CN1330378C - Medicine composition - Google Patents
Medicine composition Download PDFInfo
- Publication number
- CN1330378C CN1330378C CNB2003101186813A CN200310118681A CN1330378C CN 1330378 C CN1330378 C CN 1330378C CN B2003101186813 A CNB2003101186813 A CN B2003101186813A CN 200310118681 A CN200310118681 A CN 200310118681A CN 1330378 C CN1330378 C CN 1330378C
- Authority
- CN
- China
- Prior art keywords
- crude drug
- pharmaceutical composition
- sense
- taking
- discomfort
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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- 230000014860 sensory perception of taste Effects 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
- 235000012239 silicon dioxide Nutrition 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- JHJLBTNAGRQEKS-UHFFFAOYSA-M sodium bromide Inorganic materials [Na+].[Br-] JHJLBTNAGRQEKS-UHFFFAOYSA-M 0.000 description 1
- 229940075581 sodium bromide Drugs 0.000 description 1
- IDBYLPRJLWSMAI-UHFFFAOYSA-M sodium;1,2,3,3a,4,5,6,7,8,8a-decahydroazulene-1-sulfonate Chemical compound [Na+].C1CCCCC2C(S(=O)(=O)[O-])CCC21 IDBYLPRJLWSMAI-UHFFFAOYSA-M 0.000 description 1
- JGMJQSFLQWGYMQ-UHFFFAOYSA-M sodium;2,6-dichloro-n-phenylaniline;acetate Chemical compound [Na+].CC([O-])=O.ClC1=CC=CC(Cl)=C1NC1=CC=CC=C1 JGMJQSFLQWGYMQ-UHFFFAOYSA-M 0.000 description 1
- RGHFKWPGWBFQLN-UHFFFAOYSA-M sodium;5,5-diethylpyrimidin-3-ide-2,4,6-trione Chemical compound [Na+].CCC1(CC)C([O-])=NC(=O)NC1=O RGHFKWPGWBFQLN-UHFFFAOYSA-M 0.000 description 1
- GFWRVVCDTLRWPK-KPKJPENVSA-N sofalcone Chemical compound C1=CC(OCC=C(C)C)=CC=C1\C=C\C(=O)C1=CC=C(OCC=C(C)C)C=C1OCC(O)=O GFWRVVCDTLRWPK-KPKJPENVSA-N 0.000 description 1
- 229950004782 sofalcone Drugs 0.000 description 1
- 208000024794 sputum Diseases 0.000 description 1
- 210000003802 sputum Anatomy 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 229960004274 stearic acid Drugs 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- BDHFUVZGWQCTTF-UHFFFAOYSA-M sulfonate Chemical compound [O-]S(=O)=O BDHFUVZGWQCTTF-UHFFFAOYSA-M 0.000 description 1
- 229960004940 sulpiride Drugs 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 235000012222 talc Nutrition 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 229950006156 teprenone Drugs 0.000 description 1
- IWVCMVBTMGNXQD-UHFFFAOYSA-N terramycin dehydrate Natural products C1=CC=C2C(O)(C)C3C(O)C4C(N(C)C)C(O)=C(C(N)=O)C(=O)C4(O)C(O)=C3C(=O)C2=C1O IWVCMVBTMGNXQD-UHFFFAOYSA-N 0.000 description 1
- 229960002180 tetracycline Drugs 0.000 description 1
- 229930101283 tetracycline Natural products 0.000 description 1
- 235000019364 tetracycline Nutrition 0.000 description 1
- 150000003522 tetracyclines Chemical class 0.000 description 1
- PRZPUYBFEJPNPF-UHFFFAOYSA-J tetrasodium 3-carboxy-3,5-dihydroxy-5-oxopentanoate 2-hydroxypropane-1,2,3-tricarboxylate Chemical compound [Na+].C(CC(O)(C(=O)[O-])CC(=O)[O-])(=O)[O-].[Na+].[Na+].[Na+].C(CC(O)(C(=O)O)CC(=O)O)(=O)[O-] PRZPUYBFEJPNPF-UHFFFAOYSA-J 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 235000010296 thiabendazole Nutrition 0.000 description 1
- WJCNZQLZVWNLKY-UHFFFAOYSA-N thiabendazole Chemical compound S1C=NC(C=2NC3=CC=CC=C3N=2)=C1 WJCNZQLZVWNLKY-UHFFFAOYSA-N 0.000 description 1
- 229960004546 thiabendazole Drugs 0.000 description 1
- 239000004308 thiabendazole Substances 0.000 description 1
- 229960005053 tinidazole Drugs 0.000 description 1
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 1
- 229950001089 todralazine Drugs 0.000 description 1
- 230000001256 tonic effect Effects 0.000 description 1
- 229940125725 tranquilizer Drugs 0.000 description 1
- 239000003204 tranquilizing agent Substances 0.000 description 1
- 230000002936 tranquilizing effect Effects 0.000 description 1
- 229960005345 trimebutine Drugs 0.000 description 1
- 229960001341 troxipide Drugs 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
