CN109350652A - The composition of improvement menopause symptom containing NADH, preparation and the preparation method and application thereof - Google Patents

The composition of improvement menopause symptom containing NADH, preparation and the preparation method and application thereof Download PDF

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CN109350652A
CN109350652A CN201810514788.6A CN201810514788A CN109350652A CN 109350652 A CN109350652 A CN 109350652A CN 201810514788 A CN201810514788 A CN 201810514788A CN 109350652 A CN109350652 A CN 109350652A
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刘喜元
张慧
梁倩
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Hongbo Yuan Technology (shenzhen) Ltd Life
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Abstract

The composition of the improvement menopause symptom containing NADH that the invention discloses a kind of, preparation and the preparation method and application thereof are related to medicine and healthcare field.Composition includes component: the γ-aminobutyric acid of remote, 1-10 parts by weight DHA, 1-10 parts by weight of the Herba Epimedii secondary aglycon of NADH, 1-10 parts by weight of 1-10 parts by weight, the chondroitin sulfate of 1-10 parts by weight, the ursodesoxycholic acid of 1-10 parts by weight, the Sialic acid of 1-10 parts by weight, the s- Ademetionine of 1-10 parts by weight, the will of 1-10 parts by weight.Technical solution of the present invention, each component is played a role using suitable proportion compatibility, collaboration in composition, safety, without adverse affects comprehensive improvement menopause symptom.Formulation preparation method process flow of the invention is simple, the process time is short, no coupling product, and production cost is low, it is easy to accomplish large-scale production.

Description

The composition of improvement menopause symptom containing NADH, preparation and preparation method thereof with Using
Technical field
The present invention relates to medicine and healthcare field more particularly to a kind of combinations of the improvement menopause symptom containing NADH Object, preparation and the preparation method and application thereof.
Background technique
Menopausal syndrome is also known as perimenopausal syndrome, is by occurring sex hormone fluctuation before and after postmenopausal women or reducing institute What is caused is a series of based on function disorder of autonomic nervous system, with one group of syndrome of neuropsychological symptom.Menopause can be divided into Natural menopause and two kinds of artificial menopause.Natural menopause refers to that ovarian follicle is used up in ovary or remaining ovarian follicle loses promoting sexual gland hormone Reaction, ovarian follicle are no longer developed and are secreted estrogen, cannot stimulate endometrial growth, lead to menopause.Artificial menopause refers to hand Art cuts off bilateral ovaries or stops ovarian function, such as radiotherapy and chemotherapy with other methods.It individually cuts off uterus and retains Side or bilateral ovaries person, not as artificial menopause.Menopausal syndrome mostly occurs in 45~55 years old, and most of women may occur in which Equal symptom, someone have not started to occur, continue to post menopausal 2~3 years weight in menopause transition symptom, and a few peoples are sustainable Just mitigated or disappeared to 5~10 years symptoms of post menopausal.Artificial menopause person often may occur in which climacteric in 2 weeks after surgery Syndrome, postoperative 2 months reach peak, sustainable 2 years as long as.Climacteric women due to ovarian function gradually fail until lose, Cause estrogen secretion levels to decline to a great extent, thus just causes a series of bodies based on vegetative nerve Wen Luan ﹑ dysbolism The problem of body and spirit.Traditional medicine thinks that climacteric syndrome is that viscera function gradually fails, yin-Yang disequilibrium, Thus there is flushing Chao Re ﹑ dizziness Tou Zhang ﹑ agitation Yi Nu ﹑ depression You Chou ﹑ Xin to throb with fear Shi Mian ﹑ vaginal dryness Zhuo Re ﹑ waist abdomen Bei Tong ﹑ sclerotin The symptoms such as loose.Climacteric syndrome torments patient in spirit and animally, and even more serious can also cause a series of old age Xing Ji Bing ﹑ cancer etc., seriously jeopardizes the health of patient's latter half of one's life.
Country's treatment method major sexual hormonotherapy and medicinal treatment, female-progestogen therapy change in which can dramatically at present Kind spirit-somatization.Total effective rate 84~97%.But its side effect is also obvious: gastrointestinal side effect and estrogen Dosage is related with dosage form.But women's tolerance is good.To reduce side reaction, principle of individuation should be followed, using minimum effective agent Amount is reduced or is discontinued after symptom and sign alleviation.Currently, the drug treatment to female dimacteric syndrome mainly has two Kind.(1) western medical treatment method: doctor trained in Western medicine thinks that hormone replacement therapy is maximally efficient method, and hormone replacement therapy generally comprises Estrogen, progestin combinations therapy and estrin treatment is applied alone, can improve the hectic fever of patient, insomnia, tired, mood is depressed, The symptoms such as the dry pain of emotional agitation, minor depressive, Urogenital atrophy and vagina.(2) Chinese traditional treatment method: Chinese medicine thinks, Female dimacteric syndrome mostly caused by kidney deficiency, women it is close it is premenopausal after, a virtual loss is appointed in kidney qi degradation, punching, and menses will exhaust, essence and blood Deficiency, imbalance between YIN and YANG, there is the deficiency of the kidney yin, sun loses hiding or decline of kidney-YANG, passages through which vital energy circulates lose supported in temperature, internal organs qi and blood not phase It is phenomena such as coordination, not normal so as to cause viscera function.Therefore often there is worried, depressed, irritated, suspicious even happiness anger of worrying too much The symptoms such as impermanence.The treatment method of doctor trained in Western medicine is the estrogen manually synthesized, such as diethylstilbestrol, Nilestriol, ethinyloestradiol, but These artificial synthesized estrogen are used for a long time, endometrium hyperplasia, uterine hemorrhage can be caused, in addition cause cervical carcinoma, Breast cancer, these above-mentioned treatment method toxic side effects are larger.
