CN108670985A - A kind of composition and preparation method thereof for fibroid - Google Patents

A kind of composition and preparation method thereof for fibroid Download PDF

Info

Publication number
CN108670985A
CN108670985A CN201810880249.4A CN201810880249A CN108670985A CN 108670985 A CN108670985 A CN 108670985A CN 201810880249 A CN201810880249 A CN 201810880249A CN 108670985 A CN108670985 A CN 108670985A
Authority
CN
China
Prior art keywords
haematococcus pluvialis
powder
vacuum degree
egcg
chitosan oligosaccharide
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201810880249.4A
Other languages
Chinese (zh)
Inventor
白东跃
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to CN201810880249.4A priority Critical patent/CN108670985A/en
Publication of CN108670985A publication Critical patent/CN108670985A/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/3533,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/702Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7032Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a polyol, i.e. compounds having two or more free or esterified hydroxy groups, including the hydroxy group involved in the glycosidic linkage, e.g. monoglucosyldiacylglycerides, lactobionic acid, gangliosides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/722Chitin, chitosan
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/02Algae
    • A61K36/05Chlorophycota or chlorophyta (green algae), e.g. Chlorella
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Biotechnology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Reproductive Health (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Abstract

The present invention relates to a kind of healthy product composition, and preparation method thereof.A kind of in particular to healthy product composition for fibroid, and preparation method thereof.Health product composition of the present invention contains EGCG, chitosan oligosaccharide, haematococcus pluvialis, sugar alcohol substance, can safely and effectively inhibit fibroid.

