CN103721265A - Orally disintegrating composition with desloratadine citrate disodium - Google Patents
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- CN103721265A CN103721265A CN201310686141.9A CN201310686141A CN103721265A CN 103721265 A CN103721265 A CN 103721265A CN 201310686141 A CN201310686141 A CN 201310686141A CN 103721265 A CN103721265 A CN 103721265A
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Abstract
The invention aims to provide an orally disintegrating composition with desloratadine citrate disodium and particularly relates to an orally disintegrating tablet containing the desloratadine citrate disodium, and a preparation method thereof. The stability of the medicine can be obviously improved, and the safety of clinical medication can be ensured.
Description
Technical field
The present invention relates to a kind of compositions of Chinese holly Desloratadine, be specifically related to the oral cavity disintegration tablet of the compositions of Chinese holly Desloratadine, belong to field of medicaments.
Background technology
Urticaria, (Urticaria) is a kind of common dermatosis.It is the mucocutaneous vascular reactivity disease of one due to multiple different reason.Show as flickering, well-defined, red or white pruritus welt, the traditional Chinese medical science claims " urticaria ", is commonly called as " rubella wheal ".Pathogenesis: the reasons such as allergy, autoimmune, medicine, diet, inhalation (inhalatio), infection, physical stimulation, sting cause the release of the inflammatory mediator (histamine, 5-hydroxy tryptamine, kassinin kinin and slow reacting substance etc.) that mastocyte dependency and non-mastocyte dependency cause, causes that vasodilation, vascular permeability increase, inflammatory cell infiltration.
Chinese holly Desloratadine is Chinese holly Desloratadine to be reacted with disodium hydrogen citrate and a kind of new salt compounds that forms, and this product in vivo rapid conversion is that Chinese holly Desloratadine plays a role.Chinese holly Desloratadine is the long-acting tricyclic antidepressants antihistaminic of non-sedating, for the active metabolite of Chinese holly Desloratadine, can be by optionally blocking peripheral H1-receptor, suppress the release that various anaphylaxis causes scorching chemical mediator, as: suppress mastocyte and basophilic leukocyte and discharge histamine, prostaglandin, interleukin etc., alleviate the related symptoms of allergic rhinitis or chronic idiopathic urticaria.It has the advantage of antiallergic, antihistamine, the unification of antiinflammatory triple effect, have rapid-action, effect strong, acardia toxicity, drug interaction are few and without advantages such as food prohibiteds.
Chinese holly Desloratadine and Chinese holly Desloratadine have tablet, capsule, dispersible tablet, syrup, granule, dry suspension, solid liposome etc. for the dosage form of selection of clinical.Tablet absorbs in vivo must be through processes such as disintegrate, strippings, through gastrointestinal absorption, could arrive blood circulation, and tablet in process of production, often because causing tablet, the reasons such as adjuvant, technique are difficult to disintegrate, medicine is difficult to stripping, absorb slowly, thereby make medicine not reach due therapeutical effect.Capsule is mainly gelatin composition, and meeting water can become sticky, and while taking, is easily bonded in the mouth, causes the difficulty of swallowing.In addition, ordinary tablet and capsule, water is swallowed, and because these dosage form volume ratios are larger, is not suitable for swallow weak old man and child and takes.Though syrup has overcome the above-mentioned shortcoming of Tablet and Capsula, its production and transportation are inconvenient, and must add antiseptic in syrup, human body is produced to injury, the less stable of medicine in solution, perishable in the process of storage simultaneously, may affect the curative effect of medicine.Due to Chinese holly Desloratadine poorly water-soluble, the medicine of its granule, dry suspension can not dissolve completely, is suspended in water, and the absorption of taking rear medicine is slow, thereby has reduced the bioavailability of medicine.
CN1268377C discloses a kind of Chinese holly Desloratadine dry suspension and preparation method thereof, it carries out coating by Chinese holly Desloratadine raw material and is then mixed with dry suspension with other adjuvants, thereby improve the stability of Chinese holly Desloratadine, but this dry suspension technique is more complicated, produce difficulty.
