CN109953992A - Application of the ferroheme in the drug, Food and hygienical food of improvement baby diarrhea - Google Patents

Application of the ferroheme in the drug, Food and hygienical food of improvement baby diarrhea Download PDF

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Publication number
CN109953992A
CN109953992A CN201910314708.7A CN201910314708A CN109953992A CN 109953992 A CN109953992 A CN 109953992A CN 201910314708 A CN201910314708 A CN 201910314708A CN 109953992 A CN109953992 A CN 109953992A
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food
diarrhea
purposes
pharmaceutical composition
ferroheme
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CN201910314708.7A
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Chinese (zh)
Inventor
于茂泉
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Shanghai Pregnancy Management Partnership (limited Partnership)
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Shanghai Pregnancy Management Partnership (limited Partnership)
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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Mycology (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nutrition Science (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention provides application of the ferroheme in the drug, Food and hygienical food of improvement diarrhea.Specifically, provide ferroheme, or derivatives thereof or its analog or its pharmaceutically acceptable salt purposes, it is used to prepare pharmaceutical composition, preparation, food or health food, diarrhea is treated for (a) or improved to described pharmaceutical composition, preparation, food or health food；(b) improve symptom relevant to diarrhea.Pharmaceutical composition or food of the invention, Halth-care composition can not only fast and effeciently improve baby diarrhea, and be convenient for oral absorption, and bioavilability is high, and administration route is convenient, and safety is good.