Description

A kind of composition and preparation method thereof for fibroid
Technical field
The present invention relates to a kind of healthy product composition, and preparation method thereof.It is in particular to a kind of to be used for uterus muscle The healthy product composition of tumor, and preparation method thereof.It is health product composition of the present invention, including but not limited to drug, medical Food, special diet, health food or functional food, nutritious health product, ordinary food etc..
Background technology
Fibroid be in female sex organ in the most common type benign tumour and human body most common tumour it One, also known as fibromyoma, fibroma uteri.Since fibroid is mainly formed by Uterine Smooth Cell hyperplasia, wherein There is a small amount of fibrous connective tissue to exist as a kind of supporting tissue, therefore also known as leiomyoma of uterus.Fibroid is to women Harm it is very big.On the one hand, for benign fibroid, although non-lethal fibroid, fibroid Can cause colporrhagia, menstruation irregularis, menorrhagia, abdominal mass, an awful ache in the belly, intrauterine infection, gynaecological disease recurrent exerbation, Pressure symptom disease, influences love life, fatiguability, physically weak etc. at infertile or miscarriage, seriously affects the physical and mental health of women.It is another There is the possibility deteriorated in aspect, fibroid, in the patient of benign fibroid, there are about 0.8% can occur canceration, lead to son Palace cancer seriously threatens the life and health of women.
Currently, medically for the therapy of fibroid, mainly there are medicine food therapy treatment and operative treatment.Due to uterus muscle The generation of tumor and hormonal readiness, inherent cause, age, obesity, gestation, abortion history, living habit, living environment, life mood Related to the factors such as pressure, experienced doctor or expert can be according to the myomata size of patient, myomata position, single-shots or multiple The situations such as type myomata, patient symptom, patient age, the myomata speed of growth formulate different therapeutic schemes.Although operation is treatment The effective ways of the disease, but due to operation risk, damage and secondary shortcoming, the trial for exploring non-operative treatment is increasingly subject to weight Depending on.Non-operative treatment is mainly based on medicine food therapy treatment.However, disadvantageously, commonly treating the medicine of fibroid in the market Object such as mifepristone, danazol, tamoxifen etc., the problem of having larger side effect mostly or should not be used for a long time.
EGCG, i.e. Epigallo-catechin gallate (EGCG).It is a kind of naturalization that extracting and developing obtains from green tea Object is closed, is most efficient active monomer component in tea polyphenols, there is good safety and extensive physiological activity.Research Show that EGCG has antitumor, antiviral, antibacterial, adjusts immune, Green Tea Extract damage, anti-oxidant, anti-oxidation stress, anti-blood Bolt formation, anti arteriosclerosis, protection nervous system, antiangiogenic, protection cardiovascular and cerebrovascular and anti-inflammatory effect, it is strong for human body Health is particularly significant.There is correlative study to show that EGCG can effectively inhibit Leiomyoma Cell in foreign countries(ELT3 it) is proliferated, and lures Lead fibroid Apoptosis.
Chitosan oligosaccharide is called Chitosan poly oligosaccharide, chitosan oligomer, is that chitosan is degraded through special biological enzyme technology A kind of degree of polymerization oligosaccharide product between 2~20, molecular weight≤3200Da are that water solubility is preferable, function is big, bioactivity High low molecular weight product.It has the unexistent higher solubility of chitosan, is dissolved in water entirely, is easy to be absorbed and utilized by organism Etc. many unique functions, it acts as 14 times of chitosan, to the immunological regulation of human body, antitumor, reducing blood lipid, blood is adjusted Sugar improves liver and cardio-pulmonary function and other different physiological roles important roles.
Haematococcus pluvialis is called lake life haematococcus or lake green blood ball algae again, is a kind of green alga of generally existing, belongs to group Cutleriales, haematococcus section.Currently, haematococcus pluvialis is acknowledged as producing the best biology of natural astaxanthin in nature.Astaxanthin It is generally acknowledged forth generation antioxidant, and the strongest antioxidant of nature that the mankind have found so far, antioxidant activity, The ability of free radical is removed considerably beyond existing any product, is 1100 times of vitamin E, 50 times of Co-Q10.By Decades clinical application proves that natural astaxanthin has anti-oxidant, protection skin and eyes, resists radiation, anti-aging, resists and swell Tumor, anti-inflammatory, it is antifatigue, prevent cardiovascular and cerebrovascular disease the effects that, to enhancing human immune system and slow down aging all have Significance is described as " healthy soft gold ", " edible diamond " by life scholar.
Invention content
Inventor further study show that, the combination of EGCG, chitosan oligosaccharide, haematococcus pluvialis and sugar alcohol substance, Neng Gouan Complete effective inhibition fibroid.
