CN104688704B - A kind of pharmaceutical composition containing Troxerutin and preparation method thereof - Google Patents
A kind of pharmaceutical composition containing Troxerutin and preparation method thereof Download PDFInfo
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- CN104688704B CN104688704B CN201510070353.3A CN201510070353A CN104688704B CN 104688704 B CN104688704 B CN 104688704B CN 201510070353 A CN201510070353 A CN 201510070353A CN 104688704 B CN104688704 B CN 104688704B
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Abstract
The invention discloses a kind of pharmaceutical composition containing Troxerutin, including plain piece and coatings, wherein plain piece contains Troxerutin as active component, includes filler, adhesive, wetting agent；Coatings contain sweetener, extender, excipient, can also include surfactant, colouring agent and/or polishing agent；Pharmaceutical composition of the present invention can not only fater disintegration, it is often more important that ensure that effective dissolution of medicine, dissolution rate reaches the 80% of labelled amount in 45 minutes, it is ensured that medicine can be utilized sufficiently in vivo.Meanwhile the content of unknown component is also tighter controlled, single largest component≤10.0%, other single component≤5.0%, each component and≤20.0%, the side effect that unknown component is brought to patient is reduced, so as to improve drug quality.Tested by study on the stability, outward appearance, loss on drying, dissolution rate, content and relevant material etc. are showed no significant change, and it is stable in normal circumstances to show pharmaceutical composition of the present invention.
Description
Invention field
It is more particularly to a kind of to contain the pharmaceutical composition of Troxerutin and its preparation side the present invention relates to medicinal chemistry art
Method.
Background technology
Troxerutin (Troxerutin) is mixture of the rutin through semi-synthetic chromocor compound made of hydroxyethylation, is fitted
For the hemiplegia caused by cerebral thrombosis and cerebral embolism, aphasia and premyocardial infarction syndrome, artery sclerosis, centrality view
Film inflammation, thrombophlebitis, varication, oedema etc. caused by vasopermeability rise.
Existing literature discloses Troxerutin sustained release preparation, effervescent tablet and polypharmacy etc., the Qu Kelu listed
Fourth preparation has tablet, parenteral solution, particle, capsule etc., but the QUKELUDING PIAN dissolution rate of existing listing is low, it is difficult to controls medicine
Validity, limit the clinical practice of Troxerutin, meanwhile, unknown impuritie and outward appearance also need further to control and change
It is kind.
The content of the invention
It is an object of the invention to provide a kind of pharmaceutical composition containing Troxerutin and preparation method thereof, medicine of the present invention
Compositions can not only effective dissolution, and there is preferable stability and outward appearance.
The purpose of the present invention is achieved by the following technical solution：
A kind of pharmaceutical composition containing Troxerutin, including plain piece and coatings, wherein plain piece contain Troxerutin work
For active component, coatings contain sweetener, extender, excipient；
Active component Troxerutin in wherein described plain piece is prepared according to art methods；
Wherein described coatings can also include surfactant；
Wherein described coatings can also further include colouring agent and/or polishing agent；
Sweetener includes but is not limited to Steviosin, lactose, starch sugar, sucrose, xylitol, malt wherein described in coatings
One or more in sugar and Aspartame, preferably sucrose；
Extender includes but is not limited to talcum powder, starch, calcium carbonate, magnesium carbonate, acrylic acid tree wherein described in coatings
One or more in fat, preferably talcum powder；
Excipient includes but is not limited to sodium carboxymethylcellulose, gelatin, zein, Arab wherein described in coatings
One or more in glue, shellac, CAP, peach gum, preferably Arabic gum；
Wherein described in coatings surfactant include but is not limited to lauryl sodium sulfate, Stepanol MG,
Neopelex, sodium hexadecyl sulfate, Tween 80, sapn, glycerin monostearate, preferably dodecyl sulphate
Sodium；
Wherein Troxerutin accounts for the 5%-70% of described pharmaceutical composition, preferably 15%-60% by weight in plain piece；
Wherein sweetener accounts for the 5%-60% of described pharmaceutical composition, preferably 10%-50% by weight in coatings；
Wherein extender accounts for the 5%-55% of described pharmaceutical composition, preferably 10%-45% by weight in coatings；