Description

Application of the ferroheme in the drug, Food and hygienical food of improvement baby diarrhea
Technical field
The present invention relates to medicine, food, field of health care food, relate more specifically to ferroheme in the medicine for improving baby diarrhea Application in object, Food and hygienical food.
Background technique
Baby diarrhea, be one group by more cause of diseases it is multifactor caused by, using diarrhea as the disease of main clinic symptoms, also known as abdomen Disease is rushed down, Infants Below is multiple within 2 years old, wherein about 50% is person within 1 years old.More Acute onsets, if failing thoroughly healing or children Nutrition condition is poor, can develop into persisting diarrhea (course of disease 2 weeks to 2 months) or chronic diarrhea (course of disease is more than 2 months).Pathogenic factors Specifically include that 1, infective agent: infection and extra intestinal infection as caused by enteron aisle inner virus, bacterium, helminth etc.；Infant The main reason for immune development function is not perfect, and easily hair infects；2, non-infective agent: based on dietary factor, mostly by feeding Support it is improper caused by, such as nursing not timing, overfeeding or very few, diatery supplement type are not suitable for, and also have individual infants because of food Allergy does not tolerate and diarrhea occurs, and hair patient is mostly artificial feeding infant；3, predisposing factor: infant's digestive system development is not yet Perfect, growth and development is again fast, does not adapt to the large change of food quality and quantity, therefore be easy to happen the disorders of digestion.
Infantile diarrhea can lead to patient and faint from fear, and long-term diarrhea will cause the shortage of minerals and vitamins, influence The body development and intellectual development of children.Long-term diarrhea can aggravate the home nursing service of parent.
The treatment method of baby diarrhea is in addition to anti-infectives of suiting the medicine to the illness at this stage, there are also medicine administered by injection combination, massage, navel paster, Montmorillonite powder, probiotics etc., but persisting diarrhea and the disease incidence of chronic diarrhea are high, seriously affect children's body Matter causes the shortage of minerals and vitamins, thus aggravates diarrhea, causes vicious circle.
Therefore there is an urgent need in the art to develop the drug or food of the improvement diarrhea that a kind of curative effect is fast, toxic side effect is small.
Summary of the invention
The purpose of the present invention is overcoming above-mentioned improvement anti-diarrhea drug, a kind of quick, significant in efficacy, malicious pair is provided Act on drug, food and the health food of small improvement baby diarrhea.
In the first aspect of the present invention, provide a kind of ferroheme, or derivatives thereof or its analog or its pharmaceutically The purposes of acceptable salt, is used to prepare pharmaceutical composition, preparation, food or health food, described pharmaceutical composition, preparation, Diarrhea is treated for (a) or improved to food or health food；(b) improve symptom relevant to diarrhea.
In another preferred example, the improvement diarrhea, which refers to, takes 1-50 days, 40% or more, preferably 50% or more it is tested Person's diarrhea is effectively improved.
In another preferred example, the subject is selected from the group: the diarrhea patient of untreated, invalid through drug therapy Patient.
In another preferred example, the subject is 2 years old or less crowd.
In another preferred example, the drug is selected from the group: anti-infectives, alimentary canal mucous membrane protective agent, intestinal flora Regulator etc..
In another preferred example, the ferroheme has structure shown in formula A:
In another preferred example, the ferroheme is hemin.
In another preferred example, the diarrhea is selected from the group: acute diarrhea, persisting diarrhea, chronic diarrhea.
In another preferred example, the symptom relevant to diarrhea is selected from the group: times of defecation increases, stool amount increases, Overflow cream, vomiting, abdominal pain, fever, thirsty, anus is red, appetite stimulator, dehydration, agitation, apathetic, drowsiness, pale complexion, white Cell count is obviously increased or combinations thereof.
In another preferred example, contain 0.001-99wt% in described pharmaceutical composition, preparation, food or health food, Preferably 0.1-90wt%, the more preferably ferroheme of 1-80wt%, or derivatives thereof or its analog or its solvate or Its pharmaceutically acceptable salt, by the total weight of composition, preparation, food or health food.
In another preferred example, contain 0.001-99wt%'s in described pharmaceutical composition, preparation, food or health food Hemin.
In another preferred example, contain 0.1-90wt% in described pharmaceutical composition, preparation, food or health food, compared with Good ground 1-80wt%, more preferably 5-60wt%, the most preferably hemin of 20-50wt%.
In another preferred example, the pharmaceutical composition, preparation, food or health food can also be living containing other drugs Acceptable carrier in property ingredient, pharmaceutically acceptable carrier or food, health food.
In another preferred example, the carrier is selected from the group: diluent, filler, adhesive, wetting agent, collapses excipient Solve agent, sorbefacient, sweetener, flavouring agent.
In another preferred example, the pharmaceutical composition, preparation, food or health food can made of dosage form be selected from The following group: tablet, pulvis, capsule, granule, oral fluid agent, ointment, injection, aerosol, pill, paste, suppository.
In another preferred example, the dosage form is that ferroheme is enable to be efficiently entering intracorporal all dosage forms.
In another preferred example, the pharmaceutical composition, preparation, food or health food can also contain other micro members Element, such as: zinc, calcium, selenium.