- 229960000820 zopiclone Drugs 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Alternative & Traditional Medicine (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Provided is a medicinal composition effective for solving the problem of the increase in tablet size to cause difficulty in taking caused by the use of a large amount of additives other than an active component for masking the disagreeable taste of the active component, and the problem of the use of mainly a sweetener for the masking of the disagreeable taste of the active component to cause inadequency from the view point of preference of a person of stomach discomfort to hate a medicine necessitating a high administration dose and having strong sweetness and that of the restriction for a person of diabetes, or the like, restricted to take sugars.This medicinal composition having improved administration feeling contains the active component giving discomfortable feeling when taking in combination with a stomachic herb drug. The pharmaceutical composition can reduce the use of additives such as sweetener and mask the taste of a component giving discomfortable feeling in taking.
Description
Technical field
In the oral cavity, produce bitterness when the present invention relates to take, when tart flavour, the active ingredient preparation of senses of discomfort such as astringent taste, suppress pharmaceutical composition of its sense of discomfort effect excellence and preparation method thereof.Further, the present invention relates to produce the covering method of the active ingredient of sense of discomfort such as above-mentioned bitterness, and above-mentioned sense of discomfort is suppressed the use of the crude drug of effect excellence as screening agent.
Background technology
In the physiologically active ingredient as the medicine use, in the oral cavity, produce bitterness when taking, tart flavour, the composition of senses of discomfort such as astringent taste is a lot.In order to relax, the sense of discomfort when suppressing this taking has been carried out various trials.
Past in order to alleviate the bitterness of ascorbic acid calcium salt, has proposed the mixing aspartame, water-soluble saccharides (reduction maltose) and free physiologically active ingredient as required, the invention of compression molding preparationization.In this communique, the compression molding preparation of the bitterness of long-time inhibition ascorbic acid calcium salt is disclosed, its preparation method, and covering method.In addition, the invention of putting down in writing in this communique, the special sense of discomfort flavor that suppresses glucide also is purpose (for example, Japanese documentation 1).
But, the invention of putting down in writing in this communique, the use amount of additive reduction maltose is many, and tablet maximizes and is difficult to take, and exists device to maximize problems such as particularization in the manufacturing.In addition, this invention relates to the content of compression molding preparation, and dosage form for example is defined as fancy food or tablets such as drop, confection, contains tablet, and oral cavities such as SHEXIAPIAN tablet can not be expected powder, the effect of dosage forms such as granule.
The formability preparation (for example, Japanese documentation 2) of the water-soluble saccharides of the slaine that contains based on the physiologically active ingredient with bitterness, glucide, reduction maltose is disclosed in addition.
But, with above-mentioned compression molding preparation similarly, the use amount of water-soluble saccharides such as additive reduction maltose is many, produces tablet and maximizes and take difficulty, device maximizes in the preparation, problems such as particularization.In addition, can not expect powder, the effect of dosage forms such as granule.
