CN105726505A - Phloroglucinol oral tablet - Google Patents
Phloroglucinol oral tablet Download PDFInfo
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- CN105726505A CN105726505A CN201610244856.2A CN201610244856A CN105726505A CN 105726505 A CN105726505 A CN 105726505A CN 201610244856 A CN201610244856 A CN 201610244856A CN 105726505 A CN105726505 A CN 105726505A
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- phloroglucinol
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- tablet
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/05—Phenols
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to a phloroglucinol oral tablet which is prepared from active component phloroglucinol, polyethylene glycol 1000, glyceryl monostearate, lactose, hydroxypropyl methylcellulose, cross-linking polyvinylpyrrolidone, microcrystalline cellulose and magnesium stearate. By means of the reasonable raw material and auxiliary material ratio and the preparation technology, the prepared tablet is high in stability, dissolution rate and bioavailability.
Description
Technical field
The present invention relates to oral phloroglucinol tablet and preparation method thereof, belong to pharmaceutical technology field.
Background technology
Phloroglucinol (Phloroglucinol) is the novel spasmolytic abroad recently developing and being applied to clinic, is widely used to the disease that treatment is caused by smooth muscle spasm in Europe.China is in the phloroglucinol injection (trade name: Phloroglucinol in the big pharmaceutical factory of calendar year 2001 approval of import France Lafon) and oral freeze-dried slices listing, there is domestic phloroglucinol injection to go through to list later successively.Phloroglucinol belongs to a kind of novel relieving spasm to stop pain medicine, and it can directly act on gastrointestinal tract and the smooth muscle of urogenital tract spasm, is parent's flesh, non-atropine, non-Semen Papaveris bases smooth muscle spasmolysis medicine.Compared with other smooth muscle spasmolysis medicine, it is characterized in not having cholinolytic effect, while releasing smooth muscle spasm, a series of cholinolytic sample side effect will not be produced, the symptoms such as hypotension, increased heart rate, arrhythmia will not be caused, cardiovascular function is not affected.Its another pharmacological property is to act only on the smooth muscle of spasm, and the impact of normal smooth muscle is minimum.Phloroglucinol can directly act on gastrointestinal tract and urogenital tract smooth muscle, treats smooth muscle spasmodic disease.Pain caused by smooth muscle spasm is very common clinically, the acute painful muscle spasms that causes such as digestive system and biliary tract function of patients obstacle, gynecological's spasmic pain, acute spastic urethra, bladder, renal colic etc..
Cause owing to phloroglucinol contains three phenolic hydroxyl groups its easily oxidized, to photaesthesia and due in water poor solubility and cause that its prolonged cold (less than 10 DEG C) is deposited can crystallization.The less stable of the phloroglucinol in injection dosage form simultaneously, transport simultaneously and storage inconvenience.
Document 1, Fu Xudong, Deng (prescription and the technique of Spaston orally disintegrating tablets are preferred, " science and technology and engineering ", 7th volume the 20th phase in 2007,5345-5347 page) that phloroglucinol tablet has carried out technique is preferred, but prepare gained tablet by this technique and fail the low problem of effectively solution phloroglucinol dissolution and bioavailability；Document 2, Zhao Lei, Deng (the preparation technology screening of phloroglucinol phosphatide complexes and physicochemical property research thereof, " China Dispensary ", 20th volume the 19th phase in 2009,1488-1490 page) phloroglucinol phosphatide complexes carried out preparation research, but only rest on the research on combination process, do not prepare into Clinical Dosage Form.
Summary of the invention
The present invention is aiming at the problems referred to above and provides oral phloroglucinol tablet and preparation method thereof, self-emulsifying systems is prepared with phloroglucinol, cetomacrogol 1000, glyceryl monostearate, then preparing tablet with all the other adjuvants through rational proportion, gained phloroglucinol tablet stability, disintegrative, dissolution and bioavailability are superior in prior art phloroglucinol peroral dosage form.
