CN102525980B - Children cetirizine hydrochloride composition - Google Patents
Children cetirizine hydrochloride composition Download PDFInfo
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- CN102525980B CN102525980B CN 201210029075 CN201210029075A CN102525980B CN 102525980 B CN102525980 B CN 102525980B CN 201210029075 CN201210029075 CN 201210029075 CN 201210029075 A CN201210029075 A CN 201210029075A CN 102525980 B CN102525980 B CN 102525980B
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Abstract
The invention discloses a children cetirizine hydrochloride composition, relating to the technical field of medicinal preparations. The children cetirizine hydrochloride composition is composed of a main medicine and adjuvants in a formula and is characterized in that the main medicine is cetirizine hydrochloride and the adjuvants comprise a skeleton agent, a forming agent and a flavoring agent, wherein mannitol is selected as the skeleton agent, gelatin is selected as the forming agent, and sucralose is selected as the flavoring agent; and the proportions of the main medicine and the adjuvants in terms of the total weight of the formula are as follows: 25wt% of cetirizine hydrochloride, 75-79wt% of mannitol, 2-4wt% of gelatin, and 0.1-0.15wt% of sucralose. The invention further provides a freeze-dried orally disintegrating tablet of the children cetirizine hydrochloride composition and a preparation method of the freeze-dried orally disintegrating tablet, wherein the freeze-dried orally disintegrating tablet comprises simple components, is taken without water and chewing, disintegrates in the oral cavity of a human body within 2 seconds, has the advantages of high effect-taking speed, fewer intestinal tract residue, absorption sufficiency, low side effect and good mouthfeel, and is particularly suitable for being taken by infants and babies.
Description
Technical field
The present invention relates to technical field of medicine, be specifically related to a kind of children cetirizine hydrochloride composition and contain children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet that above-mentioned composition makes and preparation method thereof.
Background technology
Cetirizine hydrochloride is a kind of potent H1 receptor antagonist, oral entering in body, and the histamine H1-receptor on target cell membrane is combined rapidly, and blocking histamine activates target cell.Cetirizine is without obvious cholinolytic and antiserotonergic effect.Under normal dose, be difficult for seeing through blood brain barrier.This product can suppress the histamine transmission of allergy initial stage, reduces the mediator release in active and allergy later stage of the migration of inflammatory cell, thus to delay-action stage allergy also effective.This product is a kind of H1 receptor antagonist of high selectivity, finds no so far cardiac electrical activity is produced harmful effect.Cetirizine hydrochloride is second filial generation H1 antihistaminic, is long-acting tool oral potent anti-allergic drug optionally.The H1 receptor antagonist has good antiallergic action, is usually used in allergic rhinitis, allergic skin pruritus, conjunctivitis etc.It is few and can tolerate that cetirizine hydrochloride has a good anti-allergic effects side reaction.
The cetirizine hydrochloride structural formula is as follows:
The cetirizine hydrochloride common formulations of listing has at present: ordinary tablet, dry suspension, dispersible tablet, chewable tablet, granule, capsule, pressing port cavity disintegrating tablet etc.Wherein tablet is extrusion forming, and disintegrate is slower, and bioavailability is lower, and some patients were swallows more difficultly, particularly takes very inconvenient for child patient.Oral cavity disintegration tablet has taking convenience, needn't use water delivery service, and absorption is fast, bioavailability is high, and side effect is low.Given this, the present invention is proposed.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of composition simple, easily manufactured, rapid-action children cetirizine hydrochloride composition and contain children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet that above-mentioned composition makes and preparation method thereof.
Technical problem to be solved by this invention realizes by the following technical solutions.
A kind of children cetirizine hydrochloride composition, the prescription of said composition is made of principal agent and accessory drugs, it is characterized in that: wherein principal agent is cetirizine hydrochloride, and accessory drugs includes skeleton agent, forming agent, correctives;
Mannitol is selected in described skeleton agent, and described forming agent is selected gelatin, and described correctives is selected sucralose;
Wherein principal agent and accessory drugs by weight the prescription total amount in shared ratio be:
Another object of the present invention is to provide a kind of children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet that contains above-mentioned children cetirizine hydrochloride composition, this freeze-dry orally disintegrating tablet component is simple, need not water when taking, need not to chew, disintegration time was no more than for 2 seconds in human oral cavity, rapid-action, intestinal is residual few, absorbs fully, and side effect is low, mouthfeel is good, is particularly suitable for the infant patient and takes.
A kind of children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet that contains above-mentioned children cetirizine hydrochloride composition is characterized in that: its composition by following weight ratio is prepared from:
Described children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet specification is 5mg/ sheet, 10mg/ sheet.
