CN102327244B - Ambroxol hydrochloride orally disintegrating tablet and preparation method thereof - Google Patents
Ambroxol hydrochloride orally disintegrating tablet and preparation method thereof Download PDFInfo
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- CN102327244B CN102327244B CN 201110293404 CN201110293404A CN102327244B CN 102327244 B CN102327244 B CN 102327244B CN 201110293404 CN201110293404 CN 201110293404 CN 201110293404 A CN201110293404 A CN 201110293404A CN 102327244 B CN102327244 B CN 102327244B
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Abstract
The invention discloses an ambroxol hydrochloride orally disintegrating tablet. The orally disintegrating tablet comprises ambroxol hydrochloride and is prepared by proportioning the following raw auxiliary materials in part by weight: ambroxol hydrochloride flavor masking particles are prepared by coating and contain 1 part of ambroxol hydrochloride agents, 1-2 parts of filling agents, 0.1-0.25 part of disintegrating agents, 0.5-1 part of flavoring agents, 0.01-0.05 part of mouth cooling agents, 0.029-0.05 part of lubricating agents and 0.03-0.05 part of flow agents. The ambroxol hydrochloride orally disintegrating tablet has a good disintegrating effect and good dissolution rate. As a certain proportion of mouth cooling agents are added in the auxiliary materials, the discomfort generated to an oral cavity and a throat part is effectively alleviated after drug taking. The ambroxol hydrochloride orally disintegrating tablet has good mouthfeel and short duration of bad mouthfeel, can bring good drug taking process to a patient after being taken and is suitable for industrialization production.
Description
(1) technical field
The present invention relates to a kind of Oral Chemical medicine quick releasing formulation, be specifically related to a kind of Orally disintegrating tablet of ambroxol hydrochloride and preparation method thereof.
(2) background technology
Ambroxol hydrochloride is a kind of novel expectorant that shows unique characteristics, and its phlegm-dispelling functions is stronger than bromhexine.This product has can make mucolysis, promote pulmonary surfactant to synthesize reaches effects such as activating the mucociliary purification function, reduces in addition the adhesion strength of sputum and cilium, make sputum be easy to the effect of expectoration.
Due to the determined curative effect of ambroxol hydrochloride, untoward reaction is few, is present clinical most popular expectorant, and is applicable to old man and child.Therefore, developing the novel formulation that is suitable for different crowd is very necessary with the needs that satisfy clinical application.
Oral cavity disintegration tablet can facilitate the part population medication as a kind of new dosage form and a kind of new administrated method, as the patient's medication under old man, child, dysphagia or special environment.This dosage form is compared with conventional tablet, not needing to be characterized in water or only to need a small amount of water, also need not to chew, and medicine is placed on tongue, after meeting the rapid dissolving of saliva or disintegrate, borrows swallowing act to enter the stomach onset.Facilitate medication for satisfying in above-mentioned suitable crowd and environment, we have carried out the development of Orally disintegrating tablet of ambroxol hydrochloride, are the clinical novel form that a taking convenience is provided, and increase a kind of selection of clinical application.Meanwhile due to the special nature of active substance ambroxol hydrochloride, can to the patient when taking with hardship, puckery, some bad mouthfeels such as fiber crops flavor etc., and taking rear bad mouthfeel can stop a very long time, and this has caused great obstruction for application and the popularization of Orally disintegrating tablet of ambroxol hydrochloride.
Chinese patent 2007100645815 discloses a kind of Orally disintegrating tablet of ambroxol hydrochloride and preparation method thereof, but its Rotary drying that adopts and spray drying make need of production acquire special installation, have increased production cost; And its taste masking adjuvant of selecting is common adjuvant, can improve its taste but this type of material of ambroxol hydrochloride is improved DeGrain general active substance, can't effectively cover the abnormal flavour of product.
Chinese patent 201010257125.4 discloses a kind of Orally disintegrating tablet of ambroxol hydrochloride and preparation method thereof, has only carried out the supplementary material mixing of simply sieving, and only by just carrying out tabletting after wet granulation technology.This technique taste masking ability obviously can't be isolated the serious abnormal flavour of raw material.
(3) summary of the invention
The present invention seeks in taking process, the oral cavity to be produced serious taste and fiber crops flavor for the ambroxol hydrochloride oral cavity disintegration tablet, and the problem such as the bad mouthfeel persistent period is long, a kind of ambroxol hydrochloride oral cavity disintegration tablet is provided, this oral cavity disintegration tablet disintegrate is effective, dissolution is high, and mouthfeel is good, and the bad mouthfeel persistent period is short.
