CN101417072B - Effervescence tablet for treating gynecologic disease - Google Patents
Effervescence tablet for treating gynecologic disease Download PDFInfo
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- CN101417072B CN101417072B CN2008102336399A CN200810233639A CN101417072B CN 101417072 B CN101417072 B CN 101417072B CN 2008102336399 A CN2008102336399 A CN 2008102336399A CN 200810233639 A CN200810233639 A CN 200810233639A CN 101417072 B CN101417072 B CN 101417072B
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Abstract
The invention relates to a drug applied to gynecological diseases and adopting natural herbs as medicinal ingredients, which is a drug preparation of specific preparation formulation. Effervescent tablets are prepared by crude drugs, a disintegrant, a diluting agent and an anti-friction agent according to weight percentage: 38 percent to 42 percent of the crude drugs, 36 percent to 44 percent of the disintegrant, 2.5 percent to 5 percent of the diluting agent and 14 percent to 17 percent of the anti-friction agent; the crude drugs are prepared by mixing powdered extract prepared by 150 portions of bur beggarticks, 100 portions of smilax glabra rhizome, 150 portions of rhizoma paridis, 100 portions of phellodendron, 100 portions of snphora angustifolia, 95 portions of rhizoma atractylodis, 100 portions of fruit of common cnidium, 100 portions of dictamni cortex, 30 portions of periostracum cicadae, 50 portions of Chinese honeylocust spine and 20 portions of peel of bunge pricklyash after being distilled by water, volatile oil extracted from rhizoma atractylodis, peel of bunge pricklyash and fruit of common cnidium, and 5 portions of menthol crystal. As the disintegrant is added into the specific formula and repeated trials are carried out to determine the special mixture ratio for preparing the preparation formulation convenient in use, thereby obviously increasing the cure rate of gynecological disorders. The function of the drug preparation is much better than that of lotion for external application.
Description
Technical field
The present invention relates to a kind of is the medicine that is used for gynaecopathia of medicinal component with the natural plants, is the pharmaceutical preparation of particular dosage form.
Background technology
World Health Organization (WHO) shows Chinese women's investigation: the women of China 41% suffers from vaginitis in various degree; Married woman's sickness rate reaches 70%; And the sickness rate of relevant disease such as cervicitis, adnexitis rises year by year, and gynecological inflammation produce market scale enlarges rapidly, along with the transformation and the growth in the living standard with idea of popularizing of health knowledge; Consumer demand cleans to the use lotion from simple clear water, has formed good curing, health care custom.
Along with development of technology with to improving the demand of cure rate; Educational circles of gynecological and pharmaceutical industry have been developed the higher novel form effervescent of a kind of technology content in recent years; Received the welcome of consumer after the effervescent listing, but most effervescent tablets are all Western medicine prepn, mostly its main component is hormones or the bigger antibacterial class of side effect; Though can play the short run effect that gets instant result to the patient; But life-time service will be with following untoward reaction: mucosa drying, mucosa dysbolismus, skin pruritus etc., What is more possibly cause hepatorenal damage, or brings out precancerous lesion.Thereby employing Chinese medicine effervescent tablet treatment gynaecopathia is very effectively and is beneficial to health.
One Chinese patent application 200310116636.4 discloses a kind of " external-use lotion of gynaecopathia and the method for preparing of this lotion ", and this invents described lotion is the medicament of being processed by the following weight proportion raw material: Herba Bidentis Tripartitae 80-250, Rhizoma Smilacis Glabrae 50-150, Rhizoma Paridis 80-250, Cortex Phellodendri 50-150, Radix Sophorae Flavescentis 50-150, Rhizoma Atractylodis 50-150, Fructus Cnidii 50-150, Cortex Dictamni 50-150, Periostracum Cicadae 10-100, Spina Gleditsiae 10-150, Mentholum 1-20, Pericarpium Zanthoxyli 10-100, Radix Arnebiae (Radix Lithospermi) 50-250.This invents the treatment that said medicine is mainly used in gynaecopathia, is applicable to fumigation in treating.This application is disclosed to be a kind of lotion that is used for mucosa, and well-known, lotion is applicable to fumigation in treating, because wash time is of short duration, the time that causes medicament to contact with mucosa, too short consequently medicine can not be brought into play drug action fully.