Chinese medicine thinks the generation of menopausal syndrome with deficiency of kidney-essence, and menses failure, asthenia of essence and blood, it is basic that punching, which is appointed obstructed, Reason, clinical according to different syndrome type, the characteristics of traditional Chinese medicine treatment can play too many levels, multi-level, multi-angle, multiple target effect. It is the method effected a permanent cure that marrow is filled out in enriching yin and nourishing kidney, bone strengthening, and soothing liver-qi stagnation, strengthening the spleen and stomach are the plan suited the medicine to the illness, and QI invigorating resolving sputum, activating microcirculation and removing stasis medicinal are then Prevent the requisite measure that the state of an illness further develops.By treatment, mitigate symptom, shorten the course of disease, adjusts patient's hormone-endocrine system System function, improves body internal and external environment, to alleviate or mitigate the various symptoms of menopausal syndrome, reaches new dynamic Balance, therefore a kind of composition treatment menopausal syndrome of Chinese medicine material is selected, have ten for treatment menopausal syndrome Divide important clinical meaning.
Summary of the invention
It is an object of the invention to overcome the shortcomings of existing treatment method, a kind of improvement Menopause symptom, peace are provided Composition completely without toxic side effect and preparation and preparation method containing the composition.To achieve the goals above, the present invention mentions For following technical solution:
A kind of composition of the improvement menopause symptom containing NADH, including following component: NADH, 1- of 1-10 parts by weight Herba Epimedii secondary aglycon, the chondroitin sulfate of 1-10 parts by weight, the ursodesoxycholic acid of 1-10 parts by weight, the 1-10 weight of 10 parts by weight The amount Sialic acid of part, the s- Ademetionine of 1-10 parts by weight, the will of 1-10 parts by weight are remote, DHA, 1-10 of 1-10 parts by weight are heavy Measure the γ-aminobutyric acid of part.
Preferably, composition further includes at least ten kinds of in the auxiliary material of following weight parts: 4-15 parts of rhizoma acori gramineis, 8-20 parts it is red Chinese herbaceous peony, 20-30 part seed of Oriental arborvitae, 20-30 parts of theanine, 10-20 parts of rhizoma anemarrhenaes, 10-20 parts of centellas, 4-15 parts of folium panacis japonici cum caules, 5-12 parts And oneself, 5-10 parts of silver wire grass, 5-10 parts of dragon-boat flowers, 5-10 parts of Chinese trumpet creepers, 5-10 parts of conical silene herbs, 4-8 parts of Aquilegia yabeanas, 4-8 Part pyrola, 3-6 parts of Caulis Kadsuraes, 8-20 portions of fructus lyciis, 7-17 parts of radix rehmanniae preparatas, 4-15 parts of Radix Angelicae Sinensis, 4-15 portions of Semen Cuscutaes, 4-15 parts Rhizoma anemarrhenae, 7-17 part Morinda officinalis, 4-15 parts of Herba Epimedii, 4-15 parts of frutus cnidiis, 4-15 parts of Rhizoma Chuanxiongs, the 7-17 parts of root barks of tree peony, 7-17 parts prolong recklessly Rope, 7-17 part uncaria, 4-15 parts of mulberry fruits, 4-15 portions of rhizoma cyperis, 4-15 parts of semen coicis, the 4-15 parts of roots of Dahurain angelica, 5-20 parts of dried immature fruit of citron oranges, 5-13 Part fleece-flower root, 15-20 portions of Radix Curcumaes, 5-13 parts of Flos Albiziaes, 10-25 parts of semen ziziphi spinosaes, 10-25 portions of Radix Glycyrrhizaes, 4-15 portions of hawthorn collagen eggs White powder, 5-20 part jujube powder, 5-30 parts of L-Trps, 5-30 parts of vitamin Cs, 5-13 parts of vitamin Es, 5-30 parts of vitamin B1s, 4-15 parts of vitamin B6s, 4-15 parts of vitamin B12s, 5-30 parts of folic acid.
Preferably, composition further includes that auxiliary material moors golden complex ester, fumaric acid, phosphate, xylitol, microcrystalline cellulose, mistake Water Span, magnesium stearate, croscarmellose sodium, magnesium hydroxide, pregelatinated form sediment, calcium sulfate, gas phase two Silica, at least three kinds in lactose.
A kind of preparation of the improvement menopause symptom containing NADH, including the above-mentioned improvement menopause symptom containing NADH Composition.
The preparation method of the preparation of the above-mentioned improvement menopause symptom containing NADH, includes the following steps:
Raw material is subjected to proportion weighing, relevant auxiliary materials are added, mixes and tablet, pill, particle, capsule or aqua is made.
Preferably, the step specifically includes:
Dried supplementary material is crossed into 30-80 mesh respectively, supplementary material keeps drying, the raw material screened is matched Relevant auxiliary materials are added in weighing, and 50 DEG C are warming up to after adding water that mixing is sufficiently stirred at 25-40 DEG C, are made described after stirring 1~2h Preparation.
Preferably, the step specifically includes:
Dried supplementary material is crossed into 30-80 mesh respectively, drying is kept, the raw material screened is subjected to proportion weighing, Relevant auxiliary materials are added simultaneously, is uniformly mixed, tablet is made.
Preferably, the step specifically includes:
A) it prepares content: dried supplementary material is crossed into 30-80 mesh respectively, supplementary material keeps drying, then will sieve The raw material chosen carries out proportion weighing, while relevant auxiliary materials are added, and is uniformly mixed;
B) prepare capsule: by above-mentioned prepared content and flexible glue utricule by pelleting, sizing is dry, wash ball, the ball that dries in the air, It picks up ball and packs and soft capsule is made.