The purpose of the invention is to overcome the shortcomings of background technology, a kind of composition for fibroid is provided.
The present invention also aims to provide a kind of preparation method of the composition for fibroid.
A kind of composition for fibroid of the invention, contains EGCG, chitosan oligosaccharide, haematococcus pluvialis, sugar alcohol substance.
The use of EGCG, chitosan oligosaccharide, haematococcus pluvialis in the composition are to meet the new resources food of state approval The requirement of product bulletin.
Sugar alcohol substance in the composition includes following one or more ingredients:Steviol glycoside, Sucralose, A Si Ba Tian, acesulfame potassium, stachyose, neotame, xylitol, fructose, oligofructose, xylo-oligosaccharide, polydextrose, mannitol, sucrose, Portugal Grape sugar, resistant dextrin, D-sorbite, maltose, isomalt, Oligomeric manna sugar, dextrin, cyclodextrin, hydroxy propyl-Beta-ring Dextrin, microcrystalline cellulose, carboxymethyl cellulose, hypromellose, pregelatinized starch, starch, starch sugar, lactose, carboxylic first Base sodium starch, protein sugar.
The composition is oral solid formulation, such as pulvis, granule, tablet, capsule etc..
It should be appreciated that being selected generally according to different medicaments according to method well known in the art for oral solid formulation With or the pharmaceutical carrier that is applied in combination, include optionally adhesive, such as povidone (polyvinylpyrrolidone), first Base cellulose, hydroxymethyl cellulose, hypromellose, pregelatinized starch, sodium carboxymethyl starch, hydroxypropyl cellulose, hydroxyl Ethyl cellulose, gelatin, guar gum, xanthans, etc.;Further include lubricant, such as magnesium stearate, stearic acid, talcum powder, hard Aliphatic radical fumaric acid sodium, lauryl sodium sulfate, etc.;Also include optionally disintegrant, such as sodium carboxymethyl starch, low takes For hydroxypropyl cellulose, sodium carboxymethylcellulose, crosslinked polyvinylpyrrolidone, croscarmellose sodium, crosslinking carboxylic first Base sodium starch, pregelatinized starch, etc.;Also include optionally surfactant or cosolvent, such as dodecyl sulphate Sodium, Tween-80, etc.;It may also include pH adjusting agent or buffer or cosolvent, such as phosphate buffer, lemon Acid, sodium citrate, acetate buffer, dilute hydrochloric acid, lactic acid, sodium carbonate, sodium hydroxide, alkaline organic compound, as arginine, Lysine, meglumine, tromethamine, etc.;Also optionally include preservative, such as sodium benzoate, potassium sorbate, to hydroxyl Yl benzoic acid methyl esters, propylparaben, etc.;Also include optionally stabilizer and antioxidant, such as metal network Mixture select ethylenediamine tetra-acetic acid and its salt (mosatil, natrium adetate) etc., sodium sulfite, sodium pyrosulfite, Vitamin C, vitamin E, etc.;Also include optionally taste conditioning agent, such as maltitol, fructose, sucrose, saccharin Sodium, flavoring orange essence, strawberry essence, etc.;It additionally can include other conventional, appropriate additives.It is also understood that combination Can be film coating when agent type is tablet or capsule.For the material of film coating, including suitable coating agent, such as Hypromellose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose phthalate (enteric coating Material), etc.;It also may include plasticizer, such as polyethylene glycol, triethyl citrate, etc.;Also include optionally suitable Suitable solubilizer, such as Polyoxyethylene Sorbitan Monooleate;;It also may include suitable pigment, such as titanium dioxide, various iron oxide, pink color Element, etc..It should be appreciated that above-mentioned " including optionally " refers to that can optionally select to use, can not also use.
Specifically, the present invention provides a kind of composition for fibroid, the prescription containing weight percent composition is such as Under:EGCG 1%~5%, chitosan oligosaccharide 2%~8%, haematococcus pluvialis 1%~10%, sugar alcohol substance 50%~96%.
Preferably, the present invention provides a kind of composition for fibroid, and the prescription containing weight percent composition is such as Under:EGCG 2.5%~3.5%, chitosan oligosaccharide 3%~6%, haematococcus pluvialis 2%~8%, sugar alcohol substance 60%~90%.
A kind of preparation method of composition for fibroid, the preparation method use following steps:
Step 1:EGCG, chitosan oligosaccharide, haematococcus pluvialis, sugar alcohol substance are crushed respectively, the powder size of acquisition reaches It is more than 100 mesh;
Step 2:It is to keep vacuum degree in 0.060MPa~0.098MPa containers that haematococcus pluvialis powder, which is placed in vacuum degree, 30min~90min is handled at 45 DEG C~80 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree to normal Atmospheric pressure is to get to the haematococcus pluvialis of eliminating fishy smell or partial removal;
Step 3:The haematococcus pluvialis powder that above-mentioned defishying is crossed is placed in closed container, 1.2~2.5 air are forced into Pressure handles 30min~60min at 40 DEG C~70 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree To normal atmosphere (An) to get the haematococcus pluvialis powder of de- control raw meat;
Step 4:By the haematococcus pluvialis powder and EGCG powder, chitosan oligosaccharide powder, glycitols material powder equivalent obtained by step 3 It is incremental to be uniformly mixed, it then can be made into the oral solid formulations such as pulvis, granule, tablet, capsule as needed.