Phloroglucinol tablet provided by the invention, is made up of active component phloroglucinol, cetomacrogol 1000, glyceryl monostearate, lactose, hypromellose, crospolyvinylpyrrolidone, microcrystalline Cellulose, magnesium stearate.
One, formula and preparation technology
The tablet stable for the preparation present invention, dissolution high, trap is high, invents the kind to adjuvant and has done further selection (see table 6-7), using ratio of adjuvant shown in table 1 (embodiment 1) as the basic prescription of the application.
Table 1 tablet supplementary material proportioning (100g phloroglucinol makes 1000):
| Cetomacrogol 1000 | 100g |
| Lactose | 180g |
| Glyceryl monostearate | 120g |
| Hypromellose (inside adds) | 19g |
| Crospolyvinylpyrrolidone | 50g |
| Hypromellose (additional) | 19g |
| Microcrystalline Cellulose | 15g |
| 50-70% ethanol | In right amount |
| Magnesium stearate | 3g |
Take table 1 consumption, prepare according to following technique
(1), taking polyethylene glycol 1000, glyceryl monostearate, 40 DEG C-70 DEG C heating to molten condition, then while stirring add phloroglucinol obtain reserve liquid；
(2), take step (1) reserve liquid, add micropowder silica gel under 40 DEG C-70 DEG C stirrings, mix homogeneously；
(3), again by microcrystalline Cellulose, lactose, 1/2 hypromellose, crospolyvinylpyrrolidone mix homogeneously in mixer, spreading in dish, put and be dried into powder in baking oven, baking temperature is: 60-85 DEG C, drying time is: 4-5 hour, standby；Mixer rotating speed: 10～15r/min；
(4), by the powder of step 4 gained adding percent by volume is the ethanol of 50～70%, and 60 DEG C～80 DEG C dry, and it is added in granulator wet granulation; spreading in dish, put in baking oven and be dried, baking temperature is: 50-60 DEG C; drying time is: 4-5 hour, and granulate is standby；
(5), above-mentioned granule adds the hypromellose of magnesium stearate, residue 1/2, be sufficiently mixed uniformly, join tabletting in tablet machine hopper, to obtain final product.
Two, screening experiment
(1) principal agent and adjuvant compatibility test:
With reference to " chemicals medicine investigative technique guideline ", adjuvant in this product proportioning and raw material have been carried out compatibility test, in order to more clearly discriminate whether the impact being adjuvant to medicine, will place under crude drug equal conditions, there to be related substance to investigate 10 days at high temperature 40 DEG C for index.The relatively larger microcrystalline Cellulose of moisture, lactose, hypromellose be have also been made compatibility test at 70 DEG C after dry 3～4 hours.Investigate result in Table 2:
Table 2 supplementary material compatibility test result
Above result of the test is not it can be seen that the related substance that has of sample significantly changes, and in proportioning, adjuvant used is all better with the compatibility of principal agent；But the adjuvant that moisture is big can cause the increase of impurity A, analyzing and be because under the high temperature conditions, raw material is created impact by the moisture in adjuvant, therefore to reduce adjuvant and the moisture of final tablet in process of production as far as possible.
(2) dissolution contrast test
With document 1 tablet for reference preparation, measure the stripping curve of test agent in this product three batches (preparing according to the proportioning of said ratio technique and technique) the similarity of the outer dissolved corrosion of comparing bulk.Method, with reference to second the annex IA tablet requirement of " Chinese Pharmacopoeia " version in 2010, measures the accumulation dissolution of stipulated time point respectively, adopts the f2 factor to evaluate the similarity of In Vitro Dissolution behavior.The middle test agent of result this product and reference preparation are in 30min, accumulation dissolution reaches 97.43%, 96.54%, 96.19%, 90.37% respectively, all meets the limit of regulation, and RSD performance is good, doing dissolution contrast with document 1 tablet, concrete test situation is shown in table 3 below:
Table 3 dissolution comparative test result
From upper table 3, the dissolution of Tablets is substantially better than document 1 tablet.
