CN105497161A - Bezoar detoxicating soft capsule - Google Patents

Bezoar detoxicating soft capsule Download PDF

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Publication number
CN105497161A
CN105497161A CN201610045197.XA CN201610045197A CN105497161A CN 105497161 A CN105497161 A CN 105497161A CN 201610045197 A CN201610045197 A CN 201610045197A CN 105497161 A CN105497161 A CN 105497161A
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soft capsule
radix
gelatin
powder
minutes
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CN105497161B (en
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陈铎
王俊峰
王爱荣
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Beijing Kangerfu Pharmaceutical Co Ltd
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Beijing Kangerfu Pharmaceutical Co Ltd
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    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/37—Digestive system
    • A61K35/413—Gall bladder; Bile
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/36—Arsenic; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/34—Campanulaceae (Bellflower family)
    • A61K36/346—Platycodon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484—Glycyrrhiza (licorice)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/539—Scutellaria (skullcap)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/708—Rheum (rhubarb)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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  • Health & Medical Sciences (AREA)
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Abstract

The invention relates to a bezoar detoxicating soft capsule which is high in bioavailability, stable in quality and free of leakage. The bezoar detoxicating soft capsule comprises contents and a soft capsule shell. According to the bezoar detoxicating soft capsule, the soft capsule shell is prepared from 1 part of gelatin, 1 part of plasticiser and 0.6 part of water, and the plasticiser is selected from one or multiple types of glycerin and sorbitol. The glycerin and the sorbitol are preferably selected, and the weight ratio of the glycerin and the sorbitol is 1 to 1.