In US2002/123504, disclose the instable method of several solution Chinese holly Desloratadine preparation, having comprised: 1. used anhydrous Chinese holly Desloratadine raw material; 2. increase the particle diameter of Chinese holly Desloratadine; 3. adopt the Chinese holly Desloratadine of no hygroscopicity; 4 use protectiveness adjuvants are to Chinese holly Desloratadine raw material coating; 5. avoid using the adjuvants such as acidic excipient and lactose.Chinese holly Desloratadine is secondary-amine compound; to acid and glucide sensitivity; very easily there is maillard reaction and produce N-formylated Chinese holly Desloratadine; moreover; the primary amine of Chinese holly Desloratadine is to oxygen sensitive; easily oxidation by air, degraded generates the impurity such as dechlorination Chinese holly Desloratadine and dehydrogenation Chinese holly Desloratadine, causes preparation color burn to become brown.
Patent CN102614178A discloses a kind of oral cavity disintegration tablet of Chinese holly Desloratadine, and it is added with Citric acid calcium, microcrystalline Cellulose, mannitol, low replacement carboxy-propyl cellulose, xylitol, aspartame, magnesium stearate, Polyethylene Glycol, Pulvis Talci.
In existing Chinese holly Desloratadine preparation, the content of the related substance of Chinese holly Desloratadine has become a key parameter of quality control, and up to the present, the stability control problem of Chinese holly Desloratadine is not well solved always.According to clinical needs, and in order to overcome prior art defect, we have developed good stability, good patient compliance, technique is simple, cost is low Chinese holly Desloratadine preparation.
Can be widely used in the multiple allergosis with IgE mediation, comprise bronchial asthma, asthmatic bronchitis, allergic cough, allergic rhinitis, anaphylaxis pollinosis, anaphylaxis conjunctivitis, acute or chronic urticaria, atoipc dermatitis, contact dermatitis, photoallergic dermatitis, food allergy, drug allergy, insectean metamorphosis reaction etc.For the vasculitis type pathological changes being caused by immune complex, also there is certain curative effect as anaphylactoid purpura etc.
CN101524353A discloses a kind of and oral irritated compound levocetirizine.
But in prior art, do not have the use in conjunction about Chinese holly Desloratadine, more there is no a kind of stable oral cavity disintegration tablet.
Summary of the invention
Inventor finds by a large amount of experiments, select disintegrating tablet that Chinese holly Desloratadine is made effectively to overcome the problem of principal agent poor stability, improved the dissolution of medicine simultaneously, increased medicine retention time in vivo, synergism has been played in treatment for urticaria, has unforeseeable technique effect.
The object of the present invention is to provide a kind of Orally disintegrating compositions that comprises Chinese holly Desloratadine, concrete is a kind of oral cavity disintegration tablet that comprises Chinese holly Desloratadine, with and preparation method thereof.Can significantly improve stability of drug products, the safety of clinical application is more guaranteed.
Till now, although known, have various types of oral cavity disintegration tablets,, go back so far and do not know not need to use special excipient and manufacturing equipment etc., only utilize easy preparation method to obtain formability and the fully excellent oral cavity disintegration tablet of disintegrative.Although known oral cavity disintegration tablet has excellent Orally disintegrating at present, is noted and does not possess in use enough hardness.The inventor thinks that its reason is, excipient itself does not have both excellent disintegrative and excellent formability.Therefore, by further investigation, find: as a rule, disintegrative excellence and the poor starch of formability are by processed or when presenting αization and spend, its formability and disintegrative two aspects all have excellent character.Based on above discovery, through further research repeatedly, find that (1) will be when will have microcrystalline Cellulose and medicament mixed and making tablet, can obtain physical strength as oral cavity disintegration tablet high and take the oral cavity disintegration tablet of rear oral cavity disintegrative excellence, thereby complete the present invention.Although oral cavity disintegration tablet prepared by current known employing starch based,, people are also ignorant at present: having specific microcrystalline Cellulose can be as the excipient of the oral cavity disintegration tablet with excellent formability and disintegrative of Chinese holly Desloratadine.
