaged, and is fit to industrial applications.
Children's's cefdinir composition freeze-drying oral cavity disintegration tablet component of the present invention is simple, need not water when taking, and need not to chew; Disintegration time was no more than for 2 seconds in human oral cavity, absorbed soon, and bioavailability is high; Intestinal is residual few, and side effect is low, and liver first-pass effect is little; Mouthfeel is good, is particularly suitable for the infant patient and takes.
The specific embodiment:
For the present invention is elaborated, further specify below in conjunction with specific embodiment,
Embodiment 1
Prescription: 1000 amounts
The cefdinir of recipe quantity is dissolved in the tert-butyl alcohol of prescription consumption, under 25 ℃-30 ℃, the insulation of stirring and dissolving continued (solution a), is dissolved in the gelatin of recipe quantity in the purified water of prescription water consumption 20%-30%, is heated to dissolving (solution b) fully; The mannitol and the sucralose of recipe quantity are dissolved in the purified water of prescription water consumption 70%-80%, stirring and dissolving (solution c), merging a, b, three kinds of solution of c also stir; Regulate pH value to 6.5-7.0 with sodium bicarbonate, according to children's's cefdinir composition freeze-drying oral cavity disintegration tablet specification, confirm loading amount after; Medicinal liquid after merging is moved in the drug-containing dish by loading amount, and put into freeze drying box, medicinal liquid is carried out freezing (cryogenic temperature is-20 ℃--50 ℃); Evacuation dry (baking temperature is at+5 ℃-+20 ℃, and vacuum is 0.1 handkerchief-20 handkerchief), the control moisture is no more than 1.0%; After treating children's's cefdinir composition freeze-drying oral cavity disintegration tablet drying; In freeze drying box, seal, cut drug-containing dish after the medicament that freezes is taken out freeze drying box, and carry out finished product packing.
Embodiment 2
Prescription: 1000 amounts
The cefdinir of recipe quantity is dissolved in the tert-butyl alcohol of prescription consumption, under 25 ℃-30 ℃, the insulation of stirring and dissolving continued (solution a), is dissolved in the gelatin of recipe quantity in the purified water of prescription water consumption 20%-30%, is heated to dissolving (solution b) fully; The mannitol and the sucralose of recipe quantity are dissolved in the purified water of prescription water consumption 70%-80%, stirring and dissolving (solution c), merging a, b, three kinds of solution of c also stir; Regulate pH value to 6.5-7.0 with sodium bicarbonate, according to children's's cefdinir composition freeze-drying oral cavity disintegration tablet specification, confirm loading amount after; Medicinal liquid after merging is moved in the drug-containing dish by loading amount, and put into freeze drying box, medicinal liquid is carried out freezing (cryogenic temperature is-20 ℃--50 ℃); Evacuation dry (baking temperature is at+5 ℃-+20 ℃, and vacuum is 0.1 handkerchief-20 handkerchief), the control moisture is no more than 1.0%; After treating children's's cefdinir composition freeze-drying oral cavity disintegration tablet drying; In freeze drying box, seal, cut drug-containing dish after the medicament that freezes is taken out freeze drying box, and carry out finished product packing.
Embodiment 3
Prescription: 1000 amounts
The cefdinir of recipe quantity is dissolved in the tert-butyl alcohol of prescription consumption, under 25 ℃-30 ℃, the insulation of stirring and dissolving continued (solution a), is dissolved in the gelatin of recipe quantity in the purified water of prescription water consumption 20%-30%, is heated to dissolving (solution b) fully; The mannitol and the sucralose of recipe quantity are dissolved in the purified water of prescription water consumption 70%-80%, stirring and dissolving (solution c), merging a, b, three kinds of solution of c also stir; Regulate pH value to 6.5-7.0 with sodium bicarbonate, according to children's's cefdinir composition freeze-drying oral cavity disintegration tablet specification, confirm loading amount after; Medicinal liquid after merging is moved in the drug-containing dish by loading amount, and put into freeze drying box, medicinal liquid is carried out freezing (cryogenic temperature is-20 ℃--50 ℃); Evacuation dry (baking temperature is at+5 ℃-+20 ℃, and vacuum is 0.1 handkerchief-20 handkerchief), the control moisture is no more than 1.0%; After treating children's's cefdinir composition freeze-drying oral cavity disintegration tablet drying; In freeze drying box, seal, cut drug-containing dish after the medicament that freezes is taken out freeze drying box, and carry out finished product packing.
More than show and described ultimate principle of the present invention, principal character and advantage of the present invention.The technical staff of the industry should understand; The present invention is not restricted to the described embodiments; That describes in the foregoing description and the description is merely preference of the present invention, is not used for limiting the present invention, under the prerequisite that does not break away from spirit and scope of the invention; The present invention also has various changes and modifications, and these variations and improvement all fall in the scope of the invention that requires protection.The present invention requires protection domain to be defined by appending claims and equivalent thereof.
