CN109223751A - Compound L-citrulline plant capsule of high-content active constituent and preparation method thereof - Google Patents
Compound L-citrulline plant capsule of high-content active constituent and preparation method thereof Download PDFInfo
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- CN109223751A CN109223751A CN201810918114.2A CN201810918114A CN109223751A CN 109223751 A CN109223751 A CN 109223751A CN 201810918114 A CN201810918114 A CN 201810918114A CN 109223751 A CN109223751 A CN 109223751A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/485—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Abstract
The present invention relates to compound L-citrulline plant capsules of a kind of high-content active constituent and preparation method thereof, it is characterized by: based on parts by weight, supplementary material components composition includes 50-60 parts of L-arginine, 20-30 parts of L-citrulline, 0.5-2 parts of glycine zine, 0-0.5 parts of silica, 14-18 parts of plant hollow capsule.A kind of compound L-citrulline plant capsule of high-content active constituent of the present invention and preparation method thereof production technology is easy, and by controlling material size, order by merging reaches purpose easy to industrialized production, and products obtained therefrom quality is stablized, and industrialized production is easy to；Phenomena such as each storeroom has good compatibility, and products obtained therefrom can keep quality to stablize in a long time, will not send out the moisture absorption, agglomeration, meets the needs transport, store, using.
Description
Technical field
The present invention relates to compound L-citrulline plant capsules of a kind of high-content active constituent and preparation method thereof.
Background technique
1, title and physicochemical property
[L-citrulline] English name: L-Citrulline, CAS No.:372-75-8, molecular formula: C6H13N3O3, molecule
Amount: 175.19, structural formula:
Appearance characteristics: white crystalline body or crystalline powder have tart flavour, are slightly soluble in water, do not dissolve in ethyl alcohol
And ether；20D+24.5~+26.8 ° of [α]；PH 5.0~7.0.
[L-arginine] English name: L (+)-Arginine, CAS No.:74-79-3, molecular formula: C6H14N4O2, molecular weight:
174.20 structural formula:Appearance characteristics: white diamond crystallization, odorless, bitter；It is soluble easily in water
(solubility is 83g/L in 0 DEG C of water, and solubility is 400g/L in 50 DEG C of water), it is atomic to be dissolved in ethyl alcohol, do not dissolve in ether；pI6.0；
It is heated to losing two molecular crystalline water at 105 DEG C, 230 DEG C of whens darken, and decomposition point is 244 DEG C；Specific rotatory power [α] 20D+
12.5 ° (0.5-2.0mg/ml, H2O), 20D+27.3 ° of [α] (0.5-2.0mg/ml, 6mol/L HCl)；Aqueous solution is in 205nm
There is absorption maximum at place.
[glycine zine] Chinese name: glycine zine (an anhydrous or water), English name: Zinc glycinate, molecular formula: Zn
(C2H4NO2)2Or Zn (C2H4NO2)2·H2O, molecular weight: 213.51 or 231.51, structural formula: (anhydrous)Appearance characteristics: white crystals, particulate powder, it is tasteless；It is slightly soluble in water, does not dissolve in ethyl alcohol, easily
It is dissolved in slightly acidic water；Middle stability is good.Theoretical Zn content containing the crystallization water is 28.24%, and anhydrous theory Zn content is
30.62%.
2, physiological action and effect
L-citrulline is gained the name from the watermelon for extracting citrulling first, it is a kind of alpha amino acid, to human body
Speech, citrulling is a kind of nonprotein amino acid, is not involved in the synthesis of protein.Past often thinks that citrulling does not have clinical meaning
Justice, but recent studies have found that citrulling and a variety of diseases in relation to its judge index that can be used as injury of gastrointestinal tract；Arginine lacks
Effective supplement drug of patient；The evidence of septicopyemia change of illness state；And it in the forming process of citrulling, is led as antigen
The generation of patient's rheumatoid arthritis is caused, rheumatoid arthritis can sentence in early days by detection citrulling associated antibodies
It is disconnected；Citrulling has certain diagnosis and therapeutic effect also for certain diseases；In addition, citrulling is answered in terms of safeguarding human health
With extensive.