Preferably, the step specifically includes:
(A) auxiliary material component is taken, coarse granule is made, adds 70% ethyl alcohol heating and refluxing extraction, is filtered;Filter residue adds 70% ethyl alcohol again Heating and refluxing extraction, filtering;Filtrate is merged, the thick paste of relative density 1.35~1.40 is concentrated into, it is spare;
(B) add water to step 1 gained thick paste, heating and refluxing extraction volatile oil divides the volatile oil for taking layering, spare;Volatilization After oil after the resulting dregs of a decoction and medical fluid coarse filtration, filtrate centrifuge separation takes supernatant and the dregs of a decoction to distinguish spare;
(C) it takes raw material components to merge with the dregs of a decoction obtained by S2 step, adds water to cook and extract secondary rear coarse filtration, filtrate centrifugation point From extracting to obtain supernatant twice;Supernatant merges with supernatant obtained by S2 step, is concentrated into the thick of relative density 1.35~1.40 Cream, it is spare;
(D) dextrin, superfine silica gel powder are taken, is mixed, is added obtained by S3 step in thick paste, stirs evenly, laying, vacuum drying, It crushes, dextrin is added, spray into the volatile oil that S2 step obtains, sieving mixes, and is packed into capsule body, the capsule of system.
The composition of the above-mentioned improvement menopause symptom containing NADH improves drug and the health care of menopause symptom in preparation It is applied in product.
In technical solution of the present invention, each component is matched using be suitable in the composition of the improvement menopause symptom containing NADH 5 ratios, collaboration play a role, safety, without adverse affects comprehensive improvement menopause symptom.Formulation preparation method of the invention Process flow is simple, the process time is short, no coupling product, and production cost is low, it is easy to accomplish large-scale production.
Specific embodiment
To make technical staff more fully understand the present invention, the embodiment of the present invention is clearly and detailedly illustrated below, But it is not as a limitation of the invention.Obviously, described embodiment is only a part of the embodiments of the present invention, rather than complete The embodiment in portion.Based on the embodiments of the present invention, those of ordinary skill in the art are without creative efforts Every other embodiment obtained, shall fall within the protection scope of the present invention.
The composition for the improvement menopause symptom containing NADH that present invention firstly provides a kind of, including following weight parts Raw material components: the Herba Epimedii secondary aglycons of NADH, 1-10 parts by weight of 1-10 parts by weight, 1-10 parts by weight chondroitin sulfate, The ursodesoxycholic acid of 1-10 parts by weight, the Sialic acid of 1-10 parts by weight, the s- Ademetionine of 1-10 parts by weight, 1-10 parts by weight Remote, 1-10 parts by weight DHA, 1-10 parts by weight of will γ-aminobutyric acid.
Wherein NADH, that is, nicotinamide adenine dinucleotide (reduced nicotinamide adenine Dinucleotide reduced Coenzyme I, chemical formula C21H27N7O14P2, molecular weight 663.43) are also referred to as.Its oxidised form For nicotinamide adenine dinucleotide (oxidized nicotinamide adenine dinucleotide, be abbreviated as NAD), Play the role of transmitting hydrogen and electronics in biological oxidation, play an important role to the growth of maintenance cell, differentiation and energetic supersession.It Participate in the life processes such as metabolism, the rhythm and pace of moving things, lesion, aging and the apoptosis of body cell.NADH preparation method includes following step at present It is rapid: to extract the crude extract or its pure enzyme of nicotinamide-nucleotide adenylyltransferase;Immobilization recombinates the transfer of nicotinamide riboside adenylyl The crude extract of enzyme or its pure enzyme;It is catalyzed with immobilization recombination nicotinamide-nucleotide adenylyltransferase, with nicotinamide nucleotide and three Adenosine phosphate disodium (ATP) is that substrate prepares nicotinamide adenine dinucleotide.Specifically, NADH's the preparation method is as follows:
By the plasmid pRSET-bmj transformed competence colibacillus bacterial cell of niacinamide-containing nucleosides adenylyl transferase gene E.coliHB101 is cultivated 24 hours at upper 37 DEG C of Luriabroth (LB) plate (kanamycins containing 100mg/L).Inoculation is single Be cloned in 5 milliliters of LB liquid mediums (kanamycins containing 100mg/L) in 30 DEG C culture 20-24 hours.Thalline were collected by centrifugation, And it is suspended in 1 milliliter of 100mM Tris hydrochloride buffer (pH7.5).Then ultrasonic treatment bacterial cell is used.Centrifugation (10 DEG C, 17,800g, 10 minutes) and collect supernatant, as thick leach protein (or crude extract).The nicotinamide riboside adenosine of recombination Acyltransferase thick leach protein is heat-treated 10 minutes through 70 DEG C, is centrifuged (10 DEG C, 17,800g, 10 minutes) and is collected supernatant, as Partially purified albumen.
Nicotinamide-nucleotide adenylyltransferase immobilization: take nicotinamide-nucleotide adenylyltransferase thick leach protein or part pure The albumen of change is diluted to protein content 5- with enzyme buffer liquid (0.02MTris-HCl/0.001MEDTA, pH7.0 solution) is washed 10mg/ml.Enzyme dilution and PB solution (2.0mol/L potassium dihydrogen phosphate, pH7.5) are mixed in equal volume, epoxy type is added and fixes Change zymophore LX-3000 (10 milligrams of enzymes/gram carrier), is reacted 20 hours for 25 DEG C in shaking table (revolving speed 100rpm).Reaction is completed Sock filtration is used afterwards, is cleaned 5-6 times with enzyme buffer liquid is washed, is obtained immobilization nicotinamide-nucleotide adenylyltransferase.
Nicotinamide adenine dinucleotide is prepared with immobilization nicotinamide-nucleotide adenylyltransferase:
Prepare substrate solution: trinosin (ATP), the 100mMTris of nicotinamide nucleotide, 10mM containing 5mM The MgCl2 of hydrochloride buffer and final concentration of 10mM adjusts pH to 7.5.1 milliliter of substrate solution is taken, 0.05 gram of fixation is then added Change nicotinamide-nucleotide adenylyltransferase, reaction 2-20 hours is carried out in 37 DEG C.Centrifugation (10 DEG C, 17,800g, 15 minutes) is simultaneously received Collect supernatant.The content of nicotinamide adenine dinucleotide in the supernatant as obtained by high pressure liquid chromatography (HPLC) measurement.Knot The conversion ratio that fruit nicotinamide nucleotide is converted into nicotinamide adenine dinucleotide is more than 80%.