A further object of the present invention is to provide a kind of preparation method of children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet, this preparation method uses the tertiary butanol and water cosolvent as solvent, can accelerate the distillation cycle of medicine, shorten lyophilization cycle, increase the cetirizine hydrochloride dissolving, strengthen medicine stability, promote the crystallization of medicine.
For realizing a further object of the present invention, a kind of preparation method of children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet adopts following technical scheme:
A) cetirizine hydrochloride with recipe quantity is dissolved in the tert-butyl alcohol of recipe quantity, and stirring and dissolving continues to stir at normal temperatures, preparation solution a;
B) with recipe quantity mannitol, sucralose be dissolved in the purified water of prescription with purified water total amount 70%-80%, preparation solution b;
C) again the gelatin of recipe quantity is dissolved in the purified water of prescription water consumption 20%30%, is heated to dissolve fully preparation solution c;
D) merge above-mentioned b, two kinds of solution of c become solution d, and stir, then mixed solution is cooled to below 5 ℃;
E) mix a, two kinds of solution of d, and stir, regulate pH value to 6.0-6.5 with sodium bicarbonate;
E) according to children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet specification, after determining loading amount, medicinal liquid after merging is moved in 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 0 ℃-5 ℃, vacuum-more than 0.09MPa), control moisture and be no more than 1.0%;
F) after children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet drying, seal in freeze drying box;
G) will cut drug-containing dish after the medicament taking-up freeze drying box that freeze, and carry out finished product packing.
Formulated relevant detection method for the disintegration rate of children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet:
1, disintegration
According to inspection technique disintegration (two appendix xA of Chinese Pharmacopoeia version in 2010), the stainless steel shaft of hanging basket by the upper end hung on metal rack, immerse in the 1000ml beaker, and when regulating the hanging basket position it being descended screen cloth apart from beaker bottom 25mm, fill temperature in beaker and be the water of 37 ℃ ± 1 ℃, when regulating height of water level and making hanging basket increase, screen cloth is at 15mm place, underwater.
Except as otherwise herein provided, get 4 groups of test samples (every group of dosage is 150mg), be set up respectively in the glass tubing of stating hanging basket, add baffle plate, start disintegration tester and check.Result is as shown in the table.
Dosage equates, the disintegration time of different Cetirizine hydrochloride Tablets agent
To children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet of the present invention and the common pressing port cavity disintegrating tablet of cetirizine hydrochloride comparative determination, children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet disintegration time of the present invention is significantly shorter than the common compacting oral cavity disintegration tablet of cetirizine hydrochloride as stated above.
The children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet runs in the oral cavity after saliva can disintegrate rapidly within 2 seconds, without grittiness, good mouthfeel, easily swallow, to the oral mucosa nonirritant.
The selected adjuvant of children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet is all the adjuvants that are suitable for this tablet of preparation.Find according to research, the water solublity of cetirizine hydrochloride is very poor, we adopt the tertiary butanol and water cosolvent as solvent in technique, be insoluble in the cetirizine hydrochloride of water with tert-butyl alcohol dissolving, dissolve other adjuvants with purified water, then both mix with suitable ratio, obtain the clear and bright cosolvent of common dissolved water dissolubility and liposoluble substance, use this technique to have multiple advantage.
First because the freezing point of the tert-butyl alcohol is high, just can freeze at normal temperatures, and also can just can solidify in the subzero several years after water mixes; And tert-butyl alcohol vapour pressure is high, and vapour pressure is high is conducive to distillation, so use the tertiary butanol and water cosolvent can shorten freeze-drying time as solvent, the obtained freeze-drying product still keeps porous simultaneously.
Second tert-butyl alcohol can mix with any ratio with water, and the medicine that will be insoluble in like this water is dissolved in the tert-butyl alcohol, can strengthen the stability of medicine.
The 3rd tert-butyl alcohol add the crystalline state that membership changes water, and then the drug crystallization state that is dissolved in water is changed, improve freezing point, rate of sublimation improves greatly,
The 4th tert-butyl alcohol toxicity is low, and after lyophilizing residual quantity seldom, the safety of the drug use that this just guarantees.
Main in order to satisfy infant and child's medication demand due to children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet of the present invention added the correctives sucralose in prescription.In traditional production application, aspartame flavour mouthfeel is pretty good, but easily decomposes, and is unstable; Cyclamate, glucide safety are subjected to dispute to a certain extent, and bitterness after easily producing; 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 can not be damaged in freezing dry process; Sweet taste is pure, and is similar to the sucrose sweet taste, can not produce bitter rear sense and abnormal flavour as some other intense sweeteners; Low price, more cheap than sucrose under identical sugariness, be fit to industrial applications.