L-arginine is a kind of amino acid, is also 20 kinds of universal one of natural amino acid.In mammals, arginine
It is classified as the half necessary or necessary amino acid of conditionity, depending on stage of development and health status.L-arginine is a kind of α
Amino acid, be primarily involved in urea metabolism and excretion and DNA synthesis and protein production.It is nitric oxide
(NO) a important as precursors, plays a role in blood vessel dilatation.For adult, though be not required amino acid has in vivo
Important function, male sexual disfunction can be improved, expansion blood vessel increases blood flow, improves systemic circulation, and can prevent height
Blood pressure, respiratory tract infection and increase insulin secretion.
Glycine zine is a kind of amino-acid zinc, and zinc plays a significant role human body, shows themselves in that the growth of 1, promotion human body
Development: if the children and adolescents zinc-deficiency in growth and development stage, will lead to depauperation.When lacking serious, it will cause "
Nanism " and intellectual development are bad；2, maintain human normal appetite: zinc-deficiency will lead to sense of taste decline, anorexia, partial eclipse occurs even
Different food；3, enhance human immunity: Zn-ef ficiency is the nutrient of immune organ thymus development, and only zinc amount abundance could be protected effectively
Thymus development is demonstrate,proved, normal differentiation T lymphocyte promotes cellular immune function；4, promote the healing of wound and wound: zinc supplementation agent
It is applied to clinical be exactly to be used to treat skin disease earliest；5, metabolism and the normal vision of vitamin A: zinc clinically table are influenced
Now to be beneficial to eyes, exactly because zinc plays the role of promoting vitamin A absorption.The absorption of vitamin A be unable to do without zinc.Vitamin
It is stored in liver when A is flat, when human body needs, vitamin A is transported in blood, this process is " dynamic to complete by zinc
Member " work: 6, maintain the normal spermatogenesis of male: Zn-ef ficiency is largely present in male testical, participates in the entire of sperm
It generates, mature and capacitation process.Once male's zinc-deficiency will lead to sperm quantity reduction, vigor decline, semen liquefaction not
Good, zinc-deficiency, which also results in teenager, does not have secondary sex characters to occur, be unable to normal reproductive development.The sweet ammonia of carrier as Zn-ef ficiency
Acid belongs to one kind of gal4 amino acid, has benefiting action, superior now widely used zinc sulfate, gluconic acid to human body
Zinc, zinc lactate and zinc citrate etc..
There is silica good preparation to help stream effect, and dosage is few in preparation manufacture, reduces volumes of formulation weight, subtracts simultaneously
The dose of few unnecessary substance of human body；Plant hollow capsule derives from plant rather than source compared with traditional gelatine capsule
In animal tissue, advantage is extremely obvious, and clean safety, supplementary material compatibility is good, and product stability is higher.
Although L-citrulline and L-arginine can make human body produce a nitrogen oxides, such as two kinds of amino acid are combined and are made
With under the synergistic effect of L-citrulline, human body being allowed to generate an a large amount of oxygen with L-arginine for nitric oxide production basic substance
Change nitrogen；It is remarkably reinforced compared to single use L-arginine effect；It adds glycine zine and Zn-ef ficiency is provided, meeting physiological need
Zn-ef ficiency needed for sperm manufactures is replenished in time simultaneously, its solidification group is combined into a novel perfect medicinal properties field of food
The apparent complex of effect with antioxidation, the intracorporal Free Radical of removing people, the muscle strength for enhancing human body and resists
Fatigue effect, promotes the effect of sperm manufacture level at expansion blood vessel function.Silica is selected to cook retention agent, plant in product manufacturing
Object Capsules do filling softgel shell, produce compound L-citrulline plant capsule, meet the need for producing, transport, storing and using
It wants, provides service for the healthy living of people, meet adult male and changing and improving physical efficiency, improving function of immune system, balance
Blood glucose level, maintenance cardiovascular system, the health care demand for improving fecundity.
It there are no the report of the compound preparation and its preparation process that close mentioned component composition at present.
Summary of the invention
Have effects that the high-content for meeting adult male improvement physiological function is living the purpose of the present invention is to provide a kind of
The compound L-citrulline plant capsule and preparation method thereof of property ingredient.
