CN109432409A - Application of the ferroheme in the drug, Food and hygienical food of improvement dysmenorrhea - Google Patents

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

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Publication number
CN109432409A
CN109432409A CN201811554513.1A CN201811554513A CN109432409A CN 109432409 A CN109432409 A CN 109432409A CN 201811554513 A CN201811554513 A CN 201811554513A CN 109432409 A CN109432409 A CN 109432409A
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food
dysmenorrhea
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ferroheme
preparation
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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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/41—Porphyrin- or corrin-ring-containing peptides
    • A61K38/42—Haemoglobins; Myoglobins
    • 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
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/18—Peptides; Protein hydrolysates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
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  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
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  • Animal Behavior & Ethology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Reproductive Health (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Endocrinology (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Biomedical Technology (AREA)
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  • 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 dysmenorrhea.Specifically, the present invention provides ferroheme, or derivatives thereof or its analog or its solvate or its pharmaceutically acceptable salt purposes, they be used to prepare pharmaceutical composition, preparation, food or health food, and dysmenorrhea is treated for (a) or improved to described pharmaceutical composition, preparation, food or health food；(b) improve symptom relevant to dysmenorrhea.

Description

Application of the ferroheme in the drug, Food and hygienical food of improvement dysmenorrhea
Technical field
The present invention relates to medicine, food, field of health care food, relate more specifically to ferroheme the drug for improving dysmenorrhea, Application in Food and hygienical food.
Background technique
Dysmenorrhea is one of most common symptom of gynaecology, refers to pass through front and back or menstrual period, hypogastralgia, falling inflation, companion occurs The malaise symptoms such as the soreness of waist, Nausea and vomiting, cold limbs and headache, very then severe pain faintness person.According to whether there is or not the organic diseases of pelvic cavity Become, primary dysmenorrhea and acquired dysmenorrhea can be divided into.The incidence of dysmenorrhea about 30~80%, not only affects female normal Work, life, it is also possible to cover the state of an illness, be delayed the treatment of pernicious gynecological disease, or even threaten to fertility and life.
Currently, clinically mainly using drug therapy to dysmenorrhea: Western medicine and Chinese medicine.Common Western medicine mainly has non-steroid anti- Scorching medicine, contraceptive etc., although these drug good effects, side effect are more；And Chinese patent drug has taken individual difference, effect It is undesirable.
Therefore the drug and food for finding the improvement dysmenorrhea that a kind of curative effect is fast, toxic side effect is small are with regard to particularly important.
Ferroheme is a kind of important nitrogenous compound in body, it is hemoglobin, myoglobins and cytochromes etc. The prothetic group of substance has important physiological function.Clinical research proves that ferroheme is good iron supplementary, to hypoferric anemia There is apparent therapeutic effect.Compared with other iron supplementaries, has many advantages, such as that absorptivity is high, has no toxic side effect, be currently on the market Main iron supplementary.There is good auxiliary therapeutic action to hepatic diseases and tumour simultaneously.
But report of the ferroheme in terms of improving dysmenorrhea is had no at present.
Summary of the invention
The purpose of the present invention is overcoming above-mentioned improvement dysmenorrhea drug, a kind of quick, significant in efficacy, malicious pair is provided Act on drug, food and the health food of small improvement dysmenorrhea.
The first aspect of the present invention provide a kind of ferroheme, or derivatives thereof or its analog or its can pharmaceutically connect The purposes for the salt received is used to prepare pharmaceutical composition, preparation, food or health food, described pharmaceutical composition, preparation, food Or dysmenorrhea is treated for (a) or improved to health food；(b) improve symptom relevant to dysmenorrhea.
In another preferred example, the improvement dysmenorrhea, which refers to, takes 15-60 days, 40% or more, preferably 50% or more by Examination person's dysmenorrhea be improved significantly.
In another preferred example, the improvement dysmenorrhea, which refers to, takes 15-60 days, and 5% or more, preferably 15% or more, it is more excellent 35% or more, and more preferable 45% or more subject's dysmenorrhea is selected to be fully recovered.