In addition, disclose in the mixture of composition with uncomfortable flavor and correctives and applied the body of powder that shear strength obtains, perhaps added the paraffin composition in the body of powder, further will apply the granulation compositions of having sheltered the sense of discomfort flavor that the body of powder of shear strength is granulated and formed.And, can enumerate saccharide, synthetic sweetener, aminoacid, acidic flavoring agent etc. as correctives.The purpose of the invention of this communique record provides and is suppressed at the discomfort flavor of feeling in the mouth, has the successive granulation compositions of good flavoring and this effect.In addition, be purpose (for example, Japanese documentation 3) so that cheap equipment, simple preparation method to be provided
But the manufacture method of granulation compositions is made of simple operation, but the pelletize compositions in order to obtain sheltering, it is indispensable cutting off processing.Therefore, cut off processing increase operation, on the manufacturing cost this point, have problems owing to operate this.And, owing to be to have the composition of uncomfortable flavor, be difficult to from the problem of granulation thing stripping effective ingredient after having so-called administration by the form that the paraffin composition surrounds.
Like this, above-mentioned prior art is common to be to use principal agent composition additive in addition in a large number, mainly uses sweeting agent to suppress sense of discomfort.Can enumerate aspartame as sweeting agent, glucide (gluside), reduction maltose etc.But, showing that for stomach people's dose of sense of discomfort symptom is many, it is suitable that the preparation that sweet taste is strong can not be said so from the viewpoint of hobby property.In addition, also there is the problem of difficulty in fact in the people's administration for this class restriction sugar picked-up of diabetes.
[Japanese documentation 1]
No. 3110299 communique of Japan Patent (the 1st～4 hurdle)
[Japanese documentation 2]
The open 2000-103746 communique (the 1st～3 hurdle) of Japan Patent
[Japanese documentation 3]
The open 2000-191517 communique (the 1st～3 hurdle) of Japan Patent
As mentioned above, invention disclosed in the prior art document is because a large amount of principal agent composition additive in addition that uses under the situation as tablet formulation, exists so-called tablet to maximize and takes the problem of difficulty.In addition, mainly, use sweeting agent to suppress the discomfort flavor of effective ingredient, can enumerate aspartame as sweeting agent, glucide, reduction maltose etc.But, showing that for stomach people's dose of sense of discomfort class symptom is too much, it is suitable that the preparation that sweet taste is strong can not be said so from the viewpoint of hobby property.In addition, there is the administration problem of difficulty in fact in the people who limits sugar picked-up like that for diabetes.
Therefore, aspect additive use amount reductions such as sweeting agent, expectation can suppress to take the pharmaceutical composition of taste of the composition of sense difference, with and preparation method thereof exploitation.In addition, as its preparation method, expectation is made of simple operation, and process number is few, preparation method cheaply.
Summary of the invention
Present inventors, in order to solve above-mentioned problem, the result of further investigation, the physiologically active ingredient that produces sense of discomfort when making us finding uncannily to take mixes with the crude drug that is good for the stomach, and when taking said composition, has relaxed this sense of discomfort down to having finished the present invention.Owing in the original effect that is good for the stomach of the crude drug composition that keeps being good for the stomach, work as correctives, can successfully reduce the use amount of the additives such as sweeting agent that the past uses as correctives for physiologically active ingredient.Therefore, during preparation of drug combination of the present invention, the wet granulation method that discovery need not be common is suitable for the dry granulation method.That is, in the pharmaceutical composition of the present invention by the dry granulation manufactured, be surprised to find that the flavoring effect of comparing blended crude drug with simple mixture increases, and, the sense of taking that has improved pharmaceutical composition.
Take the medicine that digestive tract side effects occurs, or in mouth, produce the physiologically active ingredient of sense of discomfort when taking,, can reduce or eliminate above-mentioned side effect, in addition, can shelter uncomfortable taste by making pharmaceutical composition of the present invention.