Wherein excipient accounts for the 0.001%-0.1% of described pharmaceutical composition by weight in coatings, preferably
0.005%-0.08%；
Comprising filler, adhesive, wetting agent in wherein described plain piece, further also comprising glidant, lubricant；
It is fine that the filler includes but is not limited to hydroxypropul starch, sodium carboxymethyl starch, starch, pregelatinized starch, crystallite
Tie up the one or more in element, Icing Sugar, lactose, calcium carbonate, calcium sulfate, light magnesium oxide, preferably starch；
Described adhesive includes but is not limited to beta-schardinger dextrin, dextrin, hydroxypropyl-β-cyclodextrin, hydroxypropyl methylcellulose, poly- dimension
One or more in ketone, syrup, starch slurry, gelatine size, corn starch liquid, mucialga of arabic gummy, cellulose, preferably dextrin；
The wetting agent is ethanol, wherein the preferred 50%-90% ethanol of ethanol, more preferably 60%-70% ethanol；
The glidant in vaseline, silica, hydrogenated vegetable oil, polyethylene glycol, magnesium laurylsulfate one
Kind is several, preferably silica；
The lubricant is selected from magnesium laurylsulfate, magnesium stearate, calcium stearate, zinc stearate, superfine silica gel powder, benzoic acid
One or more in sodium, atoleine, preferably magnesium stearate；
Wherein filler accounts for the 0.5%-20% of described pharmaceutical composition, preferably 1%-10% by weight in plain piece；
Wherein adhesive accounts for the 0.5%-15% of described pharmaceutical composition, preferably 0.5%-8% by weight in plain piece；
Wherein wetting agent accounts for the 3%-40% of described pharmaceutical composition, preferably 5%-20% by weight in plain piece；
Pharmaceutical composition of the present invention can be prepared according to any conventional method, including but not limited to following methods：
By the Troxerutin of recipe quantity, filler, adhesive, wetting agent, pelletized, dried, whole grain using wet-mixing；Add
Enter glidant and/or mix lubricant, tabletting, be coated, dry, produce.
The dry-mixed time of wherein described wet-mixing granulation is 1-4 minutes, preferably 2 minutes；The wet mixing time is 0.5-5 points
Clock, preferably 1 minute；
EAT when wherein described dry is 50 DEG C -90 DEG C, preferably 70 DEG C；Temperature of charge is 40 DEG C -80 DEG C, excellent
Select 50 DEG C；During every 2-10 minutes tremble bag once, preferably 5 minutes；Drying time is 10-40 minutes, and preferably 20-30 divides
Clock；
Wherein described addition glidant and/or mix lubricant, incorporation time are 5-30 minutes, preferably 15 minutes.
Pharmaceutical composition of the present invention can not only fater disintegration, it is often more important that effective dissolution of medicine is ensure that, 45
Dissolution rate reaches the 80% of labelled amount in minute, it is ensured that medicine can be utilized sufficiently in vivo.Meanwhile also tighter control
The content of unknown component, single largest component≤10.0%, other single component≤5.0%, each component and≤20.0%, reduce
The side effect that unknown component is brought to patient, so as to improving drug quality.Tested by study on the stability, outward appearance, drying
Weightlessness, dissolution rate, content and relevant material etc. are showed no significant change, show that pharmaceutical composition of the present invention is in normal circumstances
Stable.
Following experimental examples and embodiment are used to further prove but be not limited to the present invention.
The prescription screening of experimental example 1.
First, plain piece prescription screening
The foundation one of screening prescription is the complexity of granulation, the mobility of particle；Second, tablet appearance, disintegration time limited,
Hardness, friability and dissolution in vitro.Prescription screening experiment is carried out by following several method respectively：
The plain piece prescription screening of table 1 is tested
Every detection has been done to 6 kinds of prescriptions in table 1, it is as a result as follows：
The prescription screening of table 2 experiment grain forming is investigated
As a result：From the data in table 2, it can be seen that particle prepared by above-mentioned 7 kinds of prescriptions, prescription 2, prescription 5 and prescription 7 are glued due to auxiliary material
Sex chromosome mosaicism, cause to be not easy granulating, and tabletting is not smooth, yield is relatively low, therefore eliminate；The particle yield of prescription 3 is low, also eliminates；Prescription
1st, prescription 4 and 6 every result of prescription meet the requirements, but prescription 4 is better than prescription 1 and prescription 6.