The technical solution used in the present invention is:
A kind of Orally disintegrating tablet of ambroxol hydrochloride, described oral cavity disintegration tablet comprise ambroxol hydrochloride, taste masking coating material and add adjuvant, and described oral cavity disintegration tablet is made by the supplementary material that comprises following quality proportioning:
Described ambroxol hydrochloride adopts the street drug that meets 2010 editions two ones of Chinese Pharmacopoeias;
the described coated ambroxol hydrochloride taste masked particle of making, make as follows: take binding agent and cover bitter agent as coating material, take binding agent with after ethanol water dissolving, add and cover bitter agent and fully stir, make the taste masking coating solution, ambroxol hydrochloride is carried out coating by the taste masking coating solution make taste masked particle, described ambroxol hydrochloride and taste masking coating material mass ratio are 1: 0.2～0.4, described binding agent is 1: 0.1～0.4 with covering bitter agent mass ratio, described binding agent is hydroxypropyl methylcellulose, describedly cover bitter agent and cover the mixing of essence-TP0551 (Firmenich Firmenich Aromatics (China) Co., Ltd.) arbitrary proportion for (Masking flavor) taste masking essence-TP5004 (Firmenich Firmenich Aromatics (China) Co., Ltd.) and/or (BITTERNESS Masking flavor) bitterness, above ethanol water plays the aid adhesion effect in pelletization, granule coating, dry rear ethanol water evaporation are so be not counted in the amount of ethanol water in component.
Described filler is one or more in mannitol, sorbitol, lactose and microcrystalline Cellulose (Ph101);
Described disintegrating agent is one or more in cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose (street drug that meets 2010 editions two ones of Chinese Pharmacopoeias);
Described correctives is one or more of saccharin sodium, aspartame, stevioside, tartaric acid, citric acid, Mint Essence, apple essence;
Described cool mouthful of agent is WS-23 (WS-23) and/or N-ethyl-2-isopropyl-5-methyl-cyclohexyl alkane Methanamide (WS-3);
Described lubricant is one or both in Pulvis Talci, magnesium stearate;
Described fluidizer is silicon dioxide, and described silicon dioxide molecules formula is SiO
2-xH
2O。
Further, described Orally disintegrating tablet of ambroxol hydrochloride, described oral cavity disintegration tablet is comprised of the supplementary material of following quality proportioning:
The preferred described coated ambroxol hydrochloride taste masked particle of making of the present invention makes as follows: take binding agent with cover bitter agent as coating material, take binding agent with after ethanol water dissolving, add and cover bitter agent and fully stir, make the taste masking coating solution, ambroxol hydrochloride is made taste masked particle by taste masking coating solution coating, described ambroxol hydrochloride and taste masking coating material mass ratio are 1: 0.25, described binding agent is 1: 0.103 with the mass ratio of covering bitter agent, described binding agent is hydroxypropyl methylcellulose, and covering bitter agent is that bitterness is covered essence-TP0551.
Further, preferred described oral cavity disintegration tablet is made by the supplementary material of following quality proportioning:
Correctives of the present invention is preferably aspartame, tartaric acid, citric acid, apple essence or Mint Essence.
It is that 30mg determines that sheet heavily is about 122.11mg that the present invention recommends described Orally disintegrating tablet of ambroxol hydrochloride to contain effective composition ambroxol hydrochloride by every.
The preparation method of Orally disintegrating tablet of ambroxol hydrochloride of the present invention is: 1) press formula ratio, take binding agent with after ethanol water dissolving, add and cover bitter agent and fully stir, make the taste masking coating solution; 2) get the formula ratio ambroxol hydrochloride and put in fluid bed, with step 1) the taste masking coating solution prepared, adopt the mode of end spray evenly to be sprayed at the ambroxol hydrochloride surface, make the coated granule that contains ambroxol hydrochloride through fluid bed; 3) take filler, disintegrating agent, correctives, cool mouthful of agent, lubricant and fluidizer by formula ratio, with the coated granule that ambroxol hydrochloride is arranged in mixer fully after mix homogeneously, containing effective composition ambroxol hydrochloride by every is that 30mg determines that sheet heavily is about the 122.12mg tabletting, obtains described Orally disintegrating tablet of ambroxol hydrochloride.