Description

A kind of antiphlogistic bezoar soft capsule
Technical field
The present invention relates to a kind of antiphlogistic bezoar soft capsule.
Background technology
Antiphlogistic bezoar soft capsule has clearly been documented in pharmacopeia, and prescription is artificial Calculus Bovis 2.5g, Realgar 25g, Gypsum Fibrosum 100g, Radix Et Rhizoma Rhei 100g, Radix Scutellariae 75g, Radix Platycodonis 50g, Borneolum Syntheticum 12.5g, Radix Glycyrrhizae 25g, above eight tastes, except artificial Calculus Bovis, and Borneolum Syntheticum porphyrize; Realgar water flies into impalpable powder; Radix Et Rhizoma Rhei powder is broken into fine powder; Four tastes such as all the other Radix Scutellariaes decoct with water secondary, each 2 hours, collecting decoction, and filter, filtrate is condensed into thick paste, adds Radix Et Rhizoma Rhei, Realgar powder, dry, then add artificial Calculus Bovis, Borneolum Syntheticum and soybean oil, and mixing, incapsulates, make 1000, to obtain final product.Can heat-clearing and toxic substances removing.Contain in burning hot, laryngopharynx swelling and pain, gingival swelling and pain, aphtha of the mouth and tongue, conjunctival congestion and swelling pain.
But soft capsule as well known to those skilled in the art in use there will be cross-linking reaction or long storage time can be leaked, thus cause active component run off or cause the dissolution rate of capsule to decline, applicant is by a large amount of tests, by the ratio of Suitable content thing and the composition of softgel shell, solve soft capsule and easily leak the technical problem with prolonged disintegration.
Summary of the invention
The object of this invention is to provide that a kind of bioavailability is high, steady quality, the antiphlogistic bezoar soft capsule do not leaked, comprises content and soft capsule shell.
According to soft capsule of the present invention, wherein said soft capsule shell comprise gelatin, water, plasticizer ratio be 1:1:0.6, described plasticizer be selected from glycerol, sorbitol one or more.Preferably glycerine and sorbitol, and the two weight ratio is 1:1.
The preparation of content:
Batch 600,000 prescriptions:
Get the Radix Scutellariae of specified quantity, Radix Platycodonis, Radix Glycyrrhizae, the Gypsum Fibrosum four taste prepared slices of Chinese crude drugs, water extraction: the Radix Scutellariae after weighing, Radix Platycodonis, Radix Glycyrrhizae, Gypsum Fibrosum are dropped in multi-function extractor, add medical material 10 times amount (W/L) drinking water, be warming up to micro-boiling, steam pressure remains on 0.02-0.04MPa, decoct 2 hours, decoction liquor filters through 100 mesh sieves, in filtrate suction basin; 8 times amount (W/L) are added again in extraction pot.Drinking water, be warming up to micro-boiling, steam pressure remains on 0.02-0.04MPa, and decoct 2 hours, decoction liquor filters through 100 mesh sieves, in filtrate suction basin, merges with decocting liquid last time, for subsequent use.Economic benefits and social benefits concentrate: by decoction liquor decompression suction dual-effect energy-saving concentration tank in basin, close inlet valve, carry out economic benefits and social benefits to concentrate, one effect thickening temperature 65 ~ 80 DEG C, the vacuum degree control of one effect vaporization chamber is at 0.02 ~ 0.06Mpa, two effect thickening temperatures 50 ~ 70 DEG C, two effect vaporization chamber vacuum degree control are under 0.05 ~ 0.08Mpa condition, and concentration of liquid medicine to extractum relative density is 1.10-1.15 (65 DEG C); Vacuum concentration: the extractum vacuum after economic benefits and social benefits being concentrated carries out vacuum concentration by economic benefits and social benefits concentration tank suction vacuum concentration pot, vacuum degree control is at 0.01 ~ 0.08Mpa, thickening temperature 50 ~ 70 DEG C, being concentrated into extractum relative density is 1.35-1.40 (50 DEG C).
Get the Radix Et Rhizoma Rhei powder of ormal weight, Realgar powder, cross No. 9 sieves (200 order).First mixed homogeneously by the equivalent method of progressively increasing with Radix Et Rhizoma Rhei powder by Realgar powder, be added in jacketed pan, more slowly add extractum while stirring, extractum mixes 20 minutes with Realgar and Radix Et Rhizoma Rhei fine powder mixture.
Dry: the extractum mixed is loaded in the stainless steel disc of the cleaning of square vacuum drier, be loaded on square vacuum drier inner drying, in dry run, vacuum degree control exists: 0.02 ~ 0.08Mpa, and baking temperature controls: 60 ~ 75 DEG C, dry 24 hours, dry cream moisture requirement≤5.0%
Dried cream powder is broken: dry cream 100 mesh sieve is ground into fine powder, the double-deck medicinal Low Density Polyethylene bag splendid attire of the dried cream powder after pulverizing.
The preparation of capsule material:
Get gelatin 150.00 ㎏, purified water 150.00 ㎏, glycerol 90.00 ㎏
Change glue: by gelatin: purified water: glycerol=1: drop in water-bath type glue tank at 1: 0.6.Change in glue process, start when temperature rises to 65 ~ 70 DEG C to stir, (during stirring, temperature remains on 65 ~ 70 DEG C), when gelatin dissolves completely, start evacuation, vacuum degree control is at 0.01 ~ 0.09Mpa, evacuation 30 minutes, open and put glue mouth valve, by the gelatin solution changed, through 80 mesh screen, put into gelatin heat-preserving container, be incubated 60 ~ 70 DEG C, leave standstill, at least place and can use (for subsequent use) for 4 hours.
