CN101461788B - Phloroglucine orally disintegrating tablet and preparation method thereof - Google Patents
Phloroglucine orally disintegrating tablet and preparation method thereof Download PDFInfo
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- CN101461788B CN101461788B CN2007101725183A CN200710172518A CN101461788B CN 101461788 B CN101461788 B CN 101461788B CN 2007101725183 A CN2007101725183 A CN 2007101725183A CN 200710172518 A CN200710172518 A CN 200710172518A CN 101461788 B CN101461788 B CN 101461788B
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- phloroglucinol
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Abstract
The invention discloses a phloroglucinol orally disintegrating tablet and a preparation method thereof. The phloroglucinol orally disintegrating tablet is prepared by adopting a powder pelletization and compression method by a wet method and contains a therapeutically effective amount of phloroglucinol and a pharmaceutical excipient, and the excipient comprises a disintegrant; and according to the total weight of the tablet, the content of the phloroglucinol is between 15 and 30 percent, the content of the excipient is between 70 and 85 percent, and the content of the disintegrant is between 3 and 23 percent. The phloroglucinol orally disintegrating tablet has the advantages of higher hardness, simple preparation technology, and remarkable curative effect, is quickly disintegrated within 10 seconds at the soonest when contacting saliva in an oral cavity, and is convenient for patients to take.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, particularly a kind of Spaston orally disintegrating tablets and preparation method thereof.
Background technology
The pain that smooth muscle spasm causes is one of modal emergency case clinically, the acute spasmic pain that causes as digestive system and biliary tract dysfunction; Acute spastic urethra, bladder, renal colic; Gynecological's spasmic pain etc.External exploitation recently and in clinical practice novel non-atropine of close flesh, the pure flat sliding flesh spasmolytic of non-Semen Papaveris bases: phloroglucinol (Phloroglucinol, trade name: the rich Spasfon of this handkerchief), it can directly act on the smooth muscle of gastrointestinal tract and urogenital tract, remove smooth muscle spasm, and can not produce a series of cholinolytic sample side effect as atropic category, Semen Papaveris bases smooth muscle spasmolysis medicine, can not cause symptoms such as hypotension, heart rate quickening, arrhythmia, to not influence of cardiovascular function yet.Phloroglucinol is extremely important clinically.
The phloroglucinol dosage form has injection and oral cavity disintegration tablet at present.Drug administration by injection need medical personnel be assisted patient's poor compliance.
(Orally Disintegrating Tablet is a kind of new medicinal preparation that rises both at home and abroad in recent years ODT) to oral cavity disintegration tablet, and its characteristics are: do not need water or only need low amounts of water, also need not to chew, medicine places lingual surface, after the disintegrate, borrows swallowing act to go into the stomach onset rapidly.Can make things convenient for part patient medication, as dysphagia person (especially old man, child), or the medicine quick acting is wished in patient's medication and specific occasion under the special environment that can not obtain water.Oral cavity disintegration tablet is directed to special sufferer colony, and its exploitation is not subjected to the constraint of character of medicine own or pharmacological action, has bigger application prospect.
The method for preparing oral cavity disintegration tablet at present both at home and abroad has: lyophilization pressed disc method, direct powder compression and widely used at home powder wet method grain-making and squash method.The Orally disintegrating piece preparation method that present preceding two kinds of methods are comparative maturities, the oral cavity disintegration tablet quality of preparation is loose, and the disintegrate effect is relatively good, and disintegration is generally in 15 seconds.But there is deficiency in the both: the hardness of finished product is less, and crisp broken degree is higher, even through extra package, also is difficult to guarantee its outward appearance integrity when storing and transport; And preparation method all has specific characteristics, to process conditions and equipment requirements than higher.Adopt the oral cavity disintegration tablet of powder wet granule compression tablet method preparation, for obtaining quickly disintegrated effect, usually in prescription, add a large amount of disintegrating agent (addition inside and outside general the employing), the oral cavity rapid disintegration tablet porosity of pressing preparation is little, disintegrate is slow slightly, but preparation technology is simple, and mechanical strength is better.
Present Spaston orally disintegrating tablets is prepared from the lyophilization pressed disc method, and drug effect is remarkable, however to process conditions and equipment requirements than higher, technology is special, development cost is higher, costs an arm and a leg, hardness is lower, is not easy to packing, stores and transportation.
Summary of the invention
Therefore, the technical problem to be solved in the present invention just provides a kind of new Spaston orally disintegrating tablets, this Spaston orally disintegrating tablets is guaranteeing under the respond well prerequisite of disintegrate, reach also that preparation technology is simple, production cost is lower, finished product hardness is higher, is convenient to packing, storage and requirements on transport.