A kind of compound L-citrulline plant capsule combination preparation of high-content active constituent of the present invention, it is characterised in that: with
Parts by weight meter, supplementary material components composition include 50-60 parts of L-arginine, 20-30 parts of L-citrulline, glycine zine
0.5-2 parts, 0-0.5 parts of silica, 14-18 parts of plant hollow capsule.
Preferably, based on parts by weight, raw material components include 52-58 parts of L-arginine, 24-28 parts of L-citrulline, sweet
0.7-1.5 parts of propylhomoserin zinc, 0.1-0.3 parts of silica, 15-17 parts of plant hollow capsule.
A kind of compound L-citrulline plant capsule of high-content active constituent of the present invention, it is characterised in that the active constituent
Containing also containing only L-arginine, L-citrulline and three kinds of glycine zine, fix prescription is L-arginine based on parts by weight
50-60 parts, 20-30 parts of L-citrulline, glycine zine 0.5-2.
A kind of compound L-citrulline plant capsule of high-content active constituent of the present invention, it is characterised in that it is described it is nonactive at
It is divided to and is no more than two kinds, silica, plant hollow capsule, and the parts by weight shared by entire auxiliary material component composition are total does not surpass
Cross 20%.
A kind of compound L-citrulline plant capsule of high-content active constituent of the present invention, it is characterised in that the L- melon
Propylhomoserin is the levo form of citrulling, and is free radical；L-arginine is arginic levo form, and is free radical；Glycine zine
For Zn-ef ficiency carrier, it is amino acid, excludes inorganic acid sulfuric acid zinc salt, organic acid gluconic acid zinc salt, lactic acid zinc salt and citron
Sour zinc salt.
A kind of compound L-citrulline plant capsule of high-content active constituent of the present invention, it is characterised in that the silica
It is partial size less than the anti-antiplastering aid of 80 purposes；Plant hollow capsule, main chemical compositions be plant cellulose, model 0.
A kind of compound L-citrulline plant capsule of high-content active constituent of the present invention, preparation method are as follows:
1) feeding is sieved: weigh supplementary material by recipe quantity, L-arginine and L-citrulline crossed into 40 meshes, glycine zine with
Silica crosses 80 meshes, spare；
2) mix: first will L-arginine and L-citrulline it is just mixed, glycine zine and silica are just mixed, then by glycine zine
Just L-arginine is added with L-citrulline just mixed material in mixed material with silica, is uniformly mixed, mixing before must filling
Material；
3) it fills: taking plant hollow capsule, on capsule filling machine, above-mentioned satisfactory mixed material is directly filled
In plant capsule, the compound L-citrulline plant capsule combination preparation of this product high-content active constituent is obtained.
What above-mentioned technique referred to pulverize and sieve, mix, filling and etc. can carry out in GMP environmental condition, without being important to
It asks.
A kind of compound L-citrulline plant capsule of high-content active constituent of the present invention and preparation method thereof, preparation process
Full powder filling technique technique is taken, key control parameter is each material size of control, as L-arginine crosses 40 mesh, L-citrulline
40 mesh are crossed, glycine zine crosses 80 mesh, and silica crosses 80 mesh；Crucial order by merging, it is first that L-arginine and L-citrulline is just mixed,
Glycine zine and silica are just mixed, then will be at the beginning of the first mixed material of glycine zine and silica and L-arginine and L-citrulline
Mixed material mixing, final mixture are not only uniformly mixed, and mobility is also good, can meet full powder and directly be filled in No. 0 plant
Capsules, entire preparation process not only ensure that product can be cut products obtained therefrom quality and be stablized with industrialized production.