Be installed on equipment by medicinal liquid agitating oar, equipment feeding system is connected with medicinal liquid heat-preserving container by pneumatic diaphragm pump.Get gelatin solution, gelatin box is installed on equipment, with gelatin pipeline, gelatin heat-preserving container is connected with equipment gelatin box.Regulate the temperature of gelatin box and heating jacket, it is made to remain on 60-65 DEG C, regulate rubber wheel temperature≤15 DEG C, left and right, the thickness regulating rubber is 0.75-0.80mm, sprinkler body temperature is 38-42 DEG C, and loading amount regulates, every weight (containing the rubber) 0.58-0.65g after compacting, every loading amount is 0.36-0.44g, starts to produce after qualified;
Pelleting: get 10 and heavily check average particle in pelleting process every 30 minutes, every weight (containing the rubber) 0.58-0.65g after compacting, every loading amount is 0.36-0.44g, after pressure, soft capsule formalizes in rotating cage.
Select ball: temperature 18 ~ 26 DEG C, relative humidity less than 65%;
Dry in the air ball: be laid in uniformly by the soft capsule suppressed on stainless steel mesh and carry out drying, stir once in dry run every 2 hours, checks that soft capsule hardness is suitable for can putting into drying rotating cage drying, washing ball;
Dry, wash ball: every cage soft capsule adds special mercerized towel (use 75% ethanol wet) and opens aerator simultaneously, within every 30 minutes, changes mercerized towel once, and the bright oil stains-less of range estimation soft capsule is clean up, have certain hardness without adhesion phenomenon.
Select ball: often coil on soft capsule work platform for placing, the defective soft capsule such as inadequate to leakage of oil, abnormity, loading amount is chosen.
Plastic-aluminum: every plate fills 12, upper plate heats 125 DEG C ~ 130 DEG C, lower plate heats 125 DEG C ~ 130 DEG C, heat-sealing roll temperature 195-205 DEG C, and stamping-out speed 20-60Hz, pressing is tight.
Embodiment 1: the screening of soft capsule material formula
Gelatin, glycerol, water are put in water-bath glue tank according to a certain percentage, and 85 DEG C of-90 DEG C of heating in water bath dissolve, and stir 2h, after vacuumize degassing, 50-60 DEG C of insulation hold over night, second day, compacting soft gelatin capsule, drying, keep sample investigation three months, investigates soft capsule outward appearance and physical property, dry, keep sample investigation three months, investigates soft capsule outward appearance and physical property, the results are shown in Table 1:
The selection of table 1 soft capsule material
Embodiment 2
Soft capsule shell formula: the capsule material of 1-3 in difference option table 1, the soft capsule prepared according to preceding method corresponds to test article 1-3 respectively, and distinguish the softgel shell of 1-3 in option table 1, soybean oil being added to total amount is that 250.00kg and 230.00kg obtains soft capsule, correspond to test article 4-9 respectively, be respectively that capsule material is 100g gelatin, 60g glycerol, 100g water and soybean oil add to the content (test article 4) that total amount is 250.00kg; Capsule material is 100g gelatin, 60g glycerol, 100g water and soybean oil add to the content (test article 5) that total amount is 230.00kg; Capsule material is 100g gelatin, 60g sorbitol, 100g water and soybean oil add to the content (test article 6) that total amount is 250.00kg; Capsule material is 100g gelatin, 60g sorbitol, 100g water and soybean oil add to the content (test article 7) that total amount is 230.00kg; Capsule material is 100g gelatin, 30g glycerol, 30g sorbitol, 100g water and soybean oil add to content (test article 8) that total amount is 250.00kg, capsule material is 100g gelatin, 30g glycerol, 30g sorbitol, 100g water and soybean oil add to the content (test article 9) that total amount is 230.00kg.
Obtain above 9 kinds of soft capsules are placed in high-density polyethylene bottle lid sealing (each formula often bottled 50, each formula with 2 bottles totally 100 test), placement in the Constant Temperature and Humidity Chambers of 40 DEG C of relative humiditys 75% is after 10 months, check the leakage number of different prescription gained soft capsule, leak number divided by each formula 100, obtain slip (%) (slip can represent with R), the results are shown in Table 2:
Table 2
Embodiment 3 Acceleration study
Test method: test article 1-3 and commercially available antiphlogistic bezoar soft capsule in embodiment 2; be placed on 40 DEG C, in the calorstat of relative humidity 75%, sample in the different time periods; measure disintegration time according to regulation under Chinese Pharmacopoeia 2010 editions related annex, the results are shown in Table 3:
Table 3 accelerated test
0 day 1 month 2 months 3 months 4 months 5 months 6 months 7 months
Test article 1 8 minutes 9 minutes 9 minutes 10 minutes 10 minutes 10 minutes 11 minutes 12 minutes
Test article 2 8 minutes 9 minutes 9 minutes 10 minutes 10 minutes 11 minutes 11 minutes 12 minutes
Test article 3 8 minutes 9 minutes 9 minutes 9 minutes 9 minutes 9 minutes 10 minutes 10 minutes
Commercially available 8 minutes 9 minutes 9 minutes 10 minutes 11 minutes 12 minutes 14 minutes 16 minutes
Result shows to prepare soft capsule according to the inventive method, and disintegrate is qualified, and bioavailability is high.