In another preferred example, the improvement dysmenorrhea refers to that subject's dysmenorrhea of 6-10% is fully recovered 15 days.
In another preferred example, the improvement dysmenorrhea refers to that subject's dysmenorrhea of 19-25% is fully recovered 30 days.
In another preferred example, the improvement dysmenorrhea refers to that subject's dysmenorrhea of 36-45% is fully recovered 45 days.
In another preferred example, the improvement dysmenorrhea refers to that subject's dysmenorrhea of 40-49% is fully recovered 60 days.
In another preferred example, the subject is selected from the group: the dysmenorrhea patient of untreated, through Western medicine and Chinese traditional treatment Invalid patient.
In another preferred example, the Western medicine and tcm therapy are selected from the group: nonsteroidal anti-inflammatory agent, contraceptive, calcium ion Channel blocker, spasmolysis sedative, receptor stimulating agent, vitamin E, dialectical treatment, specially square proved prescription, the side's of being fixed into treatment, Cycle therapy, acupuncture and moxibustion therapy and other treatment.
In another preferred example, the ferroheme has structure shown in formula A:
In another preferred example, the ferroheme has structure shown in formula A1:
In another preferred example, the ferroheme is hemin.
In another preferred example, the dysmenorrhea is selected from the group: primary dysmenorrhea, acquired dysmenorrhea.
In another preferred example, the symptom relevant to dysmenorrhea is selected from the group: lower abdomen and waist spasmic pain, pendant It is swollen, with the soreness of waist, Nausea and vomiting, loss of appetite, cold limbs, headache, have a stomachache, have a pain in the leg, overall pain, out of strength, dizzy, diarrhea, Insomnia, depression, irritability, nervousness, 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, effective taking dose of ferroheme can be changed according to actual demand, be not limited to this hair Dosage described in bright.
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
The present inventor has found that ferroheme (structure is shown in formula I) can be significant by depth studying extensively for the first time Ground improves menalgia and symptom relevant to dysmenorrhea.Experiment shows pharmaceutical composition or Halth-care composition of the invention The dysmenorrhea of almost all different degrees of (slight, moderate, severe) and relevant to dysmenorrhea can not only fast and effeciently be improved Symptom is convenient for oral absorption, and bioavilability is high, and administration route is convenient, and safety is good.On this basis, the present invention is completed.
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 crystal form shapes of a kind of compound ferroheme for improving dysmenorrhea, its derivative and the like Formula, pharmaceutically acceptable salt, hydrate or solvate.
It is preferably carried out in mode at of the invention one, the change of the improvement dysmenorrhea according to the present invention as effective component Closing object ferroheme has formula A structure:
It is preferably carried out in mode at of the invention one, the change of the improvement dysmenorrhea according to the present invention as effective component Closing object ferroheme has formula A1 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 dysmenorrhea at present Report in terms of function.
Composition and method of administration
The present invention provides a kind of for improving the composition of dysmenorrhea.The composition includes (but being not limited to): medicine Compositions, 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, being used for the treatment of dysmenorrhea.
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 absorption rate is high (bioavilability is high), is free from side effects to stomach and intestine；
(2) ferroheme is to have been used to clinical oral healthcare drug, and administration route is convenient, and safety is good；
(3) ferroheme can be effectively improved various dysmenorrheas caused by different reasons, can especially be effectively improved 18 years old with The dysmenorrhea of upper women population；
(4) ferroheme can be effectively improved different degrees of (slight, the moderate, severe) of almost all dysmenorrhea and with pain Through relevant symptom.
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 calculated by weight.
Material
The material used in the present invention is the chlorinated forms (i.e. hemin) of ferroheme, is separated from animal blood The ferroheme of the high-purity of extraction crystallizes.
Hemin is a kind of bioactive substance extracted from animal blood.It is with molecular forms directly by intestines What mucous membrane absorbed, have many advantages, such as bioavilability height, without iron rust taste, non-stimulated to stomach and intestine.
Hemin and lactose are uniformly mixed, through granulation, drying, tabletting, coating, gained tablet is sample, often Piece 400mg, mesohemin content are 18mg/ piece.
For lactose through granulation, drying, tabletting, coating, gained tablet is reference substance, every 400mg.
Embodiment 1, which is directed to, has 18 years old or more crowd of dysmenorrhea symptom to observe and evaluate using the effect of following preparations
1.1 sample
Take hemin as test sample, 18mg/ parts.
1.2 study subject
