CN105832771B - A kind of drug and preparation method thereof for treating gastrointestinal candidiasis - Google Patents
A kind of drug and preparation method thereof for treating gastrointestinal candidiasis Download PDFInfo
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- CN105832771B CN105832771B CN201610344266.7A CN201610344266A CN105832771B CN 105832771 B CN105832771 B CN 105832771B CN 201610344266 A CN201610344266 A CN 201610344266A CN 105832771 B CN105832771 B CN 105832771B
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
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- A61K35/60—Fish, e.g. seahorses; Fish eggs
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
The present invention discloses a kind of drug for treating gastrointestinal candidiasis, each ingredient and weight percent are as follows: nystatin bulk pharmaceutical chemicals 1.8-2.7%, cod-liver oil 23-38%, Tween-80 and/or lecithin 4.0-5.0%, D-sorbite 15-28%, methylparaben 0.1000-0.1300%, propylben 0.0100-0.0200%, diethanol amine 5-18%, propylene glycol is in right amount to 100%.The invention also discloses preparation methods.The present invention is directed to gastrointestinal candidiasis significant effect, and specificity is strong, convenient to take, for gastrointestinal candidiasis significant effect.
Description
Technical field
The present invention relates to formulation art more particularly to a kind of drugs and its preparation side for treating gastrointestinal candidiasis
Method.
Background technique
Gastrointestinal candidiasis often shows as pseudomembrane, ulcer or the gruel of thrush, glossitis, angular stomatitis, small intestine and crissum
Rotten, general upper digestive tract is more than lower digestive tract, and children's morbidity is again more than adult, and patient is often by indigestion, chronic disease, evil
Property tumour or prolonged application antibiotic and immunosuppressor medical history, clinical symptoms rely on Fungus examination and food without specificity, diagnosis
Pipe barium meal x-ray inspection, prevention should remove risk factor first, and passive protective physical fitness is continuously improved, and amphotericin B can be selected, and make mould
Rhzomorph, the treatment such as clotrimazole, nystatin 1g are 4,400,000 units.
Amphotericin B is polyene antifungal antibiotic, plays inhibition fungi growth by influencing permeability of cell membrane
Effect.Clinically for treating internal organ caused by serious deep fungal or general infection.In addition to causing Nausea and vomiting fever cold
Outside adverse reactions, renal toxicity is also relatively conventional, the symptoms such as Urine proteins, cylindruria easily occurs for war etc., easily lead to leucocyte decline,
The serious conditions such as anaemia, peripheral neuritis, hepatic lesion, in addition intravenous injection is also possible to cause thrombophlebitis.Clotrimazole etc.
Antifungal belongs to broad-spectrum antifungal drug, has antibacterial action to various fungies, can external application for the adverse reactions such as itch,
It takes orally other than causing the adverse reactions such as gastrointestinal tract Nausea and vomiting, hepatic lesion, leucocyte, granulocyte reduction etc. can be caused.More
The serious is may cause psychiatric disorder or entanglement, the serious adverse reaction such as disorientation, illusion, drowsiness, depressed.
Amphotericin B is polyene antifungal antibiotic, plays inhibition fungi growth by influencing permeability of cell membrane
Effect.Clinically for treating internal organ caused by serious deep fungal or general infection.In addition to causing Nausea and vomiting fever cold
Outside adverse reactions, renal toxicity is also relatively conventional, the symptoms such as Urine proteins, cylindruria easily occurs for war etc., easily lead to leucocyte decline,
The serious conditions such as anaemia, peripheral neuritis, hepatic lesion, in addition intravenous injection is also possible to cause thrombophlebitis.Clotrimazole etc.
Antifungal belongs to broad-spectrum antifungal drug, has antibacterial action to various fungies, can external application for the adverse reactions such as itch,
It takes orally other than causing the adverse reactions such as gastrointestinal tract Nausea and vomiting, hepatic lesion, leucocyte, granulocyte reduction etc. can be caused.More
The serious is may cause psychiatric disorder or entanglement, the serious adverse reaction such as disorientation, illusion, drowsiness, depressed.