Summary of the invention
The objective of the invention is to overcome the deficiency of prior art, a kind of effervescent tablet that can give full play to the treatment gynaecopathia of drug action is provided.
The effervescent tablet of treatment gynaecopathia of the present invention is processed by following raw material medicines in percentage by weight, disintegrating agent, diluent and lubricant: crude drug 38%～42%, disintegrating agent 36%～44%, diluent 2.5%-5%, lubricant 14%～17%; Described crude drug is by 150 parts of Herba Bidentis Tripartitaes, 100 parts of Rhizoma Smilacis Glabraes, 150 parts of Rhizoma Paridis, 100 parts of Cortex Phellodendris, 100 parts of Radix Sophorae Flavescentiss, 95 parts of Rhizoma Atractylodis, 100 parts of Fructus Cnidiis, 100 parts of Cortex Dictamnis, 30 parts of Periostracum Cicadaes, 50 parts of Spina Gleditsiaes, 20 parts in Pericarpium Zanthoxyli, after volatile oil that the extract powder processed behind the water extraction and Rhizoma Atractylodis, Pericarpium Zanthoxyli, Fructus Cnidii extract and 5 parts of mixing of Mentholum, processes; Described disintegrating agent is that alkali is formed with acid is common; Alkali wherein is a kind of in sodium bicarbonate, sodium carbonate or the potassium bicarbonate; Percentage by weight in the shared disintegrating agent is 38%～45%; Acid is a kind of in tartaric acid, malic acid, citric acid or the citric acid, and the percentage by weight in the shared disintegrating agent is 62%～55%; Described diluent is a kind of in lactose, mannitol, sorbitol or the starch; Described lubricant is for gathering ethanedioic acid 6000 (PEC6000), gathering a kind of in ethanedioic acid 4000 (PEG4000) or the carboxymethyl starch sodium.
Because the present invention has added disintegrating agent and through repetition test, has confirmed special proportioning in special formulation, process easy-to-use dosage form, has significantly improved the gynecological diseases cure rate.Its effect is superior to external-use lotion greatly.The application has proposed an innovation that can solve foregoing problems basically.
The design of prescription of the present invention is to combine with clinical practice according to medication experience among the people, aims at gynecological's pudendum illness and establishes, and Herba Bidentis Tripartitae has another name called three and splits Herba Bidentis Bipinnatae in the side, function heat-clearing and toxic substances removing, dissipating blood stasis for subsidence of swelling, and it is rather good that the skin infection effect is controlled in external; Rhizoma Smilacis Glabrae can blood-cleaning detoxifying, dampness removing is dispelled heat, the skin that can be used for showing effect repeatedly or mucosa illness, with the compatible merit of receiving Synergistic of Herba Bidentis Bipinnatae, so the two is all it " monarch drug " among the we.Rhizoma Paridis ability heat-clearing and toxic substances removing, mass dissipating and swelling eliminating; Skin ulcer is treated in Cortex Phellodendri clearing away heat-fire, dampness detoxifcation, and it is thick to be apt to control the foul Huang of women's damp-heat vaginal discharge, controls damp and hot having better effect in 5 habit title " two is wonderful " (first Dan Xi sides) mutually with the Rhizoma Atractylodis of dispeiling pathogenic wind and removing dampness; But Radix Sophorae Flavescentis heat clearing away, dampness, dispel the wind, parasite killing, antipruritic, can control the disease of damp and hot sore or damp invasion of lower energizer; Fructus Cnidii dampness, parasite killing, dispelling wind for relieving itching, the kind pruritus due to damp pathogen of controlling all diseases of cysthus; The Cortex Dictamni bitter cold, can heat clearing and damp drying dispelling wind for relieving itching, kindly control damp and hot sore skin pruritus, with Radix Sophorae Flavescentis, Fructus Cnidii, two wonderful mutual compatibilities control the damp and hot skin infection of woman's pudendum and pruritus imitate good, so be all it " ministerial drug " among the we.It is stronger that Spina Gleditsiae is attacked diffusing power, and the merit of subduing swelling and detoxicating evacuation of pus is arranged, and is external treatment with Chinese medicine article commonly used, with assist " adjuvant drug " in the antipruritic Periostracum Cicadae side of being all of wind-dispelling heat-dissipating, rash; But Fructus Zanthoxyli cold expelling, dampness, expelling insect and relieving itching; The hot cool heat radiation of Mentholum is warded off dirty antipruriticly, and the two is altogether in the side it " messenger drug ".Behind the common compatibility of above Chinese medicine, can gather heat-clearing and toxic substances removing, damp eliminating removes wind, killing parasites for relieving itching, and drug effect is remarkable.