The prescription screening of table 3 experiment tablet moulding process is investigated
As a result：From the data in table 3, it can be seen that plain piece, dissolution rate, content and other components etc. prepared by 3 kinds of prescriptions conforms to
Ask, but 6 weights of prescription are unstable, it is undesirable.
Conclusion：Grain forming Journal of Sex Research result shows that 3 kinds of prescriptions are qualified, but is assessed from particle yield and mobility, place
Side 4 is better than prescription 1 and prescription 6；Tablet compactibility result of study shows that prescription 6 is not adopted because piece weight is unstable.It is comprehensive again
Close and consider indices and the costs such as grain forming, particle yield, content, plain piece hardness, it is final to determine that prescription 4 is the best of it
Side.
2nd, it is coated prescription screening
In the case where supplementary material prescription determines, coating prescription is screened, concrete outcome is seen description below.
Table 4 is coated prescription screening experiment
The prescription screening of table 5 tests coating tablet technological parameter
As a result：Understand that prescription 4-1,4-2,4-6,4-7 dissolution rate is unqualified by data above, and prescription 4-2,4-3,4-6
It is unilateral to have piebald, not finishing, so discarding；Prescription 4-4, prescription 4-5 indices are qualified.
3rd, QUKELUDING PIAN study on the stability
Afterwards to technology preparation, the qualified QUKELUDING PIAN of coating prescription indices has done stability experiment, one
Fixed condition (40 ± 2 DEG C of temperature；Temperature 75 ± 5%) under closed preservation, the results are shown in Table 6, table 7.
The Troxerutin tablet recipe 4-4 stability experiment parameters of table 6
The Troxerutin tablet recipe 4-5 stability experiment parameters of table 7
As a result show：Prescription 4-4 dissolution rates are unqualified after being placed 30 days in closed environment；Prescription 4-5 its outward appearance, drying
Weightlessness, dissolution rate, content and relevant material etc. are showed no significant change, show that prescription 4-5 products are relatively more steady in home
It is fixed.
4th, QUKELUDING PIAN dissolution rate is investigated
The QUKELUDING PIAN for taking prescription 4-5 to produce has done dissolution rate and has investigated experiment, and concrete outcome is shown in Table 8.
The QUKELUDING PIAN dissolution rate of table 8 is investigated
As a result：Understood according to data above, dissolution rate can reach more than the 80% of labelled amount during 45min, and RSD values are less than
5.0%, show there is preferable dissolution rate by the prescription 4-5 QUKELUDING PIANs produced.
Experimental example 2：Technological parameter is investigated
1 dry-mixed time was investigated
Be respectively 1 from the dry-mixed time, 2,4min, investigate the dry-mixed time to system by detecting Troxerutin content in particle
The influence of grain mouldability.Experimental result is shown in Table 9.
The 9 dry-mixed time of table is investigated
Conclusion：It is little to understand that the dry-mixed time influences in 1-4min on pelletizing forming by result above.
2 wet mixing times were investigated
Be respectively 0.5 from the wet mixing time, 1,3min, investigate influence of the wet mixing time to pelletizing forming.Experimental result
It is shown in Table 10.
The wet mixing time of table 10 is investigated
Conclusion：Understand that the wet mixing time influences little, optimal selection in 0.5-3min on pelletizing forming by result above
1-2min。
3 Fluidbedgranulatingdrier temperature of charge are investigated
It is respectively 40,50,60,70 DEG C from temperature of charge, investigates influence of the temperature of charge to pelletizing forming.Experiment knot
Fruit is shown in Table 11.
The temperature of charge of table 11 is investigated
Conclusion：From data above, temperature of charge is little to granule content and other components influences in 40-70 DEG C.
It is optimal to choose 50-60 DEG C with reference to production efficiency.
4 drying times are investigated
Be respectively 10 from drying time, 20,30,40min, investigate influence of the drying time to pelletizing forming.Experiment
It the results are shown in Table 12.
The investigation of the drying time of table 12
Conclusion：From data above, drying time is in all easy tablettings of 10-40min.Extend with drying time, particle is done
Dry weightlessness tapers into, optimal to choose 20-30 DEG C in conjunction with the complexity of tabletting.
5 mixing times are investigated
The incorporation time of whole good particle and additional auxiliary material, influences the content uniformity of total mixed particle, therefore selects mixing
Time is respectively 5,15,20min, investigate mixing time.Experimental result is shown in Table 13.
