CN1682966A - Yunnan Manyleaf paris Rhizome extract ora disintegration tablet and its preparing process - Google Patents
Yunnan Manyleaf paris Rhizome extract ora disintegration tablet and its preparing process Download PDFInfo
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Abstract
The present invention discloses orally disintegrating Gongxuening tablet as a kind of medicine preparation for treating menorrhagia, metrorrhagia and chronic pelvic inflammation. The medicine preparation has the functions of cooling blood, arresting bleeding, clearing away heat, eliminating wetness, dispersing blood clots and relieving pain. The present invention also relates to the preparation process of orally disintegrated Gongxuening tablet, and the preparation process includes preparing pellet, coating powder and tablet pressing.
Description
Technical field
The present invention relates to have cooling blood for hemostasis, removing damp-heat, the effect of blood-activating analgetic, the clinical GONGXUENING oral cavity disintegration tablet that is usually used in treating menorrhagia or diseases such as metrorrhagia, chronic pelvic inflammatory disease, and the preparation method of GONGXUENING oral cavity disintegration tablet.
Background technology
It is the oral disintegrated preparation that raw material is made that GONGXUENING oral cavity disintegration tablet system adopts Rhizoma Paridis.Rhizoma Paridis is the dry rhizome of liliaceous plant Rhizoma Paridis Paris polyphylla Smith var.yunnanensis (Franch.) Hand.-Mazz. or Rhizoma Paridis Paris polyphylla Smith var.chinensis (Franch.) Hara
[1], Rhizoma Paridis is Chinese distinctive rare medicinal herbs, is perennial herb, Rhizoma Paridis records in Shennong's Herbal with the name of Rhizoma Paridis the earliest, at present mainly by artificial culture.Leaf 6-10 sheet is verticillate, the long 5-20mm of petiole, and blade ground paper matter, lanceolar, ovum shape Long Circle be to obovate, long 5-11cm, wide 2-4.5cm.Bennet is extracted out from the stem top, and a flower is given birth on the top; The flower both sexes, bending lanceolar or long avette, green, long 3.5-6cm; Tapel is linear and show slightly lanceolar, yellow, long for sepal about 1/2 to closely isometric, the above wide 2-6mm in middle part; Stamen 8-10, the long 1-1.5cm of flower pesticide; Filigree is shorter than flower pesticide, connective ledge 1-2mm.Rhizoma Paridis contains multiple steroid saponin, for diosgenin (diosgenin) and pennogenin (pennogenin) two, three, the tetrose glycoside, other contains β-ecdyson, daucosterol etc., is the primary raw material of YUNNAN BAIYAO, GONGXUENING, total saponins sheet.The pharmacological action that with the Rhizoma Paridis is raw material " GONGXUENING " made is as follows.
Contraction to the isolated rat uterus
[2]Does not shrink under static state in the isolated rat uterus, when adding GONGXUENING to 25 μ g/ml, can cause the contraction of isolated uterine rhythmicity, increase with GONGXUENING concentration, uterine contraction tension force strengthens, frequency is accelerated, contraction intensity obviously increases, GONGXUENING 50,100, the shrink tension of 200 μ g/ml, frequency is organized than highly significant difference (p＜0.001) is arranged with 25 μ g/ml with intensity, GONGXUENING 100,200 μ g/ml all have significant difference (p＜0.01 with 50 μ g/ml group than every index, 0.001), and GONGXUENING 100 and 200 μ g/ml group do not have selective difference, show that the uterine contraction effect of GONGXUENING has significant dose-effect relationship within the specific limits.
GONGXUENING can obviously cause the contraction in isolated rat uterus, and the persistent period is longer, and it shrinks strong and weak relevant with dosage, is a kind of medicine that has than the contraction of hadron palace.Uterine contraction is oppressed myometrial blood vessel, can reach the purpose that reduces metrorrhagia, and therefore, GONGXUENING is the one of the main reasons that can be used for gynecological's metrorrhagia.