In another preferred example, the pharmaceutical composition, preparation, food or health food can also contain other auxiliary types Agent, such as: lactose, sorbierite.
It should be understood that above-mentioned each technical characteristic of the invention and having in below (eg embodiment) within the scope of the present invention It can be combined with each other between each technical characteristic of body description, to form a new or preferred technical solution.As space is limited, exist This no longer tires out one by one states.
Specific embodiment
After extensive and in-depth study, developing ferroheme (structure is shown in formula I) for the first time can be significant by the present inventor Ground improves baby diarrhea and symptom relevant to diarrhea, without gastrointestinal irritation and liver kidney side effect.Experiment shows medicine of the invention Compositions or Halth-care composition can not only fast and effeciently improve baby diarrhea, and be convenient for oral absorption, biological utilisation Degree is high, and administration route is convenient, and safety is good.The present invention is completed on this basis.
Unless otherwise defined, otherwise whole technologies used herein and scientific term all have such as fields of the present invention The normally understood identical meanings of those of ordinary skill.As used herein, in use, term in mentioning the numerical value specifically enumerated " about " mean that the value can change not more than 1% from the value enumerated.For example, as used herein, statement " about 100 " includes 99 Hes 101 and between whole values (for example, 99.1,99.2,99.3,99.4 etc.).
Although can be used in implementation or test of the invention and heretofore described similar or of equal value any method And material, place enumerates preferred method and material herein.
Effective component
The present invention provides the various crystalline substances of a kind of compound ferroheme for improving baby diarrhea, its derivative and the like Type form, pharmaceutically acceptable salt, hydrate or solvate.
It is preferably carried out in mode at of the invention one, the improvement baby diarrhea according to the present invention as effective component Compound ferroheme have formula A structure:
It in the present invention, further include the pharmaceutically acceptable salt of formula A compound.Term " pharmaceutically acceptable salt " refers to The compounds of this invention and acid or alkali are formed by the salt for being suitable as drug.Pharmaceutically acceptable salt includes inorganic salts and organic Salt.A kind of preferred salt is the salt that the compounds of this invention and acid are formed.The acid for suitably forming salt includes but is not limited to: hydrochloric acid, The inorganic acids such as hydrobromic acid, hydrofluoric acid, sulfuric acid, nitric acid, phosphoric acid, formic acid, acetic acid, propionic acid, oxalic acid, malonic acid, succinic acid, rich horse Acid, maleic acid, lactic acid, malic acid, tartaric acid, citric acid, picric acid, methanesulfonic acid, benzene methanesulfonic acid, the organic acids such as benzene sulfonic acid；With And the acidic amino acids such as aspartic acid, glutamic acid.
Formula A compound of the invention can be used method well known to those skilled in the art in the prior art and be prepared, right The response parameter of each step is not particularly limited.In addition, typical compound of the invention can also be obtained by commercially available mode.
In vivo, ferroheme (structure is shown in above-mentioned formula A) is the prothetic group of the substances such as hemoglobin, myoglobins, cytochromes, With the ability for combining oxygen and transmitting electronics.Blood red cellulose product has bioavilability height, without iron rust as irony hardening agent Taste, it is non-stimulated to stomach and intestine the advantages that.Ferroheme be modern generally acknowledged infant, pregnant woman's first choice benefit iron enrich blood product.
Some researches show that ferroheme can be expressed with HO-1 in inductor, improve CO, bilirubin and biliverdin water in blood It is flat, it to slow down heart failure and chronic renal failure process, while can protect vascular endothelial cell, reduce Apoptosis Rate.Therefore, ferroheme has potential application in terms of organ and cytoprotection.But have no that ferroheme improves children at present Report in terms of diarrhea function.
Composition and method of administration
The present invention provides a kind of for improving the composition of baby diarrhea.The composition includes (but and unlimited In): pharmaceutical composition, food compositions, dietary supplements, beverage composition for treating dental erosion etc..
In the present invention, the pharmaceutical composition can be directly used for disease treatment, for example, controlling for baby diarrhea It treats.
The present invention also provides a kind of pharmaceutical composition, it contains the compounds of this invention and pharmaceutically of safe and effective amount Acceptable carrier or excipient.This kind of carrier includes (but being not limited to): salt water, buffer, glucose, water, glycerol, second Alcohol, pulvis, and combinations thereof.Pharmaceutical preparation should match with administration mode.
By taking pharmaceutical composition as an example, composition of the invention can be made into injection form, such as with physiological saline or contain There are glucose and the aqueous solution of other adjuvants to be prepared by conventional method.The pharmaceutical composition of such as tablet and capsule etc Object can be prepared by conventional method.Pharmaceutical composition such as injection, solution, tablet and capsule preferably aseptically manufacture. Pharmaceutical composition of the invention can also be made into pulvis for Neulized inhalation.
The dosage of effective component is therapeutically effective amount, such as about 5 mg/kg body of about 1 microgram/kg body weight-daily Weight.In addition, ferroheme of the invention, its derivative and the like can be also used together with other therapeutic agents.
