CN103127009B - 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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- CN103127009B CN103127009B CN201110396774.7A CN201110396774A CN103127009B CN 103127009 B CN103127009 B CN 103127009B CN 201110396774 A CN201110396774 A CN 201110396774A CN 103127009 B CN103127009 B CN 103127009B
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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 carthamin yellow sublingual tablet and its preparation method and application.
Background technology
Carthamus yellow is the natural pigment extracted for raw material with feverfew Flos Carthami, it has blood circulation promoting and blood stasis dispelling, effect of coronary circulation-promoting pain-relieving, can be used for the stable type angina pectoris (disease sees that chest pain is uncomfortable in chest, nervous and breathe hard) for the treatment of stagnation of heart-blood I, II of causing and III level.
At present, Carthamus yellow preparation only has powder ampoule agent for injection, and development novel form is of crucial importance for its clinical application range of expansion.Because the Carthamus yellow half-life is shorter, oral poor through gastrointestinal absorption, generally believe that the potentiality being prepared as oral formulations are little.
Summary of the invention
Technical problem to be solved by this invention is the needs in order to satisfied development Carthamus yellow preparation novel form, and provides a kind of carthamin yellow sublingual tablet and preparation method thereof.
The present inventor for Carthamus yellow poor fluidity, easily adsorb, there is bitterness, and to ins and outs such as disintegrate influential effect are large, grope through experiment, finishing screen is selected to be had preferably disintegrate effect, can be rapidly absorbed, and the carthamin yellow sublingual tablet of better mouthfeel and outward appearance can be had, thus 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 carthamin 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 by existing various method crude product or the fine work of the Carthamus yellow extract taking Flos Carthami as raw material extraction.Wherein, described fine work is generally containing the S-A Hydroxysafflor yellow A of mass percent 75 ~ 95%.Concrete preparation method can by the literature procedures of a large amount of Carthamus yellows reported in prior art and preparation method thereof, the such as disclosed method being prepared purification Carthamus yellow by macroporous resin adsorption and membrance concentration method of ZL 03157479.3.
Wherein, described filler be selected from mannitol, sorbitol, xylitol and lactose one or more, be preferably one or more in mannitol, sorbitol and xylitol, to obtain better mobility and mouthfeel, best is lower-cost mannitol.
Wherein, described disintegrating agent be selected from polyvidone, sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose and carboxymethyl starch sodium one or more, be preferably cross-linking sodium carboxymethyl cellulose, to obtain better disintegrate effect and mouthfeel.
In addition to the aforementioned ingredients, as required, carthamin 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 taste, as strawberry flavor.The consumption of described correctives is selected routinely, generally can be 0.1 ~ 0.5% of carthamin yellow sublingual tablet quality.The lubricant that described lubricant can adopt this area conventional, as magnesium stearate.The consumption of described lubricant is selected routinely, preferably can be 0.1 ~ 2% of carthamin yellow sublingual tablet quality.
The present invention one preferred embodiment is: the formula of described carthamin 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 carthamin yellow sublingual tablet, it comprises the steps:, by above-mentioned formula, to prepare through conventional method for preparing tablet thereof.
Before preparation, routinely, can by each composition sieving for standby respectively, be preferably 50 ~ 120 mesh sieves, better was 80 mesh sieves.The described preferred direct powder compression of conventional tablet preparation method or wet granule compression tablet method.Described wet granulation can operate by conventional wet granulation method, granulates or extrudes granulate as stirred.The solvent preparing soft material in wet granulation step can select common solvent, is preferably ethanol water, and better is volume ratio 50 ~ 90% ethanol water.In wet granule compression tablet method, the feed postition of filler and disintegrating agent is preferably inside and outside addition, concrete is: by formula, by Carthamus yellow, partially filled agent (preferably 1/5 ~ 4/5, more preferably the filler of 1/2) and partial disintegration agent (preferably 1/5 ~ 4/5, more preferably the disintegrating agent of 1/2) carry out wet granulation, granulate, afterwards by gained granule and residue filler and disintegrating agent, and mix lubricant, tabletting (hardness preferably controls to be 2 ~ 5kgf, and better control is 2 ~ 3kgf).Routinely, if also comprise other adjuvants in formula, other adjuvants mix in wet granulation step.