There is a dysmenorrhea symptom, 18-50 years old crowd of no other diseases 210,
1.3 are included in examination trencherman's standard
Selection suffers from the volunteer of dysmenorrhea.
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
105 people of control group；105 people of test-meal group.Test-meal group takes the test sample in 1.1,3 times a day, 1 part every time；Control Group is blank control.During test-meal, control group and test-meal group do not change original eating habit, normal diet.Given the test agent is given Give the time 60 days.
2. validity is observed
2.1 Symptom Observation
Mainly recorded in terms of whether examination trencherman tests front and back dysmenorrhea situation 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) whether examination trencherman's self assessment dysmenorrhea improves before and after test-meal.
2) dysmenorrhea improves number.
2.4 test result
1) harmonious before test to compare
Completion subject is 200 people, 100 people of control group；100 people of test-meal group.Subject age 18-50 years old, age of menarche 11-14 years old, the menstrual cycle 23-37 days, menstruation continuous days 3-7 days.Through χ2It examines, test-meal group and control group age distribution difference Not statistically significant (P > 0.05).By table 1-1 as it can be seen that two groups of subject's dysmenorrhea situations are relatively without difference.
Ordinary circumstance compares before table 1-1 test-meal
1) dysmenorrhea situation compares before and after test-meal
Examination trencherman's dysmenorrhea situation is recorded, is classified and is counted by slight, moderate, severe, grade scale is shown in Table 1- 2。
Table 1-2 dysmenorrhea situation grade scale
Test-meal test result is shown in Table 1-3.
Dysmenorrhea situation compares before and after table 1-3 test-meal
Note: wherein "None" indicates no dysmenorrhea symptom, i.e. subject (patient) fully recovers.
The test result of table 1-3 shows: after test-meal, test-meal group dysmenorrhea situation compared with being obviously improved before test-meal, test-meal group with it is right It is statistically significant according to group difference.After test-meal group takes 15 days, moderate pain is reduced to 22 via 30, wherein 6 recoveries from illness；It takes After 30 days, severe pain is reduced to 16 via 18, moderate pain decreased 56.67%, wherein there is 19 complete incidence graphs；Take 45 After it, severe dysmenorrhea patient reduces 38.89%, moderate pain decreased 60.00%, 36.00% patient's recovery from illness；Take 60 After it, severe pain is reduced to 8 via 18, reduces 55.56%, and moderate pain is reduced to 11 via 30, reduces 63.33%, 49.00% patient's recovery from illness.
Allergy, poisoning and other adverse reactions are not observed during test-meal.
Conclusion
Above-mentioned experiment results proved:
1. ferroheme can fast and effeciently improve almost women population all different degrees of (slight, moderates, severe) Dysmenorrhea and symptom relevant to dysmenorrhea；
2. ferroheme absorption rate is high, it is free from side effects to stomach and intestine.
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 dysmenorrhea；(b) improve symptom relevant to dysmenorrhea.
2. purposes as described in claim 1, which is characterized in that the ferroheme has structure shown in formula A:
3. purposes as described in claim 1, which is characterized in that the ferroheme is hemin.
4. purposes as described in claim 1, which is characterized in that the dysmenorrhea is selected from the group: primary dysmenorrhea, secondary pain Through.
5. purposes as described in claim 1, which is characterized in that the symptom relevant to dysmenorrhea is selected from the group: lower abdomen and waist Portion's spasmic pain, falling inflation, with the soreness of waist, Nausea and vomiting, loss of appetite, cold limbs, headache, have a stomachache, have a pain in the leg, overall pain, Out of strength, dizzy, diarrhea, insomnia, depression, irritability, nervousness, 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 contain in described pharmaceutical composition, preparation, food or health food There is the hemin of 0.001-99wt%.
8. the purposes as described in any in claim 1-7, which is characterized in that pharmaceutical composition, preparation, food or the guarantor Health food can also contain acceptable in other drugs active constituent, pharmaceutically acceptable carrier or food, health food Carrier.
9. purposes as claimed in claim 8, which is characterized in that the carrier is selected from the group: diluent, excipient, filler, Adhesive, wetting agent, disintegrating agent, sorbefacient, sweetener, flavouring agent.
10. the purposes as described in any in claim 1-7, which is characterized in that the pharmaceutical composition, preparation, food or Health food can made of dosage form be selected from the group: tablet, pulvis, capsule, granule, oral fluid agent, ointment, injection Agent, aerosol, pill, paste, suppository.
CN201811554513.1A 2018-12-19 2018-12-19 Application of the ferroheme in the drug, Food and hygienical food of improvement dysmenorrhea Pending CN109432409A (en)

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CN109953992A (en) * 2019-04-18 2019-07-02 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 baby diarrhea

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