For pharmaceutical composition of the invention, required object (such as people and the inhuman food in one's mouth can be applied to by way of conventional Newborn animal).Representative method of application includes (but being not limited to): oral, injection, Neulized inhalation etc..
It is by the medicament administration of safe and effective amount in mammal when using pharmaceutical composition, the wherein safe and effective amount Typically at least about 10 micrograms/kg body weight, and in most cases no more than about 8 mg/kg weight, the preferably agent Amount is about 1 mg/kg weight of about 10 micrograms/kg body weight-.Certainly, specific dosage is also contemplated that administration route, patient health The factors such as situation, within the scope of these are all skilled practitioners technical ability.
Main advantages of the present invention include:
1) ferroheme can be effectively improved various diarrhea caused by different reasons, can especially be effectively improved 2 years old or less The diarrhea of crowd；
2) ferroheme does not have any toxic side effect to human body；
3) ferroheme is to have been used to clinical oral healthcare drug, and administration route is convenient, and safety is good.
Present invention will be further explained below with reference to specific examples.It should be understood that these embodiments are merely to illustrate the present invention Rather than it limits the scope of the invention.In the following examples, the experimental methods for specific conditions are not specified, usually according to conventional strip Part, such as Sambrook et al., molecular cloning: laboratory manual (New York:Cold Spring Harbor Laboratory Press, 1989) condition described in, or according to the normal condition proposed by manufacturer.Unless otherwise stated, no Then percentage and number are weight percent and parts by weight.
Embodiment 1.
The present embodiment is directed to 2 years old or less the crowd with diarrhea and observes and evaluate using the effect of following preparations.
1.1 sample
Take hemin as test sample, 30mg/ parts.
1.2 study subject
Times of defecation >=4 times/day, diarrhea period >=14 day, 0-2 years old crowd of no other diseases 328.
1.3 are included in examination trencherman's standard
Selection suffers from the volunteer of diarrhea.
1.4 exclude examination trencherman
1.4.1 intentionally, liver, the important organs complication such as kidney；
1.4.2 merge other serious primary disease persons；
1.4.3 data does not determine curative effect person accurately completely without method；
1.5 test-meal methods
164 people of control group；164 people of test-meal group.Two groups are given conventional Primary Care, including give oral salt fluid infusion, Or venous transfusion, lactose-free milk powder is fed, regular anti-infective therapy is carried out for infection infant.In addition test-meal group is taken Test sample in 1.1,3 times a day, 1 part every time.10 days as a treatment course, continuously take two courses for the treatment of, and nonresponder continues to take 3 A course for the treatment of.
2. validity is observed
2.1 Symptom Observation
Mainly recorded in terms of whether examination trencherman tests front and back diarrhea and improve.
2.2 safety observations
Whether there is or not the toxic side effects such as allergy, poisoning, gastrointestinal reaction for observation.
2.3 Effective judgement standards
1) times of defecation < 4 times/day, forming, clinical symptoms (vomiting, fever) have certain improvement as effective.
2) diarrhea is effectively improved number.
2.4 test result
2) harmonious before test to compare
Completion subject is 300 people, 150 people of control group；150 people of test-meal group.Subject age 2-24 months.Through χ2Inspection It tests, test-meal group and control group age and Sex distribution no significant difference (P > 0.05).
Ordinary circumstance compares before table 1-1 test-meal
2) diarrhoea status compares before and after test-meal
Examination trencherman's curative effect is recorded and is classified, grade scale is shown in Table 1-2.Total effectively number of cases is recovery from illness, effective and have The sum of number of cases of effect.
Table 1-2 curative effect grade scale
After test-meal, for test-meal group diarrhea number compared with being substantially reduced before test-meal, test-meal group and control group difference are statistically significant. After test-meal group takes first course for the treatment of, having 39 in 150, effectively 7 effective, and there are also 3 recoveries from illness；And control group only has 14 to have Effect, 1 effective.After taking two courses for the treatment of, test-meal group has 14 recoveries from illness, and 37 effective, and 55 effectively, and total effective rate reaches 70.67%；Control group has 27 effectively, and 1 effective, and total effective rate only has 21.33%, substantially less than test-meal group.
Test-meal group nonresponder continues to take sample in 1.1, and after three courses for the treatment of, subject's diarrhea is effectively improved.
Allergy, poisoning and other adverse reactions are not observed during test-meal.
Two groups of diarrhea validity comparisons (example) after table 1-3 test-meal
Two groups of diarrhea total effective rates compare (%) after table 1-4 test-meal
Grouping Number of cases (example) First course for the treatment of is efficient Second course for the treatment of is efficient
Control group 150 10 21.33
Test-meal group 150 32.37 70.67
Conclusion
1. ferroheme can be effectively improved various diarrhea caused by different reasons, and not have toxic side effect to human body.
2. the diarrhea that ferroheme can be effectively improved 2 years old or less crowd.
All references mentioned in the present invention is incorporated herein by reference, independent just as each document It is incorporated as with reference to such.In addition, it should also be understood that, after reading the above teachings of the present invention, those skilled in the art can To make various changes or modifications to the present invention, such equivalent forms equally fall within model defined by the application the appended claims It encloses.