Clinically, GONGXUENING can be used for the treatment of post-artificial abortion hemorrhage
[3]People such as Li Dan have studied the influence of GONGXUENING to post-artificial abortion hemorrhage, and there were significant differences for medication group as a result and matched group (p＜0.05).People such as Lu Qian have carried out clinical observation to GONGXUENING JIAONANG medicine hemorrhage 198 examples post-abortion
[4], the result shows treatment group and matched group relatively, bleeding stopping period obviously shortens (p＜0.01).Vaginal bleeding after drug abortion time lengthening and uterine cavity have residual tissue, and uterine contraction is bad relevant, and a QI and blood dash is appointed in damage behind the drug induced abortion, and blood stasis due to qi deficiency is moved not normally, and congestion does not go, fresh blood must not return through, so vaginal hemorrhage is continuous.The function of GONGXUENING is cooling blood for hemostasis, removing damp-heat, blood-activating analgetic.Show that by clinical research GONGXUENING is rapid-action in therapeutic process, effect is strong, short treating period, and safe, no obvious toxic-side effects, clinical efficacy is sure, is to be worthy to be popularized at present to be used for the medicine of gynecopathy therapeutic.
Beneficial effect
Owing to reasons such as technologies of preparing, exist that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor after most of oral formulations are taken and problem such as bioavailability is lower, thereby influence the performance of drug effect, also directly affect the effect of treatment.In addition, traditional oral formulations needs a large amount of water to send down when taking, and this makes the patient of water intaking inconvenience be difficult to take.Therefore, be necessary to prepare and take convenient dosage form to satisfy the multiple needs that clinical treatment and family use.
The present invention has satisfied this demand of the prior art by a kind of GONGXUENING oral cavity disintegration tablet is provided.Oral cavity disintegration tablet is meant not to be needed water or only needs low amounts of water, need not to chew, and tablet places lingual surface, and chance saliva is collapsed broken rapidly, and reflexive enters in the body with swallowing act.Be characterized in that absorption is fast, bioavailability is high, intestinal is residual few, taking convenience.Oral cavity disintegration tablet needn't be used water delivery service, and saliva can make its disintegrate, for dysphagia, the inconvenient person of water intaking take medicine convenience is provided.The disintegration time of oral cavity disintegration tablet of the present invention is short, and is generally can disintegrate in 60 seconds complete, helps medicine stripping and absorption, and onset is rapid.
Summary of the invention
The present invention provides a kind of GONGXUENING oral cavity disintegration tablet in one aspect, and it is raw material with the Rhizoma Paridis extract, is adjuvant with filler, disintegrating agent, correctives, fluidizer, lubricant etc., and randomly use binding agent, coating material and effervescent.
In one embodiment, comprise following compositions (by weight percentage) in the GONGXUENING oral cavity disintegration tablet of the present invention:
1. Rhizoma Paridis (80～94) %, 2. binding agent (0～5) %,
3. filler (3～15) %, 4. coating material (0.2～3.0) %,
5. disintegrating agent (1～8) %, 6. correctives (0.05～0.5) %,
7. fluidizer (0.05～2.0) %, 8. lubricant (0.05～0.5) %,
9. effervescent (0～5) %,
In the present invention, the raw material Rhizoma Paridis is the dry rhizome of liliaceous plant Rhizoma Paridis or Rhizoma Paridis.The Rhizoma Paridis extractum that is used as raw material adopts following method to extract and obtains.
Get Rhizoma Paridis and be ground into coarse powder, add 3～5 times 40%～80% ethanol, return to heat up in a steamer and extract 3 times, 5 hours for the first time, 4 hours for the second time, 3 hours for the third time, merge extractive liquid, filtered, and decompression filtrate recycling ethanol becomes thick paste standby.Thick paste can add aqueous dispersion and become suspension, and the suspension spray drying is made fine powder.
In oral cavity disintegration tablet of the present invention, the preferred content of Rhizoma Paridis extract is 80%～94%, more preferably 80%～90%.