Summary of the invention
The purpose of the present invention is to provide a kind of drugs for treating gastrointestinal candidiasis, and it is another object of the present invention to mention
For the preparation method of the drug.
Object of the present invention is to what is be achieved through the following technical solutions:
A kind of drug for treating gastrointestinal candidiasis, each ingredient and weight percent are as follows: nystatin bulk pharmaceutical chemicals 1.8-
2.7%, cod-liver oil 23-38%, Tween-80 and/or lecithin 4.0-5.0%, D-sorbite 15-28%, methylparaben
0.1000-0.1300%, propylben 0.0100-0.0200%, diethanol amine 5-18%, propylene glycol is in right amount to 100%.
Preferably, a kind of drug for treating gastrointestinal candidiasis, each ingredient and weight percent are as follows: nystatin raw material
Medicine 2.0-2.5%, cod-liver oil 25-35%, Tween-80 and/or lecithin 4.0-5.0%, D-sorbite 18-25%, nipalgin
Methyl esters 0.1000-0.1300%, propylben 0.0100-0.0200%, diethanol amine 8-15%, propylene glycol is in right amount extremely
100%.
Preferably, a kind of drug for treating gastrointestinal candidiasis, each ingredient and weight percent are as follows: nystatin raw material
Medicine 2.3%, cod-liver oil 30%, Tween-80 and/or lecithin 4.4%, D-sorbite 22%, methylparaben 0.1125%, Buddhist nun
Golden propyl ester 0.0125% is moored, diethanol amine 10%, propylene glycol adds to 100% in right amount.
A kind of drug for treating gastrointestinal candidiasis, each ingredient and dosage are as follows: nystatin bulk pharmaceutical chemicals 1-3g, cod-liver oil
20-40ml, Tween-80 and/or lecithin 4-6g, D-sorbite 15-30g, methylparaben 0.1000-0.1300g, nipalgin
Propyl ester 0.0080-0.0200g, diethanol amine 5-20ml, propylene glycol add to 100ml.
Preferably, a kind of drug for treating gastrointestinal candidiasis, each ingredient and dosage are as follows: nystatin bulk pharmaceutical chemicals
2.0g, cod-liver oil 25ml, Tween-80 and/or lecithin 4.0g, D-sorbite 18g, methylparaben 0.1000g, nipalgin third
Ester 0.0080g, diethanol amine 8ml, propylene glycol add to 100ml.
A kind of drug for treating gastrointestinal candidiasis, each ingredient and dosage can be with are as follows: nystatin bulk pharmaceutical chemicals 2.3g,
Cod-liver oil 30ml, Tween-80 and/or lecithin 4.4g, D-sorbite 22g, methylparaben 0.1125g, propylben
0.0125g, diethanol amine 10ml, propylene glycol add to 100ml.
A kind of drug for treating gastrointestinal candidiasis, each ingredient and dosage can be with are as follows: nystatin bulk pharmaceutical chemicals 2.7g,
Cod-liver oil 38ml, Tween-80 5.0g, D-sorbite 28g, methylparaben 0.1300g, propylben 0.0200g, diethyl
Hydramine 18ml, propylene glycol add to 100ml.
A kind of drug for treating gastrointestinal candidiasis, each ingredient and dosage can be with are as follows: nystatin bulk pharmaceutical chemicals 1.8g,
Cod-liver oil 23ml, Tween-80 4.0g, D-sorbite 15g, methylparaben 0.1000g, propylben 0.0100g, diethyl
Hydramine 5ml, propylene glycol is in right amount to 100ml.
Above-mentioned drug adds the common auxiliary material of pharmacy, and capsule is made, granule, tablet, pill, powder, takes orally
The preparations such as liquid, suspension.