The present invention relates to following content: a kind of oral cavity disintegration tablet, wherein in this tablet, disperse to have microcrystalline Cellulose, and it contains Chinese holly Desloratadine and saccharide.Wherein, described saccharide is trehalose.
A preparation method for oral cavity disintegration tablet, is characterized in that, Chinese holly Desloratadine, microcrystalline Cellulose and saccharide is mixed to tabletting.
Described oral cavity disintegration tablet, also contains other binder starch and sticks with paste, and described gelatinized corn starch is general, without the starch of special processing.Described oral cavity disintegration tablet, wherein by microcrystalline Cellulose, Chinese holly Desloratadine, the described gelatinized corn starch of trehalose.
A preparation method for oral cavity disintegration tablet, wherein, by microcrystalline Cellulose, Chinese holly Desloratadine and saccharide gelatinized corn starch, then by this thing and mixed with excipients, and beat sheet.
In this manual, term " oral cavity disintegration tablet " refers to without absorb water in order to take tablet, in oral cavity, substantially only rely on saliva in 1 minute, preferably in 40 seconds, the more preferably tablet of disintegrate in 30 seconds.Above-mentioned intraoral disintegration time, refers to when tablet is contained in oral cavity, the value under the activity in the raw of tongue etc.For example, in healthy adult man's oral cavity, not moisture in mouthful, only containing test tablet, required time while only relying on saliva make the complete disintegrate of described tablet and dissolve by mensuration, carry out thus to determine time of intraoral disintegration.Needn't limit the naturally movable etc. of tongue therebetween.
In the present invention, if intraoral disintegration time in 40 seconds, thinks that it has good Orally disintegrating.
In this manual, term " (tablet) hardness " refers to the hardness of the tablet by playing the formation such as sheet.For example, the hardness of tablet is with representing the broken needed power of this tablet (unit: N), and this numerical value more bolus is harder.In the present invention, when oral cavity disintegration tablet is evaluated, owing to thering is excellent manufacturing and there is excellent storage stability in the process of circulation, so (for example), when carrying out tablet hardness mensuration, use normally used Schleuniger tablet hardness tester (manufacture of Schleuniger company) to measure, and using 50N as assay standard.
In oral cavity disintegration tablet of the present invention, with respect to the gross weight of said preparation, the ratio of contained microcrystalline Cellulose is 30～70 % by weight, is preferably 40～80 % by weight, more preferably 50～70 % by weight.
Trehalose is so-called " formability high (saccharide) ", and it belongs to the stamp pestle that (for example) is 8mm with diameter, at 10～50kg/cm
2beat while the saccharide of 150mg being beaten to sheet under sheet pressure, hardness is shown as sugar more than 2kg.Its formability is high, to preparation, has brought enough hardness, has guaranteed again good disintegrative, and the formabilities such as glucose, mannitol are lower, and required hardness cannot be provided.While meanwhile, adopting Polyethylene Glycol etc. to guarantee hardness, reduced again disintegrating property.With respect to the weight of tablet, described addition is preferably 20～55 % by weight, more preferably 30～45 % by weight.The addition of described Chinese holly Desloratadine is 5～20 % by weight.The addition of the starch through the starch of processing using in the present invention, with respect to the starch through processing and the gross weight of saccharide, is 0.5～25 % by weight.
In the present invention, for method, have no particular limits, as long as can be by the form of Chinese holly Desloratadine and excipient formation.Described method can be enumerated: for example, utilize the whole bag of tricks such as spray drying method, fluosolids method, paddling process, method of rotation to be prepared.
The specific embodiment
In following each embodiment, utilize following each test method to carry out various evaluations to oral cavity disintegration tablet.