The invention has the advantages that production technology is easy, by controlling material size, order by merging reaches and is easy to industrialize
Purpose is produced, and products obtained therefrom quality is stablized, and industrialized production is easy to；Each storeroom has good compatibility, and gained produces
Phenomena such as product can keep quality to stablize in a long time, will not send out the moisture absorption, agglomeration, meets the need transport, store, using
It wants.A kind of compound L-citrulline plant capsule of high-content active constituent of the present invention contains there are three types of active constituent, reasonable recipe, has
There is synergistic effect；Two kinds of non-active ingredients, proportion is few in component, this component selection silica as glidant, although
Dosage is few but is able to satisfy production needs；Softgel shell select plant capsule, exclude gelatine capsule, not only safety but also meet production requirement.It should
There is good compatibility between each component of the compound L-citrulline plant capsule of high-content active constituent, while there is industrialization
The convenience of production, the stability of product, carrying convenience and take adaptability.The compound L- melon of the high-content active constituent
Propylhomoserin plant capsule preparation unit as a whole, is highly suitable for adult male, and meeting adult male improves physiological function
The effect of, it shows and changes and improves physical efficiency, improves horizontal function of immune system, balance blood sugar, maintenance cardiovascular system, promotion essence
Sub- manufacture level improves fecundity, often takes in the compound L-citrulline plant capsule of high-content active constituent of the invention,
Fatigue can not only be effectively relieved, improve immunity, more can help to improve sperm quality, improve fecundity.
Specific embodiment
Below with reference to embodiment, the present invention is described in further detail, but the embodiment invented is without being limited thereto.
Embodiment 1: a kind of compound L-citrulline plant capsule combination preparation of high-content active constituent, with parts by weight
Meter, supplementary material components composition includes 50 parts of L-arginine, 20 parts of L-citrulline, 0.5 part of glycine zine, silica 0.1
Part, 14 parts of plant hollow capsule.
The L-citrulline is the levo form of citrulling, and is free radical；L-arginine is arginic levo form, and
For free radical；Glycine zine be Zn-ef ficiency carrier, be amino acid, exclude inorganic acid sulfuric acid zinc salt, organic acid gluconic acid zinc salt,
Lactic acid zinc salt and citric acid zinc salt.
Silica is partial size less than the anti-antiplastering aid of 80 purposes；Plant hollow capsule, main chemical compositions are that plant is fine
Dimension element, model 0.
A kind of compound L-citrulline plant capsule of high-content active constituent, preparation method are as follows:
1) feeding is sieved: weigh supplementary material by recipe quantity, L-arginine and L-citrulline crossed into 40 meshes, glycine zine with
Silica crosses 80 meshes, spare；
2) mix: first will L-arginine and L-citrulline it is just mixed, glycine zine and silica are just mixed, then by glycine zine
Just L-arginine is added with L-citrulline just mixed material in mixed material with silica, is uniformly mixed, mixing before must filling
Material；
3) it loads: taking plant hollow capsule, on capsule filling machine, above-mentioned satisfactory mixed material is directly filled
In plant capsule, the compound L-citrulline plant capsule combination preparation of this product high-content active constituent is obtained.
Embodiment 2: embodiment 1: a kind of compound L-citrulline plant capsule combination preparation of high-content active constituent, with weight
Number meter is measured, supplementary material components composition includes 60 parts of L-arginine, 30 parts of L-citrulline, 2 parts of glycine zine, silica
0.5 part, 18 parts of plant hollow capsule.
The L-citrulline is the levo form of citrulling, and is free radical；L-arginine is arginic levo form, and
For free radical；Glycine zine be Zn-ef ficiency carrier, be amino acid, exclude inorganic acid sulfuric acid zinc salt, organic acid gluconic acid zinc salt,
Lactic acid zinc salt and citric acid zinc salt.
Silica is partial size less than the anti-antiplastering aid of 80 purposes；Plant hollow capsule, main chemical compositions are that plant is fine
Dimension element, model 0.
A kind of compound L-citrulline plant capsule of high-content active constituent, preparation method are as follows:
2) feeding is sieved: weigh supplementary material by recipe quantity, L-arginine and L-citrulline crossed into 40 meshes, glycine zine with
Silica crosses 80 meshes, spare；
2) mix: first will L-arginine and L-citrulline it is just mixed, glycine zine and silica are just mixed, then by glycine zine
Just L-arginine is added with L-citrulline just mixed material in mixed material with silica, is uniformly mixed, mixing before must filling
Material；
3) it loads: taking plant hollow capsule, on capsule filling machine, above-mentioned satisfactory mixed material is directly filled
In plant capsule, the compound L-citrulline plant capsule combination preparation of this product high-content active constituent is obtained.
Embodiment 3: embodiment 1: a kind of compound L-citrulline plant capsule combination preparation of high-content active constituent, with weight
Number meter is measured, supplementary material components composition includes 56 parts of L-arginine, 24 parts of L-citrulline, 1 part of glycine zine, silica
0.2 part, 16 parts of plant hollow capsule.