The preparation method of above-mentioned drug, step are as follows:
(1) nystatin bulk pharmaceutical chemicals are put into grinder grinding, nystatin bulk pharmaceutical chemicals and cod-liver oil after grinding, mixing
It is sufficiently stirred as suspension solution；
(2) methylparaben and propylben mixing, take appropriate propylene glycol sufficiently to dissolve, place；
(3) take D-sorbite addition propylene glycol appropriate, dissolution；
(4) by step (2) (3) solution is added separately to suspension solution obtained by step (1), mix, add Tween-80 or
Lecithin, so that mixed solution all dissolves；
(5) diethanol amine and surplus propylene glycol are added in mixed solution obtained by step (4), adjust pH to 7-8.5, obtains
Nystatin oral administration mixed suspension.
The invention has the benefit that
1, nystatin oral administration mixed suspension specificity of the invention is strong, for gastrointestinal candidiasis significant effect, compared with it
His antimycotic drug side-effect is small.
2, nystatin oral administration mixed suspension of the invention has galenic pharmacy advantage, and stability is superior.
3, the advantages that nystatin oral mixed suspension liquid preparing process of the invention is easy, curative effect is rapid so that of the invention
Product is in production and storage process, and galenic pharmacy is stablized, to ensure that the quality of product.
Specific embodiment
The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention..
Embodiment 1
Nystatin bulk pharmaceutical chemicals 2.3g, cod-liver oil 30ml, Tween-80 4.4g, D-sorbite 22g, methylparaben
0.1125g, propylben 0.0125g, diethanol amine 10ml, propylene glycol to 100ml；
Preparation method:
(1) nystatin bulk pharmaceutical chemicals are put into medicinal grinder to grind, nystatin bulk pharmaceutical chemicals and cod-liver oil after grinding,
Mixing is sufficiently stirred as suspension solution；
(2) methylparaben and propylben mixing, take appropriate propylene glycol sufficiently to dissolve, place；
(3) take D-sorbite addition propylene glycol appropriate, dissolution；
(4) step (2) (3) are obtained into solution and are added separately to suspension solution obtained by step (1), mixed, add Tween-80,
So that mixed solution all dissolves；
(5) diethanol amine and surplus propylene glycol are added in mixed solution obtained by step (4), adjust pH to 7-8.5, obtains
Nystatin oral administration mixed suspension.
Embodiment 2
Nystatin bulk pharmaceutical chemicals 1.8g, cod-liver oil 23ml, Tween-80 4.0g, D-sorbite 15g, methylparaben
0.1000g, propylben 0.0100g, diethanol amine 5ml, propylene glycol is in right amount to 100ml；
Preparation method:
(1) nystatin is put into medicinal grinder to grind, nystatin and cod-liver oil after grinding, mixing are sufficiently stirred
For suspension solution；
(2) methylparaben and propylben mixing, take appropriate propylene glycol sufficiently to dissolve, place；
(3) take D-sorbite addition propylene glycol appropriate, dissolution；
(4) step (2) (3) are obtained into solution and are added separately to suspension solution obtained by step (1), mixed, add Tween-80,
So that mixed solution all dissolves；
(5) diethanol amine and surplus propylene glycol are added in mixed solution obtained by step (4), adjust pH to 7-8.5, i.e.,
Obtain nystatin oral administration mixed suspension.
Embodiment 3
Nystatin bulk pharmaceutical chemicals 2.7g, cod-liver oil 38ml, Tween-80 5.0g, D-sorbite 28g, methylparaben
0.1300g, propylben 0.0200g, diethanol amine 18ml, propylene glycol to 100ml.Bulk pharmaceutical chemicals 1.8g, cod-liver oil 23ml, spits
Temperature -80 4.0g, D-sorbite 15g, methylparaben 0.1000g, propylben 0.0100g, diethanol amine 5ml, propylene glycol
In right amount to 100ml；
Preparation method:
(1) nystatin is put into medicinal grinder to grind, nystatin and cod-liver oil after grinding, mixing are sufficiently stirred
For suspension solution；
(2) methylparaben and propylben mixing, take appropriate propylene glycol sufficiently to dissolve, place；
(3) take D-sorbite addition propylene glycol appropriate, dissolution；
(4) step (2) (3) are obtained into solution and are added separately to suspension solution obtained by step (1), mixed, add Tween-80,
So that mixed solution all dissolves；
(5) diethanol amine and surplus propylene glycol are added in mixed solution obtained by step (4), adjust pH to 7-8.5, obtains
Nystatin oral administration mixed suspension.