(3), stability contrast test
Based on table 1 supplementary material proportioning, table 4 stability experiment tablet of the present invention is prepared according to preparation technology of the present invention, preparing tablet with document 1 supplementary material proportioning and technique and obtain table 5 stability experiment tablet, both stability experiment results are such as shown in table 4-5:
Table 4 stability experiment result of the present invention
Table 5 document 1 tablet stability result of the test
From above-mentioned table 4-5 result it can be seen that the having good stability of Tablets, and it is better than the tablet disclosed in document 1.
The present invention further study show that, when lactose, glyceryl monostearate, Polyethylene Glycol, microcrystalline Cellulose and magnesium stearate take specific proportioning, can obtain beyond thought technique effect, and the test that the present invention does is such as shown in following table 6-7:
Table 6100g phloroglucinol supplementary material proportioning (makes 1000, unit: g)
| Each ingredient names | Embodiment 1 | Embodiment 2 | Embodiment 3 |
| Cetomacrogol 1000 | 100 | 80 | 90 |
| Lactose | 180 | 150 | 120 |
| Glyceryl monostearate | 120 | 150 | 180 |
| Hypromellose (inside adds) | 19 | 19 | 19 |
| 50-70% ethanol | In right amount | In right amount | In right amount |
| Hydroxypropyl fiber rope (additional) | 19 | 19 | 19 |
| Microcrystalline Cellulose | 15 | 12 | 10 |
| Crospolyvinylpyrrolidone | 50 | 50 | 50 |
| Magnesium stearate | 3 | 6 | 8 |
Table 7 tablet testing result
By result of the test it can be seen that embodiment 1 stripping curve is significantly better than other proportionings, comparing enforcement 2 and implement 3, embodiment 3 achieves beyond thought technique effect, it is thus determined that embodiment 1 is the basic scheme of the present invention.
(3) slaking test
Tablet the invention process 1 technique prepared and the experiment of document 1 disintegration of tablet performance comparison, be shown in data below:
| The present invention | Document 1 | |
| Disintegration (min) | 9 | 18 |
| Friability (%) | 0.33 | 0.69 |
| Dissolution (%) | 99.06 | 91.22 |
Visible, its disintegrating property of the tablet that instant component and technique prepare is far superior to commercially available prod, achieves unexpected disintegrate effect.
Be experiments show that by above-mentioned, the present invention limits more specifically by the preparation method of the selection of each active component and adjuvant and consumption and preparation has been made and optimizes, make prepared pharmaceutical preparation have more preferably combination property, significantly improve release and the stability of active constituents of medicine.
Detailed description of the invention
Give an actual example description below to the principle of the invention and feature, and example is served only for explaining the present invention, is not intended to limit the scope of the present invention.
Embodiment 1
100g phloroglucinol, 100g cetomacrogol 1000,120g glyceryl monostearate, 180g lactose, 38g hypromellose, 50g crospolyvinylpyrrolidone, 15g microcrystalline Cellulose, 3g magnesium stearate.
Weigh supplementary material according to above-mentioned weight, prepare according to following technique
(1), taking polyethylene glycol 1000, glyceryl monostearate, 40 DEG C-70 DEG C heating to molten condition, then while stirring add phloroglucinol obtain reserve liquid；
(2), take step (1) reserve liquid, add micropowder silica gel under 40 DEG C-70 DEG C stirrings, mix homogeneously；
(3), again by microcrystalline Cellulose, lactose, 1/2 hypromellose, crospolyvinylpyrrolidone mix homogeneously in mixer, spreading in dish, put and be dried into powder in baking oven, baking temperature is: 60-85 DEG C, drying time is: 4-5 hour, standby；Mixer rotating speed: 10～15r/min；
(4), by the powder of step 4 gained adding percent by volume is the ethanol of 50～70%, and 60 DEG C～80 DEG C dry, and it is added in granulator wet granulation; spreading in dish, put in baking oven and be dried, baking temperature is: 50-60 DEG C; drying time is: 4-5 hour, and granulate is standby；
(5), above-mentioned granule adds the hypromellose of magnesium stearate, residue 1/2, is sufficiently mixed uniformly, join compacting in tablet machine hopper standby become 1000, to obtain final product.