Herba Epimedii secondary aglycon directlys adopt beta-glucosidase enzymatic hydrolysis using icariin as raw material in above-mentioned raw materials component Icariin prepares baohuoside Ⅰ, and β-D-Glucose of cutting icariin C-7 prepares the baohuoside Ⅰ of high-purity, reacts Formula is as follows:
The composition of improvement menopause symptom containing NADH of the invention, further include in the auxiliary material of following weight parts extremely Few 10 kinds: 4-15 part of rhizoma acori graminei, 8-20 parts of radix paeoniae rubras, the 20-30 parts of seed of Oriental arborvitaes, 20-30 parts of theanine, 10-20 parts of rhizoma anemarrhenaes, 10-20 Part centella, 4-15 parts of folium panacis japonici cum caules, 5-120 parts and oneself, 5-10 parts of silver wires grass, 5-10 parts of dragon-boats flowers, 5-10 parts of Chinese trumpet creepers, 5-10 Part conical silene herb, 4-8 parts of Aquilegia yabeanas, 4-8 portions of pyrolas, 3-6 parts of Caulis Kadsuraes, 8-20 portions of fructus lyciis, 7-17 parts of radix rehmanniae preparatas, 4- 15 parts of Radix Angelicae Sinensis, 4-15 portions of Semen Cuscutaes, 4-15 parts of rhizoma anemarrhenaes, 7-17 parts of Morinda officinalis, 4-15 parts of Herba Epimedii, 4-15 parts of frutus cnidiis, 4-15 Part Rhizoma Chuanxiong, the 7-17 parts of root barks of tree peony, 7-17 parts of rhizoma corydalis, 7-17 parts of uncarias, 4-15 parts of mulberry fruits, 4-15 portions of rhizoma cyperis, 4-15 portions of coix lacryma-jobi Benevolence, 4-15 part root of Dahurain angelica, the 5-20 parts of dried immature fruit of citron oranges, the 5-13 parts of fleece-flowers root, 15-20 portions of Radix Curcumaes, 5-13 parts of Flos Albiziaes, 10-25 parts of semen ziziphi spinosaes, 10-25 portions of Radix Glycyrrhizaes, 4-15 parts of hawthorn collagen protein powders, 5-20 parts of jujube powders, 5-30 parts of L-Trps, 5-30 parts of vitamin Cs, 5- 13 parts of vitamin Es, 5-30 parts of vitamin B1s, 4-15 parts of vitamin B6s, 4-15 parts of vitamin B12s, 5-30 parts of folic acid.
The composition of improvement menopause symptom of the invention containing NADH simultaneously further includes that auxiliary material moors golden complex ester, rich horse Acid, phosphate, xylitol, microcrystalline cellulose, sorbitan fatty acid ester, magnesium stearate, croscarmellose sodium, hydrogen Magnesia, pregelatinated form sediment, calcium sulfate, fumed silica, at least three kinds in lactose.
The composition of improvement menopause symptom disclosed by the invention containing NADH, each component is using suitable compatibility ratio Example, it is the composition for capableing of a kind of comprehensive climacteric care for multiple links that collaboration, which plays a role,.Specifically: this hair Bright to be formed using pure Chinese medicine rational proportion, reasonable recipe, compatibility is proper, and NADH and Herba Epimedii secondary aglycon are monarch drug in a prescription, s- in side Ademetionine enriching yin nourishing liver and kidney, three are monarch drug in a prescription altogether, adjust gonad axis comprehensively, nourish and repair impaired ovary, restore female, pregnant and swash Plain normal secretions make female incretion remain at equilibrium state, and long-term use delays gonad axis aging periods, postpone menopause Phase improves sexual function.Sialic acid strengthening the spleen and replenishing qi in ministerial drug, ursodesoxycholic acid enriches blood, blood circulation, and multiple medicine shares, to reach help The effect of qi and blood, and have certain adjustment effect to endocrine, hypothalamus-hypophysis-gonad axis function can be enhanced.
In adjuvant, while it is defeated to help the remote precise and tiny and sufficient qi and blood that enables to achieve one's ambition with s- Ademetionine, dredging the channel It send in kidney, thus nourshing kidney consolidating the yin, what congenital essence was able to is supported.γ-aminobutyric acid and DHA are to make medicine, coordinating the drug actions of a prescription, are altogether assistant Make.The above-mentioned all medicines of monarch are harmonious, altogether the replenishing essence of having reinforce the kidney, tonifying Qi and blood, Heibei provincial opera yin-yang, arrest sweating of promoting blood circulation, calming the liver tranquilizing the mind function, Also there is apparent menstruation regulating cold dispelling, improve sexual function, anti-aging, improve Abwehrkraft des Koepers, blood-enrich, supporting and hold skin care, improve The effect of the treatment climacteric syndromes such as sleep, reduction perspiration.
Medicinal material compatibility selected by Chinese materia medica preparation of the present invention is suitable, meets traditional Chinese medicine and modern medicine is theoretical, easy to use, absorbs Effect is good, without bad and toxic side effect, according to clinical verification, can mitigate symptom, shorten the course of disease, adjust endocrine system function, change Kind body internal and external environment is suitable for menopausal syndrome clinical treatment to alleviate or mitigate the various symptoms of menopausal syndrome It is promoted and applied with nursing.