In GONGXUENING oral cavity disintegration tablet of the present invention, binding agent is a kind of optional member.The material that can be used for preparing binding agent includes but are not limited to ethanol, starch, pregelatinized Starch, dextrin, maltodextrin, sucrose, arabic gum, methylcellulose, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone (PVP), alginic acid, alginate, xanthan gum, hydroxypropyl emthylcellulose (HPMC), acrylic resin or Eudragit series plastics etc., they can use separately, also can be used.In GONGXUENING oral cavity disintegration tablet of the present invention, the content of binding agent is preferably 0～4%, and more preferably 0～3%.
In the present invention, coating material is a kind of optional member.Can be used for coating material among the present invention includes but are not limited to coating material and is selected from acrylic resin, ethyl cellulose, methylcellulose, hydroxypropyl emthylcellulose, chitosan, carboxymethyl cellulose salt, cellulose acetate phthalate ester.Can use separately, also can be used.In GONGXUENING oral cavity disintegration tablet of the present invention, the content of coating material is preferably 0.5～2.5%, and more preferably 0.8～2.0%.
In the present invention, filler can be selected from mannitol, microcrystalline Cellulose, dextrin, lactose, starch, xylitol, sorbitol, erythrose, glucose, polymerization sugar, SMCC or pregelatinized Starch etc., perhaps their combination in any, but be not limited thereto.In GONGXUENING oral cavity disintegration tablet of the present invention, the content of filler is preferably 4%～13%, and more preferably 5%～12%.
In the present invention, disintegrating agent can be selected from crospolyvinylpyrrolidone (PPVP), carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (L-HPC), cross-linking sodium carboxymethyl cellulose etc., perhaps their combination in any, but be not limited thereto.In GONGXUENING oral cavity disintegration tablet of the present invention, the content of disintegrating agent is preferably 2%～7%, and more preferably 2%～6%.
In the present invention, correctives can be selected from mannitol, lactose, stevioside, gelatin, Aspartane, cyclamate, glycyrrhizin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid or citric acid etc., perhaps their combination in any, but be not limited thereto.In GONGXUENING oral cavity disintegration tablet of the present invention, the content of correctives is preferably 0.05%～0.4%, and more preferably 0.05%～0.3%.
In the present invention, effervescent also is the optional adjuvant that uses, and comprises the mixture of citric acid for example or fumaric acid or maleic acid and sodium bicarbonate or sodium carbonate, but is not limited thereto.In GONGXUENING oral cavity disintegration tablet of the present invention, the content of effervescent is preferably 0～4%, and more preferably 0～3%
The invention still further relates to the preparation method of GONGXUENING oral cavity disintegration tablet, a kind of preparation method of GONGXUENING oral cavity disintegration tablet is as follows.
The first step is got Rhizoma Paridis and is ground into coarse powder, adds 3～5 times 40%～80% ethanol, returns to heat up in a steamer and extracts 3 times, and 5 hours for the first time, 4 hours for the second time, 3 hours for the third time, merge extractive liquid, filtered, and decompression filtrate recycling ethanol becomes thick paste standby.
Second step added ethanol dilution to having good mobility with Rhizoma Paridis extractum, and get diluent and put into mixer granulator, be binding agent with the extractum that dilutes, make granule with stirring, granule was dried 30 mesh sieve granulate; Or Rhizoma Paridis extractum mixed with filler, sieving and make granule, granule was dried 30 mesh sieve granulate;
The 3rd step will make granule takes by weighing also mix homogeneously according to quantity with other filler, disintegrating agent, effervescent, correctives, fluidizer, it is standby to add the lubricant mixing at last;
The 4th step gained material detects through intermediate, determine that sheet is heavy after, tabletting is promptly.
The another kind of preparation method of GONGXUENING oral cavity disintegration tablet is as follows.
Get Rhizoma Paridis and be ground into coarse powder, add 3～5 times 40%～80% ethanol, return to heat up in a steamer and extract 3 times, 5 hours for the first time, 4 hours for the second time, 3 hours for the third time, merge extractive liquid, filtered, and decompression filtrate recycling ethanol becomes thick paste standby.Thick paste can add aqueous dispersion and become suspension, and the suspension spray drying is made fine powder.