The L-citrulline is the levo form of citrulling, and is free radical；L-arginine is arginic levo form, and
For free radical；Glycine zine be Zn-ef ficiency carrier, be amino acid, exclude inorganic acid sulfuric acid zinc salt, organic acid gluconic acid zinc salt,
Lactic acid zinc salt and citric acid zinc salt.
Silica is partial size less than the anti-antiplastering aid of 80 purposes；Plant hollow capsule, main chemical compositions are that plant is fine
Dimension element, model 0.
A kind of compound L-citrulline plant capsule of high-content active constituent, preparation method are as follows:
3) feeding is sieved: weigh supplementary material by recipe quantity, L-arginine and L-citrulline crossed into 40 meshes, glycine zine with
Silica crosses 80 meshes, spare；
2) mix: first will L-arginine and L-citrulline it is just mixed, glycine zine and silica are just mixed, then by glycine zine
Just L-arginine is added with L-citrulline just mixed material in mixed material with silica, is uniformly mixed, mixing before must filling
Material；
3) it loads: taking plant hollow capsule, on capsule filling machine, above-mentioned satisfactory mixed material is directly filled
In plant capsule, the compound L-citrulline plant capsule combination preparation of this product high-content active constituent is obtained.
Embodiment 4: the compound L-citrulline plant capsule combination preparation of high-content active constituent
[composition]
[preparation process]
The present embodiment 4 selects carrier of the general anhydrous glycine zinc as Zn-ef ficiency, carries out experimental study, and recipe quantity is pressed
Pilot scale recipe quantity feeds intake, and technical process is as follows:
1, each supplementary material (without Capsules shell) is taken, is pulverized and sieved, L-arginine and L-citrulline cross 40 meshes, anhydrous
Glycine zine and silica cross 80 meshes；
2, L-arginine, L-citrulline, anhydrous glycine zinc, silica are weighed by recipe quantity；
3, first will L-arginine and L-citrulline it is just mixed, anhydrous glycine zinc and silica are just mixed, then by anhydrous sweet ammonia
Just L-arginine is added with L-citrulline just mixed material in mixed material for sour zinc and silica, is uniformly mixed, before obtaining filling
Mixed material；
4, intermediate detects, and above-mentioned material is carried out content and water content detection, spare after meeting the requirements；
5, No. 0 type plant hollow capsule is taken, on capsule filling machine, above-mentioned satisfactory mixed material is directly filled
In plant capsule, this product compound L-citrulline plant capsule combination preparation, every weight 470mg or so are obtained；
6, it packs, takes coloured plastics material canopy, above-mentioned capsule is packed on packing machine, every bottle is not less than 60, then pastes
Upper label mixes specification, last carton package.
7, full inspection is sampled full inspection to above-mentioned packaged compound L-citrulline plant capsule combination preparation product, symbol
Standardization is let pass.
Embodiment 5: the compound L-citrulline plant capsule combination preparation of high-content active constituent
[composition]
[Dissolution Rate Testing]
Embodiment 4 is measured by the first method (turning blue laws) in 2015 editions two annex XC dissolution methods of Chinese Pharmacopoeia
With the dissolution rate of the compound L-arginine plant capsule combination preparation sample of 5 high-content active constituent of embodiment.Condition: dissolution is situated between
Matter: purified water 900ml；
Revolving speed: 100 turns；
Temperature: 37 DEG C；
Sample time: 15 minutes；
Detection: using the amount of dissolution of important activity ingredient L-citrulline as Testing index.
As a result: 15 minutes the amount of dissolutions of L-citrulline are not less than 80%.
[content detection]
Method: high performance liquid chromatography, using the content of important activity ingredient L-citrulline as Testing index.Its efficient liquid
Phase chromatographic condition: ODS C18 (250mm × 4.6mm, 5 μm) chromatographic column, using 0.03mmol/L phosphoric acid as mobile phase, flow velocity
0.7mL/min, 30 DEG C of column temperature, Detection wavelength 202nm.
As a result: the content of L-citrulline is the 90%-110% of labelled amount.