The investigation of the incorporation time of table 13
As a result：From data above, incorporation time 5-20min, RSD value are less than 5.0%, illustrate to meet the requirements.But
In view of the size and production efficiency of combined amount, optimal selection incorporation time is 15min.
Embodiment 1
Plain piece prescription：
It is coated prescription：
Sucrose 36kg
Talcum powder 39kg
Arabic gum 0.054kg
The Troxerutin, starch, dextrin of recipe quantity are put into granulator successively, dry-mixed 2 minutes, add 65%-67% second
Alcohol, wet mixing 1 minute, granulation are completed.Fluidbedgranulatingdrier dry, 70 DEG C of EAT, 50 DEG C of temperature of charge, during every
Tremble bag once within 5 minutes, drying time is 20-30 minutes.Dried particle is fitted into the dying grain system of 14 eye mesh screens, carried out whole
Grain, tabletting, is coated and produces.
Embodiment 2
Plain piece prescription：
It is coated prescription：
Lactose 19kg
Talcum powder, starch 70kg
Gelatin 0.128kg
The Troxerutin, starch, dextrin of recipe quantity are put into granulator successively, dry-mixed 1 minute, add 65%-67% second
Alcohol, wet mixing 5 minutes, granulation are completed.Fluidbedgranulatingdrier dry, 90 DEG C of EAT, 40 DEG C of temperature of charge, during every
Tremble bag once within 2 minutes, drying time is 30-40 minutes.Dried particle is fitted into the dying grain system of 14 eye mesh screens, carried out whole
Grain, tabletting, is coated and produces.
Embodiment 3
Plain piece prescription：
It is coated prescription：
Steviosin 48kg
Talcum powder, calcium carbonate 15kg
Zein 0.008kg
The Troxerutin, starch, dextrin of recipe quantity are put into granulator successively, dry-mixed 4 minutes, add 65%-67% second
Alcohol, wet mixing 0.5 minute, granulation are completed.Fluidbedgranulatingdrier is dried, 50 DEG C of EAT, 80 DEG C of temperature of charge, during it is every
Bag was trembled every 10 minutes once, and drying time is 10-20 minutes.Dried particle is fitted into the dying grain system of 14 eye mesh screens, entered
Row whole grain, tabletting, is coated and produces.
Embodiment 4
Plain piece prescription：
It is coated prescription：
The Troxerutin, starch, dextrin of recipe quantity are put into granulator successively, dry-mixed 2 minutes, add 65%-67% second
Alcohol, wet mixing 1 minute, granulation are completed.Fluidbedgranulatingdrier dry, 70 DEG C of EAT, 50 DEG C of temperature of charge, during every
Tremble bag once within 5 minutes, drying time is 20-30 minutes.Dried particle is fitted into the dying grain system of 14 eye mesh screens, carried out whole
Grain, tabletting, is coated and produces.
Embodiment 5
Plain piece prescription：
It is coated prescription：
The Troxerutin, starch, dextrin of recipe quantity are put into granulator successively, dry-mixed 2 minutes, add 65%-67% second
Alcohol, wet mixing 4 minutes, granulation are completed.Fluidbedgranulatingdrier dry, 80 DEG C of EAT, 45 DEG C of temperature of charge, during every
Tremble bag once within 3 minutes, drying time is 20-30 minutes.Dried particle is fitted into the dying grain system of 14 eye mesh screens, carried out whole
Grain, tabletting, is coated and produces.
Embodiment 6
Plain piece prescription：
It is coated prescription：
The Troxerutin, starch, dextrin of recipe quantity are put into granulator successively, dry-mixed 3 minutes, add 65%-67% second
Alcohol, wet mixing 1 minute, granulation are completed.Fluidbedgranulatingdrier dry, 60 DEG C of EAT, 60 DEG C of temperature of charge, during every
Tremble bag once within 8 minutes, drying time is 20-30 minutes.Dried particle is fitted into the dying grain system of 14 eye mesh screens, carried out whole
Grain, tabletting, is coated and produces.
Embodiment 7
Plain piece prescription：
It is coated prescription：
The Troxerutin, starch, dextrin of recipe quantity are put into granulator successively, dry-mixed 2 minutes, add 65%-67% second
Alcohol, wet mixing 1 minute, granulation are completed.Fluidbedgranulatingdrier dry, 70 DEG C of EAT, 50 DEG C of temperature of charge, during every
Tremble bag once within 5 minutes, drying time is 20-30 minutes.Dried particle is fitted into the dying grain system of 14 eye mesh screens, carried out whole
Grain, whole good particle and silica and magnesium stearate are filled in two-dimensional motion mixer, are mixed 15 minutes, tabletting, coating
Produce.