Described step 1) in, alcoholic solution is 50% ethanol water.
Preferably, described step 1) in, binding agent is 1: 0.1 with covering the bitter agent mass ratio that feeds intake, ambroxol hydrochloride and the taste masking coating material mass ratio that feeds intake is 1: 0.25, and described binding agent is hydroxypropyl methylcellulose, and described to cover bitter agent be that bitterness is covered essence-TP0551.
The present invention is preferred, described step 3) in the mass ratio that feeds intake of ambroxol hydrochloride and filler, disintegrating agent, correctives, the agent of cool mouth, lubricant and fluidizer be 1: 1.5～1.8: 0.16～0.24: 0.6～9: 0.02～0.05: 0.029～0.04: 0.03～0.05.
The preferred coating inlet temperature of the present invention is controlled at 40 ℃ ± 5 ℃, atomizing pressure is 1.8-2pa, and the coated granule of described ambroxol-hydrochloride-containing mixes in mixer with other adjuvants, and incorporation time is 10min, granule after always mixing is carried out tabletting, and the tabletting Hardness Control is at 20N-30N.
Ambroxol hydrochloride chemical name of the present invention is the amino 3.5-dibromo-benzyl of trans-4-[(2-) amino] the Hexalin hydrochlorate, molecular formula is C
13H
18Br
2N
2OHCL, molecular weight are 414.57: molecular structure is suc as formula shown in (I):
(I)
The present invention adopts taste bud competitiveness to cover bitter agent coating to reach the purpose of taste masking: (1) utilizes taste bud competitiveness to cover the bonded area of bitter agent reduction bitterness and taste bud to reduce bitter sense and picotement; (2) utilize the packaging material material to the coating of active substance ambroxol hydrochloride, reach the rate of release that slows down its bitterness, alleviate numb feeling in the tongue.
The present invention adds and adds cool mouthful of agent of certain proportion in adjuvant, effectively alleviates the rear sense of discomfort to oral cavity and bottleneck throat generation of taking medicine, and makes the user follow refrigerant sense in the process of swallowing; Use the certain proportion acidic flavoring agent in correctives, as tartaric acid, citric acid, when covering the fiber crops flavor, promote the secretion of saliva of buccal cavity, accelerate the speed of disintegrate.
The present invention adopts water soluble adjuvant for mainly adding adjuvant, and is loose thereby the assurance Orally disintegrating tablet of ambroxol hydrochloride collapses rapidly after meeting water, simultaneously in conjunction with the powerful expansive force of disintegrating agent, reaches the purpose of the rapid disintegrate of oral cavity disintegration tablet.
The art for coating that the present invention relates to and hybrid technique extensive use in suitability for industrialized production: fluidized-bed process compare traditional wet granulation energy consumption low, save labor hour.
By the blind test to the volunteer, result shows that 90% above experimenter thinks: the sweet slightly bitter and numb flavor of distinguishing the flavor of, but uncomfortable sensation namely disappears after 30 seconds to 1 minute, and the process of taking is with refrigerant sense.
Compared with prior art, beneficial effect of the present invention is mainly reflected in: Orally disintegrating tablet of ambroxol hydrochloride disintegrate of the present invention is effective, dissolution is high, add cool mouthful of agent of certain proportion in adjuvant of the present invention, effectively alleviate the rear sense of discomfort to oral cavity and bottleneck throat generation of taking medicine, mouthfeel is good, and the bad mouthfeel persistent period is short, after taking also can to the patient bring can be good the medication process, be suitable for suitability for industrialized production.
(4) specific embodiment
The present invention is described further below in conjunction with specific embodiment, but protection scope of the present invention is not limited in this:
Taste masking essence-TP5004 of the present invention ((Firmenich Firmenich Aromatics (China) Co., Ltd.)), bitterness is covered essence-TP0551 ((Firmenich Firmenich Aromatics (China) Co., Ltd.)), apple essence (high fields, Suzhou spice company limited), Mint Essence (high fields, Suzhou spice company limited).
