CN103127009A - Carthamin yellow sublingual tablet and preparation method and application thereof - Google Patents
Carthamin yellow sublingual tablet and preparation method and application thereof Download PDFInfo
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- CN103127009A CN103127009A CN2011103967747A CN201110396774A CN103127009A CN 103127009 A CN103127009 A CN 103127009A CN 2011103967747 A CN2011103967747 A CN 2011103967747A CN 201110396774 A CN201110396774 A CN 201110396774A CN 103127009 A CN103127009 A CN 103127009A
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Abstract
The invention discloses a carthamin yellow sublingual tablet. The carthamin yellow sublingual tablet comprises, by weight, one part of carthamin yellow, 3-4 parts of filling agents and 1-2 parts of disintegrating agents. The filling agents are one or more of mannitol, sorbitol, xylose and lactose. The disintegrating agents are one or more of crosslinking povidone, cross-linked carboxymethyl starch and sodium carboxymethyl cellulose and sodium. The invention further discloses the preparation method of the carthamin yellow sublingual tablet and application in preparing medicines for curing ischemic brain injury. The carthamin yellow sublingual tablet has good disintegrating effect, can be absorbed quickly, has good taste and appearance, and provides a new way for clinical application of carthamin yellow.
Description
Technical field
The present invention relates to a kind of Carthamus yellow Sublingual tablet and its preparation method and application.
Background technology
The natural pigment of Carthamus yellow for extracting take the feverfew Flos Carthami as raw material, it has blood circulation promoting and blood stasis dispelling, the effect of coronary circulation-promoting pain-relieving can be used for treating the stable type angina pectoris (disease see chest pain is uncomfortable in chest, nervous and breathe hard etc.) of I, II that stagnation of heart-blood causes and III level.
At present, the Carthamus yellow preparation only has powder ampoule agent for injection, and the development novel form is of crucial importance for enlarging its clinical application range.Because the Carthamus yellow half-life is shorter, oral relatively poor through the gastrointestinal absorption, generally believe that the potentiality that are prepared as oral formulations are little.
Summary of the invention
Technical problem to be solved by this invention is the needs that develop Carthamus yellow preparation novel form in order to satisfy, and a kind of Carthamus yellow Sublingual tablet and preparation method thereof is provided.
The inventor for the Carthamus yellow poor fluidity, easily adsorb, have bitterness, and to ins and outs such as the disintegrate influential effect are large, grope through experiment, finishing screen is selected to have better disintegrate effect, can be rapidly absorbed, and can have the Carthamus yellow Sublingual tablet of better mouthfeel and outward appearance, thereby widen the clinical application range of Carthamus yellow.
Concrete, the present invention is achieved through the following technical solutions above-mentioned technique effect:
The formula of Carthamus yellow Sublingual tablet of the present invention comprises 1 part of Carthamus yellow, 3～4 parts of filleies and 1～2 portion of disintegrating agent, and part is weight portion; Described filler is one or more in mannitol, sorbitol, xylitol and lactose, and described disintegrating agent is one or more in polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose and carboxymethyl starch sodium.
Wherein, described Carthamus yellow can be crude product or the elaboration of the Carthamus yellow extract that extracts take Flos Carthami as raw material by existing the whole bag of tricks.Wherein, described elaboration generally contains the S-A Hydroxysafflor yellow A of mass percent 75～95%.Concrete preparation method can be by the document operation of a large amount of Carthamus yellows of having reported in prior art and preparation method thereof, for example disclosed method for preparing the purification Carthamus yellow by macroporous resin adsorption and membrance concentration method of ZL 03157479.3.
Wherein, described filler is selected from one or more in mannitol, sorbitol, xylitol and lactose, one or more that better is in mannitol, sorbitol and xylitol, to obtain better mobility and mouthfeel, best is lower-cost mannitol.
Wherein, described disintegrating agent is selected from one or more in polyvidone, sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose and carboxymethyl starch sodium, and better is cross-linking sodium carboxymethyl cellulose, to obtain better disintegrate effect and mouthfeel.
Except mentioned component, as required, Carthamus yellow Sublingual tablet of the present invention also can contain the acceptable adjuvant of other pharmaceutical fields, as correctives and/or lubricant etc.Described correctives can be the correctives of existing various tastes, as strawberry flavor.The consumption of described correctives is selected routinely, generally can be 0.1～0.5% of Carthamus yellow Sublingual tablet quality.Described lubricant can adopt this area lubricant commonly used, as magnesium stearate.The consumption of described lubricant is selected routinely, better 0.1～2% of the Carthamus yellow Sublingual tablet quality that can be.