The present invention one preferred embodiment is the carthamin yellow sublingual tablet adopting following method to prepare: by formula, Carthamus yellow, the filler of 1/2 and the disintegrating agent of 1/2 are dry mixed 10 ~ 15 minutes, soft material is prepared with volume ratio 80% ethanol water, granulate through 20 ~ 40 mesh sieves (more preferably 24 mesh sieves) extruding again, then in 60 ~ 65 DEG C of oven dry, granulate afterwards, by gained granule with residue filler and disintegrating agent, and mix lubricant, tabletting, Hardness Control is 3kgf.
The invention further relates to the application of carthamin yellow sublingual tablet of the present invention in the medicine of preparation treatment ischemic brain injury.
On the basis meeting this area general knowledge, above-mentioned each optimum condition, can combination in any, obtains the preferred embodiments of the invention.
Agents useful for same of the present invention and raw material are all commercially.
Positive progressive effect of the present invention is: carthamin yellow sublingual tablet of the present invention has preferably disintegrate effect, can be rapidly absorbed, and can have better mouthfeel and outward appearance.The present invention is that the clinical practice of Carthamus yellow provides new approach.
Accompanying drawing explanation
Fig. 1 is the dog medicine pharmacokinetic curve figure of embodiment 5 carthamin yellow sublingual tablet and injection.
Fig. 2 is the presetting period curve chart of embodiment 5 carthamin yellow sublingual tablet and injection.
Fig. 3 is the complete solidifying time plot of embodiment 5 carthamin yellow sublingual tablet and injection.
Detailed description of the invention
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, conventionally and condition, or selects according to catalogue.
Carthamus yellow is that Zhejiang Yongning Pharmaceutical Co., Ltd produces, and lot number 100501, wherein general flavone content is 85.1%, and S-A Hydroxysafflor yellow A content is 85%.
The different filler of embodiment 1
Adopt variety classes filler as shown in table 1, by every sheet 100mg containing Carthamus yellow, 400mg filler, the formula of 100mg cross-linking sodium carboxymethyl cellulose and 5mg magnesium stearate, with direct powder compression film-making, result is as shown in table 1.
Table 1
| Numbering | Filler | Tablet molding situation | Tablet mouthfeel |
| 1 | Starch | Be difficult to molding | Poor, powder sense is strong |
| 2 | Dextrin | Be difficult to molding | Poor, powder sense is strong |
| 3 | Mannitol | Can molding | Good, there is refrigerant sense, substantially without powder sense |
| 4 | Sorbitol | Can molding | Good, there is refrigerant sense, substantially without powder sense |
| 5 | Xylitol | Can molding | Good, there is refrigerant sense, substantially without powder sense |
| 6 | Lactose | Can molding | Mouthfeel is general, has certain powder sense |
| 7 | Polyethylene Glycol | Be difficult to molding | Mouthfeel is poor, has certain powder sense |
From table 1 result, mannitol, sorbitol, xylitol and lactose all can realize tablet molding, and have preferably mouthfeel, and especially mannitol, sorbitol and xylitol can realize better mouthfeel.In addition, consider sorbitol and xylitol price higher, therefore most preferably adopt mannitol.
The carthamin yellow sublingual tablet of the different disintegrating agent of embodiment 2 and preparation method
1, direct powder compression preparation
Adopt variety classes disintegrating agent as shown in table 2, by the formula of every sheet containing 100mg Carthamus yellow, 300mg lactose, 200mg disintegrating agent and 5mg magnesium stearate, with direct powder compression preparation, result is as shown in table 2.