The present invention is put forward for the first time plus specific effectively with NADH and Herba Epimedii secondary aglycon etc. on the basis of conventional formulation The theory of ingredient, and proved by a large amount of pharmacological evaluations.Current both NADH and Herba Epimedii secondary aglycon are used as health care product Raw material is used alone, and not yet retrieves any composition that the two is used in conjunction with to preparation at present, the present invention is by deploying The technical effect of 1+1 > 2 is arrived.Composition of the invention has the effect of strengthening the spleen and replenishing qi, nourshing blood and promoting blood circulation, clearing and activating the channels and collaterals, can show It writes and promotes patients serum's estrogen level and Estrogen Receptor, increase InhB protein expression, improve ovary weight, promote big Mouse gonad granulocyte proliferation.For treating ovarian-senescence, significant effect;It is adjustable human endocrine, adjustment hormone, Increase blood manufacture, improve anaemia, the deficiency of vital energy, enhance cell viability, improves human immunologic function, so that Menopause is postponed, Alleviate climacteric syndrome symptom.
The preparation of improvement menopause symptom disclosed by the invention containing NADH, more including the above-mentioned improvement containing NADH The composition of term symptom.Preparation and its preparation side below with reference to embodiment to the above-mentioned improvement menopause symptom containing NADH Method is further described:
Embodiment 1
(1) raw material: the NADH of 5 parts by weight, the Herba Epimedii secondary aglycon of 5 parts by weight, the chondroitin sulfate of 5 parts by weight, 5 weights Measure that the ursodesoxycholic acid of part, the Sialic acid of 5 parts by weight, the s- Ademetionine of 5 parts by weight, the will of 5 parts by weight is remote, 5 parts by weight DHA, 5 parts by weight γ-aminobutyric acid.
(2) auxiliary material:
Including following weight parts: 15 parts of rhizoma acori gramineis, 8 parts of radix paeoniae rubras, 30 parts of seed of Oriental arborvitaes, 20 parts of theanine, 20 parts of rhizoma anemarrhenaes, 10 Part centella, 15 parts of folium panacis japonici cum caules, 5 parts and oneself, 10 parts of silver wire grass, 5 parts of dragon-boats flowers;Auxiliary material further includes mooring golden complex ester, fumaric acid, Fumed silica.
(3) preparation method:
First dried supplementary material is crossed into 30-80 mesh respectively, keep distribution of particle sizes uniform, mobility is more preferable, former auxiliary Material keeps drying;
Then the raw material screened is subjected to proportion weighing, relevant auxiliary materials is added, add water to be sufficiently stirred at 25-40 DEG C mixed After being warming up to 50 DEG C, stirring 1 hour after even, the preparation of the improvement menopause symptom containing NADH is obtained.
Embodiment 2
(1) raw material: the NADH of 10 parts by weight, the Herba Epimedii secondary aglycon of 1 parts by weight, the chondroitin sulfate of 10 parts by weight, 1 The ursodesoxycholic acid of parts by weight, the Sialic acid of 10 parts by weight, the s- Ademetionine of 1 parts by weight, the will of 10 parts by weight is remote, 1 weight Measure the DHA of part, the γ-aminobutyric acid of 10 parts by weight
(2) auxiliary material:
Including following weight parts: 4 parts of rhizoma acori gramineis, 20 parts of radix paeoniae rubras, 20 parts of seed of Oriental arborvitaes, 30 parts of theanine, 10 parts of rhizoma anemarrhenaes, 20 parts Centella, 4 parts of folium panacis japonici cum caules, 12 parts and oneself, 5 parts of silver wire grass, 10 parts of dragon-boat flowers, 5 parts of Chinese trumpet creepers, 10 parts of conical silene herbs, 4 parts of North China an animal-drawn seed ploughs Struggle against dish, 8 portions of pyrolas, 3 parts of Caulis Kadsuraes, 20 portions of fructus lyciis, 7 parts of radix rehmanniae preparatas, 15 parts of Radix Angelicae Sinensis, 4 portions of Semen Cuscutaes, 15 parts of rhizoma anemarrhenaes, 7 parts Morinda officinalis, 15 parts of Herba Epimedii, 4 parts of frutus cnidiis, 15 parts of Rhizoma Chuanxiongs, 7 parts of root barks of tree peony, 17 parts of rhizoma corydalis, 7 parts of uncarias, 15 parts of mulberry fruits, 4 Part rhizoma cyperi, 15 parts of semen coicis, 4 parts of roots of Dahurain angelica, 20 parts of dried immature fruit of citron oranges, 5 parts of fleece-flowers root, 20 portions of Radix Curcumaes, 5 parts of Flos Albiziaes, 25 parts of semen ziziphi spinosaes, 10 Part Radix Glycyrrhizae, 4 parts of hawthorn collagen protein powders, 20 parts of jujube powders, 5 parts of L-Trps, 30 parts of vitamin Cs, 5 parts of vitamin Es, 30 parts of dimensions Raw element B1,4 parts of vitamin B6s, 15 parts of vitamin B12s, 5 parts of folic acid.
Auxiliary material further includes mooring golden complex ester, fumaric acid, phosphate, xylitol, microcrystalline cellulose, sorbitan fatty acid Ester, magnesium stearate, croscarmellose sodium, magnesium hydroxide, pregelatinated form sediment, calcium sulfate, fumed silica.
(3) preparation method:
First dried supplementary material is crossed into 60 meshes respectively, keep distribution of particle sizes uniform, mobility is more preferable, and supplementary material is protected Hold drying;
Then the raw material screened is subjected to proportion weighing, while relevant auxiliary materials is added, stirred evenly;
The sample mixed is pelletized in granulator, and is dried and then carries out whole grain;
Above-mentioned particle is then put into tablet press machine, adjusts tablet press machine parameter, carries out tabletting, theoretical slice weight is 500mg, most Film coating, inspection and packaging are carried out afterwards.
Embodiment 3
(1) raw material: the NADH of 1 parts by weight, the Herba Epimedii secondary aglycon of 10 parts by weight, the chondroitin sulfate of 1 parts by weight, 10 The ursodesoxycholic acid of parts by weight, the Sialic acid of 1 parts by weight, the s- Ademetionine of 10 parts by weight, the will of 1 parts by weight is remote, 10 weights Measure the DHA of part, the γ-aminobutyric acid of 1 parts by weight.