?(1) hardness test
Use Schleuniger tablet hardness tester (Schleuniger company system) to measure.The hardness of tablet uses required power (unit: N) while making tablet broken to represent, this numerical value more tablet is harder.
?(2) Orally disintegrating test
Healthy adult man is in oral cavity under water-free condition, and buccal test tablets, measures that tablet only relies on saliva and disintegrate completely, needed time while dissolving.
The present invention not only provides a kind of oral cavity disintegration tablet, more be to provide a kind of compositions of coupling of Chinese holly Desloratadine, both play the beyond thought synergism for urticaria, the preparation of preparation all has good disintegrative and enough hardness, stability in transportation and storage process is better, has improved economic and social benefit.
Embodiments of the invention are only used for the present invention is described and provide, are not for restriction of the present invention.So simple modifications of the present invention is all belonged to the scope of protection of present invention under method prerequisite of the present invention.
Embodiment 1
This microcrystalline Cellulose 4.5g, Chinese holly Desloratadine 0.25g, trehalose 4.55g, magnesium stearate 0.05g, gelatinized corn starch 0.5g are mixed.Utilizing tablet machine, use the drift of diameter 8.0mm, curvature 9.6R, beating under the condition that sheet pressure is 12kN, is that weight is the tablet of 200mg by this mixture forming.The hardness of the tablet obtaining is 55N, and the disintegration time in oral cavity is 15 seconds.
Embodiment 2
Real microcrystalline Cellulose 5g, Chinese holly Desloratadine 1g, trehalose 2.95g, magnesium stearate 0.05g, gelatinized corn starch 0.6g are mixed.Utilizing tablet machine, use the drift of diameter 8.0mm, curvature 9.6R, beating under the condition that sheet pressure is 12kN, is that weight is the tablet of 200mg by this mixture forming.The hardness of the tablet obtaining is 45N, and the disintegration time in oral cavity is 18 seconds.
Embodiment 3
Microcrystalline Cellulose 6.5g, Chinese holly Desloratadine 0.5g, trehalose 3.05g, magnesium stearate 0.05g, gelatinized corn starch 0.6g are mixed.Utilizing tablet machine, use the drift of diameter 8.0mm, curvature 9.6R, beating under the condition that sheet pressure is 10kN, is that weight is the tablet of 200mg by this mixture forming.The hardness of the tablet obtaining is 48N, and the disintegration time in oral cavity is 23 seconds.
Embodiment 4
Microcrystalline Cellulose 5g, Chinese holly Desloratadine 1g, trehalose 2.55g, magnesium stearate 0.05g, gelatinized corn starch 0.8g are mixed.Utilizing tablet machine, use the drift of diameter 8.0mm, curvature 9.6R, beating under the condition that sheet pressure is 10kN, is that weight is the tablet of 200mg by this mixture forming.The hardness of the tablet obtaining is 50N, and the disintegration time in oral cavity is 14 seconds.
Embodiment 5
This microcrystalline Cellulose 4.5g, Chinese holly Desloratadine 0.25g, trehalose 4.55g, magnesium stearate 0.05g, gelatinized corn starch 0.5g are mixed.Utilizing tablet machine, use the drift of diameter 8.0mm, curvature 9.6R, beating under the condition that sheet pressure is 12kN, is that weight is the tablet of 200mg by this mixture forming.The hardness of the tablet obtaining is 58N, and the disintegration time in oral cavity is 13 seconds.
Embodiment 6
This microcrystalline Cellulose 4.5g, Chinese holly Desloratadine 0.25g, trehalose 4.55g, magnesium stearate 0.05g, gelatinized corn starch 0.5g are mixed.Utilizing tablet machine, use the drift of diameter 8.0mm, curvature 9.6R, beating under the condition that sheet pressure is 12kN, is that weight is the tablet of 200mg by this mixture forming.The hardness of the tablet obtaining is 53N, and the disintegration time in oral cavity is 43 seconds.