Embodiment 4
Nystatin bulk pharmaceutical chemicals 2.3g, cod-liver oil 30ml, lecithin 4.4g, D-sorbite 22g, methylparaben
0.1125g, propylben 0.0125g, diethanol amine 10ml, propylene glycol to 100ml；
Preparation method:
(1) nystatin is put into medicinal grinder to grind, nystatin and cod-liver oil after grinding, mixing are sufficiently stirred
For suspension solution；
(2) methylparaben and propylben mixing, take appropriate propylene glycol sufficiently to dissolve, place；
(3) take D-sorbite addition propylene glycol appropriate, dissolution；
(4) step (2) (3) are obtained into solution and is added separately to suspension solution obtained by step (1), mixed, add lecithin, make
Mixed solution is obtained all to dissolve；
(5) diethanol amine and surplus propylene glycol are added in mixed solution obtained by step (4), adjust pH to 7-8.5, obtains
Nystatin oral administration mixed suspension.
Embodiment 5
Nystatin bulk pharmaceutical chemicals 2.7g, cod-liver oil 38ml, lecithin 5.0g, D-sorbite 28g, methylparaben
0.1300g, propylben 0.0200g, diethanol amine 18ml, propylene glycol to 100ml.
Preparation method:
(1) nystatin is put into medicinal grinder to grind, nystatin and cod-liver oil after grinding, mixing are sufficiently stirred
For suspension solution；
(2) methylparaben and propylben mixing, take appropriate propylene glycol sufficiently to dissolve, place；(3) D-sorbite is taken
It is appropriate that propylene glycol is added, dissolution；
(4) step (2) (3) are obtained into solution and is added separately to suspension solution obtained by step (1), mixed, add lecithin, make
Mixed solution is obtained all to dissolve；
(5) diethanol amine and surplus propylene glycol are added in mixed solution obtained by step (4), adjust pH to 7-8.5, obtains
Nystatin oral administration mixed suspension.
Embodiment 6
Nystatin bulk pharmaceutical chemicals 2.3%, cod-liver oil 30%, Tween-80 4.4%, D-sorbite 22%, methylparaben
0.1125%, propylben 0.0125%, diethanol amine 10%, propylene glycol adds to 100% in right amount；
Preparation method:
(1) nystatin is put into medicinal grinder to grind, nystatin and cod-liver oil after grinding, mixing are sufficiently stirred
For suspension solution；
(2) methylparaben and propylben mixing, take appropriate propylene glycol sufficiently to dissolve, place；(3) D-sorbite is taken
It is appropriate that propylene glycol is added, dissolution；
(4) step (2) (3) are obtained into solution and are added separately to suspension solution obtained by step (1), mixed, add Tween-80,
So that mixed solution all dissolves；
(5) diethanol amine and surplus propylene glycol are added in mixed solution obtained by step (4), adjust pH to 7-8.5, obtains
Nystatin oral administration mixed suspension.
Embodiment 7
Nystatin bulk pharmaceutical chemicals 2.3%, cod-liver oil 30%, lecithin 4.4%, D-sorbite 22%, methylparaben
0.1125%, propylben 0.0125%, diethanol amine 10%, propylene glycol adds to 100% in right amount；
Preparation method:
(1) nystatin is put into medicinal grinder to grind, nystatin and cod-liver oil after grinding, mixing are sufficiently stirred
For suspension solution；
(2) methylparaben and propylben mixing, take appropriate propylene glycol sufficiently to dissolve, place；(3) D-sorbite is taken
It is appropriate that propylene glycol is added, dissolution；
(4) step (2) (3) are obtained into solution and is added separately to suspension solution obtained by step (1), mixed, add lecithin, make
Mixed solution is obtained all to dissolve；
(5) diethanol amine and surplus propylene glycol are added in mixed solution obtained by step (4), adjust pH to 7-8.5, obtains
Nystatin oral administration mixed suspension.