In addition,, in mouth, produce the physiologically active ingredient of sense of discomfort and the crude drug that is good for the stomach mixing when taking, can shelter uncomfortable taste by the gastrointestinal drug composition beyond the crude drug that will be good for the stomach.And, can obtain gastrointestinal drug and the crude drug effect that multiplies each other of drug effect separately that is good for the stomach.
The specific embodiment
The present invention when producing the physiologically active ingredient preparation of sense of discomfort in the time will taking, can extensively utilize.Can be listed below as these compositions.During preparation, can mix following compositions more than a kind and 2 kinds.And, they and other active ingredient can be made up and preparationization.
(1) gastrointestinal drug composition is taken the composition example of sense difference
1) can enumerate following ingredients as drug for peptic ulcer.
Sucralfate, aceglutamide aluminum, gefarnate, sulpiride, lattice dragon bromine ammonium, proglumide, sofalcone, teprenone, Amicos (Banyu), troxipide, plaunotol, (the thunder mud is for fourth for histamine H2 receptor antagonist, cimetidine, famotidine, nizatidine, roxatidine), proton pump inhibitor (omeprazole)
2) digestive organs medication
Metoclopramide, aclatonium napadisilate, Trimebutine Maleate etc.
3) as antacid
Aluminium Hydroxide, silicic acid magnesium aluminate, magnesium silicate, synthetic aluminium silicate, synthetic hydrotalcite, magnesium oxide, aluminum magnesium hydroxide, aluminium hydroxide-sodium bicarbonate coprecipitated product, aluminium hydroxide-magnesium carbonate combination drying gel, aluminium hydroxide-magnesium carbonate coprecipitated product, magnesium hydroxide, sodium bicarbonate, magnesium carbonate, winnofil, silicic acid magnesium aluminate, calcium phosphate dibasic anhydrous, calcium hydrogen phosphate etc.
In mouth, produce the composition example of sense of discomfort when (2) biological active substances with digestive system side effect is taken
1) hypnosis tranquilizer:
Barbital, sodium bromide, Butoctamide Semisuccinate, Zopiclone etc.
2) antipyretic analgesic:
Acetaminophen, mefenamic acid, aspirin, ethenzamide, isopropylantipyrine, diclofenac sodium, ibuprofen, ketoprofen, indomethacin, Dimaten (Promeco) etc.
3) relieving cough and eliminating sputum medicine:
Dihydrocodeine phosphate, dextromethmorphan hydrobromide, Perocan (Toyo Jozo)., hydrochloric acid eprazinone, this fourth of hydrochloric acid chlorine piperazine, narcotine, guaiacol, potassium sulfonate, ephedrine hydrochloride, d1-hydrochloride methyl ephedrine etc.
4) antihistaminic:
Chlorphenamine maleate, phentolamine hydrochloride, clemastine fumarate etc.
5) cardiac tonic:
Aminophylline, diprofene, digitophyllin etc.
6) the dizzy medicine in town:
Dimenhydrinate, difenidol hydrochloride, d1-isoprenaline etc.
7) diabetes medication:
The hydrochloric acid metformin, andere etc.
8) hypotensor:
Todralazine Hydrochloride, alseroxylon, guanethidine monosulphate, clonidine hydrochloride etc.
9) inorganic formulation:
Potassium gluconate, potassium chloride, iron sulfate, ferrotrenine, tetrasodium biscitrate ferrate etc.
10) hormone:
Dexamethasone, betamethasone etc.
11) antibiotic:
Cefradine, cefaclor, erythromycin, clarithromycin, kitasamycin, midecamycin, tetracycline, oxytetracycline, chloromycetin, lincomycin hydrochloride, a kanamycin sulfate, paromomycin sulfate, Lyphocin (Fujisawa) etc.