Table 2
| Numbering | Disintegrating agent | Disintegration time (n=6) | Disintegration | Tablet mouthfeel |
| 1 | Low-substituted hydroxypropyl cellulose | 6-7min | Defective | Generally, powder sense is stronger |
| 2 | Polyvinylpolypyrrolidone | 1-2min | Qualified | Generally, certain powder sense is had |
| 3 | Cross-linking sodium carboxymethyl cellulose | 2-3min | Qualified | Suitable, there is certain powder sense |
| 4 | Carboxymethyl starch sodium | 3-4min | Qualified | Generally, certain powder sense is had |
2, wet granulation preparation
Adopt variety classes disintegrating agent as shown in table 3, by the formula of every sheet containing 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, adds volume ratio 80% alcoholic solution and prepares soft material in right amount; Granulate through 24 mesh sieves; In 60 DEG C ~ 65 DEG C oven dry; Granulate, mix with after disintegrating agent and magnesium stearate lubricant, tabletting, Hardness Control is at 2-3kgf.
Table 3
| Numbering | Disintegrating agent | Disintegration time (n=6) | Disintegration | Tablet mouthfeel |
| 1 | Cross-linking sodium carboxymethyl cellulose | 4-5min | Qualified | Mouthfeel is suitable for |
| 2 | Carboxymethyl starch sodium | 4min | Qualified | Mouthfeel is general |
From table 2 and table 3 result, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose and carboxymethyl starch sodium all can realize preferably disintegrate effect, wherein best with cross-linking sodium carboxymethyl cellulose mouthfeel again.
The carthamin yellow sublingual tablet of embodiment 3 different ratio
Formula (the every sheet of mg/): except filler and disintegrating agent as shown in table 4 except, 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 |
From table 4 result, when mannitol and cross-linking sodium carboxymethyl cellulose amount ratio are 4: 1, reach qualified disintegration, then increased disintegrating agent consumption and have little significance, and mouthfeel can be made poorer, therefore most preferably 4: 1 mannitol and cross-linking sodium carboxymethyl cellulose.
Further, in the formula of above-mentioned numbering 1 ~ 4, add 0.6mg correctives strawberry flavor, make gained Sublingual tablet have strawberry aroma.
The carthamin yellow sublingual tablet of embodiment 4 Different Preparation
Formula (the every sheet of mg/): Carthamus yellow 100mg, mannitol 400mg, cross-linking sodium carboxymethyl cellulose 100mg.When adopting wet granule compression tablet method, also comprise 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 of prescription half amount, the cross-linking sodium carboxymethyl cellulose of half amount, add 80% ethanol water and prepare soft material in right amount; Granulate through 24 mesh sieves; In 60 ~ 65 DEG C of oven dry; Granulate, mix after adding magnesium stearate lubricant, tabletting, Hardness Control is at 2 ~ 3kgf.
Table 5
| Preparation method | Disintegration time | Disintegration | Whether there is piebaldism | Mouthfeel |
| Direct powder compression | 2min50s | Qualified | Have | Mouthfeel is suitable for |
| Wet granule compression tablet method | 4min30s | Qualified | There is a small amount of piebaldism | Mouthfeel is suitable for |
From table 5 result, adopt direct powder compression and wet granule compression tablet method all can obtain preferably disintegration time, to adopt the wet granule compression tablet Fa Gengjia of inside and outside addition.
The pharmacokinetic of embodiment 5 carthamin yellow sublingual tablet
One, sample: the carthamin yellow sublingual tablet that Carthamus yellow, embodiment 4 wet granule compression tablet method are obtained.