Example 1: the preparation of Orally disintegrating tablet of ambroxol hydrochloride
(1) Orally disintegrating tablet of ambroxol hydrochloride quality formula:
(2) preparation method
1) take hydroxypropyl emthylcellulose and taste masking essence-TP5004 as coating material, get above-mentioned formula ratio 6.3g hydroxypropyl emthylcellulose (HPMC), add the 80ml50% ethanol water to its whole dissolvings, be formulated as 8% HPMC ethanol water, add 0.63g taste masking essence-TP5004, fully stirring and dissolving, make the taste masking coating solution; 2) getting 30g ambroxol hydrochloride powder puts in fluid bed, with step 1) coating solution prepared evenly is sprayed at the ambroxol hydrochloride powder surface with end spray spray gun, air intake is controlled at 40 ℃ ± 5 ℃, and atomizing pressure is 1.8-2pa, makes the coated granule that contains ambroxol hydrochloride through fluid bed; 3) by above-mentioned formula ratio, with step 2) coated granule and other adjuvant (mannitol of ambroxol-hydrochloride-containing, lactose, cross-linking sodium carboxymethyl cellulose, saccharin sodium, tartaric acid, apple essence, Mint Essence, W-23, magnesium stearate, silicon dioxide) mix in mixer, incorporation time is 10min, and the granule after always mixing is carried out tabletting, and the tabletting Hardness Control prepares 1000 Orally disintegrating tablet of ambroxol hydrochloride at 15N-25N, every middle ambroxol hydrochloride effective content is 30mg, the heavy 123.61g of sheet is limited to 40 seconds, dissolution 99.5% when collapsing external solution.
Simultaneously 8 healthy volunteers are carried out mouthfeel investigation, be with little hardship in comprehensive 8 experimenters feedback sweet without grittiness, flavor, picotement is arranged, disappeared afterwards in average lasting 34 seconds, follow refrigerant sense simultaneously when taking, be 30 seconds average disintegration in the oral cavity, the results are shown in Table 1～table 8 always.
Example 2: the preparation of Orally disintegrating tablet of ambroxol hydrochloride
(1) Orally disintegrating tablet of ambroxol hydrochloride quality formula:
(2) preparation method:
Experimental implementation prepares 1000 of ambroxol hydrochloride cavity disintegrating tablets with embodiment 1, and every middle ambroxol hydrochloride effective content is 30mg, and the heavy 132.5mg of sheet is limited to 35 seconds, dissolution 98.5% when collapsing external solution.
Simultaneously 8 healthy volunteers are carried out mouthfeel investigation, comprehensive 8 experimenters feed back sweetly without grittiness, flavor, and a little picotement is arranged, and on average continue to disappear afterwards in 37 seconds, follow refrigerant sense when taking, and be 32 seconds average disintegration in the oral cavity, the results are shown in Table 1～table 8.
Example 3: the preparation of Orally disintegrating tablet of ambroxol hydrochloride
(1) Orally disintegrating tablet of ambroxol hydrochloride quality formula
(2) preparation method
Experimental implementation prepares 100 Orally disintegrating tablet of ambroxol hydrochloride with embodiment 1, and every middle ambroxol hydrochloride effective content is 30mg, and the heavy 120.72mg of sheet is limited to 30 seconds, dissolution 97.9% when collapsing external solution.
Simultaneously 8 healthy volunteers are carried out mouthfeel investigation, comprehensive 8 experimenters feed back sweetly without grittiness, flavor, and a little picotement is arranged, disappeared afterwards in average lasting 39 seconds, the refrigerant sense of accompanied by intense when taking, be 27 seconds average disintegration in the oral cavity, the results are shown in Table 1～table 8.
Example 4: the preparation of Orally disintegrating tablet of ambroxol hydrochloride
(1) Orally disintegrating tablet of ambroxol hydrochloride quality formula
(2) preparation method:
Experimental implementation prepares 1000 Orally disintegrating tablet of ambroxol hydrochloride with embodiment 1, and every middle ambroxol hydrochloride effective content is 30mg, and the heavy 123.48mg of sheet is limited to 32 seconds, dissolution 99.0% when collapsing external solution.
Simultaneously 8 healthy volunteers are carried out the mouthfeel investigation, flavor is slightly bitter, and a little picotement is arranged, and on average disappears afterwards in lasting 56 seconds, follows refrigerant sense when taking, and be 30 seconds average disintegration in the oral cavity, the results are shown in Table 1～table 8.