The technical problem that the present invention also will solve provides the preparation method of described Spaston orally disintegrating tablets.
The inventor is in order to simplify the production technology of Spaston orally disintegrating tablets, reduce production cost, studied and adopted existing domestic powder wet method grain-making and squash method production technology commonly used to prepare Spaston orally disintegrating tablets, find out the prescription that is suitable for above-mentioned production technology, and make the oral cavity disintegration tablet that makes have good disintegrate effect.
Therefore, the present invention solves the problems of the technologies described above the technical scheme that is adopted: a kind of Spaston orally disintegrating tablets, can comprise the phloroglucinol and the pharmaceutically useful excipient for the treatment of effective dose, comprise disintegrating agent in the described excipient, by the tablet total weight amount, the content of phloroglucinol is 15～30%, and the content of described excipient is 70～85%, and the content of described disintegrating agent is 3～23%.
More excellent, the optional self-crosslinking polyvidone of described disintegrating agent (PVPP), cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium (CMS-Na) and low-substituted hydroxypropyl cellulose (L-HPC).
Preferable, described excipient also can comprise the excipient that other is pharmaceutically commonly used, for example filler, pH regulator agent, binding agent, sweeting agent, coloring agent, aromatic and lubricant etc. except disintegrating agent.
Wherein, described filler can be selected from mannitol, microcrystalline Cellulose (MCC), lactose, pregelatinized Starch, dextrin, sorbitol, Icing Sugar and glucose etc., preferred mannitol, microcrystalline Cellulose and lactose;
Described pH regulator agent is optional from organic acid, can be selected from citric acid, tartaric acid, succinic acid, lactic acid, glycolic, oxalic acid, gluconic acid, Citric anhydride, succinic anhydrides and winestone anhydride etc., and commonly used is citric acid and tartaric acid;
Described binding agent can be selected from PVP (polyvinylpyrrolidone) and starch, and consumption is an appropriate amount, and forming " agglomerating, promptly the loosing of touching of alunite " state with soft material is criterion;
Described sweeting agent can be selected from aspartame, aspartame, acesulfame potassium, saccharin sodium and Neohesperidin Dihydrochalcone Herba Menthae etc.;
Described coloring agent can be selected from lemon yellow and ferrum oxide etc.;
Described aromatic can be selected from Herba Menthae, Fructus Citri Limoniae essence, Herba Menthae essence and Fructus Citri tangerinae essence etc.;
Described lubricant can be selected from magnesium stearate, Pulvis Talci and Stepanol MG etc.
Preferable, by the tablet total weight amount, the content of described filler is 45～70%;
The content of described pH regulator agent is 0～3%;
The content of described binding agent is 0.5～3%;
The content of described sweeting agent is 0～5%;
The content of described coloring agent is 0～3%;
The content of described aromatic is 0～3%;
The content of described lubricant is 0.5～3%.
Better, described Spaston orally disintegrating tablets is by the tablet total weight amount, can contain following component: phloroglucinol 15～25%, filler 55～70%, disintegrating agent 7.5～11.5%, sweeting agent 1.5～3.5%, aromatic 1～2%, coloring agent 1～1.5%, pH regulator agent 1～2%, binding agent 0.8～1.5%, lubricant 0.8～1.5%.
The present invention also provides a kind of preparation method of described Spaston orally disintegrating tablets, and it can adopt existing conventional powder wet granule compression tablet method, can comprise following steps:
A) phloroglucinol and various excipient are pulverized;
B) take by weighing described each material and mix homogeneously except that binding agent and lubricant, add binding agent then and make soft material, and then make wet granular;
C) behind the described wet grain drying, add lubricant, compacting in flakes behind the mixing.
Preferable, after pulverizing, each material described in the step a) can cross 80 eye mesh screens.
Soft material described in the step b) can be crushed to wet granular by 20 mesh sieves.
Behind the wet grain drying described in the step c), add lubricant, available tablet machine compacting in flakes.
Major advantage of the present invention is:
1) adopt powder wet granule compression tablet method, simple to process conditions and equipment requirements, can adopt domestic existing manufacturing technique, production cost is lower;
2) finished product hardness higher (usually 10-20N) is difficult for crisp brokenly, can tolerate the various processing under the routine operation condition and its character is not produced bigger influence, also need not pass through extra package, the outward appearance integrity in the time of just can keeping storing and transporting.