The composition of the present invention is had no adverse reaction by clinical observation, can inhibit to significant effective the growth of fibroid.
Specific implementation mode
In the implementation process of the present invention, those of ordinary skill in the art are not departing from scope and spirit of the present invention reality The various embodiments generated on the basis of matter and modification are obvious and are easy to perform.Pass through following implementation Example is further elaborated with the application etc. of the present invention, it is not intended that embodiment limitation of the present invention.
Embodiment 1, a kind of granule and preparation method thereof for fibroid
Recipe quantity by weight percentage, contains:
EGCG 3%, chitosan oligosaccharide 5%, haematococcus pluvialis 6%, steviol glycoside 0.02%, isomalt 30%, D-sorbite 20%, Oligomeric manna sugar 10%, xylitol 26%;
Preparation method uses following steps:
Step 1:Respectively by EGCG, chitosan oligosaccharide, haematococcus pluvialis, isomalt, D-sorbite, Oligomeric manna sugar, xylose Alcohol crushes, and the powder size of acquisition is up to more than 100 mesh;
Step 2:It is to keep vacuum degree in 0.060MPa~0.098MPa containers that haematococcus pluvialis powder, which is placed in vacuum degree, 30min~90min is handled at 45 DEG C~80 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree to normal Atmospheric pressure is to get to the haematococcus pluvialis of eliminating fishy smell or partial removal;
Step 3:The haematococcus pluvialis powder that above-mentioned defishying is crossed is placed in closed container, 1.2~2.5 air are forced into Pressure handles 30min~60min at 40 DEG C~70 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree To normal atmosphere (An) to get the haematococcus pluvialis powder of de- control raw meat;
Step 4:By the haematococcus pluvialis powder and EGCG powder, chitosan oligosaccharide powder, isomalt, sorb obtained by step 3 Sugar alcohol, Oligomeric manna sugar, xylitol equal increments are uniformly mixed, and steviol glycoside is dissolved in 75% ethanol solution, wet granulation, 45 DEG C~60 DEG C dryings to moisture be less than 5%, whole grain is 3g/ bag, filling, seal to get.
Embodiment 2, a kind of tablet and preparation method thereof for fibroid
Recipe quantity by weight percentage, contains:
EGCG 3%, chitosan oligosaccharide 5%, haematococcus pluvialis 6%, steviol glycoside 0.02%, isomalt 30%, D-sorbite 20%, Oligomeric manna sugar 10%, xylitol 24%, croscarmellose sodium 1%, magnesium stearate 1%;
Preparation method uses following steps:
Step 1:Respectively by EGCG, chitosan oligosaccharide, haematococcus pluvialis, isomalt, D-sorbite, Oligomeric manna sugar, xylose Alcohol, croscarmellose sodium crush, and the powder size of acquisition is up to more than 100 mesh;
Step 2:It is to keep vacuum degree in 0.060MPa~0.098MPa containers that haematococcus pluvialis powder, which is placed in vacuum degree, 30min~90min is handled at 45 DEG C~80 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree to normal Atmospheric pressure is to get to the haematococcus pluvialis of eliminating fishy smell or partial removal;
Step 3:The haematococcus pluvialis powder that above-mentioned defishying is crossed is placed in closed container, 1.2~2.5 air are forced into Pressure handles 30min~60min at 40 DEG C~70 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree To normal atmosphere (An) to get the haematococcus pluvialis powder of de- control raw meat;
Step 4:By the haematococcus pluvialis powder and EGCG powder, chitosan oligosaccharide powder, isomalt, sorb obtained by step 3 Sugar alcohol, Oligomeric manna sugar, xylitol, croscarmellose sodium equal increments are uniformly mixed, and steviol glycoside is dissolved in 75% Ethanol solution, wet granulation, 45 DEG C~60 DEG C dryings to moisture are less than 5%, whole grain, and magnesium stearate mixing is added after whole grain, 1.5g/ pieces, tabletting to get.
Embodiment 3, a kind of capsule and preparation method thereof for fibroid
Recipe quantity by weight percentage, contains:
EGCG 3%, chitosan oligosaccharide 5%, haematococcus pluvialis 6%, steviol glycoside 0.02%, isomalt 30%, D-sorbite 20%, Oligomeric manna sugar 10%, xylitol 25%, magnesium stearate 1%;
Preparation method uses following steps:
Step 1:Respectively by EGCG, chitosan oligosaccharide, haematococcus pluvialis, isomalt, D-sorbite, Oligomeric manna sugar, xylose Alcohol crushes, and the powder size of acquisition is up to more than 100 mesh;
Step 2:It is to keep vacuum degree in 0.060MPa~0.098MPa containers that haematococcus pluvialis powder, which is placed in vacuum degree, 30min~90min is handled at 45 DEG C~80 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree to normal Atmospheric pressure is to get to the haematococcus pluvialis of eliminating fishy smell or partial removal;
Step 3:The haematococcus pluvialis powder that above-mentioned defishying is crossed is placed in closed container, 1.2~2.5 air are forced into Pressure handles 30min~60min at 40 DEG C~70 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree To normal atmosphere (An) to get the haematococcus pluvialis powder of de- control raw meat;