The present invention has following beneficial effect:
The first disintegrate is rapid, and drug effect is fast.Children cetirizine hydrochloride composition freeze-dry orally disintegrating 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 makes its performance curative effect fast.
The second drug absorption is abundant.Children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet of the present invention is disintegrate fully in the oral cavity, can just begin to absorb in the oral cavity, makes the absorption of medicine more abundant, is conducive to like this improve the bioavailability of medicine.
The 3rd taking convenience, mouthfeel is good.Children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet of the present invention needn't be used water delivery service, saliva can make its complete disintegrate, be particularly useful for the patient of old man, children's's dysphagia and the inconvenient person that fetches water takes medicine, due to the compliance that wherein adds the sweet child of being conducive to of suitable correctives cool taste flavor to take medicine, solve the problem of taking baby ' difficulty again.Compare with liquid preparation and have that dosage advantage accurately, the present invention can guarantee in time the taking of medicine, dosage is accurate and curative effect is rapid.
The specific embodiment
For technological means, creation characteristic that the present invention is realized, reach purpose and effect is easy to understand, below in conjunction with specific embodiment, further set forth the present invention.
Embodiment 1
Prepare the children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet as an example of the 10mg/ sheet example,
Prescription: 1000 amounts
Preparation technology:
With the cetirizine hydrochloride of recipe quantity be dissolved in recipe quantity the tert-butyl alcohol (solution a) in, stirring and dissolving at normal temperatures, continue to stir, with recipe quantity mannitol, sucralose be dissolved in the purified water (solution b) of prescription with purified water total amount 70%-80%; Gelatin with recipe quantity is dissolved in the purified water (solution c) of prescription water consumption 20%-30% again, is heated to dissolve fully; Merge above-mentioned b, two kinds of solution of c become solution d, and stir, then mixed solution is cooled to below 5 ℃.Mix a, two kinds of solution of d, and stir, regulate pH value to 6.0-6.5 with sodium bicarbonate.According to children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet specification, after determining loading amount, the medicinal liquid after merging is moved in drug-containing dish by loading amount, and put into freeze drying box, medicinal liquid is carried out freezing, evacuation is dry, controls moisture and is no more than 1.0%; After children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet drying, seal in freeze drying box; Cut drug-containing dish after the medicament that freezes is taken out freeze drying box, and carry out finished product packing.
Embodiment 2
Prepare the children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet as an example of the 10mg/ sheet example,
Prescription: 1000 amounts
Preparation technology:
With the cetirizine hydrochloride of recipe quantity be dissolved in recipe quantity the tert-butyl alcohol (solution a) in, stirring and dissolving at normal temperatures, continue to stir, with recipe quantity mannitol, sucralose be dissolved in the purified water (solution b) of prescription with purified water total amount 70%-80%; Gelatin with recipe quantity is dissolved in the purified water (solution c) of prescription water consumption 20%-30% again, is heated to dissolve fully; Merge above-mentioned b, two kinds of solution of c become solution d, and stir, then mixed solution is cooled to below 5 ℃.Mix a, two kinds of solution of d, and stir, regulate pH value to 6.0-6.5 with sodium bicarbonate.According to children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet specification, after determining loading amount, the medicinal liquid after merging is moved in drug-containing dish by loading amount, and put into freeze drying box, medicinal liquid is carried out freezing, evacuation is dry, controls moisture and is no more than 1.0%; After children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet drying, seal in freeze drying box; Cut drug-containing dish after the medicament that freezes is taken out freeze drying box, and carry out finished product packing.
Embodiment 3
Prepare the children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet as an example of the 10mg/ sheet example,
Prescription: 1000 amounts
Preparation technology:
With the cetirizine hydrochloride of recipe quantity be dissolved in recipe quantity the tert-butyl alcohol (solution a) in, stirring and dissolving at normal temperatures, continue to stir, with recipe quantity mannitol, sucralose be dissolved in the purified water (solution b) of prescription with purified water total amount 70%-80%; Gelatin with recipe quantity is dissolved in the purified water (solution c) of prescription water consumption 20%-30% again, is heated to dissolve fully; Merge above-mentioned b, two kinds of solution of c become solution d, and stir, then mixed solution is cooled to 5 ℃ once.Mix a, two kinds of solution of d, and stir, regulate pH value to 6.0-6.5 with sodium bicarbonate.According to children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet specification, after determining loading amount, the medicinal liquid after merging is moved in drug-containing dish by loading amount, and put into freeze drying box, medicinal liquid is carried out freezing, evacuation is dry, controls moisture and is no more than 1.0%; After children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet drying, seal in freeze drying box; Cut drug-containing dish after the medicament that freezes is taken out freeze drying box, and carry out finished product packing.
