CN102600153A - Pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets and manufacturing method thereof - Google Patents
Pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets and manufacturing method thereof Download PDFInfo
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- CN102600153A CN102600153A CN2012100290560A CN201210029056A CN102600153A CN 102600153 A CN102600153 A CN 102600153A CN 2012100290560 A CN2012100290560 A CN 2012100290560A CN 201210029056 A CN201210029056 A CN 201210029056A CN 102600153 A CN102600153 A CN 102600153A
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Abstract
The invention discloses pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets and a manufacturing method of the pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets, relating to the technical field of pharmaceuticals and pharmaceuticals manufacturing methods. The pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets comprise the following components by weight: 1.47-2% anisodamine hydrobromide, 0.14-0.2% chlorpheniramine maleate, 64-90% mannitol, 6-10% gelatin and 0.2-0.3% sucralose. The manufacturing method adopts the above components to manufacture the pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets. The freeze-dried orally disintegrating tablets have simple components, need no water for administration, do not need to be chewed, have a disintegration time of less than 2 minutes in an oral cavity of a human body, have the advantages of rapid absorption, high bioavailability, low intestinal tract residues, low hepatic first pass effect, less side effects and good mouthfeel, and are especially 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 compound recipe hydrobromic acid anisodamine and chlorphenamine maleate lyophilizing oral cavity disintegration tablet and preparation method thereof.
Background technology:
The hydrobromic acid anisodamine is the anticholinergic agent of blocking-up M cholinoceptor.Act on similar with atropine or slightly a little less than.Have relaxing smooth muscle, remove vasospasm, the effect of microcirculation improvement, and analgesic activity is arranged.But a little less than the effect of platycoria and inhibition glandular secretion, and seldom cause the central excitation symptom.Clinically be used for following disease: 1, infect toxic shock; 2, vascular illness; 3, multiple neuralgia; 4, smooth muscle spasm; 5, dizziness; 6, the optical fundus eye is suffered from; 7, sudden deafness etc.; 8, can be used for the treatment of organophosphate poisoning.
Chlorphenamine maleate plays anti-allergic effects through the antagonism to the H1 receptor, is mainly used in rhinitis, skin mucosa allergy and cold symptoms such as alleviation is shed tears, sneeze, watery nasal discharge.
Dosage form to children's's compound recipe hydrobromic acid anisodamine and chlorphenamine maleate has at present: ordinary tablet, chewable tablet, slow releasing tablet, effervescent tablet, dispersible tablet, capsule, granule, effervescent granule, syrup, suppository, drop, oral cavity disintegration tablet (pressing manufacturing) etc.Wherein oral formulations is many need be very big with water delivery service or slice, thin piece hardness; This patient for dysphagia or water intaking inconvenience takes and has certain difficulty, particularly takes very inconvenience for child patient, and what sell on the market is with multiple adjuvant and disintegrating agent to children's's compound recipe hydrobromic acid anisodamine and chlorphenamine maleate oral cavity disintegration tablet; Utilize traditional tablet machine compacting to form; 30 seconds of the minimum needs of its disintegration time in human oral cavity, and mouthful in grains of sand sense is arranged, also suitable to the child.
Summary of the invention:
The object of the invention is to overcome the defective of prior art; When being provided, a kind of taking need not water; Need not to chew; The fast children's's compound recipe hydrobromic acid anisodamine of disintegration rate and chlorphenamine maleate lyophilizing oral cavity disintegration tablet 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 hydrobromic acid anisodamine and chlorphenamine maleate, also includes skeleton agent (mannitol), forming agent (gelatin), solubilising, correctives (sucralose).
For realizing the object of the invention, technical scheme realizes through following mode:
A kind of children's's compound recipe hydrobromic acid anisodamine and chlorphenamine maleate lyophilizing oral cavity disintegration tablet is characterized in that, are prepared from following component and component quantity ratio:
The preferred ingredient quantity ratio of said each component is:
The method for preparing of a kind of children's's compound recipe hydrobromic acid anisodamine and chlorphenamine maleate lyophilizing oral cavity disintegration tablet is characterized in that the concrete steps of this method for preparing are:
A) in the purified water of the 70%-80% that the hydrobromic acid anisodamine and the chlorphenamine maleate of group component is dissolved in the component water total amount, under stirring, be heated to 55 ℃, continue to stir and add mannitol, the sucralose of group component;
B) gelatin with group component is dissolved in the purified water of component water consumption 20%-30%, is heated to dissolving fully;
C) merge two kinds of solution that above-mentioned steps a, step b obtain and stirring;
D) regulate pH value to 5.5-6.5 with sodium bicarbonate;
E) according to children's's hydrobromic acid anisodamine and chlorphenamine maleate 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%;
F) treat children's's hydrobromic acid anisodamine and chlorphenamine maleate freeze-dry orally disintegrating tablet drying after, in freeze drying box, seal;
G) cut drug-containing dish after the medicament that freezes is taken out freeze drying box, and carry out finished product packing.