Example 5: the preparation of Orally disintegrating tablet of ambroxol hydrochloride
(1) Orally disintegrating tablet of ambroxol hydrochloride quality formula
(2) preparation method
Experimental implementation prepares the Orally disintegrating tablet of ambroxol hydrochloride of 1000 with embodiment 1, and every middle ambroxol hydrochloride effective content is 30mg, and the heavy 123.68mg of sheet is limited to 50 seconds, dissolution 100.2% when collapsing external solution.
Simultaneously 8 healthy volunteers are carried out the mouthfeel investigation, comprehensive 8 experimenters feed back without grittiness, sour in the mouth, follow refrigerant sense when taking without picotement, and other bad mouthfeels on average continue disappearance afterwards in 21.13 seconds, be 33 seconds average disintegration in the oral cavity, the results are shown in Table 1-8.
Example 6: the preparation of Orally disintegrating tablet of ambroxol hydrochloride
(1) Orally disintegrating tablet of ambroxol hydrochloride quality formula
(2) preparation method
Experimental implementation prepares 1000 of Orally disintegrating tablet of ambroxol hydrochloride with embodiment 1, and every middle ambroxol hydrochloride effective content is 30mg, the heavy 128.55mg of sheet, and it is limited to 32 seconds when collapsing external solution, dissolution 98.6%.
Simultaneously 8 healthy volunteers are carried out the mouthfeel investigation, comprehensive 8 experimenters feed back gradually sweetly after the slightly bitter several seconds without the grittiness flavor, and picotement is arranged, disappeared afterwards in average lasting 51 seconds, follow refrigerant sense when taking, be 36 seconds average disintegration in the oral cavity, the results are shown in Table 1～table 8.
Example 7: the preparation of Orally disintegrating tablet of ambroxol hydrochloride
(1) Orally disintegrating tablet of ambroxol hydrochloride quality formula
(2) preparation method
Experimental implementation prepares the Orally disintegrating tablet of ambroxol hydrochloride of 1000 with embodiment 1, and every middle ambroxol hydrochloride effective content is 30mg, the heavy 129.08mg of sheet, and it is limited to 48 seconds when collapsing external solution, dissolution 99.6%.Simultaneously 8 healthy volunteers are carried out the mouthfeel investigation, comprehensive 8 experimenters feed back sweetly without the aftertaste of grittiness bitter in the mouth, and accompany a little picotement, disappeared afterwards in average lasting 23 seconds and lose, follow refrigerant sense when taking, be 43 seconds average disintegration in the oral cavity, the results are shown in Table 1～table 8.
Example 8: the preparation of Orally disintegrating tablet of ambroxol hydrochloride
(1) Orally disintegrating tablet of ambroxol hydrochloride quality formula
(2) preparation method
Experimental implementation prepares 1000 Orally disintegrating tablet of ambroxol hydrochloride with embodiment 1, and every middle ambroxol hydrochloride effective content is 30mg, the heavy 120.8mg of sheet, and it is limited to 36 seconds when collapsing external solution, dissolution 98.7%.Simultaneously 8 healthy volunteers are carried out the mouthfeel investigation, comprehensive 8 experimenters feed back to such an extent that a little bitterness and picotement are arranged without grittiness, flavor after sweet, on average continue to disappear afterwards in 25 seconds, follow refrigerant sense when taking, be 32 seconds average disintegration in the oral cavity, the results are shown in Table 1-8.
Example 9: the preparation of Orally disintegrating tablet of ambroxol hydrochloride
(1) Orally disintegrating tablet of ambroxol hydrochloride quality formula
(2) preparation method
Experimental implementation prepares 1000 Orally disintegrating tablet of ambroxol hydrochloride with embodiment 1, and every middle ambroxol hydrochloride effective content is 30mg, the heavy 122.12mg of sheet, and it is limited to 44 seconds when collapsing external solution, dissolution 98.9%.Simultaneously 8 healthy volunteers are carried out the mouthfeel investigation, comprehensive 8 experimenters feed back slightly bitterly without grittiness, flavor, without picotement, other bad mouthfeels on average continue disappearance afterwards in 20 seconds, follow refrigerant sense when taking, be 22 seconds average disintegration in the oral cavity, the results are shown in Table 1-8.
