CN109846846A - A kind of effervesce sustained release agent and its preparation method and application containing probiotics - Google Patents

A kind of effervesce sustained release agent and its preparation method and application containing probiotics Download PDF

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Publication number
CN109846846A
CN109846846A CN201811560178.6A CN201811560178A CN109846846A CN 109846846 A CN109846846 A CN 109846846A CN 201811560178 A CN201811560178 A CN 201811560178A CN 109846846 A CN109846846 A CN 109846846A
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China
Prior art keywords
sustained release
release agent
effervesce
mixture
probiotics
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CN201811560178.6A
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Chinese (zh)
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马浤轩
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Senecin Biotechnology (shanghai) Co Ltd
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Senecin Biotechnology (shanghai) Co Ltd
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Priority to CN201811560178.6A priority Critical patent/CN109846846A/en
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Abstract

The invention discloses a kind of effervesce sustained release agent and its preparation method and application containing probiotics, belongs to medical applications technical field.It includes following several components according to mass fraction: microcrystalline cellulose 5%-20%, sodium bicarbonate 10%-30%, tartaric acid 15%-25%, lactic acid powder 3%-16%, chitosan oligosaccharide 7%-18%, EGCG 6%-10%, Brij35 5%-12%, superfine silica gel powder 2%-10%, PVP K30 and dehydrated alcohol mixed solution 0.5%-5%, probiotic composition 15%-45%, magnesium stearate 0.2%-6%.Main component is probiotic composition in the present invention, it is cultivated by modern crafts, there is preferable blending with the intrinsic probiotics of human body, in addition EGCG, chitosan oligosaccharide and lactic acid for containing in pure natural components tea polyphenols in this formula etc., there is stronger killing effect to harmful bacteria, it can be used as the nutriment of probiotics again simultaneously, there is great help in the field planting of female genital tract to probiotics, lactic acid can largely be generated, the substance of the killing harmful bacteria such as hydrogen peroxide, restore self immune system, fundamentally solves the problems, such as inflammatory diseases of female genital tract recurrent exerbation.