3) disintegrate effect is better, reaches the disintegrate requirement of oral cavity disintegration tablet, and the external test disintegration time can be controlled in 30 seconds, mostly less than 10 seconds, and can be than the superior less than 5 seconds.
4) taste good, no grains of sand sense and bad mouthful/smell flavor.
5) contain the pH regulator agent in the oral cavity disintegration tablet of the present invention, make it behind intraoral disintegration, form weakly acidic condition, be beneficial to medicine and see through the mucosa absorption, improve bioavailability.
The specific embodiment
Further specify the present invention with embodiment below, the condition that other not concrete experiment conditions that indicate are advised according to routine or manufacturer, but the present invention is not so limited.Remove explanation in addition, otherwise % is weight percentage.
Embodiment 1
According to the form below takes by weighing each component, progressively increases method with phloroglucinol and each the adjuvant mix homogeneously except that binding agent and lubricant by equivalent.The mixture of gained is crossed 40 mesh sieves twice, and the gained material is placed appropriate containers.In described container, add the PVP aqueous solution of binding agent 5% (g/100ml), make soft material.Described soft material is crushed to wet granular by 20 mesh sieves.Described wet granular is placed in the dried enamel tray, and puts into the air blast thermostatic drying chamber together, 50 ℃ of dryings 2 hours.The weight of weighing dried particles adds lubricant, with the tablet machine compacting in flakes, obtains containing the oral cavity disintegration tablet of phloroglucinol behind the mixing.
Measure the hardness of slice, thin piece with hardness tester, and measure granularity situation, disintegration time and the dissolution of prepared oral cavity disintegration tablet, the results are shown in following table according to following method.
The granularity inspection technique:
1 of oral cavity disintegration tablet is placed the 2ml distilled water, should disintegrate in 1 minute, whether the granule after the disintegrate is observed all by 30 eye mesh screens with the suitable quantity of water flushing.
Slaking test:
The mensuration of disintegration time is carried out according to two appendix XA of Pharmacopoeia of People's Republic of China version in 2005 method disintegration.Sieve aperture internal diameter 2mm adds baffle plate, comes and goes frequency per minute 30-35 time.
Dissolution test:
Carry out dissolution test according to two appendix X of Pharmacopoeia of the People's Republic of China version in 2005 C dissolution method.Oral cavity disintegration tablet is put into 900 ml distilled waters under constant temperature and stable the stirring, in the time of the 15th minute, get 5 milliliters of samples.With 0.45 micron filtering with microporous membrane sample, measure stripping medicament contg with the HPLC method then, calculate stripping percent according to total dose again.Stir speed (S.S.) is 50 rev/mins, and thermostat temperature is 37 ± 0.5 ℃.
The component and the measurement result of Spaston orally disintegrating tablets are as follows.
| Function | Component | Form (mg) | ％ |
| The active component filler | The phloroglucinol microcrystalline Cellulose | 40 80 | 19.6 39.2 |
| Filler disintegrating agent binding agent lubricant | Lactose CMS-Na PVP magnesium stearate | 60 20 2 2 | 29.4 9.8 1.0 1.0 |
| Total amount | 204 | 100 | |
| Hardness (N) granularity situation disintegration time (second) dissolution (%) | 13.6 all by 8.2 ± 0.52 94% | ||
Embodiment 2
Preparation method is with embodiment 1, and binding agent is mixed with 10% (g/100ml) aqueous solution and uses, and the component and the measurement result of Spaston orally disintegrating tablets are as follows.
| Function | Component | Form (mg) | ％ |
| Active component filler filler disintegrating agent sweeting agent aromatic coloring agent pH regulator agent binding agent lubricant | Phloroglucinol microcrystalline Cellulose mannitol L-HPC saccharin sodium Herba Menthae essence iron oxide alcohol stone acid-starch Pulvis Talci | 40 20 80 20 5 3 2 3 2 2 | 22.6 11.3 45.2 11.3 2.9 1.7 1.1 1.7 1.1 1.1 |
| Total amount | 177 | 100 | |
| Hardness (N) granularity situation disintegration time (second) dissolution (%) | 15.3 it is basic all by 5.7 ± 0.82 96% |
Embodiment 3
Preparation method is with embodiment 1, and the component and the measurement result of Spaston orally disintegrating tablets are as follows.