The present invention's one preferred embodiment is: the formula of described Carthamus yellow Sublingual tablet comprises 1 part of Carthamus yellow, 4 portions of mannitol and 1 part of cross-linking sodium carboxymethyl cellulose, and part is weight portion.Better, it also contains the magnesium stearate of the correctives Flos Carthami flavochrome quality 5% of Carthamus yellow quality 0.6%.
The invention still further relates to the preparation method of this Carthamus yellow Sublingual tablet, it comprises the steps: by above-mentioned formula, through conventional method for preparing tablet thereof preparation, gets final product.
Before preparation, routinely, can be with each composition difference sieving for standby, better was 50～120 mesh sieves, better was 80 mesh sieves.The preferred direct powder compression of described conventional tablet preparation method or wet granule compression tablet method.Described wet granulation can by wet granulation method operation commonly used, be granulated or push granulation etc. as stirring.In the wet granulation step, the solvent of preparation soft material can be selected common solvent, and better is ethanol water, and better is volume ratio 50～90% ethanol waters.In the wet granule compression tablet method, filler and disintegrating agent add mode better for inside and outside addition, concrete is: by formula, with Carthamus yellow, partially filled agent (preferred 1/5～4/5, more preferably 1/2 filler) and part disintegrating agent (preferred 1/5～4/5, more preferably 1/2 disintegrating agent) carry out wet granulation, granulate, afterwards with gained granule and residue filler and disintegrating agent, and mix lubricant, tabletting (hardness better be controlled to be 2～5kgf, better is controlled to be 2～3kgf), gets final product.Routinely, if also comprise other adjuvants in formula, other adjuvants mix in the wet granulation step.
The present invention's one preferred embodiment is for adopting the Carthamus yellow Sublingual tablet of following method preparation: by formula, Carthamus yellow, 1/2 filler and 1/2 disintegrating agent are dry mixed 10～15 minutes, prepare soft material with volume ratio 80% ethanol water, granulate through 20～40 mesh sieves (more preferably 24 mesh sieves) extruding again, then in 60～65 ℃ of oven dry, granulate afterwards, with the gained granule with residue filler and disintegrating agent, and mix lubricant, tabletting, Hardness Control is 3kgf.
The invention further relates to the application of Carthamus yellow Sublingual tablet of the present invention in the medicine of preparation treatment ischemic brain injury.
On the basis that meets this area general knowledge, above-mentioned each optimum condition, but combination in any namely get the preferred embodiments of the invention.
Agents useful for same of the present invention and raw material be commercially available getting all.
Positive progressive effect of the present invention is: Carthamus yellow Sublingual tablet of the present invention has better disintegrate effect, can be rapidly absorbed, and can have better mouthfeel and outward appearance.The present invention provides new approach for the clinical practice of Carthamus yellow.
Description of drawings
Fig. 1 is the dog medicine pharmacokinetic curve figure of embodiment 5 Carthamus yellow Sublingual tablets and injection.
Fig. 2 is the presetting period curve chart of embodiment 5 Carthamus yellow Sublingual tablets and injection.
Fig. 3 is the complete solidifying time plot of embodiment 5 Carthamus yellow Sublingual tablets and injection.
The specific embodiment
Mode below by embodiment further illustrates the present invention, but does not therefore limit the present invention among described scope of embodiments.The experimental technique of unreceipted actual conditions in the following example according to conventional method and condition, or is selected according to catalogue.
Carthamus yellow is that Zhejiang Yongning Pharmaceutical Co., Ltd produces, lot number 100501, and wherein general flavone content is 85.1%, S-A Hydroxysafflor yellow A content is 85%.
The different filleies of embodiment 1
Adopt variety classes filler as shown in table 1, contain Carthamus yellow by every 100mg, the 400mg filler, the formula of 100mg cross-linking sodium carboxymethyl cellulose and 5mg magnesium stearate, with the direct powder compression film-making, result is as shown in table 1.
Table 1
| Numbering | Filler | Tablet molding situation | The tablet mouthfeel |
| 1 | Starch | Be difficult to molding | Relatively poor, the powder sense is strong |
| 2 | Dextrin | Be difficult to molding | Relatively poor, the powder sense is strong |
| 3 | Mannitol | Can molding | Good, refrigerant sense is arranged, substantially without the |
| 4 | Sorbitol | Can molding | Good, refrigerant sense is arranged, substantially without the powder sense |
| 5 | Xylitol | Can molding | Good, refrigerant sense is arranged, substantially without the |
| 6 | Lactose | Can molding | Mouthfeel is general, and certain powder sense is arranged |
| 7 | Polyethylene Glycol | Be difficult to molding | Mouthfeel is relatively poor, and certain powder sense is arranged |
By table 1 result as seen, mannitol, sorbitol, xylitol and lactose all can be realized the tablet molding, and have better mouthfeel, especially mannitol, sorbitol and xylitol and can realize better mouthfeel.In addition, consider that sorbitol and xylitol price are higher, therefore most preferably adopt mannitol.