The effect experiment of the drug of the present invention of embodiment 8
Testing program: gastrointestinal candidiasis patient 100, test group, control group one, control group two are randomly divided into.Its
Middle test group 40, control group 1 40, control group 2 30, test group takes nystatin suspension, is made according to embodiment 1
At, each ten thousand unit of 50-100,3 times a day；Experimental group 1 takes nystatin tablet, each ten thousand unit of 50-100,3 times a day；
Control group 2 takes clotrimazole piece, each 0.25-1g, three times a day.Continuous medication 4 days or more, within 12 days.Symptom or beads
Bacterium mycelia disappears or patient is not resistant to treatment and is discontinued.
Observation item: 1, criterion of therapeutical effect: using laboratory inspection as foundation, fungal hyphae disappearance be it is effective, otherwise in vain, because
It is not resistant to treat and drug withdrawal is also invalid.2, quality of life indexing situation is referring to Karuafsky grading scheme.As a result
Efficient: curative effect compares after three groups of case treatments
Efficacy result after three groups of case treatments are as follows: medication 8d, treatment group's effective percentage are significantly higher than control group, and control group
One compares, P < 0.05；Compared with control group two, P < 0.05.
Control group 1 is compared, P < 0.05, compared with control group 2, P < 0.05.Therefore, it is mixed to take nystatin for treatment
Quality of life after suspension, high compared with control group quality of life, it is more effective that nystatin suspension treats gastrointestinal candidiasis.
Claims (9)
1. a kind of drug for treating gastrointestinal candidiasis, it is characterised in that each ingredient and ratio are as follows: nystatin bulk pharmaceutical chemicals weight
Amount/volume ratio is 1.8-2.7%, and cod-liver oil volume/volume ratio is 23-38%, Tween-80 and/or lecithin weight/volume
For 4.0-5.0%, D-sorbite weight/volume is 15-28%, and methylparaben weight/volume is 0.1000-
0.1300%, propylben weight/volume is 0.0100-0.0200%, and diethanol amine volume/volume ratio is 5-18%,
Propylene glycol complements to 100% unit dose；The common auxiliary material of pharmacy is added, oral suspension formulations are made.
2. drug as described in claim 1, it is characterised in that each ingredient and ratio are as follows: nystatin bulk pharmaceutical chemicals weight/volume
Than for 2.0-2.5%, cod-liver oil volume/volume ratio is 25-35%, Tween-80 and/or lecithin weight/volume are 4.0-
5.0%, D-sorbite weight/volume is 18-25%, and methylparaben weight/volume is 0.1000-0.1300%, Buddhist nun
Mooring golden propyl ester weight/volume is 0.0100-0.0200%, and diethanol amine volume/volume ratio is 8-15%, and propylene glycol complements to
100% unit dose.
3. drug as claimed in claim 2, it is characterised in that each ingredient and ratio are as follows: nystatin bulk pharmaceutical chemicals weight/volume
Than being 2.3%, cod-liver oil volume/volume ratio is 30%, and Tween-80 and/or lecithin weight/volume are 4.4%, sorbose
Alcohol weight/volume is 22%, and methylparaben weight/volume is 0.1125%, and propylben weight/volume is
0.0125%, diethanol amine volume/volume ratio is 10%, and propylene glycol complements to 100% unit dose.
4. a kind of oral administration mixed suspension for treating gastrointestinal candidiasis, it is characterised in that each ingredient and dosage are as follows: nystatin is former
Expect medicine 1-3g, cod-liver oil 20-40ml, Tween-80 and/or lecithin 4-6g, D-sorbite 15-30g, methylparaben
0.1000-0.1300g, propylben 0.0080-0.0200g, diethanol amine 5-20ml, propylene glycol add to 100ml.