Said children's's compound recipe hydrobromic acid anisodamine and chlorphenamine maleate lyophilizing oral cavity disintegration tablet specification are hydrobromic acid anisodamine 1.5mg/ sheet, chlorphenamine maleate 0.15mg/ sheet.
We have formulated relevant detection method for the disintegration rate of children's's compound recipe hydrobromic acid anisodamine and chlorphenamine maleate lyophilizing oral cavity disintegration tablet:
Disintegration
According to inspection technique disintegration (two appendix xA of Chinese Pharmacopoeia version in 2010); 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 6 groups of test samples (every group of dosage is 1.65mg), 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 hydro bromic acid anisodamine tablet
Can find out that from above experimental result children's's hydrobromic acid anisodamine of the present invention is faster with the hydrobromic acid anisodamine and the chlorphenamine maleate oral cavity disintegration tablet of chlorphenamine maleate ordinary tablet, the manufacturing of traditional pressing than hydrobromic acid anisodamine with the disintegration rate of chlorphenamine maleate freeze-dry orally disintegrating tablet.
Advantage of the present invention:
The first, the tablet disintegrate is rapid, and drug effect is fast.Children's's compound recipe hydrobromic acid anisodamine of the present invention and chlorphenamine maleate lyophilizing oral cavity disintegration tablet be 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 compound recipe hydrobromic acid anisodamine of the present invention and chlorphenamine maleate lyophilizing oral cavity disintegration tablet be 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 compound recipe hydrobromic acid anisodamine of the present invention and chlorphenamine maleate lyophilizing oral cavity disintegration tablet 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.
Because children's's hydrobromic acid anisodamine of the present invention and chlorphenamine maleate composition freeze-drying oral cavity disintegration tablet is main in order to satisfy child's medication demand, in prescription, has added the correctives sucralose.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 compound recipe hydrobromic acid anisodamine of the present invention and chlorphenamine maleate lyophilizing oral cavity disintegration tablet component are 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 hydrobromic acid anisodamine of recipe quantity and chlorphenamine maleate are dissolved in the purified water of 70%-80% of prescription water total amount, heated and stirred and add mannitol, the sucralose of recipe quantity under stirring is dissolved in the gelatin of recipe quantity in the purified water of prescription water consumption 20%; Be heated to fully dissolving, merge above-mentioned two kinds of solution and stir, regulate pH value to 5.5-6.5 with sodium bicarbonate; According to children's's hydrobromic acid anisodamine and chlorphenamine maleate composition freeze-drying oral cavity disintegration tablet specification; After confirming loading amount, the medicinal liquid after merging is pressed in the loading amount packing drug-containing dish, and put into freeze drying box; Carry out freezing to medicinal liquid; After treating children's's hydrobromic acid anisodamine and chlorphenamine maleate composition freeze-drying oral cavity disintegration tablet drying, in freeze drying box, seal, take out back cutting, packing.
Embodiment 2
Prescription: 1000 amounts
The hydrobromic acid anisodamine of recipe quantity and chlorphenamine maleate are dissolved in the purified water of 70%-80% of prescription water total amount, heated and stirred and add mannitol, the sucralose of recipe quantity under stirring is dissolved in the gelatin of recipe quantity in the purified water of prescription water consumption 20%; Be heated to fully dissolving, merge above-mentioned two kinds of solution and stir, regulate pH value to 5.5-6.5 with sodium bicarbonate; According to children's's hydrobromic acid anisodamine and chlorphenamine maleate composition freeze-drying oral cavity disintegration tablet specification; After confirming loading amount, the medicinal liquid after merging is pressed in the loading amount packing drug-containing dish, and put into freeze drying box; Carry out freezing to medicinal liquid; After treating children's's hydrobromic acid anisodamine and chlorphenamine maleate composition freeze-drying oral cavity disintegration tablet drying, in freeze drying box, seal, take out back cutting, packing.