The Carthamus yellow Sublingual tablet of the different disintegrating agents of embodiment 2 and preparation method
1, direct powder compression preparation
Adopt variety classes disintegrating agent as shown in table 2, by every formula that contains 100mg Carthamus yellow, 300mg lactose, 200mg disintegrating agent and 5mg magnesium stearate, with the direct powder compression preparation, result is as shown in table 2.
Table 2
| Numbering | Disintegrating agent | Disintegration time (n=6) | Disintegration | The tablet mouthfeel |
| 1 | Low-substituted hydroxypropyl cellulose | 6-7min | Defective | Generally, the powder sense is stronger |
| 2 | Polyvinylpolypyrrolidone | 1-2min | Qualified | Generally, certain powder sense is arranged |
| 3 | Cross-linking sodium carboxymethyl cellulose | 2-3min | Qualified | Suitable, certain powder sense is arranged |
| 4 | Carboxymethyl starch sodium | 3-4min | Qualified | Generally, certain powder sense is arranged |
2, wet granulation preparation
Adopt variety classes disintegrating agent as shown in table 3, by every formula that contains 100mg Carthamus yellow, 400mg mannitol, 100mg disintegrating agent and 5mg magnesium stearate, with following wet granule compression tablet method (outer addition) preparation, result is as shown in table 3.
Wet granulation (outer addition): take Carthamus yellow and mannitol by formula ratio, add volume ratio 80% alcoholic solution and prepare in right amount soft material; Granulate through 24 mesh sieves; In 60 ℃～65 ℃ oven dry; Granulate, with mixing after disintegrating agent and magnesium stearate lubricant, tabletting, Hardness Control is at 2-3kgf.
Table 3
| Numbering | Disintegrating agent | Disintegration time (n=6) | Disintegration | The tablet mouthfeel |
| 1 | Cross-linking sodium carboxymethyl cellulose | 4-5min | Qualified | Mouthfeel is suitable |
| 2 | Carboxymethyl starch sodium | 4min | Qualified | Mouthfeel is general |
By table 2 and table 3 result as seen, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose and carboxymethyl starch sodium all can be realized better disintegrate effect, and be wherein best with the cross-linking sodium carboxymethyl cellulose mouthfeel again.
The Carthamus yellow Sublingual tablet of embodiment 3 different proportionings
The formula (every of mg/): except filler and disintegrating agent as shown in table 4, other are: Carthamus yellow 100mg, magnesium stearate 5mg.
Preparation method: direct powder compression
Table 4
| Numbering | Mannitol | Cross-linking sodium carboxymethyl cellulose | Disintegration time (n=6) | Disintegration |
| 1 | 500mg | 0mg | 9-10min | Defective |
| 2 | 450mg | 50mg | 6-7min | Defective |
| 3 | 400mg | 100mg | 4-5min | Qualified |
| 4 | 300mg | 200mg | 4min | Qualified |
By table 4 result as seen, mannitol and cross-linking sodium carboxymethyl cellulose amount ratio are 4: 1 o'clock, have reached qualified disintegration, then increase the disintegrating agent consumption and have little significance, therefore and can make mouthfeel poorer, most preferably mannitol and the cross-linking sodium carboxymethyl cellulose of 4: 1.
Further, add 0.6mg correctives strawberry flavor in the formula of above-mentioned numbering 1～4, make the gained Sublingual tablet have strawberry aroma.
The Carthamus yellow Sublingual tablet of embodiment 4 Different Preparation
Formula (every of mg/): Carthamus yellow 100mg, mannitol 400mg, cross-linking sodium carboxymethyl cellulose 100mg.When adopting the wet granule compression tablet method, also comprise the 5mg magnesium stearate lubricant.
Preparation method:
1, direct powder compression
2, wet granule compression tablet method (inside and outside addition): by formula ratio take principal agent and and the mannitol, the cross-linking sodium carboxymethyl cellulose of half amount of half amount of prescription, add 80% ethanol water and prepare in right amount soft material; Granulate through 24 mesh sieves; In 60～65 ℃ of oven dry; Granulate adds mixing after magnesium stearate lubricant, tabletting, and Hardness Control is at 2～3kgf.