Claims (6)

1. an antiphlogistic bezoar soft capsule, is characterized in that: soft capsule shell comprise gelatin, water, plasticizer ratio be 1:1:0.6, content is antiphlogistic bezoar fluid extract.
2. soft capsule as claimed in claim 1, is characterized in that: plasticizer be selected from glycerol, sorbitol one or more.
3. the soft capsule as described in any one of claims 1 or 2, is characterized in that: plasticizer is selected from glycerol and sorbitol, and the two weight ratio is 1:1.
4. the soft capsule as described in any one of claims 1 or 2, is characterized in that: softgel shell is prepared as follows:
Get gelatin, purified water, glycerol by weight, change glue: by gelatin: purified water: glycerol=1: drop in water-bath type glue tank at 1: 0.6; Change in glue process, start when temperature rises to 65 ~ 70 DEG C to stir, during stirring, temperature remains on 65 ~ 70 DEG C, when gelatin dissolves completely, start evacuation, vacuum degree control is at 0.01 ~ 0.09Mpa, evacuation 30 minutes, open and put glue mouth valve, by the gelatin solution changed, through 80 mesh screen, put into gelatin heat-preserving container, be incubated 60 ~ 70 DEG C, leave standstill, at least place and can use for 4 hours.
5. the soft capsule as described in any one of claims 1 or 2, is characterized in that: content is prepared as follows:
Batch 600,000 prescriptions:
Radix Scutellariae 45.00Kg Radix Platycodonis 30.00Kg Radix Glycyrrhizae 15.00Kg
Gypsum Fibrosum 60.00Kg Realgar 15.00Kg Radix Et Rhizoma Rhei 60.00Kg
Get the Radix Scutellariae of specified quantity, Radix Platycodonis, Radix Glycyrrhizae, the Gypsum Fibrosum four taste prepared slices of Chinese crude drugs, water extraction: the Radix Scutellariae after weighing, Radix Platycodonis, Radix Glycyrrhizae, Gypsum Fibrosum are dropped in multi-function extractor, add medical material 10 times amount (W/L) drinking water, be warming up to micro-boiling, steam pressure remains on 0.02-0.04MPa, decoct 2 hours, decoction liquor filters through 100 mesh sieves, in filtrate suction basin; 8 times amount (W/L) are added again in extraction pot; Drinking water, be warming up to micro-boiling, steam pressure remains on 0.02-0.04MPa, and decoct 2 hours, decoction liquor filters through 100 mesh sieves, in filtrate suction basin, merges with decocting liquid last time, for subsequent use; Economic benefits and social benefits concentrate: by decoction liquor decompression suction dual-effect energy-saving concentration tank in basin, close inlet valve, carry out economic benefits and social benefits to concentrate, one effect thickening temperature 65 ~ 80 DEG C, the vacuum degree control of one effect vaporization chamber is at 0.02 ~ 0.06Mpa, two effect thickening temperatures 50 ~ 70 DEG C, two effect vaporization chamber vacuum degree control are under 0.05 ~ 0.08Mpa condition, and concentration of liquid medicine to extractum relative density is 1.10-1.15 (65 DEG C); Vacuum concentration: the extractum vacuum after economic benefits and social benefits being concentrated carries out vacuum concentration by economic benefits and social benefits concentration tank suction vacuum concentration pot, vacuum degree control is at 0.01 ~ 0.08Mpa, thickening temperature 50 ~ 70 DEG C, being concentrated into extractum relative density is 1.35-1.40 (50 DEG C);
Get the Radix Et Rhizoma Rhei powder of ormal weight, Realgar powder, cross No. 9 sieves (200 order); First mixed homogeneously by the equivalent method of progressively increasing with Radix Et Rhizoma Rhei powder by Realgar powder, be added in jacketed pan, more slowly add extractum while stirring, extractum mixes 20 minutes with Realgar and Radix Et Rhizoma Rhei fine powder mixture;
Dry: the extractum mixed is loaded in the stainless steel disc of the cleaning of square vacuum drier, be loaded on square vacuum drier inner drying, in dry run, vacuum degree control exists: 0.02 ~ 0.08Mpa, and baking temperature controls: 60 ~ 75 DEG C, dry 24 hours, dry cream moisture requirement≤5.0%;
Dried cream powder is broken: dry cream 100 mesh sieve is ground into fine powder, the double-deck medicinal Low Density Polyethylene bag splendid attire of the dried cream powder after pulverizing.
6. the soft capsule described in any one of claim 1-5 is contained in preparation treatment is burning hot, laryngopharynx swelling and pain, gingival swelling and pain, aphtha of the mouth and tongue, the application in conjunctival congestion and swelling pain medicine.
CN201610045197.XA 2016-01-22 2016-01-22 Bezoar soft capsule for detoxifying Active CN105497161B (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108066426A (en) * 2018-01-30 2018-05-25 重庆芸峰药业有限公司 A kind of antiphlogistic bezoar capsule and preparation method thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
国家药典委员会: "《中华人民共和国药典：2015年版.一部》", 30 June 2015, 中国医药科技出版社 *
胡英等: "《药物制剂》", 28 February 2013, 中国医药科技出版社 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108066426A (en) * 2018-01-30 2018-05-25 重庆芸峰药业有限公司 A kind of antiphlogistic bezoar capsule and preparation method thereof

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