(2) auxiliary material:
Auxiliary material including following weight parts: 7 parts of rhizoma acori gramineis, 15 parts of radix paeoniae rubras, 25 parts of seed of Oriental arborvitaes, 25 parts of theanine, 15 parts know Mother, 15 parts of centellas, 10 parts of folium panacis japonici cum caules, 10 parts and oneself, 7 parts of silver wire grass, 7 parts of dragon-boat flowers, 7 parts of Chinese trumpet creepers, 7 parts of conical silene herbs, 6 parts Aquilegia yabeana, 6 portions of pyrolas, 4 parts of Caulis Kadsuraes, 15 portions of fructus lyciis, 12 parts of radix rehmanniae preparatas, 10 parts of Radix Angelicae Sinensis, 10 portions of Semen Cuscutaes, 10 parts Rhizoma anemarrhenae.
Auxiliary material further includes mooring golden complex ester, fumaric acid, phosphate, xylitol, magnesium stearate, cross-linked carboxymethyl cellulose Sodium, magnesium hydroxide, pregelatinated form sediment, calcium sulfate, fumed silica.
(3) preparation method:
A, it prepares content: dried supplementary material being crossed into 60 meshes respectively first, supplementary material keeps drying, then will sieve The raw material chosen carries out proportion weighing, while relevant auxiliary materials are added, and uniformly.
B, prepared by soft capsule body: glycerol and water are added in glue pot, gelatin is then separately added into and correlation prepares auxiliary material, Flexible glue utricule is made in stirring, vacuum outgas.
C, prepare capsule: by above-mentioned prepared content and flexible glue utricule by pelleting, sizing is dry, wash ball, the ball that dries in the air, Ball and packaging and other steps are picked up, soft capsule is made.
Embodiment 4
(1) raw material: the NADH of 8 parts by weight, the Herba Epimedii secondary aglycon of 8 parts by weight, the chondroitin sulfate of 8 parts by weight, 4 weights Measure that the ursodesoxycholic acid of part, the Sialic acid of 4 parts by weight, the s- Ademetionine of 4 parts by weight, the will of 8 parts by weight is remote, 8 parts by weight DHA, 4 parts by weight γ-aminobutyric acid.
(2) auxiliary material:
Auxiliary material including following weight parts: 10 parts of Rhizoma Chuanxiongs, 10 parts of root barks of tree peony, 10 parts of rhizoma corydalis, 10 parts of uncarias, 10 portions of mulberry fruits Son, 10 portions of rhizoma cyperis, 10 parts of semen coicis, 10 parts of roots of Dahurain angelica, 15 parts of dried immature fruit of citron oranges, 10 parts of fleece-flowers root, 17 portions of Radix Curcumaes, 10 parts of Flos Albiziaes, 20 parts Semen ziziphi spinosae, 20 portions of Radix Glycyrrhizaes, 10 parts of hawthorn collagen protein powders, 10 parts of jujube powders, 20 parts of L-Trps, 20 parts of vitamin Cs, 10 parts of dimensions Raw element E, 20 parts of vitamin B1s, 10 parts of vitamin B6s, 10 parts of vitamin B12s, 20 parts of folic acid.
Auxiliary material further includes mooring golden complex ester, fumaric acid, phosphate, xylitol, microcrystalline cellulose, sorbitan fatty acid Ester, magnesium stearate, croscarmellose sodium, magnesium hydroxide, pregelatinated form sediment, calcium sulfate, fumed silica.
(3) preparation method:
S1, auxiliary material component is taken, is broken into coarse granule, add 5 times of 70% ethyl alcohol heating and refluxing extraction 2h of amount, filtered;Filter residue adds 3 again 70% ethyl alcohol heating and refluxing extraction 1h of amount again, filtration;Filtrate after above-mentioned filtering is merged, ethyl alcohol is recycled and is concentrated under reduced pressure into 60 DEG C The thick paste of lower relative density 1.35~1.40, it is spare.
S2, the water that the resulting product of step S1 is added to 7 times of amounts, heating and refluxing extraction volatile oil 4h divide the volatilization for taking layering Oil, it is spare;The dregs of a decoction and medical fluid coarse filtration, filtrate centrifuge separation, supernatant and the dregs of a decoction are saved backup respectively.
S3, the dregs of a decoction for taking raw material components to obtain with S2 step merge, and it is secondary to add water to cook extraction;Wherein, add 18 for the first time Amount water extracts 2h again, adds 12 times of amount water extraction 1h for the second time.After adding water to cook extraction, coarse filtration is carried out, filtrate is centrifugated, twice The supernatant of extraction.The supernatant of extraction is merged with supernatant obtained by S2 step, is concentrated under reduced pressure into relative density at 60 DEG C 1.35~1.40 thick paste, it is spare.
S4: taking dextrin, superfine silica gel powder, mixes, and is added in the alcohol extracting concentration thick paste that above-mentioned S3 step obtains, is sufficiently stirred Uniformly, laying, vacuum drying, crushing, addition dextrin;The volatile oil that S2 step obtains is sprayed into later, and sieving mixes, and is packed into glue Capsule.
The preparation of the presently disclosed improvement menopause symptom containing NADH is subjected to clinical trial, to examine its effect And safety.
Experimental example:
1, case selection:
The clinical observation of menopausal syndrome Patients with 300 Cases is selected, patient is randomly divided into two groups, treatment group 150, the age 44 It is~48 years old, average age 46 years old, the course of disease 1 year~4 years, 3 years average.Control group 150, the age 43~47 years old, average age 45 It is year, the course of disease 1 year~3 years, 2 years average.The course of disease, the degrees of symptoms of two groups of cases are almost the same, no significant difference, and having can Compare property.