Description

A kind of effervesce sustained release agent and its preparation method and application containing probiotics
Technical field
The present invention relates to a kind of effervesce sustained release agent and its preparation method and application containing probiotics, belongs to medical applications technology Field.
Background technique
Currently, being solid pharmaceutical preparation respectively on the market for treating there are mainly two types of the pharmaceutical dosage forms of female genital disorders And liquid preparation, however solid pharmaceutical preparation is when in use, can exist because female genital tract internal physiological structures are pleated structure, solid Preparation cannot reach fold deep when in use, therefore bad to the diseased region therapeutic effect for being located at pleated structure deep, therefore The case where needing long period continuous medication, in addition when in use, liquid preparation can have following three to solid pharmaceutical preparation when in use Kind situation:
1. although liquid preparation, which is able to achieve, carries out comprehensive and preferable therapeutic effect, liquid system to female genital tract inside Agent is of short duration in the female genital tract internal stops time, therefore lasting effect can not be played to female genital tract inside.
2. liquid preparation trickling property is larger, administration mode is affected by external factor, and medication is inconvenient.
3. liquid preparation toward when being administered inside female genital tract, is needed by rigid appliance, however is held in administration Easily female genital tract inside is caused to damage.
In addition, it is all single sterilised products that it is most of, which all to have product, when using solid pharmaceutical preparation and liquid preparation, While to female genital tract treatment, the beneficial bacterium inside female genital tract is destroyed, the serious female genital tract itself that damages is exempted from Epidemic disease system leads to vaginitis recurrent exerbation.
Summary of the invention
Technical problem to be solved by the present invention lies in: a kind of effervesce sustained release agent and preparation method thereof containing probiotics is provided And application, it solves solid pharmaceutical preparation in administration, cannot reach fold deep and utilize solid pharmaceutical preparation and liquid preparation two When kind of administration mode, the beneficial bacterium inside female genital tract is damaged and drug efficacy time inside female genital tract It is of short duration, serious the problem of damaging female genital tract self immune system.
The technical problems to be solved by the invention take following technical scheme to realize:
A kind of effervesce sustained release agent containing probiotics, it includes following several components: microcrystalline cellulose 5%- according to mass fraction 20%, sodium bicarbonate 10%-30%, tartaric acid 15%-25%, lactic acid powder 3%-16%, chitosan oligosaccharide 7%-18%, EGCG 6%-10%, Brij35 5%-12%, superfine silica gel powder 2%-10%, PVP K30 and dehydrated alcohol mixed solution 0.5%-5%, probiotic composition 15%-45%, magnesium stearate 0.2%-6%.
As preferred embodiment, the probiotic composition includes Lactobacillus crispatus, lactobacillus gasseri, in lactobacillus acidophilus It is one or more.
Another object of the present invention is the preparation method proposed according to aforementioned pharmaceutical compositions, comprising the following steps:
(1), it takes Brij35, superfine silica gel powder to be mixed with PVP K30 and dehydrated alcohol mixed solution, adds at 60 DEG C -80 DEG C It is cooling after heat, obtain mixture A;
(2), it takes sodium bicarbonate, tartaric acid, lactic acid, EGCG to cross 80 meshes respectively, chitosan oligosaccharide is added and is uniformly mixed, obtains mixture B, Softwood processed in mixture A is added in mixture B again, 20 meshes is crossed and prepares wet granular C;Then again by wet granular C 40 DEG C~50 It is dry in DEG C drying box, whole grain is carried out after dry, obtains dry particl D;
(3), probiotic composition and magnesium stearate are added into dry particl D, and is uniformly mixed in agitator tank, obtains sustained release agent E;
(4), sustained release agent E is then subjected to tabletting, packaging again.
Another object of the present invention is the application proposed according to aforementioned pharmaceutical compositions,
Specific technical solution is as follows: application of the aforementioned pharmaceutical compositions in treatment female genital disorders drug.
The beneficial effects of the present invention are:
1, become 20mL foaming agent and can reach each fold deep of vagina, Bu Huiliu pharmaceutical composition foams in 30min It drops down, is not influenced by administration environment, 20mL foaming agent can continue 300min and slowly disappear, and drug is made to reach sustained therapeutic effect;
3, this product main component is probiotics, comes from Healthy Youth female genital tract, cultivates by modern crafts and human body is intrinsic Probiotics has preferable blending;
4, EGCG, chitosan oligosaccharide and lactic acid for containing in pure natural components tea polyphenols in this formula etc. have stronger kill to harmful bacteria The effect of going out, while can be used as the nutriment of probiotics again, there is great help in the field planting of female genital tract to probiotics;
5, the slow release of foaming agent, and vaginal epithelial cell can be adhered well to, and using efficiently stick technology into Row coating makes the bubble in foaming agent hold time long and does not rupture, and the bubble residence time time is long, there is effective component enough Time come into full contact with infection focus position, absorb completely, enable foaming agent to settle down and breed in vagina, make intravaginal shape At protectiveness flora, the substances such as acidic materials and hydrogen peroxide can be generated, prevent the adherency in vagina of pathogenic microorganisms, more Be conducive to the field planting of probiotics;And using efficiently sticking technology in formula, pharmaceutical composition by the protection of coating, completely cut off with The contact of air, moisture, activity is more stable, and curative effect is more preferably.
6, intravaginal administration of the present invention meets body fluid fater disintegration, evenly dispersed, and the motive force generated using bubble makes medicine Object is fully distributed in cervix opening and vagina, and is come into full contact with infection focus position, and diseased region is directly acted on, It is rapid-action.
7, the field planting of a large amount of probiotics can largely generate the substance that lactic acid, hydrogen peroxide etc. kill harmful bacteria, restore certainly Body immune system fundamentally solves the problems, such as inflammatory diseases of female genital tract recurrent exerbation.
Specific embodiment
In order to be easy to understand to technical means, creative features, achievable purpose and effectiveness of the invention, below with reference to tool Body embodiment, the present invention is further explained.
Embodiment one