Embodiment 2
100g phloroglucinol, 80g cetomacrogol 1000,150g glyceryl monostearate, 150g lactose, 38g hypromellose, 50g crospolyvinylpyrrolidone, 12g microcrystalline Cellulose, 6g magnesium stearate.
Weigh supplementary material according to above-mentioned weight, prepare according to following technique
(1), taking polyethylene glycol 1000, glyceryl monostearate, 40 DEG C-70 DEG C heating to molten condition, then while stirring add phloroglucinol obtain reserve liquid；
(2), take step (1) reserve liquid, add micropowder silica gel under 40 DEG C-70 DEG C stirrings, mix homogeneously；
(3), again by microcrystalline Cellulose, lactose, 1/2 hypromellose, crospolyvinylpyrrolidone mix homogeneously in mixer, spreading in dish, put and be dried into powder in baking oven, baking temperature is: 60-85 DEG C, drying time is: 4-5 hour, standby；Mixer rotating speed: 10～15r/min；
(4), by the powder of step 4 gained adding percent by volume is the ethanol of 50～70%, and 60 DEG C～80 DEG C dry, and it is added in granulator wet granulation; spreading in dish, put in baking oven and be dried, baking temperature is: 50-60 DEG C; drying time is: 4-5 hour, and granulate is standby；
(5), above-mentioned granule adds the hypromellose of magnesium stearate, residue 1/2, is sufficiently mixed uniformly, join compacting in tablet machine hopper standby become 1000, to obtain final product.
Embodiment 3
100g phloroglucinol, 90g cetomacrogol 1000,180g glyceryl monostearate, 120g lactose, 38g hypromellose, 50g crospolyvinylpyrrolidone, 10g microcrystalline Cellulose, 8g magnesium stearate.
Weigh supplementary material according to above-mentioned weight, prepare according to following technique
(1), taking polyethylene glycol 1000, glyceryl monostearate, 40 DEG C-70 DEG C heating to molten condition, then while stirring add phloroglucinol obtain reserve liquid；
(2), take step (1) reserve liquid, add micropowder silica gel under 40 DEG C-70 DEG C stirrings, mix homogeneously；
(3), again by microcrystalline Cellulose, lactose, 1/2 hypromellose, crospolyvinylpyrrolidone mix homogeneously in mixer, spreading in dish, put and be dried into powder in baking oven, baking temperature is: 60-85 DEG C, drying time is: 4-5 hour, standby；Mixer rotating speed: 10～15r/min；
(4), by the powder of step 4 gained adding percent by volume is the ethanol of 50～70%, and 60 DEG C～80 DEG C dry, and it is added in granulator wet granulation; spreading in dish, put in baking oven and be dried, baking temperature is: 50-60 DEG C; drying time is: 4-5 hour, and granulate is standby；
(5), above-mentioned granule adds the hypromellose of magnesium stearate, residue 1/2, is sufficiently mixed uniformly, join compacting in tablet machine hopper standby become 1000, to obtain final product.
Claims (3)
1. a phloroglucinol oral tablet, it is characterised in that be made up of following raw material: 10 parts of phloroglucinol, 8-10 part cetomacrogol 1000,12-18 part glyceryl monostearate, 12-18 part lactose, 3.8 parts of hypromelloses, 5 parts of crospolyvinylpyrrolidone, 1-1.5 part microcrystalline Cellulose, 0.3-0.8 part magnesium stearate.