Embodiment 8
Plain piece prescription：
It is coated prescription：
Above-mentioned supplementary material is prepared into piece agent according to common process.
Embodiment 9
Plain piece prescription：
It is coated prescription：
Above-mentioned supplementary material is prepared into piece agent according to common process.
Embodiment 10
Plain piece prescription：
It is coated prescription：
The Troxerutin, starch, dextrin of recipe quantity are put into granulator successively, dry-mixed 2 minutes, add 65%-67% second
Alcohol, wet mixing 1 minute, granulation are completed.Fluidbedgranulatingdrier dry, 70 DEG C of EAT, 50 DEG C of temperature of charge, during every
Tremble bag once within 5 minutes, drying time is 20-30 minutes.Dried particle is fitted into the dying grain system of 14 eye mesh screens, carried out whole
Grain, whole good particle and silica and magnesium stearate are filled in two-dimensional motion mixer, are mixed 15 minutes, tabletting, coating
Produce.
Claims (8)
1. a kind of pharmaceutical composition containing Troxerutin, including plain piece and coatings, it is characterised in that coatings are containing pleasantly sweet
Agent sucrose, extender talcum powder, excipient Arabic gum and surfactant sodium dodecyl base benzene sulfonic acid sodium salt, its weight ratio are
19000:20000:17:36；Plain piece contains Troxerutin, starch, dextrin, 65%-75% ethanol, silica and stearic acid
Magnesium, its weight ratio are：28500:2920:1610:7000-8500:570：481.
2. the preparation method of pharmaceutical composition as claimed in claim 1, it is characterised in that this method comprises the following steps：Will place
Troxerutin, filler, adhesive, the wetting agent just measured, are pelletized using wet-mixing, are dried, whole grain；Add glidant and/
Or mix lubricant, tabletting, it is coated, dries, produce.
3. the preparation method of pharmaceutical composition as claimed in claim 2, it is characterised in that the wet-mixing is pelletized dry-mixed
Time is 1-4 minutes, and the wet mixing time is 0.5-5 minutes.
4. the preparation method of pharmaceutical composition as claimed in claim 3, wherein the dry-mixed time 2 of wet-mixing granulation divides
Clock；The wet mixing time is 1 minute.
5. the preparation method of pharmaceutical composition as claimed in claim 2, it is characterised in that EAT when described dry is
50℃-90℃；Temperature of charge is 40 DEG C -80 DEG C；During every 2-10 minutes tremble bag once；Drying time is 10-40 minutes.
6. the preparation method of pharmaceutical composition as claimed in claim 5, it is characterised in that EAT when described dry is
70℃；Temperature of charge is 50 DEG C；During every 5 minutes trembled bag once；Drying time is 20-30 minutes.
7. the preparation method of pharmaceutical composition as claimed in claim 2, it is characterised in that the addition glidant and/or lubrication
Agent mixes, and incorporation time is 5-30 minutes.
8. the preparation method of pharmaceutical composition as claimed in claim 7, it is characterised in that the addition glidant and/or lubrication
Agent mixes, and incorporation time is 15 minutes.
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| CN109010305A (en) * | 2018-10-16 | 2018-12-18 | 南京昂科利医药科技创新研究院有限公司 | A kind of rutin natrium capsule and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1613444A (en) * | 2003-11-07 | 2005-05-11 | 邱学良 | Efferverscent tablets containing troxerutin and their preparation |
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| DE10122715A1 (en) * | 2001-05-10 | 2002-11-21 | Brench Ag | Use of rutines and escines for the treatment of auricular circulatory disorders |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1613444A (en) * | 2003-11-07 | 2005-05-11 | 邱学良 | Efferverscent tablets containing troxerutin and their preparation |
Non-Patent Citations (2)
| Title |
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| 11 种市售曲克芦丁制剂的产品质量评价;梅丹等;《中国药学杂志》;19981031;第33卷(第10期);第605-608页 * |
| 市售曲克芦丁片质量分析;曹芳;《中国药师》;20001231;第3卷(第1期);第49-50页 * |
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