A kind of effervesce sustained release agent containing probiotics, it includes following several components: microcrystalline cellulose 5%, carbon according to mass fraction Sour hydrogen sodium 10%, tartaric acid 15%, lactic acid powder 3%, chitosan oligosaccharide 7%, EGCG 6%, Brij35 5%, superfine silica gel powder 2%, povidone K30 and dehydrated alcohol mixed solution 0.5%, probiotic composition 15%, magnesium stearate 0.2%.
According to above-mentioned formula, use the preparation method is as follows:
(1), Brij35, superfine silica gel powder is taken to be mixed with PVP K30 and dehydrated alcohol mixed solution, it is cold after 60 DEG C of heating But, mixture A is obtained;
(2), it takes sodium bicarbonate, tartaric acid, lactic acid, EGCG to cross 80 meshes respectively, chitosan oligosaccharide is added and is uniformly mixed, obtains mixture B, Softwood processed in mixture A is added in mixture B again, 20 meshes is crossed and prepares wet granular C;Then again by wet granular C in 40 DEG C of dryings It is dry in case, whole grain is carried out after dry, obtains dry particl D;
(3), probiotic composition and magnesium stearate are added into dry particl D, and is uniformly mixed in agitator tank, obtains sustained release agent E;
(4), sustained release agent E is then subjected to tabletting, packaging again.
Embodiment two
A kind of effervesce sustained release agent containing probiotics, it includes following several components: microcrystalline cellulose 8%, carbon according to mass fraction Sour hydrogen sodium 15%, tartaric acid 18%, lactic acid powder 5%, chitosan oligosaccharide 10%, EGCG 7%, Brij35 6%, superfine silica gel powder 4%, povidone K30 and dehydrated alcohol mixed solution 1.5%, probiotic composition 20%, magnesium stearate 1.2%.
According to above-mentioned formula, use the preparation method is as follows:
(1), Brij35, superfine silica gel powder is taken to be mixed with PVP K30 and dehydrated alcohol mixed solution, it is cold after 65 DEG C of heating But, mixture A is obtained;
(2), it takes sodium bicarbonate, tartaric acid, lactic acid, EGCG to cross 80 meshes respectively, chitosan oligosaccharide is added and is uniformly mixed, obtains mixture B, Softwood processed in mixture A is added in mixture B again, 20 meshes is crossed and prepares wet granular C;Then again by wet granular C in 42 DEG C of dryings It is dry in case, whole grain is carried out after dry, obtains dry particl D;
(3), probiotic composition and magnesium stearate are added into dry particl D, and is uniformly mixed in agitator tank, obtains sustained release agent E;
(4), sustained release agent E is then subjected to tabletting, packaging again.
Embodiment three
A kind of effervesce sustained release agent containing probiotics, it includes following several components: microcrystalline cellulose 13%, carbon according to mass fraction Sour hydrogen sodium 20%-30%, tartaric acid 20%, lactic acid powder 9%, chitosan oligosaccharide 12%, EGCG 8%, Brij35 9%, superfine silica gel powder 6%, gather Tie up ketone K30 and dehydrated alcohol mixed solution 3%, probiotic composition 30%, magnesium stearate 3.1%.
According to above-mentioned formula, use the preparation method is as follows:
(1), Brij35, superfine silica gel powder is taken to be mixed with PVP K30 and dehydrated alcohol mixed solution, it is cold after 70 DEG C of heating But, mixture A is obtained;
(2), it takes sodium bicarbonate, tartaric acid, lactic acid, EGCG to cross 80 meshes respectively, chitosan oligosaccharide is added and is uniformly mixed, obtains mixture B, Softwood processed in mixture A is added in mixture B again, 20 meshes is crossed and prepares wet granular C;Then again by wet granular C in 45 DEG C of dryings It is dry in case, whole grain is carried out after dry, obtains dry particl D;
(3), probiotic composition and magnesium stearate are added into dry particl D, and is uniformly mixed in agitator tank, obtains sustained release agent E;
(4), sustained release agent E is then subjected to tabletting, packaging again.
Example IV
A kind of effervesce sustained release agent containing probiotics, it includes following several components: microcrystalline cellulose 18%, carbon according to mass fraction Sour hydrogen sodium 25%, tartaric acid 24%, lactic acid powder 12%, chitosan oligosaccharide 15%, EGCG 9%, Brij35 10%, superfine silica gel powder 8%, povidone K30 and dehydrated alcohol mixed solution 4.5%, probiotic composition 35%, magnesium stearate 4.5%.
According to above-mentioned formula, use the preparation method is as follows:
(1), Brij35, superfine silica gel powder is taken to be mixed with PVP K30 and dehydrated alcohol mixed solution, it is cold after 75 DEG C of heating But, mixture A is obtained;
(2), it takes sodium bicarbonate, tartaric acid, lactic acid, EGCG to cross 80 meshes respectively, chitosan oligosaccharide is added and is uniformly mixed, obtains mixture B, Softwood processed in mixture A is added in mixture B again, 20 meshes is crossed and prepares wet granular C;Then again by wet granular C in 48 DEG C of dryings It is dry in case, whole grain is carried out after dry, obtains dry particl D;
(3), probiotic composition and magnesium stearate are added into dry particl D, and is uniformly mixed in agitator tank, obtains sustained release agent E;
(4), sustained release agent E is then subjected to tabletting, packaging again.
Embodiment five
A kind of effervesce sustained release agent containing probiotics, it includes following several components: microcrystalline cellulose 20%, carbon according to mass fraction Sour hydrogen sodium 30%, tartaric acid 25%, lactic acid powder 16%, chitosan oligosaccharide 18%, EGCG 10%, Brij35 12%, superfine silica gel powder 10%, poly- dimension Ketone K30 and dehydrated alcohol mixed solution 5%, probiotic composition 45%, magnesium stearate 6%.
According to above-mentioned formula, use the preparation method is as follows:
(1), Brij35, superfine silica gel powder is taken to be mixed with PVP K30 and dehydrated alcohol mixed solution, it is cold after 80 DEG C of heating But, mixture A is obtained;
(2), it takes sodium bicarbonate, tartaric acid, lactic acid, EGCG to cross 80 meshes respectively, chitosan oligosaccharide is added and is uniformly mixed, obtains mixture B, Softwood processed in mixture A is added in mixture B again, 20 meshes is crossed and prepares wet granular C;Then again by wet granular C in 50 DEG C of dryings It is dry in case, whole grain is carried out after dry, obtains dry particl D;
(3), probiotic composition and magnesium stearate are added into dry particl D, and is uniformly mixed in agitator tank, obtains sustained release agent E;
(4), sustained release agent E is then subjected to tabletting, packaging again.
It is quasi- using female genital tract cleaning inside scale according to one~embodiment of embodiment five, it records in female genital tract Portion's probiotics content results are as follows:
According to upper table it is found that the application effect of embodiment three is best.
The above shows and describes the basic principles and main features of the present invention and the advantages of the present invention.The technology of the industry Personnel are it should be appreciated that the present invention is not limited to the above embodiments, without departing from the spirit and scope of the present invention, this hair Bright to will also have various changes and improvements, these changes and improvements all fall within the protetion scope of the claimed invention.The present invention claims Protection scope is defined by the appending claims and its equivalent thereof.