Step 4:By the haematococcus pluvialis powder and EGCG powder, chitosan oligosaccharide powder, isomalt, sorb obtained by step 3 Sugar alcohol, Oligomeric manna sugar, xylitol equal increments are uniformly mixed, and steviol glycoside is dissolved in 75% ethanol solution, wet granulation, The sieve granulation of 30 mesh, 45 DEG C~60 DEG C dryings to moisture are less than 5%, whole grain, and magnesium stearate mixing, 0.8g/ are added after whole grain Grain, by gained granule filling to Capsules to get.
Embodiment 4, for the clinical research of fibroid composition
Clinical data:
Whole patients 72 meet the 7th edition teaching material of Le Jie chief editors《Gynecotokology》Middle fibroid diagnostic criteria, by just It examines serial number and is randomly divided into two groups, observation group 36, control group 36;At minimum 26 years old of age, it is up to 52 years old, average age 35.56 ± 8.2 years old;The course of disease 6 months to 8 years, it is 3.2 ± 2.3 years average;Myomata diameter minimum 1.1cm, maximum 5.5cm, it is average 3.28±1.26cm;Whether two groups in age, clinical symptoms, myomata size and merge anaemia etc. no significant difference(P > 0.05), there is comparativity.
Diagnosis and inclusion criteria:
With reference to the 7th edition teaching material of Le Jie chief editors《Gynecotokology》Middle fibroid diagnostic criteria formulates the diagnostic criteria of this paper: (1)Patient can asymptomatic or paramenia, be mainly shown as menorrhagia, menostaxis, the menstrual cycle shorten, can be with leukorrhea Increase, hypogastralgia, the soreness of waist, lower abdomen falling inflation, secondary anemia etc..Tongue is dark violet ecchymosis, small and wiry pulse or thin puckery;(2)Gynaecology examines It looks into:Uterus irregularly increases as within pregnant 2 months sizes, and matter is hard, and there is spherical or nodositas protrusion on surface, smooth, and nothing is adhered; (3)B ultrasound is diagnosed as single-shot or multiple myomata, and single myomata diameter is less than 5cm;(4)Laboratory examination:Routinize blood count Red eggs bletilla hepatic and renal function;(5)Be not in the mood for, brain, liver, kidney important organ disease, and be required to non-operative treatment and be ready to coordinate Curer.
Therapy:
(1)Observation group:
The each 3g of 1 composition of composition embodiment of the present invention, 3 times a day, menstrual period withdraw, and 3 months are 1 course for the treatment of, even served 2 The course for the treatment of checks B ultrasound;
(2)Control group:
GUIZHI FULING JIAONANG(Kangyuan Pharmaceutical Co., Ltd., Jiangsu Prov, authentication code:Chinese medicines quasi-word Z10950005, lot number 160607)3 tablets each time, 3 times a day, menstrual period withdraw, and 3 months are 1 course for the treatment of, even served 2 courses for the treatment of, check B ultrasound.
Observation index:
(1)The variation of menstruation:Including through amount and situations such as menstruation recovery;
(2)Fibroid volume change:
Monitor the three-dimensional diameter of fibroid number and myomata volume before treatment and after treatment after 3~6 months by fixed special messenger's B ultrasound Line, i.e. length calculate the volume of fibroid.To multiple myomata patient, fibroid total volume is each myomata The sum of volume;
(3)Laboratory examination:The indexs such as hemoglobin and hepatic and renal function are monitored before treatment and after treatment.
Curative effect judging standard and result:
According to《New Chinese medicine guideline of clinical investigations》Judge curative effect;
It cures:B ultrasound shows that fibroid disappears, and clinical symptoms disappear;
It is effective:B ultrasound shows that myomata reduces 1.5cm or more, clinical symptom relief or disappearance;
Effectively:B ultrasound shows that myomata reduces 0.5~1.5cm, and clinical symptoms are unchanged without improvement or fibroid, and clinical symptoms disappear It loses;
In vain:Myomata is unchanged or increases, and clinical symptoms are without improvement;
Adverse reaction:The adverse reaction unrelated with therapeutic purposes occurs.
Statistical method:
It is handled using SPSS10.00 softwares, measurement data is examined with t, and enumeration data Chi-square Test, P < 0.05 have for difference Conspicuousness.
Treatment results:
After treating 2 courses for the treatment of, the total effective rate of observation group is apparently higher than control group, and observation group and each 36 trouble of control group In person, observation group, although there is 2 patient's clinical efficacies effective in control group, has without there is the case of adverse reaction The adverse reaction rate of different degrees of adverse reaction, observation group is significantly lower than control group, and two groups of Clinical efficacy comparisons are shown in Table 1, no Good reaction, which is compared, is shown in Table 2.
1 two groups of Clinical efficacy comparisons of table:
Note:Two groups of total effective rates compare, P < 0.05.
2 two groups of adverse reactions of table are compared:
Note:Two groups of adverse reaction rates compare, P < 0.05.
Two groups of pretherapy and post-treatment fibroid volumes are obviously reduced, and difference is significant;Comparison among groups, son before treating Palace myomata volume no significant difference, difference is significant after treatment(P < 0.05), observation group's curative effect is better than control group, two groups of use Fibroid volume change is shown in Table 3 before and after medicine.
3 two groups of fibroid volume curative effects of table compare:
Note:Compared with the control group, △ P > 0.05, △ △ P < 0.05.