Dosage form of the present invention is the novel form that educational circles of international and domestic gynecological advocates: effervescent, this system type are finally to use tablet molding easily, so be called effervescent tablet.Effervescent tablet according to the invention has following advantage: (1) has enlarged the site of action of medicine.Lotion is limited to vagina illness treatment external, and the gynecological diseases more than 95% all betides intravaginal, and effervescent tablet has overcome the shortcoming of lotion fully.(2) service efficiency of increase medicine, bioavailability is high, avoids the loss of medicine.Lotion runs off when cleaning demibain in a large number, the part drug effect is only arranged in diseased region.But effervescent tablet not only directly gets into vagina and long duration of action and does not lose in diseased region and medicine, and the significant foam that particularly when disintegrate, produces has increased contacting of medicine and diseased region, can better bring into play curative effect.(3) easy to use: the flushing of lotion and demibain receive when and where condition restriction, pollution clothes.Effervescent tablet can directly be put into intravaginal, and is extremely easy to use.(4) be easy to carry and preserve.Drug price according to the invention is cheap, and determined curative effect after putting on market, will have the good social economic benefit.
Pharmacodynamics test of the present invention:
One, the antiinflammatory action of this preparation
1, experiment material
1.1 medicine: this preparation (this preparation of following experiment is present embodiment 1 gained preparation); JIEERYIN: Chinese-foreign joint Chengdu grace prestige generation is enjoyed pharmaceutical Co. Ltd and is produced; Xylene: Beijing Hua Wuchang produces
1.2 animal: Kunming kind rabbit is provided by animal section of unming Medical College.
2, experimental technique
Get 38 of healthy male kind rabbits, body weight 700-800g is divided into 3 groups at random: normal saline group, JIEERYIN group, this preparation group.
With xylene 0.03ml/ only, be applied to kind of a two sides, rabbit auris dextra shell front and back and cause inflammation, the auris dextra shell is coated with respectively with normal saline, JIEERYIN and this preparation (3ml/kg) again after 30 minutes; After 2 hours, take off cervical vertebra and put to death, two auricles about every Mus is cut take off two auricles with diameter 7mm card punch at ears symmetry place; Weigh with analytical balance, deducting left auricle with the auris dextra sheet heavily is auris dextra swelling severe, and calculates inhibitory rate of intumesce respectively; Each drug group and matched group compare, and the result sees table 1:
Table 1
| Dosage ml/kg | Number of animals (only) | Inflammation swelling degree (X ± SD) (mg) | The P value | Suppression ratio (%) | |
| Normal saline | 3 | 12 | 7.5±3.7 | ||
| JIEERYIN | 3 | 12 | 4.8±2.5 | <0.05 | 40 |
| This preparation | 3 | 14 | 4.2±1.5 | <0.05 | 45 |
3, experimental result
This preparation group, positive drug JIEERYIN matched group, xylol lead to kind of a rabbit ease auricle swelling that obvious inhibitory action is arranged, and with the matched group comparing difference significance (P < 0.05) are arranged.
Two, the bacteriostasis of this preparation experiment
(1) medicine
Sample: for effervescent tablet according to the invention, carry out bacteriostatic experiment with five kinds of variable concentrations, concentration is respectively this preparation: No. 1: 100%, No. 2: 50%, No. 3 180%, No. 4 150%, No. 5 200% by embodiment 1; JIEERYIN (contrast is used).Above medicine is all made bacteriostatic experiment with original content.