| Function | Component | Form (mg) | ％ |
| Active component filler filler disintegrating agent sweeting agent aromatic coloring agent pH regulator agent binding agent lubricant | Phloroglucinol microcrystalline Cellulose mannitol CMS-Na saccharin sodium Herba Menthae essence iron oxide alcohol stone acid PVP Pulvis Talci | 40 20 60 5 5 3 2 3 2 2 | 28.2 14.1 42.3 3.5 3.5 2.1 1.4 2.1 1.4 1.4 |
| Total amount | 177 | 100 | |
| Hardness (N) granularity situation disintegration time (second) dissolution (%) | 14.7 it is basic all by 26.7 ± 16.81 96% | ||
Embodiment 4
Preparation method is with embodiment 1, and the component and the measurement result of Spaston orally disintegrating tablets are as follows.
| Function | Component | Form (mg) | ％ |
| Active component filler filler disintegrating agent sweeting agent aromatic coloring agent pH regulator agent binding agent lubricant | Phloroglucinol microcrystalline Cellulose mannitol CMS-Na saccharin sodium Herba Menthae essence iron oxide alcohol stone acid PVP Pulvis Talci | 40 20 60 40 5 3 2 3 2 2 | 22.6 11.3 33.9 22.6 2.9 1.7 1.1 1.7 1.1 1.1 |
| Total amount | 177 | 100 | |
| Hardness (N) granularity situation disintegration time (second) dissolution (%) | 17.2 it is basic all by 8.8 ± 2.04 95% | ||
Embodiment 5
Preparation method is with embodiment 1, and the component and the measurement result of Spaston orally disintegrating tablets are as follows.
| Function | Component | Form (mg) | ％ |
| Active component filler filler disintegrating agent | Phloroglucinol microcrystalline Cellulose mannitol CMS-Na | 40 60 120 20 | 15.6 23.3 46.6 7.8 |
| Sweeting agent aromatic coloring agent pH regulator agent binding agent lubricant | Saccharin sodium Herba Menthae essence iron oxide alcohol stone acid PVP Pulvis Talci | 5 3 2 3 2 2 | 1.9 1.2 0.8 1.2 0.8 0.8 |
| Total amount | 257 | 100 | |
| Hardness (N) granularity situation disintegration time (second) dissolution (%) | 13.9 all by 5.7 ± 1.37 96% | ||
Embodiment 6
Preparation method is with embodiment 1, and the component and the measurement result of Spaston orally disintegrating tablets are as follows.
| Function | Component | Form (mg) | ％ |
| Active component filler filler disintegrating agent sweeting agent aromatic coloring agent pH regulator agent binding agent lubricant | Phloroglucinol microcrystalline Cellulose mannitol CMS-Na saccharin sodium Fructus Citri tangerinae essence ferrum oxide winestone acid PVP Pulvis Talci | 40 20 80 20 5 3 2 3 2 2 | 22.6 11.3 45.2 11.3 2.9 1.7 1.1 1.7 1.1 1.1 |
| Total amount | 177 | 100 | |
| Hardness (N) granularity situation disintegration time (second) dissolution (%) | 15.1 all by 7.3 ± 0.52 95% |
Embodiment 7
Preparation method is with embodiment 1, and the component and the measurement result of Spaston orally disintegrating tablets are as follows.
| Function | Component | Form (mg) | ％ |
| Active component filler filler disintegrating agent sweeting agent aromatic coloring agent pH regulator agent binding agent lubricant | Phloroglucinol MCC mannitol PVPP A Siba sweet citron essence lemon yellow citric acid PVP magnesium stearate | 40 80 60 20 5 3 2 3 2 2 | 18.4 37.0 27.6 9.2 2.3 1.4 0.9 1.4 0.9 0.9 |
| Total amount | Total amount (mg) | 217 | 100 |
| Hardness (N) granularity situation disintegration time (second) dissolution (%) | 16.7 all by 4.7 ± 1.13 94% | ||
Embodiment 8
Preparation method is with embodiment 1, and the component and the measurement result of Spaston orally disintegrating tablets are as follows.