Claims (5)

1. a kind of composition for fibroid contains EGCG, chitosan oligosaccharide, haematococcus pluvialis, sugar alcohol substance;The combination Object is oral solid formulation, including pulvis, granule, tablet, capsule, and the sugar alcohol substance in the composition includes following One or more ingredients:It is steviol glycoside, Sucralose, Aspartame, acesulfame potassium, stachyose, neotame, xylitol, fructose, oligomeric Fructose, xylo-oligosaccharide, polydextrose, mannitol, sucrose, glucose, resistant dextrin, D-sorbite, maltose, isomaltoketose Alcohol, Oligomeric manna sugar, dextrin, cyclodextrin, hydroxypropyl-β-cyclodextrin, microcrystalline cellulose, carboxymethyl cellulose, hydroxypropyl are fine Tie up element, pregelatinized starch, starch, starch sugar, lactose, sodium carboxymethyl starch, protein sugar.
2. a kind of composition for fibroid, the prescription containing weight percent composition is as follows:
EGCG 2.5%~3.5%, chitosan oligosaccharide 3%~6%, haematococcus pluvialis 2%~8%, sugar alcohol substance 60%~90%;
Combinations of the above object, preparation method are as follows:
Step 1:EGCG, chitosan oligosaccharide, haematococcus pluvialis, sugar alcohol substance are crushed respectively, the powder size of acquisition reaches It is more than 100 mesh;
Step 2:It is to keep vacuum degree in 0.060MPa~0.098MPa containers that haematococcus pluvialis powder, which is placed in vacuum degree, 30min~90min is handled at 45 DEG C~80 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree to normal Atmospheric pressure is to get to the haematococcus pluvialis of eliminating fishy smell or partial removal;
Step 3:The haematococcus pluvialis powder that above-mentioned defishying is crossed is placed in closed container, 1.2~2.5 air are forced into Pressure handles 30min~60min at 40 DEG C~70 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree To normal atmosphere (An) to get the haematococcus pluvialis powder of de- control raw meat;
Step 4:By the haematococcus pluvialis powder and EGCG powder, chitosan oligosaccharide powder, glycitols material powder equivalent obtained by step 3 It is incremental to be uniformly mixed, it then can be made into the oral solid formulations such as pulvis, granule, tablet, capsule as needed.
3. a kind of granule and preparation method thereof for fibroid, recipe quantity by weight percentage, contains:
EGCG 3%, chitosan oligosaccharide 5%, haematococcus pluvialis 6%, steviol glycoside 0.02%, isomalt 30%, D-sorbite 20%, Oligomeric manna sugar 10%, xylitol 26%;
Preparation method uses following steps:
Step 1:Respectively by EGCG, chitosan oligosaccharide, haematococcus pluvialis, isomalt, D-sorbite, Oligomeric manna sugar, xylose Alcohol crushes, and the powder size of acquisition is up to more than 100 mesh;
Step 2:It is to keep vacuum degree in 0.060MPa~0.098MPa containers that haematococcus pluvialis powder, which is placed in vacuum degree, 30min~90min is handled at 45 DEG C~80 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree to normal Atmospheric pressure is to get to the haematococcus pluvialis of eliminating fishy smell or partial removal;
Step 3:The haematococcus pluvialis powder that above-mentioned defishying is crossed is placed in closed container, 1.2~2.5 air are forced into Pressure handles 30min~60min at 40 DEG C~70 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree To normal atmosphere (An) to get the haematococcus pluvialis powder of de- control raw meat;
Step 4:By the haematococcus pluvialis powder and EGCG powder, chitosan oligosaccharide powder, isomalt, sorb obtained by step 3 Sugar alcohol, Oligomeric manna sugar, xylitol equal increments are uniformly mixed, and steviol glycoside is dissolved in 75% ethanol solution, wet granulation, 45 DEG C~60 DEG C dryings to moisture be less than 5%, whole grain is 3g/ bag, filling, seal to get.