Embodiment 7
This microcrystalline Cellulose 4.5g, Chinese holly Desloratadine 0.25g, trehalose 4.55g, magnesium stearate 0.05g, gelatinized corn starch 0.5g are mixed.Utilizing tablet machine, use the drift of diameter 8.0mm, curvature 9.6R, beating under the condition that sheet pressure is 12kN, is that weight is the tablet of 200mg by this mixture forming.The hardness of the tablet obtaining is 31N, and the disintegration time in oral cavity is 16 seconds.
Embodiment 8
Microcrystalline Cellulose, Chinese holly Desloratadine 0.25g, trehalose 4.55g, magnesium stearate 0.05g, gelatinized corn starch 0.5g are mixed.Utilizing tablet machine, use the drift of diameter 8.0mm, curvature 9.6R, beating under the condition that sheet pressure is 12kN, is that weight is the tablet of 200mg by this mixture forming.The hardness of the tablet obtaining is 28N, and the disintegration time in oral cavity is 12 seconds.
Embodiment 9
Microcrystalline Cellulose 4.5g, Chinese holly Desloratadine 0.25g, mannitol 4.55g, magnesium stearate 0.05g, gelatinized corn starch 0.5g are mixed.Utilizing tablet machine, use the drift of diameter 8.0mm, curvature 9.6R, beating under the condition that sheet pressure is 12kN, is that weight is the tablet of 200mg by this mixture forming.The hardness of the tablet obtaining is 35N, and the disintegration time in oral cavity is 15 seconds.
From above-described embodiment, Chinese holly Desloratadine had both had good disintegrating property in the existence of microcrystalline Cellulose and trehalose, also had enough hardness, had guaranteed the stability of storing.
Embodiment 10
Microcrystalline Cellulose 4.5g, Chinese holly Desloratadine 0.25g, trehalose 4.55g, magnesium stearate 0.05g, gelatinized corn starch 0.5g are mixed.Utilizing tablet machine, use the drift of diameter 8.0mm, curvature 9.6R, beating under the condition that sheet pressure is 12kN, is that weight is the tablet of 200mg by this mixture forming.The hardness of the tablet obtaining is 55N, and the disintegration time in oral cavity is 15 seconds.
Embodiment 11
Microcrystalline Cellulose 4.5g, trehalose 4.55g, magnesium stearate 0.05g, gelatinized corn starch 0.5g are mixed.Utilizing tablet machine, use the drift of diameter 8.0mm, curvature 9.6R, beating under the condition that sheet pressure is 12kN, is that weight is the tablet of 200mg by this mixture forming.The hardness of the tablet obtaining is 55N, and the disintegration time in oral cavity is 15 seconds.
Embodiment 12
Measure embodiment 1,10,11 therapeutic effect for urticaria.
90 routine chronic urticaria patients, from Dermatology Outpatient Department, all meet chronic urticaria diagnostics standard, are divided at random three groups, and between three groups, sex, age, the course of disease are all without significant difference.
Therapeutic evaluation, observes patient pruritus degree, welt or pimple issue licence size and number, by level Four point system (0-3 divides), scores.Integration * 100% before symptom integral decline index=(the rear integration of integration-treatment before treatment)/treatment.
Curative effect judgement: cure symptom integral decline index >=90%; Effective 90% > symptom integral decline index >=60%; Take a turn for the better: 60% > symptom integral decline index >=20%; Invalid: symptom integral decline index < 20%. effective percentage=effectively number of cases/group number of cases * 100%.
Matched group: commercially available Chinese holly Desloratadine sheet, every day, 10mg, was used in conjunction 30 days.
Treatment group: the preparation that uses embodiment 7.Usage and dosage, Chinese holly Desloratadine, 10mg every day, is used in conjunction 30 days.
The results are shown in Table 1.
Table 1 Clinical efficacy comparison
As can be seen from the table, the application's Chinese holly Desloratadine oral disintegrated preparation and commercial preparation comparison, have beyond thought technique effect for urticaria.