Claims (4)

1. a kind of effervesce sustained release agent containing probiotics, it is characterised in that: it includes following several components: crystallite according to mass fraction Cellulose 5%-20%, sodium bicarbonate 10%-30%, tartaric acid 15%-25%, lactic acid powder 3%-16%, chitosan oligosaccharide 7%-18%, EGCG It is 6%-10%, Brij35 5%-12%, superfine silica gel powder 2%-10%, PVP K30 and dehydrated alcohol mixed solution 0.5%-5%, prebiotic Bacterium mixture 15%-45%, magnesium stearate 0.2%-6%.
2. a kind of effervesce sustained release agent containing probiotics according to claim 1, it is characterised in that: the probiotic composition Including one of Lactobacillus crispatus, lactobacillus gasseri, lactobacillus acidophilus or a variety of.
3. the preparation method that a kind of effervesce sustained release agent containing probiotics according to claims 1 to 2 is proposed, feature exist In, comprising the following steps:
(1), it takes Brij35, superfine silica gel powder to be mixed with PVP K30 and dehydrated alcohol mixed solution, adds at 60 DEG C -80 DEG C It is cooling after heat, obtain mixture A;
(2), it takes sodium bicarbonate, tartaric acid, lactic acid, EGCG to cross 80 meshes respectively, chitosan oligosaccharide is added and is uniformly mixed, obtains mixture B, Softwood processed in mixture A is added in mixture B again, 20 meshes is crossed and prepares wet granular C;Then again by wet granular C 40 DEG C~50 It is dry in DEG C drying box, whole grain is carried out after dry, obtains dry particl D;
(3), probiotic composition and magnesium stearate are added into dry particl D, and is uniformly mixed in agitator tank, obtains sustained release agent E;
(4), sustained release agent E is then subjected to tabletting, packaging again.
4. a kind of effervesce sustained release agent containing probiotics according to claims 1 to 2 treats female genital disorders in preparation Application in drug.
CN201811560178.6A 2018-12-20 2018-12-20 A kind of effervesce sustained release agent and its preparation method and application containing probiotics Pending CN109846846A (en)

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CN101496821A (en) * 2009-03-18 2009-08-05 西北农林科技大学 Lactobacillus effervescent tablet and preparation method thereof
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Application publication date: 20190607