The Orally disintegrating tablet of ambroxol hydrochloride grittiness (0 is without grittiness, and 1 for there being grittiness) of table 1 embodiment 1～9 preparation
The Orally disintegrating tablet of ambroxol hydrochloride sweet taste of table 2 embodiment 1～9 preparation (5-＞1 (strong-＞weak))
The Orally disintegrating tablet of ambroxol hydrochloride bitterness of table 3 embodiment 1～9 preparation (4-＞0 (strong-＞weak))
The Orally disintegrating tablet of ambroxol hydrochloride tart flavour of table 4 embodiment 1～9 preparation (3-＞0 (strong-＞weak))
The Orally disintegrating tablet of ambroxol hydrochloride picotement of table 5 embodiment 1～9 preparation (3-＞0 (strong-＞weak))
The refrigerant sense of Orally disintegrating tablet of ambroxol hydrochloride of table 6 embodiment 1～9 preparation (5-＞0 (strong-＞weak))
The bad mouthfeel persistent period of Orally disintegrating tablet of ambroxol hydrochloride (s) of table 7 embodiment 1～9 preparation
Disintegration time (s) in the Orally disintegrating tablet of ambroxol hydrochloride cavity of table 8 embodiment 1～9 preparation
Claims (10)
1. Orally disintegrating tablet of ambroxol hydrochloride, described oral cavity disintegration tablet comprises ambroxol hydrochloride, it is characterized in that described oral cavity disintegration tablet made by the supplementary material that comprises following quality proportioning:
Described ambroxol hydrochloride adopts the street drug that meets 2010 editions two ones of Chinese Pharmacopoeias;
the described coated ambroxol hydrochloride taste masked particle of making, make as follows: take binding agent and cover bitter agent as coating material, take binding agent with after ethanol water dissolving, add and cover bitter agent and fully stir, make the taste masking coating solution, ambroxol hydrochloride is carried out coating by the taste masking coating solution make taste masked particle, described ambroxol hydrochloride and taste masking coating material mass ratio are 1: 0.2～0.4, described binding agent is 1: 0.1～0.4 with covering bitter agent mass ratio, described binding agent is hydroxypropyl methylcellulose, it is described that to cover bitter agent be the combination that taste masking essence-TP5004 and/or bitterness are covered essence-TP0551 arbitrary proportion,
Described filler is one or more in mannitol, sorbitol, lactose and microcrystalline Cellulose;
Described disintegrating agent is one or more of cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose;
Described correctives is one or more of saccharin sodium, aspartame, stevioside, tartaric acid, citric acid, Mint Essence, apple essence;
Described cool mouthful of agent is WS-23 and/or N-ethyl-2-isopropyl-5-methyl-cyclohexyl alkane Methanamide;
Described lubricant is one or both in Pulvis Talci, magnesium stearate;
Described fluidizer is silicon dioxide.
2. Orally disintegrating tablet of ambroxol hydrochloride as claimed in claim 1 is characterized in that described oral cavity disintegration tablet is comprised of the supplementary material of following quality proportioning:
3. Orally disintegrating tablet of ambroxol hydrochloride as claimed in claim 1, it is characterized in that the described coated ambroxol hydrochloride taste masked particle of making makes as follows: take binding agent and cover bitter agent as coating material, take binding agent with after ethanol water dissolving, add and cover bitter agent and fully stir, make the taste masking coating solution, ambroxol hydrochloride is made taste masked particle by taste masking coating solution coating, described ambroxol hydrochloride and taste masking coating material mass ratio are 1: 0.25, described binding agent is 1: 0.103 with the mass ratio of covering bitter agent, described binding agent is hydroxypropyl methylcellulose, covering bitter agent is that bitterness is covered essence-TP0551.
4. Orally disintegrating tablet of ambroxol hydrochloride as claimed in claim 1 is characterized in that described oral cavity disintegration tablet made by the supplementary material of following quality proportioning:
5. Orally disintegrating tablet of ambroxol hydrochloride as claimed in claim 1, is characterized in that described correctives is aspartame, tartaric acid, citric acid, apple essence or Mint Essence.
6. Orally disintegrating tablet of ambroxol hydrochloride as claimed in claim 1, is characterized in that it is that 30mg determines that sheet is heavy that described Orally disintegrating tablet of ambroxol hydrochloride contains effective composition ambroxol hydrochloride by every.