(2) experimental strain
Totally five kinds of the staphylococcus aureus of gonococcus niikita bacteria strain P-528-1 and the preservation of this teaching and research room, colibacillus, Candida albicans, microsporon gypseum.
(3) experimental technique
Adopt cup-plate method, paper disk method carries out simultaneously.Be about to the intensive streak inoculation of above-mentioned five kinds of antibacterials difference to corresponding plating medium; On each culture plate, put two aseptic steel Oxford cups then; In the cup of Oxford, add said medicine suspension 0.2ml respectively and use the scraps of paper (subsequent use behind the diameter 6mm autoclaving) to soak into same concentration liquid simultaneously to be affixed on the flat board, antibacterial culturing is put 37 ℃ of 24-48 h observation results; Fungal culture is put 25 ℃ of one all observed result.
(4) result
Measure the Oxford cup and scraps of paper medicine bacteriostatic diameter (mm) on every side, the result sees table 2.
Table 2
(5) conclusion
Through the discriminatory analysis of experimental result, this preparation 1-5 sample is similar with the reference substance JIEERYIN to the effect of common microsporon gypseum and Candida albicans.The bacteriostasis of gonococcus, staphylococcus aureus, colibacillus except that No. 2 samples, all is superior to JIEERYIN.
Three, the foam volume of two kinds of gyniatrics agent, foaming persistent period and adhesion are relatively
(1) medicine and instrument
This preparation, JIEERYIN lotion (commercially available), 6 hole constant temperature water baths (Tianjin medium ring experimental electric furnace company limited)
(2) method and result
2.1 gas release, foam duration test: get 3 in 25ML scale test tube; Precision adds water 2ML respectively; Put in (37 ± 1) ℃ water-bath behind the 5min; Add effervescent tablet and lotion respectively in each pipe, be placed on the situation (comprising foam volume, foam character, foaming persistent period) of observing foaming on the test tube rack, the result sees table.
2.2 foamy adhesion test: get 3 of 10ML scale tests; Precision adds water 2ML respectively; Put in (37 ± 1) ℃ water-bath behind the 5min, add effervescent tablet and lotion respectively in each pipe, be placed on the situation of observing foaming on the test tube rack; Treat to have or not medicinal liquid to flow out test tube inclination 90 degree or 180 degree observations behind the complete effervescent of each kind sample, the result sees table 3.
Table 3
| Nomenclature of drug | The foam character | The foaming persistent period | Bubble is the time of staying in vitro | The foam maximum volume | Drug distribution situation in vitro |
| This preparation | Bubble is fine and smooth, the foam gap is tiny | About 160min | About 4h, bubble drop to the 6ML place | 12ML | Medicine is not stratified, and it is not obvious to flow, and tube wall has has many places foaming space sepia medicine to stick in the even test tube, and no medicinal liquid flowed out after test tube was tilted |
| The JIEERYIN lotion | There is not foaming | |
0? | 0.2ML ? | No medicine is attached on the test tube wall, and the medicine layering of test tube bottom can be flowed, and after test tube was tilted, medicinal liquid all flowed out |
2.3 result: this preparation bubble is fine and smooth, and the foam gap is tiny, on foam persistent period and foam are held time, can keep the long time; Can act on affected parts, deep such as lyra of vagina; The medicine foaming is accomplished after the test tube inclination, and this preparation does not have medicinal liquid and flows out, and explains that this preparation adhesion is better.Medicine can fully be used, and lotion does not have that medicine sticks its action time and the active drug utilization rate is all extremely low.
2.4 conclusion: explain this preparation foam hold time and adhesion aspect better, can make like this medicine rest on the affected part longer, be difficult for to flow out, guarantee better curative effect.Also can reduce pollution clothes in addition, not hinder patient's orthobiosis, the effervescent tablet therapeutic effect obviously is superior in lotion.
Four, external Release Performance experiment
1, test sample:
1.1 lotion: En Wei pharmaceutical Co. Ltd in Sichuan produces
1.2 this preparation: Yunnan Mingyang Pharmaceutical Co., Ltd. provides
1.3 laboratory animal: the Wister rat is provided by animal section of basic courses department of unming Medical College
2, test method:
Adopt rat to carry out the mucosa zoopery, measure the adhesion drug level by 2min, 4min, 6min, 8min, 10min respectively.