Second step was got selected coating material, with for example dissolvings such as ethanol, acetone or alcohol aqueous solution or aqueous acetone solution of solvent that adapt with it, and was diluted to debita spissitudo, 1%-10% (w/v) for example, preferred 2%-8% (w/v), more preferably 4%-8% (w/v) makes coating solution.Get Rhizoma Paridis extractum fine powder again and place fluid bed to make boiling, spray into coating solution with suitable speed then and carry out powder coating, get coated granule, dry back sieving for standby.
The 3rd step will make coated granule takes by weighing according to quantity and mix homogeneously with filler, disintegrating agent, effervescent, correctives, fluidizer, add the lubricant mixing at last, the gained material detects through intermediate, determine the sheet weight after, tabletting is promptly.
GONGXUENING oral cavity disintegration tablet of the present invention can adopt common press device and technology to be prepared, and the manufacturer with preparation conventional tablet all can implement.Adopt the oral cavity disintegration tablet of this method preparation to have enough hardness (intensity), can satisfy the requirement of production, packing, accumulating, have good mouthfeel and short disintegration time simultaneously again.
GONGXUENING oral cavity disintegration tablet of the present invention has cooling blood for hemostasis, removing damp-heat, and the effect of blood-activating analgetic clinically is usually used in treating menorrhagia or diseases such as metrorrhagia, chronic pelvic inflammatory disease.
Specific embodiment
For better explanation the present invention, as follows in conjunction with preparation technology's illustrative example, these embodiment just are used for further setting forth the present invention, and the content that does not limit the present invention in any way.
Embodiment 1
One, prescription
1. raw material---Rhizoma Paridis 2000.0g;
2. filler---microcrystalline Cellulose 145.0g;
Mannitol 120.0g;
3. disintegrating agent---crospolyvinylpyrrolidone 36.0g;
Low-substituted hydroxypropyl cellulose 60.0g;
4. correctives---Aspartane 4.0g;
5. lubricant---magnesium stearate 4.5g;
Make 2000 altogether
Two, preparation method
The first step is got Rhizoma Paridis and is ground into coarse powder, adds 4 times 70% ethanol, returns to heat up in a steamer and extracts 3 times, and 5 hours for the first time, 4 hours for the second time, 3 hours for the third time, merge extractive liquid, filtered, and decompression filtrate recycling ethanol becomes thick paste standby.
Second step added ethanol dilution to having good mobility with Rhizoma Paridis extractum, and get the filler microcrystalline Cellulose and put into mixer granulator, be binding agent with the extractum that dilutes, make granule with stirring, granule was dried 30 mesh sieve granulate;
The 3rd step will make granule takes by weighing also mix homogeneously according to quantity with mannitol, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, Aspartane, it is standby to add the magnesium stearate mixing at last;
The 4th step gained material detects through intermediate, determine that sheet is heavy after, tabletting is promptly.
Embodiment 2
One, prescription
1. raw material---Rhizoma Paridis 2000.0g;
2 filleies---mannitol 110.0g;
Microcrystalline Cellulose 45.0g
3. coating material---Eudragit
E100 26.0g;
4. fluidizer---micropowder silica gel 25.0g;
5. disintegrating agent---crospolyvinylpyrrolidone 40.0g;
Low-substituted hydroxypropyl cellulose 30.0g
6. correctives---Aspartane 2.0g;
Ginseng essence 1.0g;
7. lubricant---magnesium stearate 3.5g;
Make 1000 altogether
Two, preparation method
The first step is got Eudragit E100, uses dissolve with ethanol, and is diluted to 7%, and is standby as coating solution.
Second step got Rhizoma Paridis and is ground into coarse powder, added 3～5 times 70% ethanol, returned to heat up in a steamer and extracted 3 times, and 5 hours for the first time, 4 hours for the second time, 3 hours for the third time, merge extractive liquid, filtered, and decompression filtrate recycling ethanol becomes thick paste standby.Thick paste can add aqueous dispersion and become suspension, and the suspension spray drying is made fine powder.