12) anthelmintic, disease-resistant protozoon agent:
The citric acid diethylcarbamazine, thiabendazole, quinin hydrochloride, quinine sulfate, tinidazole etc.
For above-mentioned physiologically active ingredient, when taking, what is called produces sense of discomfort, be meant bitterness, astringent taste, acid, astringent taste, ferrum flavor, powder flavor, coarse sense of taste etc.
In addition,, for example can enumerate the demonstration inappetence as above-mentioned digestive system side effect, the stomach discomfort sense, stomachache, the abdominal part sensation of fullness, constipation is felt sick, vomiting, symptoms such as diarrhoea.
As the crude drug that is good for the stomach that uses in the invention pharmaceutical composition, can enumerate following crude drug group.This crude drug powder can select combination more than 1 or 2 in crude drug group as follows.
The crude drug group: Cortex cinnamomi japonici (Ramulus Cinnamomi), Flos Caryophylli, Rhizoma Zingiberis Recens, Fructus Foeniculi, Radix Gentianae, Radix Curcumae, Pericarpium Zanthoxyli, Pericarpium Citri Reticulatae, Rhizoma Alpiniae Officinarum, Cortex Phellodendri, Herba corydalis edulis, Rhizoma Coptidis is worked as medicine, Cortex Magnoliae Officinalis, Radix Paeoniae, Fructus Amomi, Radix Glycyrrhizae, Radix Scutellariae, Ramulus Et Folium Picrasmae, Rhizoma Atractylodis, Radix Ginseng, Fructus Evodiae
As follows from effective combination of these crude drug group selections.Dosage, the suitable scope of the present invention of expression.In addition, the combination of the crude drug that uses in the pharmaceutical composition of the present invention is without any qualification.
Dosage
Cortex cinnamomi japonici (Ramulus Cinnamomi) 50～333mg
Flos Caryophylli 10～50mg
Rhizoma Zingiberis Recens 10～100mg
Fructus Foeniculi 10～100mg
Radix Gentianae 10～50mg
Radix Curcumae 10～100mg
Pericarpium Zanthoxyli 2～30mg
The kind and the dosage of other crude drug of suitable pharmaceutical composition of the present invention are as follows.For these combinations, replace mentioned component to mix, also can in mentioned component, add.
Dosage
Pericarpium Citri Reticulatae 10～100mg
Rhizoma Alpiniae Officinarum 10～100mg
Cortex Phellodendri 10～50mg
Herba corydalis edulis 10～150mg
Rhizoma Coptidis 10～50mg
As medicine 10～50mg
Cortex Magnoliae Officinalis 10～100mg
Radix Paeoniae 10～100mg
Fructus Amomi 10～150mg
Radix Glycyrrhizae 10～150mg
Radix Scutellariae 10～50mg
Ramulus Et Folium Picrasmae 10～50mg
Rhizoma Atractylodis 10～50mg
Radix Ginseng 10～150mg
Fructus Evodiae 10～100mg
As the dosage form of the crude drug that is good for the stomach that uses in the pharmaceutical composition of the present invention, be preferably the powder or the dry extract of pulverizing.In addition, comminuted powder more preferably.The particle diameter of crude drug powder is preferably below the 500 μ m, more preferably below the 300 μ m, most preferably is below the 150 μ m.The composition that the combined amount of crude drug powder is taken the sense difference with respect to 1 weight portion is 0.2 weight portion～2 weight portions, more preferably 0.2 weight portion～1.0 weight portions.
When the pulverizing of above-mentioned crude drug, can use common method, rotary type for example, fluid-type, grinding modes such as impact type.In addition, also can with crude drug with liquid nitrogen freezing after lyophilizing pulverize.
Pharmaceutical composition of the present invention can carry out following preparationization.
The physiologically active ingredient that produces sense of discomfort during with taking more than a kind or 2 kinds be good for the stomach crude drug, and other physiologically active ingredient, additive etc. as required mixes with V-Mixer, it is used the roller type press compression molding, manufacture thin slice, it is waited with the roller pulverizer vibration carry out granulate then.