Embodiment 3
Prescription: 1000 amounts
The hydrobromic acid anisodamine of recipe quantity and chlorphenamine maleate are dissolved in the purified water of 70%-80% of prescription water total amount, heated and stirred and add mannitol, the sucralose of recipe quantity under stirring is dissolved in the gelatin of recipe quantity in the purified water of prescription water consumption 20%; Be heated to fully dissolving, merge above-mentioned two kinds of solution and stir, regulate pH value to 5.5-6.5 with sodium bicarbonate; According to children's's hydrobromic acid anisodamine and chlorphenamine maleate composition freeze-drying oral cavity disintegration tablet specification; After confirming loading amount, the medicinal liquid after merging is pressed in the loading amount packing drug-containing dish, and put into freeze drying box; Carry out freezing to medicinal liquid; After treating children's's hydrobromic acid anisodamine and chlorphenamine maleate composition freeze-drying oral cavity disintegration tablet drying, in freeze drying box, seal, take out.
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 (4)
1. children's's compound recipe hydrobromic acid anisodamine and chlorphenamine maleate lyophilizing oral cavity disintegration tablet is characterized in that, are prepared from following component and component quantity ratio:
2. children's's compound recipe hydrobromic acid anisodamine according to claim 1 and chlorphenamine maleate lyophilizing oral cavity disintegration tablet is characterized in that, the preferred ingredient quantity ratio of said each component is:
3. the method for preparing of a claim 1 or 2 described children's's compound recipe hydrobromic acid anisodamine and chlorphenamine maleate lyophilizing oral cavity disintegration tablet is characterized in that the concrete steps of this method for preparing are:
A) in the purified water of the 70%-80% that the hydrobromic acid anisodamine and the chlorphenamine maleate of group component is dissolved in the component water total amount, under stirring, be heated to 55 ℃, continue to stir and add mannitol, the sucralose of group component;
B) gelatin with group component is dissolved in the purified water of component water consumption 20%-30%, is heated to dissolving fully;
C) merge two kinds of solution that above-mentioned steps a, step b obtain and stirring;
D) regulate pH value to 5.5-6.5 with sodium bicarbonate;
E) according to children's's hydrobromic acid anisodamine and chlorphenamine maleate 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 put into freeze drying box; Medicinal liquid is carried out freezing, evacuation is dry, and the control moisture is no more than 1.0%;
F) treat children's's hydrobromic acid anisodamine and chlorphenamine maleate freeze-dry orally disintegrating tablet drying after, in freeze drying box, seal;
G) cut drug-containing dish after the medicament that freezes is taken out freeze drying box, and carry out finished product packing.
4. children's's compound recipe hydrobromic acid anisodamine according to claim 3 and chlorphenamine maleate lyophilizing oral cavity disintegration tablet and preparation method thereof; It is characterized in that: said children's's compound recipe hydrobromic acid anisodamine and chlorphenamine maleate lyophilizing oral cavity disintegration tablet specification are hydrobromic acid anisodamine 1.5mg/ sheet, chlorphenamine maleate 0.15mg/ sheet.
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| CN 201210029056 CN102600153B (en) | 2012-02-07 | 2012-02-07 | Pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets and manufacturing method thereof |
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| CN 201210029056 CN102600153B (en) | 2012-02-07 | 2012-02-07 | Pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets and manufacturing method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110840850A (en) * | 2018-07-24 | 2020-02-28 | 烟台药物研究所 | Celecoxib freeze-dried orally disintegrating tablet with high bioavailability and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101134022A (en) * | 2006-08-31 | 2008-03-05 | 海南海灵制药厂有限公司 | Lyophilized orally disintegrating tablets with better mechanical property and method for preparing the same |
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- 2012-02-07 CN CN 201210029056 patent/CN102600153B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101134022A (en) * | 2006-08-31 | 2008-03-05 | 海南海灵制药厂有限公司 | Lyophilized orally disintegrating tablets with better mechanical property and method for preparing the same |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110840850A (en) * | 2018-07-24 | 2020-02-28 | 烟台药物研究所 | Celecoxib freeze-dried orally disintegrating tablet with high bioavailability and preparation method thereof |
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