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CN110038014A - Application of the ferroheme in the drug, Food and hygienical food of improvement nocturnal pollakiuria - Google Patents

Application of the ferroheme in the drug, Food and hygienical food of improvement nocturnal pollakiuria Download PDF

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Publication number
CN110038014A
CN110038014A CN201910315191.3A CN201910315191A CN110038014A CN 110038014 A CN110038014 A CN 110038014A CN 201910315191 A CN201910315191 A CN 201910315191A CN 110038014 A CN110038014 A CN 110038014A
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China
Prior art keywords
food
ferroheme
purposes
pharmaceutical composition
preparation
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CN201910315191.3A
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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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Priority to CN201910315191.3A priority Critical patent/CN110038014A/en
Publication of CN110038014A publication Critical patent/CN110038014A/en
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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 OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • 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
    • A61P13/00—Drugs for disorders of the urinary system
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nutrition Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Mycology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Polymers & Plastics (AREA)
  • Food Science & Technology (AREA)
  • Epidemiology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention provides application of the ferroheme in the drug, Food and hygienical food of improvement nocturnal pollakiuria.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, nocturnal pollakiuria is treated for (a) or improved to described pharmaceutical composition, preparation, food or health food；(b) improve symptom relevant to nocturnal pollakiuria.Pharmaceutical composition or Halth-care composition of the invention can not only fast and effeciently improve nocturnal pollakiuria, 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 nocturnal pollakiuria
Technical field
The present invention relates to medicine, food, field of health care food, relate more specifically to ferroheme in the medicine for improving nocturnal pollakiuria Application in object, Food and hygienical food.
Background technique
Person in middle and old age's nocturnal pollakiuria refers to enuresis nocturna number 1 time or more；Middle and aged women excludes organic disease, is often accompanied by plant Object nerve dysfunction, spirit, mental handicape.The nocturnal pollakiuria of middle-aging male is generally attributed to chronic non-bacterial prostate Hypertrophy caused by inflammation, hypertrophy of the prostate initial stage show as number of micturitions and increase, and night few then 2-3 times, more then 5-6 times, Er Qiepai Time extension is urinated, with the further hyperplasia of prostate, urine is obstructed, and phenomenon is increasingly heavier, and urine flow attenuates, and stays in urine storage Cannot be discharged in bladder, long it, bladder compensatory capacity is faded, is lost, and hypertrophy of the prostate leads to bladder or renal infection Probability increases, and leads to the serious consequence of threat to life.Enuresis nocturna increase be hypertrophy of the prostate early stage performance, for middle-aged men and old men For, early intervention is significant.
Therefore there is an urgent need in the art to develop the drug or food of the improvement frequent micturition that a kind of curative effect is fast, toxic side effect is small.
Summary of the invention
The object of the present invention is to provide a kind of drug of improvement nocturnal pollakiuria quick, significant in efficacy, toxic side effect is small, Food and health food.
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, Nocturnal pollakiuria is treated for (a) or improved to food or health food；(b) improve symptom relevant to nocturnal pollakiuria.
In another preferred example, the improvement nocturnal pollakiuria, which refers to, takes 1-56 days, 40% or more, preferably 50% or more Subject's nocturnal pollakiuria is improved.
In another preferred example, the subject is selected from the group: the nocturnal pollakiuria patient of untreated, through drug therapy without The patient of effect.
In another preferred example, the drug is selected from the group: diuretics, antidiuretic hormone, anticholinergic agent, α1Receptor resistance Stagnant dose, β3Receptor stimulating agent, 5 alpha reductase inhibitors 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 symptom relevant to nocturnal pollakiuria is selected from the group: urgent urination, urodynia, frequent micturition, blood urine, Urinate line thin, dysuria, amount less, sleep is poor, fever, night sweat out of strength, soreness of waist tinnitus, dryness of the mouth and throat, bitter taste, complexion are white all of a sudden, companion Have vegetative nerve functional disturbance, mental depression, mental handicape, 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 nocturnal pollakiuria and symptom relevant to nocturnal pollakiuria.Experiment shows pharmaceutical composition or food of the invention, health care product Composition can not only fast and effeciently improve nocturnal pollakiuria, and be convenient for oral absorption, and bioavilability is high, administration route side Just, 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 nocturnal pollakiuria, 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 nocturnal pollakiuria 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 night at present Report in terms of frequent micturition function.