During above-mentioned mixing, also can use beyond the V-Mixer Wtypeofblender, bump container mixer, High Speed Stirring Machine, omnipotent stirring mixer etc.
During wet granulation, can use rotation granulator, mixer granulator, fluidized bed granulator, spray granulation machine, centrifugal rotation granulator, wet granulation machines such as rotational flow granulator.On the other hand, during the dry granulation method, can use the dry granulation machines such as compacting granulator of the granulous binding agent of usefulness powder etc.Also not too damage the effect of sheltering uncomfortable taste even granulate in any way, but the dry granulation method owing to do not comprise heating process, has kept the local flavor of crude drug, can obtain having the pharmaceutical composition of better taking sense.So-called dry granulation method is with having highly compressed roller compaction body of powder, shaping, the method for the thing that further its granulate obtained granulating.
As above-mentioned wet granulation method, use mixer granulator or fluidized bed granulator, the solution that has dissolved water equal solvent or binding agent is added in the body of powder granulate.In addition, can use body of powder dissolving or be distributed in the water equal solvent, with its spray-drying process method of granulating with spray drying etc.Because by these method for making drying and granulating goods, goods will heat for a long time.Because by such heating, reduced the flavored action of the desired crude drug of the present invention, under the situation about making by these method for makings, with these methods granulations, it is effective then crude drug being mixed under non-heating condition with the composition beyond the crude drug.
If the powder body made from the method for making that do not heat, can be with its compression molding (tabletting).The form of tablet can single-layer sheet, in addition, also can be two layers, three-layer tablet.
Pharmaceutical composition of the present invention also can be the dosage form of the aqueous dispersions preparation of the physiologically active ingredient of uncomfortable taste and crude drug powder.
Pharmaceutical composition of the present invention except that discomfort is taken sense composition and crude drug, also can contain other biological active substances.For example, if gastrointestinal drug can further mix antacid, digestive pharmaceutical, medicines for relieving intestinal disorders, mucosa renovation agent, diarrhea.
And, during preparation, can mix additive commonly used.The kind and the quantity of additive are not particularly limited, but the quantitative change of additive is many, and it is important that the single administration amount is exceeded.In addition, use saccharide in large quantities, it is necessary that preparation did not become sweet.As additive, can use for example following material.
Crystalline cellulose, lactose, white sugar, corn starch, potato starch, polyvinyl alcohol, calcium stearate, magnesium stearate, sucrose fatty acid ester, stearic acid, Carmellose, Carmellose calcium, carmellose sodium, big carmellose sodium (croscarmellosesodium), the low hydroxypropyl cellulose that replaces, carboxymethyl starch sodium, aqueous silicon dioxide, light silicon anhydride, titanium oxide, Talcum, gastric solubility acrylic resin, arabic gum, carboxyl ethylene polymer, hydroxypropyl cellulose, methylcellulose, ethyl cellulose, hydroxypropyl emthylcellulose etc.
The preparation of drug combination method according to the present invention can prepare with cheap simple equipments ground.In addition, according to the present invention,, can eliminate the problem that the such tablet of prior art maximizes owing to can reduce the use amount of additives such as sweeting agent.And, also can be dosage forms such as powder and granule.
[embodiment]
The present invention further describes by the following example, but the present invention is not limited to these embodiment.
[embodiment 1～9]
By the prescription shown in 1 of tabulating down, each dry powdered composition of ormal weight is collected in the polyester bag, carry out simple mixing.Merely mixing ratio writes out a prescription 1～4 under same condition, and as a comparative example 1～4.
Take a dose respectively for 10 experimenters, obtain the evaluation in 10 stages by the experimenter these drying composites.With its mean deviation of counting as the functional evaluation result.And, based on this standard determination below equalization point.And the composition that uncomfortable taste is arranged when taking is a sucralfate.