The 3rd step got Rhizoma Paridis extractum fine powder and mixes with micropowder silica gel and place fluid bed to make boiling, spray into coating solution with suitable speed then and carry out powder coating, coated granule, drying is sieving for standby afterwards.
The 4th step will make coated granule and mannitol, microcrystalline Cellulose, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, Aspartane, ginseng essence, take by weighing also mix homogeneously according to quantity, add the magnesium stearate mixing at last, the gained material detects through intermediate, after determining that sheet is heavy, tabletting promptly.
The mensuration of 3 disintegrations of embodiment
For estimating medicine, carry out following experiment in intraoral disintegrate effect.
Get 6 in the beaker of 50ml, put in 37 ℃ the water-bath, respectively add water 2ml, placed 10 minutes, make hygral equilibrium, get in the foregoing description 16 of the orally disintegrating tablet preparations of preparation, every adds in the beaker timing respectively, shake beaker gently, be as the criterion with the label that can judge not disintegrate, measure the time of complete disintegrate, should disintegrate in 60 seconds.Calculate the average disintegration time of 6 tablets, be decided to be disintegration.According to similar methods, measure the disintegration of the oral cavity disintegration tablet of preparation among the embodiment 2, in following table 1, compare side by side.
Embodiment disintegration (second)
Embodiment 1＜32 second
Embodiment 2＜26 seconds
List of references
[1] Chinese Pharmacopoeia is 2005 editions, 183 pages.
[2] Zhao Zhenhu etc. GONGXUENING is to the rhythm and pace of moving things contraction in isolated rat uterus, PLA's Acta Pharmaceutica Sinica (20) 2:93-95.
[3] Li Dan etc. GONGXUENING is to the influence of post-artificial abortion hemorrhage, and the practical combination of Chinese and Western medicine is clinical, 2004 (4) 4:49-50.
[4] Lu Qian etc. routine clinical observation post-abortions hemorrhage 198 of GONGXUENING JIAONANG medicine, the Hebei traditional Chinese medical science, 2004 (26) 2:147.
Claims (9)
1. GONGXUENING oral cavity disintegration tablet that is used for the treatment of menorrhagia or metrorrhagia or chronic pelvic inflammatory disease.Its raw material is a Rhizoma Paridis, prescription is formed and is comprised supplementary materials such as Rhizoma Paridis extract, coating material, binding agent, wetting agent, filler, disintegrating agent, effervescent, correctives, fluidizer, lubricant, weight proportion between each supplementary material is as follows: Rhizoma Paridis (80～94) %, binding agent (0～5) %, coating material 0.2%～3.0%, filler 3.0%～15%, disintegrating agent 1.0%～8.0%, correctives 0.05%～0.5%, effervescent 0～5%, fluidizer 0.05%～2.0%, lubricant 0.05%～0.5%.
2. according to the GONGXUENING oral cavity disintegration tablet of claim 1, it is characterized in that the Rhizoma Paridis that is used for raw material extracts and handles by following technology.Get Rhizoma Paridis and be ground into coarse powder, add 40%～80% ethanol, return to heat up in a steamer and extract 3 times, 5 hours for the first time, 4 hours for the second time, 3 hours for the third time, merge extractive liquid, filtered, and decompression filtrate recycling ethanol becomes thick paste standby.Thick paste can add aqueous dispersion and become suspension, and the suspension spray drying is made fine powder.
3. a kind of preparation method of the GONGXUENING oral cavity disintegration tablet in the claim 1～2 is:
(1) Rhizoma Paridis extractum being added ethanol dilution to having good mobility, get diluent and put into mixer granulator, is binding agent with the extractum that dilutes, and makes granule with stirring, and granule was dried 30 mesh sieve granulate; Or Rhizoma Paridis extractum mixed with filler, sieving and make granule, granule was dried 30 mesh sieve granulate;
(2) with the granule that makes and other filler, disintegrating agent, effervescent, correctives, fluidizer take by weighing according to quantity and mix homogeneously, it is standby to add the lubricant mixing at last;
(3) the gained material detects through intermediate, determine that sheet is heavy after, tabletting is promptly.。
4. the another kind of preparation method of the GONGXUENING oral cavity disintegration tablet in the claim 1～2 is:
(1) get coating material and dissolve, and be diluted to 2%～12% concentration with appropriate solvent, standby as coating solution.