4. a kind of tablet and preparation method thereof for fibroid, recipe quantity by weight percentage, contains:
EGCG 3%, chitosan oligosaccharide 5%, haematococcus pluvialis 6%, steviol glycoside 0.02%, isomalt 30%, D-sorbite 20%, Oligomeric manna sugar 10%, xylitol 24%, croscarmellose sodium 1%, magnesium stearate 1%;
Preparation method uses following steps:
Step 1:Respectively by EGCG, chitosan oligosaccharide, haematococcus pluvialis, isomalt, D-sorbite, Oligomeric manna sugar, xylose Alcohol, croscarmellose sodium crush, and the powder size of acquisition is up to more than 100 mesh;
Step 2:It is to keep vacuum degree in 0.060MPa~0.098MPa containers that haematococcus pluvialis powder, which is placed in vacuum degree, 30min~90min is handled at 45 DEG C~80 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree to normal Atmospheric pressure is to get to the haematococcus pluvialis of eliminating fishy smell or partial removal;
Step 3:The haematococcus pluvialis powder that above-mentioned defishying is crossed is placed in closed container, 1.2~2.5 air are forced into Pressure handles 30min~60min at 40 DEG C~70 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree To normal atmosphere (An) to get the haematococcus pluvialis powder of de- control raw meat;
Step 4:By the haematococcus pluvialis powder and EGCG powder, chitosan oligosaccharide powder, isomalt, sorb obtained by step 3 Sugar alcohol, Oligomeric manna sugar, xylitol, croscarmellose sodium equal increments are uniformly mixed, and steviol glycoside is dissolved in 75% Ethanol solution, wet granulation, 45 DEG C~60 DEG C dryings to moisture are less than 5%, whole grain, and magnesium stearate mixing is added after whole grain, 1.5g/ pieces, tabletting to get.
5. a kind of capsule and preparation method thereof for fibroid, recipe quantity by weight percentage, contains:
EGCG 3%, chitosan oligosaccharide 5%, haematococcus pluvialis 6%, steviol glycoside 0.02%, isomalt 30%, D-sorbite 20%, Oligomeric manna sugar 10%, xylitol 25%, magnesium stearate 1%;
Preparation method uses following steps:
Step 1:Respectively by EGCG, chitosan oligosaccharide, haematococcus pluvialis, isomalt, D-sorbite, Oligomeric manna sugar, xylose Alcohol crushes, and the powder size of acquisition is up to more than 100 mesh;
Step 2:It is to keep vacuum degree in 0.060MPa~0.098MPa containers that haematococcus pluvialis powder, which is placed in vacuum degree, 30min~90min is handled at 45 DEG C~80 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree to normal Atmospheric pressure is to get to the haematococcus pluvialis of eliminating fishy smell or partial removal;
Step 3:The haematococcus pluvialis powder that above-mentioned defishying is crossed is placed in closed container, 1.2~2.5 air are forced into Pressure handles 30min~60min at 40 DEG C~70 DEG C, temperature is then gradually decreased to room temperature, then gradually restore vacuum degree To normal atmosphere (An) to get the haematococcus pluvialis powder of de- control raw meat;
Step 4:By the haematococcus pluvialis powder and EGCG powder, chitosan oligosaccharide powder, isomalt, sorb obtained by step 3 Sugar alcohol, Oligomeric manna sugar, xylitol equal increments are uniformly mixed, and steviol glycoside is dissolved in 75% ethanol solution, wet granulation, The sieve granulation of 30 mesh, 45 DEG C~60 DEG C dryings to moisture are less than 5%, whole grain, and magnesium stearate mixing, 0.8g/ are added after whole grain Grain, by gained granule filling to Capsules to get.
CN201810880249.4A 2018-08-03 2018-08-03 A kind of composition and preparation method thereof for fibroid Pending CN108670985A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201810880249.4A CN108670985A (en) 2018-08-03 2018-08-03 A kind of composition and preparation method thereof for fibroid