2. a kind of phloroglucinol oral tablet as claimed in claim 1, it is characterised in that be made up of following raw material: 10 parts of phloroglucinol, 10 parts of cetomacrogol 1000s, 12 parts of glyceryl monostearates, 18 parts of lactose, 3.8 parts of hypromelloses, 5 parts of crospolyvinylpyrrolidone, 1.5 parts of microcrystalline Cellulose, 0.3 part of magnesium stearate.
3. prepare a method for phloroglucinol oral tablet described in any one of claim 1-2, comprise the following steps that:
(1), taking polyethylene glycol 1000, glyceryl monostearate, 40 DEG C-70 DEG C heating to molten condition, then while stirring add phloroglucinol obtain reserve liquid；
(2), take step (1) reserve liquid, add micropowder silica gel under 40 DEG C-70 DEG C stirrings, mix homogeneously；
(3), again by microcrystalline Cellulose, lactose, 1/2 hypromellose, crospolyvinylpyrrolidone mix homogeneously in mixer, spreading in dish, put and be dried into powder in baking oven, baking temperature is: 60-85 DEG C, drying time is: 4-5 hour, standby；Mixer rotating speed: 10～15r/min；
(4), by the powder of step 4 gained adding percent by volume is the ethanol of 50～70%, and 60 DEG C～80 DEG C dry, and it is added in granulator wet granulation; spreading in dish, put in baking oven and be dried, baking temperature is: 50-60 DEG C; drying time is: 4-5 hour, and granulate is standby；
(5), above-mentioned granule adds the hypromellose of magnesium stearate, residue 1/2, be sufficiently mixed uniformly, join tabletting in tablet machine hopper, to obtain final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610244856.2A CN105726505A (en) | 2016-04-19 | 2016-04-19 | Phloroglucinol oral tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610244856.2A CN105726505A (en) | 2016-04-19 | 2016-04-19 | Phloroglucinol oral tablet |
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| CN105726505A true CN105726505A (en) | 2016-07-06 |
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| CN201610244856.2A Pending CN105726505A (en) | 2016-04-19 | 2016-04-19 | Phloroglucinol oral tablet |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6716884B1 (en) * | 2000-05-19 | 2004-04-06 | Promindus (Actions Promotionnelles Dans L'industrie Et Le Commerce) | Pharmaceutical compositions for oral administration of phloroglucinol and preparation thereof |
| CN101049308A (en) * | 2006-05-08 | 2007-10-10 | 杨喜鸿 | Solid dispersion containing rimonabant and polyethyleneglycol, preparation and medication application |
| 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 |
| WO2011086193A1 (en) * | 2010-01-18 | 2011-07-21 | Cephalon France | Oral lyophilized compositions |
| CN103120652A (en) * | 2012-12-30 | 2013-05-29 | 湖南湘药制药有限公司 | Phloroglucin orally disintegrating tablet and preparation method thereof |
-
2016
- 2016-04-19 CN CN201610244856.2A patent/CN105726505A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6716884B1 (en) * | 2000-05-19 | 2004-04-06 | Promindus (Actions Promotionnelles Dans L'industrie Et Le Commerce) | Pharmaceutical compositions for oral administration of phloroglucinol and preparation thereof |
| CN101049308A (en) * | 2006-05-08 | 2007-10-10 | 杨喜鸿 | Solid dispersion containing rimonabant and polyethyleneglycol, preparation and medication application |
| 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 |
| WO2011086193A1 (en) * | 2010-01-18 | 2011-07-21 | Cephalon France | Oral lyophilized compositions |
| CN103120652A (en) * | 2012-12-30 | 2013-05-29 | 湖南湘药制药有限公司 | Phloroglucin orally disintegrating tablet and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 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》 * |
| 陈咏昕，等: "高效液相色谱法测定间苯三酚口服冻干片的溶出度", 《广东药学院学报》 * |
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