| Function | Component | Form (mg) | ％ |
| Active component filler filler disintegrating agent sweeting agent aromatic coloring agent pH regulator agent binding agent lubricant | Phloroglucinol microcrystalline Cellulose mannitol CMS-Na A Siba sweet citron essence lemon yellow citric acid PVP magnesium stearate | 40 80 80 20 5 3 2 3 2 2 | 16.9 33.8 33.8 8.4 2.1 1.3 0.8 1.3 0.8 0.8 |
| Total amount | 237 | 100 | |
| Hardness (N) granularity situation disintegration time (second) dissolution (%) | 17.2 all by 5.6 ± 0.97 96% | ||
Claims (4)
1. a Spaston orally disintegrating tablets is characterized in that,
Contain following component by the tablet total weight amount: phloroglucinol 15～25%, filler 55～70%, disintegrating agent 7.5～11.5%, sweeting agent 1.5～3.5%, aromatic 1～2%, coloring agent 1～1.5%, pH regulator agent 1～2%, binding agent 0.8～1.5%, lubricant 0.8～1.5%;
Described disintegrating agent is selected from polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium and low-substituted hydroxypropyl cellulose;
Described filler is selected from mannitol, microcrystalline Cellulose and lactose;
Described binding agent is selected from PVP and starch;
Described lubricant is selected from magnesium stearate and Pulvis Talci.
2. Spaston orally disintegrating tablets according to claim 1 is characterized in that,
Described pH regulator agent is selected from citric acid and tartaric acid;
Described sweeting agent is selected from aspartame and saccharin sodium;
Described coloring agent is selected from lemon yellow and ferrum oxide;
Described aromatic is selected from Fructus Citri Limoniae essence, Herba Menthae essence and Fructus Citri tangerinae essence.
3. the preparation method according to each described Spaston orally disintegrating tablets of claim 1～2 is characterized in that, comprises following steps:
A) phloroglucinol and various excipient are pulverized;
B) each material mixing that will be except that binding agent and lubricant is even, adds binding agent then and makes soft material, and then make wet granular;
C) behind the described wet grain drying, add lubricant, compacting in flakes behind the mixing.
4. the preparation method of Spaston orally disintegrating tablets according to claim 3 is characterized in that,
Each material described in the step a) is pulverized the back and is crossed 80 eye mesh screens,
Soft material described in the step b) is crushed to wet granular by 20 mesh sieves,
In blocks in the step c) with the tablet machine compacting.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2007101725183A CN101461788B (en) | 2007-12-18 | 2007-12-18 | Phloroglucine orally disintegrating tablet and preparation method thereof |
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| CN2007101725183A CN101461788B (en) | 2007-12-18 | 2007-12-18 | Phloroglucine orally disintegrating tablet and preparation method thereof |
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| CN101461788A CN101461788A (en) | 2009-06-24 |
| CN101461788B true CN101461788B (en) | 2011-08-17 |
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101874792B (en) * | 2009-12-25 | 2012-04-18 | 雷绍青 | Phloroglucinol oral disintegrating tablet and preparation method thereof |
| CN101856324B (en) * | 2010-06-10 | 2011-09-28 | 南京生命能科技开发有限公司 | Method for preparing phloroglucinol injection |
| CN103120652B (en) * | 2012-12-30 | 2014-03-26 | 湖南湘药制药有限公司 | Phloroglucin orally disintegrating tablet and preparation method thereof |
| CN103054927B (en) * | 2013-01-31 | 2014-12-31 | 成都中医药大学 | Sore-throat-relieving buccal tablet and preparation method thereof |
| CN103622936B (en) * | 2013-12-09 | 2016-04-13 | 中国人民解放军广州军区武汉总医院 | A kind of phloroglucinol Film coated tablets with anti-oxidation function and preparation method thereof |
| CN103735520B (en) * | 2014-01-20 | 2016-09-21 | 中国人民解放军广州军区武汉总医院 | A kind of phloroglucinol granule and preparation method thereof |
| CN111419809A (en) * | 2020-04-26 | 2020-07-17 | 药源生物科技（启东）有限公司 | Sublingual tablet pharmaceutical composition for acute spastic pain and preparation method thereof |
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| EP0643962A1 (en) * | 1993-09-14 | 1995-03-22 | Laboratoire L. Lafon | New galenic dosage form for phloroglucinol |
| CN101209249A (en) * | 2006-12-26 | 2008-07-02 | 海南高升医药科技开发有限公司 | Spaston orally disintegrating tablets and preparation thereof |
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2007
- 2007-12-18 CN CN2007101725183A patent/CN101461788B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0643962A1 (en) * | 1993-09-14 | 1995-03-22 | Laboratoire L. Lafon | New galenic dosage form for phloroglucinol |
| CN101209249A (en) * | 2006-12-26 | 2008-07-02 | 海南高升医药科技开发有限公司 | Spaston orally disintegrating tablets and preparation thereof |
Non-Patent Citations (2)
| Title |
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| 符旭东等.间苯三酚口腔崩解片的处方和工艺研究.《科学技术与工程》.2007,第7卷(第20期),5345-5347. * |
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