Above demonstration and described ultimate principle of the present invention and 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 above-described embodiment and description just illustrates principle of the present invention; without departing from the spirit and scope of the present invention; the present invention also has various changes and modifications, and these changes and improvements all fall in the claimed scope of the invention.The claimed scope of the present invention is defined by appending claims and equivalent thereof.
Claims (4)
1. children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet, it is characterized in that: described freeze-dry orally disintegrating tablet is prepared from by the composition of following weight:
The said components amount is in 1000 amounts, 10mg/ sheet.
2. children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet, it is characterized in that: described freeze-dry orally disintegrating tablet is prepared from by the composition of following weight:
The said components amount is in 1000 amounts, 10mg/ sheet.
3. children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet, it is characterized in that: described freeze-dry orally disintegrating tablet is prepared from by the composition of following weight:
The said components amount is in 1000 amounts, 10mg/ sheet.
4. method for preparing claim 1,2 or 3 described children cetirizine hydrochloride composition freeze-dry orally disintegrating tablets is characterized in that:
A) cetirizine hydrochloride with recipe quantity is dissolved in the tert-butyl alcohol of recipe quantity, and stirring and dissolving continues to stir at normal temperatures, preparation solution a;
B) with recipe quantity mannitol, sucralose be dissolved in the purified water of prescription with purified water total amount 70%-80%, preparation solution b;
C) gelatin of recipe quantity is dissolved in the purified water of prescription with purification water yield 20%-30% again, is heated to dissolve fully preparation solution c;
D) merge above-mentioned b, two kinds of solution of c become solution d, and stir, then mixed solution is cooled to below 5 ℃;
E) mix a, two kinds of solution of d, and stir, regulate pH value to 6.0-6.5 with sodium bicarbonate;
F) according to children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet specification, after determining loading amount, the medicinal liquid after merging is moved in drug-containing dish by loading amount, and put into freeze drying box, medicinal liquid is carried out freezing, evacuation is dry, controls moisture and is no more than 1.0%;
G) after children cetirizine hydrochloride composition freeze-dry orally disintegrating tablet drying, seal in freeze drying box;
H) will cut drug-containing dish after the medicament taking-up freeze drying box that freeze, and carry out finished product packing.
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| CN 201210029075 CN102525980B (en) | 2012-02-07 | 2012-02-07 | Children cetirizine hydrochloride composition |
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| CN 201210029075 CN102525980B (en) | 2012-02-07 | 2012-02-07 | Children cetirizine hydrochloride composition |
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| 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 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101310711A (en) * | 2007-05-24 | 2008-11-26 | 海南高升医药科技开发有限公司 | Levo-cetirizine hydrochloride orally disintegrating tablets and preparation method thereof |
| WO2008152067A1 (en) * | 2007-06-12 | 2008-12-18 | Alk-Abelló A/S | An allergen dosage form comprising an antihistamine |
| CN102038654A (en) * | 2009-10-15 | 2011-05-04 | 山东方明药业股份有限公司 | Cetirizine hydrochloride orally disintegrating tablets and preparation method thereof |
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- 2012-02-07 CN CN 201210029075 patent/CN102525980B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101310711A (en) * | 2007-05-24 | 2008-11-26 | 海南高升医药科技开发有限公司 | Levo-cetirizine hydrochloride orally disintegrating tablets and preparation method thereof |
| WO2008152067A1 (en) * | 2007-06-12 | 2008-12-18 | Alk-Abelló A/S | An allergen dosage form comprising an antihistamine |
| CN102038654A (en) * | 2009-10-15 | 2011-05-04 | 山东方明药业股份有限公司 | Cetirizine hydrochloride orally disintegrating tablets and preparation method thereof |
Non-Patent Citations (4)
| Title |
|---|
| 口腔崩解片的研究进展;李标等;《中国医院用药评价与分析》;20090228;第9卷(第2期);第159-160页 * |
| 口腔速崩片的研究进展及临床应用;张毅等;《职业与健康》;20111031;第27卷(第19期);第2254-2256页 * |
| 张毅等.口腔速崩片的研究进展及临床应用.《职业与健康》.2011,第27卷(第19期),第2254-2256页. |
| 李标等.口腔崩解片的研究进展.《中国医院用药评价与分析》.2009,第9卷(第2期),第159-160页. |
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