Table 5
| Preparation method | Disintegration time | Disintegration | Whether piebaldism is arranged | Mouthfeel |
| Direct powder compression | 2min50s | Qualified | Have | Mouthfeel is suitable |
| The wet granule compression tablet method | 4min30s | Qualified | A small amount of piebaldism is arranged | Mouthfeel is suitable |
By table 5 result as seen, adopt direct powder compression and wet granule compression tablet method all can obtain better disintegration time, to adopt the wet granule compression tablet Fa Gengjia of inside and outside addition.
The pharmacokinetic of embodiment 5 Carthamus yellow Sublingual tablets
One, sample: the Carthamus yellow Sublingual tablet that Carthamus yellow, embodiment 4 wet granule compression tablet methods make.
Two, test method:
2 of male dogs, adopt respectively two kinds of route of administration of intravenous injection and sublingual administration, fasting 12h before experiment, extract respectively before vein and Sublingual tablet administration and administration after blood sample 0.5ml (specifically get blood time as shown in table 6), be placed in the centrifuge tube that adds in advance 20 μ l heparin sodium aquas (1250u/ml), the centrifugal 5min of 5000rpm.The accurate 100 μ l plasma containing drugs of drawing, (control tube: the 50% methanol solution 40 μ l that add 10 μ g/ml standard substance) after adding 50% methanol 40 μ l, vortex 30s, the perchloric acid solution that adds 60 μ L 6%, vortex 2min, in the centrifugal 10min of 12000rpm, precision is got supernatant 60 μ l sample introductions and is carried out the HPLC analysis.HPLC analysis condition: M00003 Shimadzu chromatograph of liquid post (Yi Lite 4.6mm * 200mm, 5 μ m E14191033), mobile phase is volume ratio 20: 10: 70: 0.02 methanol, acetonitrile, water and phosphoric acid, flow velocity: 1.0ml/min, detect wavelength 403nm, sample size is 60 μ l.
After reaching administration before another extraction vein and Sublingual tablet administration, blood sample 0.5ml does thrombotest (specifically getting the blood time as shown in Table 7 and 8).
Three, experimental result:
(1) bioavailability
Blood drug level such as table 6 and shown in Figure 1.
Table 6
Prototype+metabolite absolute bioavailability is 13.74%, prototype absolute bioavailability 2.46%.
By table 6 and Fig. 1 data as seen, can detect Carthamus yellow in blood after buccal Flos Carthami Sublingual agreement that contracts a film or TV play to an actor or actress 1h, illustrate that onset is very fast; This product reaches the peak at 4h, can keep higher blood drug level in 2-8h, can play the purpose of continued treatment.
(2) thrombotest
Experimental result: shown in table 7 and 8, Fig. 2 and 3.
Table 7 presetting period
| Get the blood time (min) | 0 | 0.12 | 0.5 | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 24 | 72 | 120 |
| Sublingual tablet (S) | 408 | \ | 452 | \ | 439 | 550 | 418 | 446 | 482 | 728 | 493 | 368 | 342 |
| Injection (S) | 347 | 549 | 463 | 445 | 493 | 447 | 432 | 536 | 785 | 695 | 368 | 360 | 296 |
The entirely solidifying time of table 8
| Get the blood time (min) | 0 | 0.12 | 0.5 | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 24 | 72 | 96 | 120 |
| Sublingual tablet (S) | 450 | \ | 615 | \ | 553 | 684 | 534 | 500 | 557 | 605 | 601 | 620 | 567 | 533 |
| Injection (S) | 432 | 640 | 609 | 592 | 750 | 676 | 786 | 800 | 1215 | 987 | 516 | 555 | 575 | 541 |
By table 7 and 8 as seen, Carthamus yellow Sublingual tablet of the present invention has long clotting time, has excellent anticoagulant effect.
Claims (10)
1. Carthamus yellow Sublingual tablet, it is characterized in that: its formula comprises 1 part of Carthamus yellow, 3～4 parts of filleies and 1～2 portion of disintegrating agent, part is weight portion; Described filler is one or more in mannitol, sorbitol, xylitol and lactose, and described disintegrating agent is one or more in polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose and carboxymethyl starch sodium.
2. Carthamus yellow Sublingual tablet as claimed in claim 1, it is characterized in that: described Carthamus yellow contains the S-A Hydroxysafflor yellow A of mass percent 75～95%.