Criterion: *: poor (the functional evaluation result: 1 above less than 3) Δ: common (functional evaluation result: 3 above less thaies 6) zero: good (functional evaluation result: 6 above less thaies 8) ◎: very good (functional evaluation result: more than 8 below 10) of sense taken
[table 1]
| (mg) embodiment (mg) relatively writes out a prescription | |||||||||||||
| Prescription No. | ① | ② | ③ | ④ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
| Sucralfate | 500 | 500 | 500 | 500 | 500 | 500 | 500 | 500 | 500 | 500 | 500 | 500 | 500 |
| The azulene sodium sulfonate | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
| L-glutamic acid | 134 | 134 | 134 | 134 | 134 | 134 | 134 | 134 | 134 | 134 | 134 | 134 | 134 |
| Sodium bicarbonate | 150 | 300 | 150 | 300 | 150 | 150 | 150 | 300 | 150 | 150 | 300 | 300 | 150 |
| Synthetic hydrotalcite | 160 | 160 | 160 | 160 | 160 | 160 | 160 | 160 | 160 | 160 | 160 | 160 | 160 |
| α-Dian Fenmei SS | 20 | 20 | 20 | 20 | 20 | ||||||||
| Lipase A P6 | 20 | 20 | 20 | 20 | 20 | ||||||||
| Cortex cinnamomi japonici (Ramulus Cinnamomi) | 120 | 150 | 100 | 60 | 100 | 100 | 100 | 100 | 100 | ||||
| Fructus Amomi | 80 | 50 | 30 | ||||||||||
| Flos Caryophylli | 30 | 10 | 10 | 10 | 10 | 20 | 40 | ||||||
| Rhizoma Zingiberis Recens | 25 | 25 | 20 | 30 | 30 | 30 | 30 | 30 | 40 | ||||
| Fructus Foeniculi | 25 | 50 | 15 | 12 | 20 | 20 | 10 | 20 | |||||
| Radix Gentianae | 12 | 10 | 10 | 10 | 10 | ||||||||
| Pericarpium Citri Reticulatae | 50 | 30 | 12 | 30 | 30 | 15 | |||||||
| Pericarpium Zanthoxyli | 15 | 18 | 10 | 15 | 4 | ||||||||
| Radix Curcumae | 30 | 20 | |||||||||||
| Crude drug adds up to | 300 | 305 | 220 | 174 | 180 | 170 | 200 | 200 | 234 | ||||
| Crude drug weight ratio with respect to sucralfate | 0.6 | 0.61 | 0.44 | 0.35 | 0.36 | 0.34 | 0.4 | 0.4 | 0.47 | ||||
| Mannitol | 50 | 80 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | ||||
| The L-menthol | 10 | 5 | 3 | 6 | 2 | 2 | 2 | 2 | 2 | ||||
| Add up to (1 dose) | 946 | 1096 | 986 | 1136 | 1307 | 1337 | 1219 | 326 | 1178 | 1208 | 1388 | 1388 | 1232 |
| Estimate 10 stages of point | 3 × | 2.5 × | 2.5 × | 2.5 × | 6.6 ○ | 6 ○ | 6.4 ○ | 6.4 ○ | 5.2 ○ | 6.5 ○ | 7.5 ○ | 7.3 ○ | 8 ◎ |
From the function test result, confirm to have improved the sense of taking of sucralfate by the mixing crude drug that is good for the stomach.
[test example]
With the prescription shown in the following table 2, will take for 10 special experimenters by the preparation of following various method of granulating manufacturings, obtain taking the evaluation of sense by the experimenter.