Stability study (accelerated test)
According to by 2015 editions two annex XC stability experiment requirements of Chinese Pharmacopoeia, embodiment 4,5 preparations are carried out
Accelerated test (40 DEG C ± 2 DEG C, RH75% ± 5%), accelerated test result is as follows within 6 months:
Accelerated test investigates result
[note]: embodiment 4 and embodiment 5 are all made of coloured expected bottle packaging sample；
The above results show that addition povidone makees 4 preparation of embodiment of stabilizer, with the effervescent formulation for not adding stabilizer
It compares, produces gas phenomenon and be obviously reduced, the stability of Apparent character is significantly improved.
The above is a preferred embodiment of the present invention, has simple process, easy to industrialized production, product quality is excellent
Good, storage stability is good, can satisfy production, transport, storage, the actual needs used.It needs to particularly point out, for this skill
For the those of ordinary skill in art field, without departing from the principle of the present invention, several retouchings can also be made, these profits
Decorations are also considered as protection scope of the present invention.
Claims (6)
1. a kind of compound L-citrulline plant capsule combination preparation of high-content active constituent, it is characterised in that: with parts by weight
Meter, supplementary material components composition includes 50-60 parts of L-arginine, 20-30 parts of L-citrulline, 0.5-2 parts of glycine zine, dioxy
0-0.5 parts of SiClx, 14-18 parts of plant hollow capsule.
2. a kind of compound L-citrulline plant capsule of high-content active constituent according to claim 1, it is characterised in that
The active constituent, which contains, also contains only L-arginine, L-citrulline and three kinds of glycine zine, fixes prescription with parts by weight
It is calculated as, 50-60 parts of L-arginine, 20-30 parts of L-citrulline, glycine zine 0.5-2.
3. a kind of compound L-citrulline plant capsule of high-content active constituent according to claim l, it is characterised in that
The non-active ingredient is no more than two kinds, silica, plant hollow capsule, and the weight shared by entire auxiliary material component composition
Number is total to be no more than 20%.
4. a kind of compound L-citrulline plant capsule of high-content active constituent according to claim 2, it is characterised in that
The L-citrulline is the levo form of citrulling, and is free radical；L-arginine is arginic levo form, and for freely
Base；Glycine zine is Zn-ef ficiency carrier, is amino acid, excludes inorganic acid sulfuric acid zinc salt, organic acid gluconic acid zinc salt, zinc lactate
Salt and citric acid zinc salt.
5. a kind of compound L-citrulline plant capsule of high-content active constituent according to claim 3, it is characterised in that
The silica is partial size less than the anti-antiplastering aid of 80 purposes；Plant hollow capsule, main chemical compositions are plant cellulose,
Model 0.
6. a kind of compound L-citrulline plant capsule of high-content active constituent according to claim 1, preparation method
Are as follows:
1) feeding is sieved: weighing supplementary material by recipe quantity, L-arginine and L-citrulline are crossed 40 meshes, glycine zine and dioxy
SiClx crosses 80 meshes, spare；
2) mix: first will L-arginine and L-citrulline it is just mixed, glycine zine and silica are just mixed, then by glycine zine and two
Just L-arginine is added with L-citrulline just mixed material in mixed material to silica, is uniformly mixed, mixed material before must filling；
3) it loads: taking plant hollow capsule, on capsule filling machine, above-mentioned satisfactory mixed material is directly filled in plant
In composite capsule, the compound L-citrulline plant capsule combination preparation of this product high-content active constituent is obtained.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810918114.2A CN109223751A (en) | 2018-08-13 | 2018-08-13 | Compound L-citrulline plant capsule of high-content active constituent and preparation method thereof |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US9572848B1 (en) * | 2014-03-26 | 2017-02-21 | Aemes Research L.L.L.P. | Composition of matter for sexual dysfunction |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9572848B1 (en) * | 2014-03-26 | 2017-02-21 | Aemes Research L.L.L.P. | Composition of matter for sexual dysfunction |
Non-Patent Citations (1)
| Title |
|---|
| 美健品联盟: "美国GNC健安喜L-精氨酸+L-瓜氨酸（加强型）成人男性保养品", 《HTTP://BBS.MEIJIANPIN.COM/CRNXBJP/P6923/》 * |
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Application publication date: 20190118 |