The result sees Fig. 1.
3, experimental result
Lotion: act on vaginal mucosa, active drug concentration and time are short.(with the dipping bath time correlation, by ten minutes)
This preparation: with lotion relatively, drug release is fast, bioavailability improves greatly, this dosage form is not only sustainable to act on the vagina focus and can reach more than 160 minutes action time, makes cure rate be significantly improved.
Description of drawings
Fig. 1 for the release rate of medicine of the present invention and lotion and action time comparison diagram.
Specific embodiments
Embodiment 2, get 100 parts of 95 parts of Rhizoma Atractylodis, 20 parts in Pericarpium Zanthoxyli, Fructus Cnidii and extract volatile oil after, the aqueous solution after the distillation is collected for use, 150 parts of medicinal residues and Herba Bidentis Tripartitaes, 100 parts of Rhizoma Smilacis Glabraes, 150 parts of Rhizoma Paridis, 100 parts of Cortex Phellodendris, 100 parts of Radix Sophorae Flavescentiss, 100 parts of Cortex Dictamnis, 30 parts of Periostracum Cicadaes, 50 parts of Spina Gleditsiaes, decocte with water twice add 8 times of amounts the first time; Soaked 30 minutes, decocted 2 hours, add 6 times of amounts for the second time, decocted 1 hour; Collecting decoction and above-mentioned aqueous solution filter, and filtrating is concentrated into relative density to 1.2 (85 ℃), puts cold; Add ethanol, make to contain the alcohol amount and reach 60%, left standstill 48 hours; Filter, filtrate recycling ethanol, and be concentrated into thick paste.To relax cloudy clean thick paste in 70 ℃ ± 5 ℃ dryings, pulverizing, cross No. 6 pharmacopeia sieve extract powder, it is subsequent use to get the 100g extract powder; Wherein 50 gram extract powders and 60 gram sodium carbonate (pulverize, cross the pharmacopeia sieve No. 6) are granulated with 50% alcoholic solution; In 65 ℃ ± 5 ℃ dryings, get the alkali grain.Residue 50 gram extract powders and 40 gram malic acids (pulverize, cross the pharmacopeia sieve No. 6) are used 50% alcohol granulation; In 65 ℃ ± 5 ℃ dryings, get sour grain, with 38 gram PEG4000,7 gram mannitol, 5 gram Mentholums pulverizing; Cross the pharmacopeia sieve No. 6, get mixed material, with above-mentioned acid grain, alkali grain, mixed material mix homogeneously; Add the volatile oil of Rhizoma Atractylodis, Pericarpium Zanthoxyli, Fructus Cnidii extraction, the tabletting packing promptly gets.
Embodiment 3, get 100 parts of 95 parts of Rhizoma Atractylodis, 20 parts in Pericarpium Zanthoxyli, Fructus Cnidii and extract volatile oil after, the aqueous solution after the distillation is collected for use, 150 parts of medicinal residues and Herba Bidentis Tripartitaes, 100 parts of Rhizoma Smilacis Glabraes, 150 parts of Rhizoma Paridis, 100 parts of Cortex Phellodendris, 100 parts of Radix Sophorae Flavescentiss, 100 parts of Cortex Dictamnis, 30 parts of Periostracum Cicadaes, 50 parts of Spina Gleditsiaes, decocte with water twice add 8 times of amounts the first time; Soaked 30 minutes, decocted 2 hours, add 6 times of amounts for the second time, decocted 1 hour; Collecting decoction and above-mentioned aqueous solution filter, and filtrating is concentrated into relative density to 1.2 (85 ℃), puts cold; Add ethanol, make to contain the alcohol amount and reach 60%, left standstill 48 hours; Filter, filtrate recycling ethanol, and be concentrated into thick paste.With thick paste in 70 ℃ ± 5 ℃ dryings, pulverizing, cross No. 6 pharmacopeia sieve extract powder, it is subsequent use to get the 100g extract powder, with 50 gram extract powders and 60 gram potassium bicarbonates (pulverize, cross the pharmacopeia sieve No. 6), granulates with 50% alcoholic solution, in 65 ℃ ± 5 ℃ dryings, gets the alkali grain.Residue 50 gram extract powders and 40 gram citric acids (pulverize, cross the pharmacopeia sieve No. 6) are used 50% alcohol granulation; In 65 ℃ ± 5 ℃ dryings, get sour grain, with 38 gram shuttle methyl starch sodium, 7 gram sorbitol, 5 gram Mentholums pulverizing; Cross the pharmacopeia sieve No. 6, get mixed material, with above-mentioned acid grain, alkali grain, mixed material mix homogeneously; Add the volatile oil of Rhizoma Atractylodis, Pericarpium Zanthoxyli, Fructus Cnidii extraction, the tabletting packing promptly gets.