(2) get the Rhizoma Paridis extract fine powder and place fluid bed to make boiling, spray into coating solution with suitable speed then and carry out powder coating, get coated granule, dry back sieving for standby.
(3) with the coated granule that makes and filler, disintegrating agent, effervescent, correctives, fluidizer take by weighing according to quantity and mix homogeneously, add the lubricant mixing at last, the gained material detects through intermediate, determine that sheet is heavy after, tabletting is promptly.
5. according to the GONGXUENING oral cavity disintegration tablet of claim 4, it is characterized in that described coating material is selected from acrylic resin, ethyl cellulose, methylcellulose, hydroxypropyl emthylcellulose, chitosan, carboxymethyl cellulose salt, cellulose acetate phthalate ester, can use separately, also can be used.
6. according to the GONGXUENING oral cavity disintegration tablet of claim 1～4, it is characterized in that described filler is selected from mannitol, microcrystalline Cellulose, dextrin, lactose, starch, xylitol, sorbitol, erithritol, glucose, polymerization sugar, SMCC, pregelatinized Starch etc., perhaps its combination in any.
7. according to the GONGXUENING oral cavity disintegration tablet of claim 1～4, it is characterized in that described disintegrating agent is selected from crospolyvinylpyrrolidone (PPVP), carboxymethyl starch sodium (CMS-Na), low substituted hydroxy-propyl methylcellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa) etc., can use separately, also can be used.
8. according to the GONGXUENING oral cavity disintegration tablet of claim 1～4, it is characterized in that described correctives is selected from mannitol, lactose, stevioside, Aspartane, cyclamate, glycyrrhizin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, citric acid etc., perhaps its combination in any.
9. according to the GONGXUENING oral cavity disintegration tablet of claim 1～4, wherein can also randomly add effervescent.
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| CNB2005100552046A CN100336502C (en) | 2005-03-15 | 2005-03-15 | Yunnan Manyleaf paris Rhizome extract ora disintegration tablet and its preparing process |
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| CNB2005100552046A CN100336502C (en) | 2005-03-15 | 2005-03-15 | Yunnan Manyleaf paris Rhizome extract ora disintegration tablet and its preparing process |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100464739C (en) * | 2006-07-28 | 2009-03-04 | 北京科信必成医药科技发展有限公司 | Dispersion tablets used as gynecologic hemostatic and its prepn. method |
| CN102302652A (en) * | 2011-08-31 | 2012-01-04 | 刘巧 | Capsules for clearing away heat and toxic materials |
| CN113476422A (en) * | 2021-08-23 | 2021-10-08 | 皖西学院 | Compound rhizoma paridis effervescent tablet and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1528421A (en) * | 2003-10-01 | 2004-09-15 | 浙江天一堂集团有限公司 | Soft capsule for tranquilizing uterine blood and preparing method thereof |
-
2005
- 2005-03-15 CN CNB2005100552046A patent/CN100336502C/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100464739C (en) * | 2006-07-28 | 2009-03-04 | 北京科信必成医药科技发展有限公司 | Dispersion tablets used as gynecologic hemostatic and its prepn. method |
| CN102302652A (en) * | 2011-08-31 | 2012-01-04 | 刘巧 | Capsules for clearing away heat and toxic materials |
| CN102302652B (en) * | 2011-08-31 | 2013-05-22 | 刘巧 | Capsules for clearing away heat toxic |
| CN113476422A (en) * | 2021-08-23 | 2021-10-08 | 皖西学院 | Compound rhizoma paridis effervescent tablet and preparation method thereof |
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| CN100336502C (en) | 2007-09-12 |
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