7. the preparation method of an Orally disintegrating tablet of ambroxol hydrochloride as claimed in claim 1 is characterized in that described method is: 1) press formula ratio, take binding agent with the ethanol water dissolving after, add and cover bitter agent and fully stir, make the taste masking coating solution; 2) get the formula ratio ambroxol hydrochloride and put in fluid bed, with step 1) the taste masking coating solution prepared, adopt the mode of end spray evenly to be sprayed at the ambroxol hydrochloride surface, make the coated granule that contains ambroxol hydrochloride through fluid bed; 3) take filler, disintegrating agent, correctives, cool mouthful of agent, lubricant and fluidizer by formula ratio, with the coated granule that ambroxol hydrochloride is arranged in mixer fully after mix homogeneously, containing effective composition ambroxol hydrochloride by every is that 30mg determines sheet weight sheet, obtains described Orally disintegrating tablet of ambroxol hydrochloride.
8. Orally disintegrating tablet of ambroxol hydrochloride preparation method as claimed in claim 7, is characterized in that described step 1) in alcoholic solution be 50% ethanol water.
9. Orally disintegrating tablet of ambroxol hydrochloride preparation method as claimed in claim 7, it is characterized in that described step 1) in binding agent be 1: 0.1 with covering the bitter agent mass ratio that feeds intake, ambroxol hydrochloride and the taste masking coating material mass ratio that feeds intake is 1: 0.25, described binding agent is hydroxypropyl methylcellulose, and described to cover bitter agent be that bitterness is covered essence-TP0551.
10. Orally disintegrating tablet of ambroxol hydrochloride preparation method as claimed in claim 7, is characterized in that described step 3) in the mass ratio that feeds intake of ambroxol hydrochloride and filler, disintegrating agent, correctives, the agent of cool mouth, lubricant and fluidizer be 1: 1.5～1.8: 0.16～0.24: 0.6～9: 0.02～0.05: 0.029～0.04: 0.03～0.05.
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102614159B (en) * | 2012-02-07 | 2013-03-27 | 海南卫康制药(潜山)有限公司 | Ambroxol hydrochloride composition |
| CN102716102B (en) * | 2012-05-30 | 2014-02-05 | 杭州康恩贝制药有限公司 | Mecobalamin tablet and preparation method thereof |
| CN103565765B (en) * | 2012-07-30 | 2015-08-26 | 南京亿华药业有限公司 | The ibuprofen mouth of compound essence powder coating release by different level collapses the preparation of piller |
| CN104174023B (en) * | 2014-08-15 | 2017-10-10 | 河北菲尼斯生物技术有限公司 | One kind makes the stability-enhanced pharmaceutical composition of ambroxol hydrochloride |
| CN107569460A (en) * | 2017-06-01 | 2018-01-12 | 合肥远志医药科技开发有限公司 | A kind of Ambroxol Hydrochloride Tablets and preparation method thereof |
| CN112168793A (en) * | 2020-10-26 | 2021-01-05 | 辰欣药业股份有限公司 | Ambroxol hydrochloride orally disintegrating tablet and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1839802A (en) * | 2006-01-27 | 2006-10-04 | 无锡山禾药业股份有限公司 | Ambroxol hydrochloride oral disintegrating tablet and preparation method thereof |
| CN1864672A (en) * | 2005-12-24 | 2006-11-22 | 石药集团中奇制药技术（石家庄）有限公司 | A solid dispersion of ambroxol hydrochloride and composition thereof |
| CN101129346A (en) * | 2007-07-23 | 2008-02-27 | 重庆康刻尔制药有限公司 | Ambroxol hydrochloride oral cavity disintegrating tablet and method of producing the same |
-
2011
- 2011-09-30 CN CN 201110293404 patent/CN102327244B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1864672A (en) * | 2005-12-24 | 2006-11-22 | 石药集团中奇制药技术（石家庄）有限公司 | A solid dispersion of ambroxol hydrochloride and composition thereof |
| CN1839802A (en) * | 2006-01-27 | 2006-10-04 | 无锡山禾药业股份有限公司 | Ambroxol hydrochloride oral disintegrating tablet and preparation method thereof |
| CN101129346A (en) * | 2007-07-23 | 2008-02-27 | 重庆康刻尔制药有限公司 | Ambroxol hydrochloride oral cavity disintegrating tablet and method of producing the same |
Non-Patent Citations (2)
| Title |
|---|
| 徐春玲.正交设计优化盐酸氨溴索口腔崩解片的处方.《药学进展》.2010,第34卷(第5期),220-224. |
| 正交设计优化盐酸氨溴索口腔崩解片的处方;徐春玲;《药学进展》;20101231;第34卷(第5期);220-224 * |
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