Claims (1)
1. effervescent tablet of treating gynaecopathia; It is characterized in that processing: crude drug 38%～42% by following raw material medicines in percentage by weight, disintegrating agent, diluent and lubricant; Disintegrating agent 36%～44%, diluent 2.5%-5%, lubricant 14%～17%; Described crude drug is by 150 parts of Herba Bidentis Tripartitaes, 100 parts of Rhizoma Smilacis Glabraes, 150 parts of Rhizoma Paridis, 100 parts of Cortex Phellodendris, 100 parts of Radix Sophorae Flavescentiss, 95 parts of Rhizoma Atractylodis, 100 parts of Fructus Cnidiis, 100 parts of Cortex Dictamnis, 30 parts of Periostracum Cicadaes, 50 parts of Spina Gleditsiaes, 20 parts in Pericarpium Zanthoxyli, after volatile oil that the extract powder processed behind the water extraction and Rhizoma Atractylodis, Pericarpium Zanthoxyli, Fructus Cnidii extract and 5 parts of mixing of Mentholum, processes; Described disintegrating agent is that alkali is formed with acid is common; Alkali wherein is a kind of in sodium bicarbonate, sodium carbonate or the potassium bicarbonate; Percentage by weight in the shared disintegrating agent is 38%～45%; Acid is a kind of in tartaric acid, malic acid, citric acid or the citric acid, and the percentage by weight in the shared disintegrating agent is 62%～55%; Described diluent is a kind of in lactose, mannitol, sorbitol or the starch; Described lubricant is to gather ethanedioic acid 6000, gather a kind of in ethanedioic acid 4000 or the carboxymethyl starch sodium.
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| CN2008102336399A CN101417072B (en) | 2008-11-25 | 2008-11-25 | Effervescence tablet for treating gynecologic disease |
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| CN2008102336399A CN101417072B (en) | 2008-11-25 | 2008-11-25 | Effervescence tablet for treating gynecologic disease |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102641320B (en) * | 2012-05-09 | 2013-12-04 | 皖南医学院 | Gynaecological effervescent tablet and preparation method thereof |
| CN102793828B (en) * | 2012-08-09 | 2014-04-16 | 西安太极药业有限公司 | Externally-used washing lotion for treating female vulvitis and colpitis and preparation method thereof |
| CN104274666A (en) * | 2014-10-11 | 2015-01-14 | 中山百鸥医药科技有限公司 | Effervescent tablet for treating gynecological diseases |
| CN110038121A (en) * | 2019-04-23 | 2019-07-23 | 深圳前海千水生物科技有限公司 | A kind of plant complex enzyme gynaecology detoxicating gel |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1546126A (en) * | 2003-11-28 | 2004-11-17 | 温先敏 | Externally applied medical lotion for treating gynecopathy and its preparing process |
| CN1583088A (en) * | 2004-06-08 | 2005-02-23 | 陈志成 | Vaginal effervescent tablets for woman inflammation and their preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1546126A (en) * | 2003-11-28 | 2004-11-17 | 温先敏 | Externally applied medical lotion for treating gynecopathy and its preparing process |
| CN1583088A (en) * | 2004-06-08 | 2005-02-23 | 陈志成 | Vaginal effervescent tablets for woman inflammation and their preparation |
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