Claims (6)
1. children's's cefdinir compositions is characterized in that: said composition comprises following component and component quantity ratio:
2. children's's cefdinir compositions according to claim 1 is characterized in that, the preferred ingredient quantity ratio of said each component of children's's cefdinir compositions is:
3. the children's's cefdinir composition freeze-drying oral cavity disintegration tablet that contains the said children's's cefdinir of claim 1 compositions is characterized in that, is prepared from following component and component quantity ratio:
4. children's's cefdinir composition freeze-drying oral cavity disintegration tablet according to claim 3 is characterized in that, the preferred ingredient quantity ratio of each component of children's's cefdinir composition freeze-drying oral cavity disintegration tablet is:
5. the method for preparing of the described children's's cefdinir of claim 3 a composition freeze-drying oral cavity disintegration tablet is characterized in that the concrete steps of this method for preparing are:
A) cefdinir with group component is dissolved in the tert-butyl alcohol of amounts of components, under 25 ℃-30 ℃, and the insulation of stirring and dissolving continued;
B) gelatin with group component is dissolved in the purified water of component water consumption 20%-30%, is heated to dissolving fully;
C) mannitol and the sucralose with group component is dissolved in the purified water of component water consumption 70%-80% stirring and dissolving;
D) merging three kinds of solution that above-mentioned steps a, step b, step c obtain merges and stirs;
E) regulate pH value to 6.5-7.0 with sodium bicarbonate;
F) according to children's's cefdinir composition freeze-drying oral cavity disintegration tablet specification, confirm loading amount after, the medicinal liquid after merging is moved in the drug-containing dish by loading amount, and puts into freeze drying box, medicinal liquid is carried out freezing, evacuation is dry, the control moisture is no more than 1.0%;
G) treat children's's cefdinir composition freeze-drying oral cavity disintegration tablet drying after, in freeze drying box, seal;
H) cut drug-containing dish after the medicament that freezes is taken out freeze drying box, and carry out finished product packing.
6. children's's cefdinir composition freeze-drying oral cavity disintegration tablet according to claim 5 and preparation method thereof is characterized in that: said sucralose consumption is the 0.2%-0.6% of cefdinir quality in the component.
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| CN 201210029034 CN102579378B (en) | 2012-02-07 | 2012-02-07 | Child cefdinir composition freeze-dried oral disintegrating tablet and preparation method thereof |
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| CN 201210029034 CN102579378B (en) | 2012-02-07 | 2012-02-07 | Child cefdinir composition freeze-dried oral disintegrating tablet and preparation method thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102784126A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Rifampicin composition freeze-dried orally disintegrating tablet and preparation method thereof |
| CN102784123A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Diclofenac sodium composition freeze-dried orally disintegrating tablets and preparation method thereof |
| CN102784124A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Cefuroxime axetil composition freeze-dried orally disintegrating tablets and preparation method thereof |
| CN102784119A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Roxithromycin composition freeze-dried orally disintegrating tablets and preparation method thereof |
| CN102784122A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Isoniazid composition freeze-dried orally disintegrating tablet and preparation method thereof |
| CN102784117A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Gentamicin sulfate composition freeze-dried orally disintegrating tablet and preparation method thereof |
| CN102784125A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Cefetamet pivoxil composition freeze-dried orally disintegrating tablet and preparation method thereof |
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| CN1723905A (en) * | 2005-07-13 | 2006-01-25 | 张志生 | Cefdinir oral disintegration tablet, and its prepn. method |
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| CN1723905A (en) * | 2005-07-13 | 2006-01-25 | 张志生 | Cefdinir oral disintegration tablet, and its prepn. method |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102784126A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Rifampicin composition freeze-dried orally disintegrating tablet and preparation method thereof |
| CN102784123A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Diclofenac sodium composition freeze-dried orally disintegrating tablets and preparation method thereof |
| CN102784124A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Cefuroxime axetil composition freeze-dried orally disintegrating tablets and preparation method thereof |
| CN102784119A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Roxithromycin composition freeze-dried orally disintegrating tablets and preparation method thereof |
| CN102784122A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Isoniazid composition freeze-dried orally disintegrating tablet and preparation method thereof |
| CN102784117A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Gentamicin sulfate composition freeze-dried orally disintegrating tablet and preparation method thereof |
| CN102784125A (en) * | 2012-08-23 | 2012-11-21 | 海南卫康制药(潜山)有限公司 | Cefetamet pivoxil composition freeze-dried orally disintegrating tablet and preparation method thereof |
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