2, medicament selection:
Treatment group patient takes invention formulation, takes orally, 3 tablets once, 3 times a day, in each 1 time in the morning, afternoon and evening, after meal 1 hour Warm water delivery service, 15 days as a treatment course, usual 3 to 4 courses is effective, and chronic disease needs 5~6 courses for the treatment of.
Control group takes Geng Nian An Capsules, take orally, one time 3,3 times a day.
3, efficacy determination:
(1) cure: hectic fever, perspiration, nocturnal insomnia, the symptoms such as have a dizzy spell disappear;Body recovery from illness, gets well.
(2) effectively: above-mentioned symptom is alleviated, and body recovery from illness is got well.
(3) invalid: illness is unchanged.
4, result:
It takes in the treatment group of invention formulation, cures 108, effective 25, invalid 17, cure rate 72% always has Efficiency 88.7%.Healing 85 in control group, effective 19, invalid 46, cure rate 56.7%, total effective rate 69.3%.
The above results show that treatment group's cure rate and total effective rate are apparently higher than control group.
Staining effect table using product described in embodiment 1 for 60 volunteers is as shown in table 1:
The staining effect table of 1 volunteer of table
As can be seen from the above data, involutional symptom is varied, different for different individual performances.But It is visited menopause symptom after product 30 days described in 60 volunteer's embodiments to be also reduced to varying degrees or disappear, especially to bone The reaction effect of the tissues such as bone, muscle is obvious, can reach therapeutic effect to a variety of symptoms of most people.Only to individual symptoms, If paramenia, the function and effect of mastoptosis are unobvious, these symptoms are from physiologically in close relations with hormone.
Hereinafter typical case:
1, Wang, female, 45 years old, peasant, Jiangxi people from Fuzhou City.Patient menstrual cycle extends, and reduces through amount, last menopause, and With symptoms such as hectic fever, perspiration, nocturnal insomnias, examined by our hospital as menopausal syndrome.Once a variety of drugs were taken, effect is not It is good.1 course for the treatment of of drug therapy of the present invention is taken, symptom is relieved, continues to take 2 course for the treatment of, and the above symptom disappears.Follow-up is extremely The present does not recur.
2, hair, female, 47 years old, Enterprise Staff, Gansu people from Jinchang.Patient menstrual cycle is irregular, and menostaxis, increases through amount More or even bleeding dripping urine endlessly, then gradually decreases and stops, and mood swing rises and falls greatly, and with hectic fever, hectic fever is risen from shirtfront, Incidence is poured into, whole body, manic uneasiness are then involved.Menopausal syndrome is diagnosed as by our hospital.Take Chinese materia medica preparation 3 of the present invention After a course for the treatment of, body gradually rehabilitation, symptom is relieved, and continues to take 2 course for the treatment of, and the above symptom disappears.Follow-up is not multiple so far Hair.
3, it is virgin certain, female, 48 years old, teacher, Shaanxi people from Xi'an.Patient's flush region feels scorching hot, and rubefaction is and then quick-fried Hair property is perspired, and last for several seconds is differed to several minutes, and daily for several times to 30~50 times, night easily inspires seizure frequency, when sense it is dizzy, Occasionally there is violence impulsive action.Menopausal syndrome is diagnosed as by our hospital.After taking 2 courses for the treatment of of Chinese materia medica preparation of the present invention, symptom It is clearly better, continues after taking 3 course for the treatment of, symptom disappears, and body recovery from illness is not recurred.
4, face, female, 50 years old, peasant, people from Puyang oilfield of Henan.Patient occurs that temper is big, complaint is more recently, often blames others etc. for Feature, private prosecution nearest menstrual cycle start irregular, and interval time extends, amount is few, occur having a sleepless night and have a headache, nose heave symptom, Blood pressure is fluctuated, and with whole body paroxysmal hectic fever sense.Once a variety of drugs were taken, it is ineffective.It is diagnosed as more by our hospital Term syndrome.After taking 3 courses for the treatment of of Chinese materia medica preparation of the present invention, the above symptom is relieved, and is continued after taking 2 course for the treatment of, disease Shape disappears, and does not recur.
5, fourth, female, 51 years old, writer, people from Hefei ,Anhui.The recent menopause of patient is flushing, daytime drowsiness, nocturnal insomnia, blood Pressure increases, and often perspires, the manic uneasiness of heart, excited, emotion-thought abnormal.Menopausal syndrome is diagnosed as by our hospital.It is taking After 1 course for the treatment of of Chinese materia medica preparation of the present invention, the above symptom improves, and continues after taking 3 course for the treatment of, and the above symptom disappears, and activity is certainly Such as, there has been no recurrence since follow-up.
6, Lu, female, 54 years old, private owner, people from Yichang.There is paramenia in the recent period in patient, and hectic fever is flushing, warms Sweating, excited, heart is frenzied endlessly, the symptoms such as paresthesia of skin.Once various drugs were taken, effect is bad.Afterwards Come our hospital and is diagnosed as menopausal syndrome.After taking 1 course for the treatment of of Chinese materia medica preparation of the present invention, symptom is substantially reduced, then takes 2 After a course for the treatment of, physical recovery is normal.There has been no recurrence since follow-up.
The above description is only a preferred embodiment of the present invention, is not intended to limit the scope of the invention, all at this Under the inventive concept of invention, is extended using technology made by description of the present invention or recreation is included in patent of the invention In protection scope.

Claims (10)

1. a kind of composition of the improvement menopause symptom containing NADH, which is characterized in that including following component: 1-10 parts by weight The Herba Epimedii secondary aglycons of NADH, 1-10 parts by weight, the chondroitin sulfate of 1-10 parts by weight, 1-10 parts by weight ursodeoxycholic Acid, the will of the s- Ademetionine of the Sialic acid of 1-10 parts by weight, 1-10 parts by weight, 1-10 parts by weight are remote, 1-10 parts by weight The γ-aminobutyric acid of DHA, 1-10 parts by weight.