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201810880249.4A CN108670985A (en) 2018-08-03 2018-08-03 A kind of composition and preparation method thereof for fibroid

Publications (1)

Publication Number Publication Date
CN108670985A true CN108670985A (en) 2018-10-19

Family

ID=63816358

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201810880249.4A Pending CN108670985A (en) 2018-08-03 2018-08-03 A kind of composition and preparation method thereof for fibroid

Country Status (1)

Country Link
CN (1) CN108670985A (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104206936A (en) * 2014-08-18 2014-12-17 福州乾正药业有限公司 Fishy smell-eliminated and controlled spirulina and preparation method and use thereof
CN104922143A (en) * 2015-05-14 2015-09-23 福州乾正药业有限公司 EGCG (epigallocatechin gallate) and chitosan oligosaccharide composition as well as preparation method and application thereof
CN105362784A (en) * 2015-12-13 2016-03-02 王栋 Medicine composition for treating hysteromyoma and preparation method thereof
CN106728296A (en) * 2016-12-10 2017-05-31 济南昊雨青田医药技术有限公司 It is a kind of to prevent and treat pharmaceutical composition of fibroid and preparation method thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104206936A (en) * 2014-08-18 2014-12-17 福州乾正药业有限公司 Fishy smell-eliminated and controlled spirulina and preparation method and use thereof
CN104922143A (en) * 2015-05-14 2015-09-23 福州乾正药业有限公司 EGCG (epigallocatechin gallate) and chitosan oligosaccharide composition as well as preparation method and application thereof
CN105362784A (en) * 2015-12-13 2016-03-02 王栋 Medicine composition for treating hysteromyoma and preparation method thereof
CN106728296A (en) * 2016-12-10 2017-05-31 济南昊雨青田医药技术有限公司 It is a kind of to prevent and treat pharmaceutical composition of fibroid and preparation method thereof

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
于广利等: "《糖药物学》", 31 October 2012, 中国海洋大学出版社 *
冯延民主编: "《壳寡糖与人类健康》", 31 March 2008, 吉林大学出版社 *
张秋妍等: "EGCG对体外培养子宫肌瘤细胞增殖和凋亡的影响", 《中国医疗前沿》 *

Similar Documents

Publication Publication Date Title
US11166978B2 (en) Compositions comprising sulfated polysaccharides
KR20090010958A (en) Mucosal bioadhesive slow release carrier for delivering active principles
Namdev et al. Floating Drug Delivery Systems: An emerging trend for the treatment of peptic ulcer
CN109758580A (en) Treatment preparation and its application of injury to alimentary tract mucous membrane surface are sprayed to suitable for gastroscope
US20220023221A1 (en) Oral Unit Dosage Form Of Ivermectin
CN108670985A (en) A kind of composition and preparation method thereof for fibroid
CN111297910A (en) Application of maggot in preparing medicine for preventing and treating hyperplasia of mammary glands
CN103877508A (en) Traditional Chinese medicine composition for treating metrocarcinoma
CN110522716A (en) A kind of vagina injectant and preparation method thereof for treating uterine prolapse
EP3741368A1 (en) Capsule for treating ulcerative colitis
WO2018107324A1 (en) Calcium supplement composition for decreasing risk of hypercalcemia and use thereof
CN101773627A (en) Chinese medicament for treating postpartum lochiorrhea
CN112007006A (en) A pharmaceutical composition for treating oral ulcer, and its preparation method
CN102698043A (en) Medicinal combination for treating thyroid gland
CN107854471A (en) A kind of pharmaceutical preparation and purposes for treating cervical erosion
CN114949105B (en) Medicinal toothpaste for preventing and treating oral mucositis caused by radiotherapy and chemotherapy
CN105663577A (en) Traditional Chinese medicine composition for postpartum care and preparation method thereof
CN101069680B (en) Use of 2-hydroxyl-methyl benzenesulfonic acid in preparing medicine
CN105582035A (en) Pien Tze Huang and application of preparation of Pien Tze Huang in preparation of medicine for treating diabetic foot ulcer
TWI735658B (en) Composition for reducing metabolic syndrome and application thereof
CN107625764B (en) Application of euphorbia ebracteolata B in preparing medicine for preventing and treating diseases related to nerve cell injury
Schrock et al. Does phentermine improve cardiovascular outcomes in obese patients who lose weight taking this medication?
CN104288156B (en) Pharmaceutical composition for treating stomach cancer and application thereof
CN117530944A (en) Application of tetraoctyl itaconate in preparation of medicine for preventing and treating radioactive intestinal injury
CN112773806A (en) Medical application of pharmaceutical composition containing icaritin and madecassic acid

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
WD01 Invention patent application deemed withdrawn after publication

Application publication date: 20181019

WD01 Invention patent application deemed withdrawn after publication