Composition and method of administration
The present invention provides a kind of for improving the composition of nocturnal pollakiuria.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 nocturnal pollakiuria 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 frequent micturitions caused by different reasons；
2) ferroheme can be effectively improved the nocturnal pollakiuria of various people；
3) ferroheme does not have any toxic side effect to human body；
4) 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 the mid-aged population with nocturnal pollakiuria and is observed and evaluated using the effect of following preparations.
1.1 sample
Take hemin as test sample, 175mg/ parts.
1.2 study subject
With nocturnal pollakiuria, the mid-aged population of no other diseases 220.
1.3 are included in examination trencherman's standard
Selection suffers from the volunteer of nocturnal pollakiuria.
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
60 people of women in examination trencherman, 160 people of male, the age 38-85 years old.The test sample in 1.1 is taken, one time a day, continuously It takes 8 weeks.
2. validity is observed
2.1 Symptom Observation
Mainly recorded in terms of whether examination trencherman tests front and back nocturnal pollakiuria 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) nocturnal pollakiuria number is reduced, and sleep state is improved, as effectively.
2) nocturnal pollakiuria is effectively improved number.
2.4 test result
1) subject's situation before testing
Completion subject is 190 people, 48 people of women, 142 people of male.
Ordinary circumstance before table 1-1 test-meal
2) nocturnal pollakiuria situation 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 example that is effective and improving The sum of number.
Table 1-2 curative effect grade scale
After taking 4 weeks, two groups of subject's nocturnal pollakiuria situations are obviously improved, number of patients compared be substantially reduced before test-meal (see Table 1-3).Women totally 48 in subject, have 22 (45.83%) be it is effective, 20 (41.67%) improvements, total effective rate reaches To 87.50%；Male 142, there are 53 (37.32%) to reach effective, 37 (26.06%) are improvement, and total effective rate is 63.38%.
After taking 8 weeks, women totally 48 in subject, having 30 (62.50%) is effective, 14 (29.17%) improvements, Total effective rate has reached 91.67%；Male 142, there are 71 (50.00%) to reach effective, 50 (35.21%) are improvement, Total effective rate is 85.21%.
Allergy, poisoning and other adverse reactions are not observed during test-meal.
Nocturnal pollakiuria situation (example) after table 1-3 test-meal
Conclusion
Ferroheme can be effectively improved nocturnal pollakiuria caused by different reasons, and not have toxic side effect to human body.
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 nocturnal pollakiuria；(b) improve symptom relevant to nocturnal pollakiuria.
2. purposes as described in claim 1, which is characterized in that the improvement nocturnal pollakiuria, which refers to, takes 1-56 days, 40% with On, preferably 50% or more subject's nocturnal pollakiuria is 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 ferroheme is hemin.
5. purposes as described in claim 1, which is characterized in that the symptom relevant to nocturnal pollakiuria is selected from the group: urgent urination, Urodynia, frequent micturition, blood urine, urine line are thin, dysuria, measure less, sleep poor, fever, night sweat out of strength, soreness of waist tinnitus, dryness of the mouth and throat, mouth It is bitter, complexion is white all of a sudden, with vegetative nerve functional disturbance, mental depression, mental handicape, 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.
CN201910315191.3A 2019-04-18 2019-04-18 Application of the ferroheme in the drug, Food and hygienical food of improvement nocturnal pollakiuria Pending CN110038014A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1674942A (en) * 2002-06-21 2005-09-28 联邦高等教育系统匹兹堡大学 Pharmaceutical use of nitric oxide, heme oxygenase-1 and products of heme degradation
CN107243010A (en) * 2017-06-30 2017-10-13 上海康孕企业管理合伙企业（有限合伙） Application of the ferroheme in the medicine and health food of sleep-disorder is improved

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1674942A (en) * 2002-06-21 2005-09-28 联邦高等教育系统匹兹堡大学 Pharmaceutical use of nitric oxide, heme oxygenase-1 and products of heme degradation
CN107243010A (en) * 2017-06-30 2017-10-13 上海康孕企业管理合伙企业（有限合伙） Application of the ferroheme in the medicine and health food of sleep-disorder is improved

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
CHADALAVADA VIJAY KRISHNA ET AL.: "Heme oxygenase-1 upregulation modulates tone and fibroelastic properties of internal anal sphincter", 《AM J PHYSIOL GASTROINTEST LIVER PHYSIOL》 *
STEPHAN L.M. PETERS ET AL.: "Rho kinase: a target for treating urinary bladder dysfunction?", 《TRENDS IN PHARMACOLOGICAL SCIENCES》 *
罗滨编著: "《人体功能系统及其运动健康促进》", 31 March 2015, 中国和平出版社 *

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