Two, test method:
Male dogs 2, adopt intravenous injection and sublingual administration two kinds of route of administration respectively, fasting 12h before experiment, blood sample 0.5ml before extracting vein and Sublingual tablet administration respectively and after administration (specifically get blood time as shown in table 6), be placed in the centrifuge tube adding 20 μ l heparin sodium aquas (1250u/ml) in advance, the centrifugal 5min of 5000rpm.Accurate absorption 100 μ l plasma containing drugs, after adding 50% methanol 40 μ l (control tube: the 50% methanol solution 40 μ l then adding 10 μ g/ml standard substance), vortex 30s, add the perchloric acid solution of 60 μ L 6%, vortex 2min, in the centrifugal 10min of 12000rpm, precision is got supernatant 60 μ l sample introduction and is carried out HPLC analysis.HPLC analysis condition: M00003 Shimadzu chromatograph of liquid post (Yi Lite 4.6mm × 200mm, 5 μm of E14191033), mobile phase is the methanol of volume ratio 20: 10: 70: 0.02, acetonitrile, water and phosphoric acid, flow velocity: 1.0ml/min, determined wavelength 403nm, sample size is 60 μ l.
Blood sample 0.5ml does thrombotest (specifically getting the blood time as shown in Table 7 and 8) before another extraction vein and Sublingual tablet administration and after administration.
Three, experimental result:
(1) bioavailability
Blood drug level is as shown in table 6 and Fig. 1.
Table 6
Prototype+metabolite absolute bioavailability is 13.74%, prototype absolute bioavailability 2.46%.
From table 6 and Fig. 1 data, Carthamus yellow can be detected 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 peak at 4h, can keep higher blood drug level in 2-8h, can play the object of continued treatment.
(2) thrombotest
Experimental result: as 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 |
Table 8 is the solidifying time entirely
| 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 |
From table 7 and 8, carthamin yellow sublingual tablet of the present invention has longer clotting time, has excellent anticoagulant effect.
Claims (5)
1. a carthamin yellow sublingual tablet, is characterized in that: its formula 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; Also containing lubricant in the formula of described carthamin yellow sublingual tablet;
Described carthamin yellow sublingual tablet is obtained by following method: by described formula, Carthamus yellow, the filler of 1/2 and the disintegrating agent of 1/2 are dry mixed 10 ~ 15 minutes, soft material is prepared with volume ratio 80% ethanol water, granulate through 20 ~ 40 mesh sieve extruding again, then in 60 ~ 65 DEG C of oven dry, granulate afterwards, by gained granule and residue filler and disintegrating agent, and mix lubricant, tabletting, Hardness Control is 3kgf.
2. carthamin yellow sublingual tablet as claimed in claim 1, is characterized in that: described Carthamus yellow is containing the S-A Hydroxysafflor yellow A of mass percent 75 ~ 95%.
3. carthamin yellow sublingual tablet as claimed in claim 1, is characterized in that: described carthamin yellow sublingual tablet is also containing correctives; The consumption of described correctives is 0.1 ~ 0.5% of carthamin yellow sublingual tablet quality; The consumption of described lubricant is 0.1 ~ 2% of carthamin yellow sublingual tablet quality.
4. carthamin yellow sublingual tablet as claimed in claim 1, it is characterized in that: the formula of described carthamin yellow sublingual tablet is, it contains 1 part of Carthamus yellow, 4 portions of mannitol and 1 part of cross-linking sodium carboxymethyl cellulose, and part is weight portion; It also contains the magnesium stearate of the correctives Flos Carthami flavochrome quality 5% of Carthamus yellow quality 0.6%.
5. the preparation method of a carthamin yellow sublingual tablet, it is characterized in that it comprises the steps: by the formula described in claim 1 or 2, Carthamus yellow, the filler of 1/2 and the disintegrating agent of 1/2 are dry mixed 10 ~ 15 minutes, prepare soft material with volume ratio 80% ethanol water, then granulate through 20 ~ 40 mesh sieve extruding, again in 60 ~ 65 DEG C of oven dry, granulate afterwards, by gained granule and residue filler and disintegrating agent, and mix lubricant, tabletting, Hardness Control is 3kgf.
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| 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 |
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