2. the composition of the improvement menopause symptom containing NADH according to claim 1, which is characterized in that further include following It is at least ten kinds of in the auxiliary material of parts by weight: 4-15 parts of rhizoma acori gramineis, 8-20 parts of radix paeoniae rubras, the 20-30 parts of seed of Oriental arborvitaes, 20-30 parts of theanine, 10-20 parts of rhizoma anemarrhenaes, 10-20 parts of centellas, 4-15 parts of folium panacis japonici cum caules, 5-12 parts and oneself, 5-10 parts of silver wires grass, 5-10 part dragon-boats it is colored, 5-10 parts of Chinese trumpet creepers, 5-10 parts of conical silene herbs, 4-8 parts of Aquilegia yabeanas, 4-8 portions of pyrolas, 3-6 parts of Caulis Kadsuraes, 8-20 parts of Chinese hollys Matrimony vine, 7-17 part radix rehmanniae preparata, 4-15 parts of Radix Angelicae Sinensis, 4-15 portions of Semen Cuscutaes, 4-15 parts of rhizoma anemarrhenaes, 7-17 parts of Morinda officinalis, 4-15 parts of Herba Epimedii, 4-15 parts of frutus cnidiis, 4-15 parts of Rhizoma Chuanxiongs, the 7-17 parts of root barks of tree peony, 7-17 parts of rhizoma corydalis, 7-17 parts of uncarias, 4-15 parts of mulberry fruits, 4-15 Part rhizoma cyperi, 4-15 parts of semen coicis, the 4-15 parts of roots of Dahurain angelica, the 5-20 parts of dried immature fruit of citron oranges, the 5-13 parts of fleece-flowers root, 15-20 portions of Radix Curcumaes, 5-13 portions of silk trees Flower, 10-25 parts of semen ziziphi spinosaes, 10-25 portions of Radix Glycyrrhizaes, 4-15 parts of hawthorn collagen protein powders, 5-20 parts of jujube powders, 5-30 parts of L- color ammonia Acid, 5-30 parts of vitamin Cs, 5-13 parts of vitamin Es, 5-30 parts of vitamin B1s, 4-15 parts of vitamin B6s, 4-15 parts of vitamin B12s, 5-30 parts of folic acid.
3. the composition of the improvement menopause symptom containing NADH according to claim 2, which is characterized in that further include auxiliary material Moor golden complex ester, fumaric acid, phosphate, xylitol, microcrystalline cellulose, sorbitan fatty acid ester, magnesium stearate, crosslinking carboxylic Sodium carboxymethylcellulose pyce, magnesium hydroxide, pregelatinated form sediment, calcium sulfate, fumed silica, at least three kinds in lactose.
4. a kind of preparation of the improvement menopause symptom containing NADH, which is characterized in that described contain including claim 1-3 is any There is the composition of the improvement menopause symptom of NADH.
5. a kind of preparation method for the preparation for improving menopause symptom as claimed in claim 4, which is characterized in that including following steps It is rapid:
Raw material is subjected to proportion weighing, relevant auxiliary materials are added, mixes and tablet, pill, particle, capsule or aqua is made.
6. the preparation method of the preparation according to claim 5 for improving menopause symptom, which is characterized in that the step tool Body includes:
Dried supplementary material is crossed into 30-80 mesh respectively, supplementary material keeps drying, the raw material screened is carried out proportion title Relevant auxiliary materials are added in weight, and 50 DEG C are warming up to after adding water that mixing is sufficiently stirred at 25-40 DEG C, and the system is made after stirring 1~2h Agent.
7. the preparation method of the composition according to claim 5 for improving menopause symptom, which is characterized in that the step It specifically includes:
Dried supplementary material is crossed into 30-80 mesh respectively, drying is kept, the raw material screened is subjected to proportion weighing, simultaneously Relevant auxiliary materials are added, is uniformly mixed, tablet is made.
8. the preparation method of the composition according to claim 5 for improving menopause symptom, which is characterized in that the step It specifically includes:
A) it prepares content: dried supplementary material being crossed into 30-80 mesh respectively, supplementary material keeps drying, then will screen Raw material carry out proportion weighing, while relevant auxiliary materials are added, are uniformly mixed;
B) it prepares capsule: above-mentioned prepared content and flexible glue utricule being dried by pelleting, sizing, ball is washed, the ball that dries in the air, picks up ball Soft capsule is made with packing.
9. the preparation method of the composition according to claim 5 for improving menopause symptom, which is characterized in that the step It specifically includes:
S1, auxiliary material component is taken, coarse granule is made, add 70% ethyl alcohol heating and refluxing extraction, filtered;Filter residue adds 70% ethyl alcohol to heat again Refluxing extraction, filtering;Filtrate is merged, the thick paste of relative density 1.35~1.40 is concentrated into, it is spare;
S2, add water to step 1 gained thick paste, heating and refluxing extraction volatile oil divides the volatile oil for taking layering, spare;After volatile oil After the resulting dregs of a decoction and medical fluid coarse filtration, filtrate centrifuge separation takes supernatant and the dregs of a decoction to distinguish spare;
S3: taking raw material components to merge with the dregs of a decoction obtained by S2 step, adds water to cook and extracts secondary rear coarse filtration, filtrate centrifuge separation, and two It is secondary to extract to obtain supernatant;Supernatant merges with supernatant obtained by S2 step, is concentrated into the thick paste of relative density 1.35~1.40, standby With;
S4: taking dextrin, superfine silica gel powder, mixes, and is added obtained by S3 step in thick paste, stirs evenly, laying, vacuum drying, crushing, Dextrin is added, sprays into the volatile oil that S2 step obtains, sieving mixes, and is packed into capsule body, the capsule of system.
10. the composition of -3 any improvement menopause symptoms containing NADH improves climacteric in preparation according to claim 1 It is applied in the drug and health care product of phase symptom.
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