5. oral administration mixed suspension as claimed in claim 4, it is characterised in that each ingredient and dosage are as follows: nystatin bulk pharmaceutical chemicals
2.0g, cod-liver oil 25ml, Tween-80 and/or lecithin 4.0g, D-sorbite 18g, methylparaben 0.1000g, nipalgin third
Ester 0.0080g, diethanol amine 8ml, propylene glycol add to 100ml.
6. oral administration mixed suspension as claimed in claim 4, it is characterised in that each ingredient and dosage are as follows: nystatin bulk pharmaceutical chemicals
2.3g, cod-liver oil 30ml, Tween-80 and/or lecithin 4.4g, D-sorbite 22g, methylparaben 0.1125g, nipalgin third
Ester 0.0125g, diethanol amine 10ml, propylene glycol add to 100ml.
7. oral administration mixed suspension as claimed in claim 4, it is characterised in that each ingredient and dosage are as follows: nystatin bulk pharmaceutical chemicals
2.7g, cod-liver oil 38ml, Tween-80 5.0g, D-sorbite 28g, methylparaben 0.1300g, propylben 0.0200g,
Diethanol amine 18ml, propylene glycol add to 100ml.
8. oral administration mixed suspension as claimed in claim 4, it is characterised in that each ingredient and dosage are as follows: nystatin bulk pharmaceutical chemicals
1.8g, cod-liver oil 23ml, Tween-80 4.0g, D-sorbite 15g, methylparaben 0.1000g, propylben 0.0100g,
Diethanol amine 5ml, propylene glycol is in right amount to 100ml.
9. the preparation method of oral administration mixed suspension as described in any of the claims 1 to 8, which is characterized in that step are as follows:
(1) nystatin bulk pharmaceutical chemicals are put into grinder grinding, nystatin bulk pharmaceutical chemicals and cod-liver oil after grinding, mixing is sufficiently
Stirring is suspension solution；
(2) methylparaben and propylben mixing, take appropriate propylene glycol sufficiently to dissolve, place；
(3) take D-sorbite addition propylene glycol appropriate, dissolution；
(4) step (2) (3) are obtained into solution and is added separately to suspension solution obtained by step (1), mixed, add Tween-80 or lecithin
Rouge, so that mixed solution all dissolves；
(5) diethanol amine and surplus propylene glycol are added in mixed solution obtained by step (4), adjust pH to 7-8.5, must makes mould
Rhzomorph oral administration mixed suspension.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101254201A (en) * | 2008-04-03 | 2008-09-03 | 北京世纪博康医药科技有限公司 | Diastatin nystatin menthol combination with cooperating knife-bar |
| CN102579473A (en) * | 2012-01-17 | 2012-07-18 | 程雪翔 | Nifuratel-nysfungin gel and preparation method thereof |
| CA2946982A1 (en) * | 2016-10-31 | 2018-04-30 | Pharmascience Inc. | Nystatin nanosuspension formulation using high pressure homogenisation |
-
2016
- 2016-05-23 CN CN201610344266.7A patent/CN105832771B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101254201A (en) * | 2008-04-03 | 2008-09-03 | 北京世纪博康医药科技有限公司 | Diastatin nystatin menthol combination with cooperating knife-bar |
| CN102579473A (en) * | 2012-01-17 | 2012-07-18 | 程雪翔 | Nifuratel-nysfungin gel and preparation method thereof |
| CA2946982A1 (en) * | 2016-10-31 | 2018-04-30 | Pharmascience Inc. | Nystatin nanosuspension formulation using high pressure homogenisation |
Non-Patent Citations (1)
| Title |
|---|
| 制霉菌素鱼肝油混悬液的研制和应用;柯昌和;《中国医院药学杂志》;19870831;第7卷(第8期);374 |
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