3. Carthamus yellow Sublingual tablet as claimed in claim 1, it is characterized in that: described Carthamus yellow Sublingual tablet also contains correctives and/or lubricant; The consumption of described correctives is 0.1～0.5% of Carthamus yellow Sublingual tablet quality; The consumption of described lubricant is 0.1～2% of Carthamus yellow Sublingual tablet quality.
4. Carthamus yellow Sublingual tablet as claimed in claim 1 is characterized in that: the formula of described Carthamus yellow Sublingual tablet is, it contains 1 part of Carthamus yellow, 4 portions of mannitol and 1 part of cross-linking sodium carboxymethyl cellulose, part is weight portion; Better its also contains the magnesium stearate of the correctives Flos Carthami flavochrome quality 5% of Carthamus yellow quality 0.6%.
5. Carthamus yellow Sublingual tablet as described in claim 1～4 any one, it is characterized in that: it is made by the wet granule compression tablet method, and the mode that adds of described filler and disintegrating agent is inside and outside addition.
6. Carthamus yellow Sublingual tablet as claimed in claim 5, it is characterized in that: it is made by following method: by described formula, Carthamus yellow, 1/2 filler and 1/2 disintegrating agent are dry mixed 10～15 minutes, prepare soft material with volume ratio 80% ethanol water, then granulate through 20～40 mesh sieves extruding, again in 60～65 ℃ of oven dry, granulate afterwards, with the gained granule with residue filler and disintegrating agent, and mix lubricant, tabletting, Hardness Control are 3kgf.
7. the preparation method of a Carthamus yellow Sublingual tablet, is characterized in that it comprises the steps: by the described formula of claim 1～4 any one, through conventional method for preparing tablet thereof preparation, gets final product.
8. method as claimed in claim 7, it is characterized in that: described conventional tablet preparation method is direct powder compression or wet granule compression tablet method; In described wet granule compression tablet method, the mode that adds of filler and disintegrating agent is inside and outside addition;
What the operation of described inside and outside addition was better is: before wet granulation, filler and disintegrating agent addition are 1/5～4/5, and better is 1/2.
9. method as claimed in claim 8, it is characterized in that: by formula, Carthamus yellow, 1/2 filler and 1/2 disintegrating agent are dry mixed 10～15 minutes, prepare soft material with volume ratio 80% ethanol water, then granulate through 20～40 mesh sieves extruding, again in 60～65 ℃ of oven dry, granulate afterwards, with the gained granule with residue filler and disintegrating agent, and mix lubricant, tabletting, Hardness Control are 3kgf.
10. the application of Carthamus yellow Sublingual tablet as described in claim 1～6 any one in the medicine of preparation treatment ischemic brain injury.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115645490A (en) * | 2022-12-12 | 2023-01-31 | 元和药业股份有限公司 | Tablet for pharyngitis and preparation method thereof |
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| CN1602857A (en) * | 2004-08-03 | 2005-04-06 | 北京科信必成医药科技发展有限公司 | Orally disintegrating tablet of safflor yellow and its preparation process |
| CN1634105A (en) * | 2004-11-23 | 2005-07-06 | 云南省药物研究所 | Breviscapine sublingual tablet and its preparing process |
| CN1762342A (en) * | 2005-10-28 | 2006-04-26 | 阿尔贝拉医药控股(通化)有限公司 | Safflor yellow A-containing pharmaceutical composition, its preparation method and usage |
| CN101181267A (en) * | 2007-11-30 | 2008-05-21 | 重庆医科大学医药研究所 | Zolmitriptan tongue tablet |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1602857A (en) * | 2004-08-03 | 2005-04-06 | 北京科信必成医药科技发展有限公司 | Orally disintegrating tablet of safflor yellow and its preparation process |
| CN1634105A (en) * | 2004-11-23 | 2005-07-06 | 云南省药物研究所 | Breviscapine sublingual tablet and its preparing process |
| CN1762342A (en) * | 2005-10-28 | 2006-04-26 | 阿尔贝拉医药控股(通化)有限公司 | Safflor yellow A-containing pharmaceutical composition, its preparation method and usage |
| CN101181267A (en) * | 2007-11-30 | 2008-05-21 | 重庆医科大学医药研究所 | Zolmitriptan tongue tablet |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN115645490A (en) * | 2022-12-12 | 2023-01-31 | 元和药业股份有限公司 | Tablet for pharyngitis and preparation method thereof |
| CN115645490B (en) * | 2022-12-12 | 2023-05-16 | 元和药业股份有限公司 | Tablet for pharyngitis and preparation method thereof |
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