Claims (10)

1. a kind of ferroheme, or derivatives thereof or its analog or its pharmaceutically acceptable salt purposes, which is characterized in that It is used to prepare pharmaceutical composition, preparation, food or health food, described pharmaceutical composition, preparation, food or health food are used for (a) treat or improve diarrhea；(b) improve symptom relevant to diarrhea.
2. purposes as described in claim 1, which is characterized in that the improvement diarrhea, which refers to, takes 1-50 days, and 40% or more, it is excellent 50% or more subject's diarrhea is selected to be effectively improved.
3. purposes as described in claim 1, which is characterized in that the ferroheme has structure shown in formula A:
4. purposes as described in claim 1, which is characterized in that the diarrhea is selected from the group: acute diarrhea, unresolved abdomen It rushes down, chronic diarrhea.
5. purposes as described in claim 1, which is characterized in that the symptom relevant to diarrhea is selected from the group: times of defecation Increase, stool amount increase, overflow cream, vomiting, abdominal pain, fever, thirsty, anus is red, appetite stimulator, dehydration, agitation, it is apathetic, Drowsiness, pale complexion, white blood cell count(WBC) obviously increase or combinations thereof.
6. purposes as described in claim 1, which is characterized in that contain in described pharmaceutical composition, preparation, food or health food Have 0.001-99wt%, preferably 0.1-90wt%, more preferably the ferroheme of 1-80wt%, or derivatives thereof or its analog, Or its solvate or its pharmaceutically acceptable salt, by the total weight of composition, preparation, food or health food.
7. purposes as described in claim 1, which is characterized in that pharmaceutical composition, preparation, food or the health food is also Acceptable carrier in other drugs active constituent, pharmaceutically acceptable carrier or food, health food can be contained.
8. purposes as described in claim 1, which is characterized in that pharmaceutical composition, preparation, food or the health food can Be selected from the group with manufactured dosage form: tablet, pulvis, capsule, granule, oral fluid agent, ointment, injection, aerosol, Pill, paste, suppository.
9. purposes as described in claim 1, which is characterized in that the dosage form is intracorporal all to enable ferroheme to be efficiently entering Dosage form.
10. purposes as described in claim 1, which is characterized in that pharmaceutical composition, preparation, food or the health food Other microelements can also be contained, such as: zinc, calcium, selenium.
CN201910314708.7A 2019-04-18 2019-04-18 Application of the ferroheme in the drug, Food and hygienical food of improvement baby diarrhea Pending CN109953992A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106359978A (en) * 2016-08-29 2017-02-01 广西商大科技股份有限公司 Nutritive premixing agent for weaned pigs, in place of antibiotic for reducing diarrhoea of weaned pigs
CN109432409A (en) * 2018-12-19 2019-03-08 上海康孕企业管理合伙企业（有限合伙） Application of the ferroheme in the drug, Food and hygienical food of improvement dysmenorrhea

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106359978A (en) * 2016-08-29 2017-02-01 广西商大科技股份有限公司 Nutritive premixing agent for weaned pigs, in place of antibiotic for reducing diarrhoea of weaned pigs
CN109432409A (en) * 2018-12-19 2019-03-08 上海康孕企业管理合伙企业（有限合伙） Application of the ferroheme in the drug, Food and hygienical food of improvement dysmenorrhea

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
申昆玲 等: "《临床路径释义 小儿内科分册》", 31 July 2018 *
蔡克周 等: "血红素补铁剂对断奶仔猪生长和抗病性能的影响", 《饲料广角》 *

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