Claims (8)
1. a compositions for Chinese holly Desloratadine, is specially oral cavity disintegration tablet, it is characterized in that: it comprises Chinese holly Desloratadine and disintegrating agent.
2. Chinese holly Desloratadine compositions according to claim 1, is characterized in that comprising disintegrating agent, binding agent, filler, lubricant.
3. Chinese holly Desloratadine compositions according to claim 2, is characterized in that described disintegrating agent is the mixture of any one or multiple arbitrary proportion of crospolyvinylpyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (L-HPC), microcrystalline Cellulose (MCC), cross-linking sodium carboxymethyl cellulose, polyacrylic acid Superporous hydrogels microgranule (SPH), medicinal weak-acid cation-exchange resin Indion414, hydroxypropyl starch complex.
4. Chinese holly Desloratadine compositions according to claim 2, is characterized in that described filler is the mixture of any one or multiple arbitrary proportion in lactose, Lactis Anhydrous, glucose, mannitol, starch, dextrin, calcium carbonate, microcrystalline Cellulose, micropowder cellulose.
5. Chinese holly Desloratadine compositions according to claim 2, it is characterized in that described binding agent is starch slurry, syrup, arabic gum, trehalose and its esters, the mixture of any one in methylcellulose, sodium carboxymethyl cellulose, ethyl cellulose, polyvinylpyrrolidone, polyacrylamide or multiple arbitrary proportion.
6. the compositions of Chinese holly Desloratadine as claimed in claim 2, is characterized in that described lubricant is the mixture of any one or multiple arbitrary proportion in stearic acid, magnesium stearate, Pulvis Talci, micropowder silica gel.
7. Chinese holly Desloratadine according to claim 1, is characterized in that: said composition is oral cavity disintegration tablet, by Chinese holly Desloratadine, microcrystalline Cellulose, trehalose, starch and appropriate magnesium stearate, formed, wherein:
The addition of Chinese holly Desloratadine is 5～20% of gross weight, the addition of microcrystalline Cellulose is 30～70% of gross weight, and the addition of trehalose is gross weight 20～55%, and described starch is gelatinized corn starch, addition be microcrystalline Cellulose and trehalose weight and 0.5～25%
The gross weight sum of described microcrystalline Cellulose, Chinese holly Desloratadine, Sargassum sugar and starch magnesium stearate is below 100% of described oral cavity disintegration tablet gross weight.
8. the preparation method of the oral cavity disintegration tablet of Chinese holly Desloratadine according to claim 7, it is characterized in that: comprise following steps: with other binding agents by bonding to microcrystalline Cellulose, Chinese holly Desloratadine and trehalose, again this thing is mixed with magnesium stearate, and tabletting.
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Citations (3)
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|---|---|---|---|---|
| CN1286631A (en) * | 1998-03-16 | 2001-03-07 | 山之内制药株式会社 | Tablets quickly disintegrating in oral cavity and process for producing same |
| CN1397556A (en) * | 2002-08-27 | 2003-02-19 | 何广卫 | Alkali-metal or alkali-earth metal salt of polyprotic acid delotadine and its medical composition |
| CN102389404A (en) * | 2011-09-02 | 2012-03-28 | 深圳信立泰药业股份有限公司 | Desloratadine medicament compound |
-
2013
- 2013-12-16 CN CN201310686141.9A patent/CN103721265A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1286631A (en) * | 1998-03-16 | 2001-03-07 | 山之内制药株式会社 | Tablets quickly disintegrating in oral cavity and process for producing same |
| CN1397556A (en) * | 2002-08-27 | 2003-02-19 | 何广卫 | Alkali-metal or alkali-earth metal salt of polyprotic acid delotadine and its medical composition |
| CN102389404A (en) * | 2011-09-02 | 2012-03-28 | 深圳信立泰药业股份有限公司 | Desloratadine medicament compound |
Non-Patent Citations (1)
| Title |
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| 孙冠男等: "提高口崩片崩解性能的措施", 《中国医药工业杂志》 * |
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