[table 2]
(1) extruding is granulated
Get a part of 3g of binding agent, adding water, to make total weight be 25g, as binding agent liquid.The mentioned component of L-menthol is removed in weighing, drops into High Speed Stirring Machine NMG-1L (strain) nara machinery and makes made) in, mixed 1 minute.Drop into above-mentioned binder solution then, in High Speed Stirring Machine, mixed 1 minute.For this mixture, push granulation by the granulator Dome Gran DGL-1 (Fuji Paudal (strain) system) that 0.6mm sieve has been installed.And, the granulation thing is handled with the sphering that Marmerizer 0-230 (Fuji Paudal (strain) system) carries out about 30 seconds, with its at 60 ℃ with SAFTY OVEN SPH-101 (ESPEC (strain) system) drying 3 hours.According to the yield of making thing, calculate the amount of menthol, weighing is pulverized it with mortar, add the granule of manufacturing to.
(2) fluidized bed pelletize
Get the 2g binding agent, become 50g to wherein adding entry, dissolving is called binding liquid.Further, the mentioned component that menthol is removed in weighing sieves, and mixes in polymer pouches.Mixture is packed in the fluidized bed granulator New Marmeizer NQ-125 type (Fuji Paudal (strain) system); above-mentioned binder solution is granulated (to 60 ℃ in gas with top spray (top-spray) fluidized bed; 35 ℃ of product temperature), then, by fluidized bed 60 ℃ of dryings 30 minutes.With the granulation thing with the sub-granulate of 30 mesh sieves, will by 30 purpose products and (1) similarly menthol mortar milling product mix.
(3) spray drying 1
The mentioned component of menthol is removed in weighing, is adjusted into the aqueous dispersions that solid constituent is 30wt%.For this dispersion liquid spray dryer-L-8 type (the former worker's machine in great river (strain) system), in the about 120 ℃ of following spray dryinges of inlet temperature.In this granulation thing with (1), the mixing menthol ground product that (2) are same.
(4) spray drying 2
Weighing is removed menthol and the mentioned component of the crude drug that is good for the stomach, and is adjusted into the aqueous dispersions that solid formation is divided into 30wt%.For this dispersion liquid spray dryer-L-8 type (the former worker's machine in great river (strain) system), in the about 120 ℃ of following spray dryinges of inlet temperature.The menthol comminuted powder is mixed in polymer pouches with the granulation thing with crude drug powder.
(5) dry granulation
With the mentioned component weighing, sieve, put into roller type press-WP90 * 30 (TURBO KOGYO (strain) system) and compression, sheet.Then, this thin slice is vibrated granulate with roller pulverizer-GRN-T53S (Japanese グ ラ ニ ユ レ--(strain) system) with 30 purposes.
(6) simple mixing
With the mentioned component weighing, in polymer pouches, mix.
The preparation of method for making manufacturing that will be by above-mentioned (1)～(6) takes for respectively 10 special experimenters, and it takes the following standard evaluation of sense.
Standard: * tasty, △ is slightly somewhat tasty, and zero drinks well reluctantly, and ◎ drinks well
The results are shown in down tabulation 3.
[table 3]
The result
| Method for making | Estimate |
| Simple mixing spray drying 1 spray drying 2 dry granulations extruding granulation fluidized bed is granulated | ○ △ ○ ◎ △ △ |
The preferred granulation process, particularly preferred dry granulation that uses crude drug without long-time heating.
The physiologically active ingredient that will produce sense of discomfort by will take the time mixes with the crude drug that is good for the stomach, in the original effect that is good for the stomach of the crude drug composition that keeps being good for the stomach, as its effect of correctives, successfully reduce the use amount of the additives such as sweeting agent that use under the existing purpose for physiologically active ingredient.And, owing to can pass through the dry granulation manufactured, further increase as the effect of correctives, improved and taken sense.
Medicine by use finding the digestive system side effect or the physiologically active ingredient that produces sense of discomfort when taking in mouth are made pharmaceutical composition of the present invention, can reduce or eliminate above-mentioned side effect, in addition, can shelter sense of discomfort.In addition, use gastrointestinal drug beyond the crude drug that is good for the stomach, when producing the physiologically active ingredient of sense of discomfort in the mouth when taking, can shelter uncomfortable taste by the mixing crude drug that is good for the stomach.And, can expect gastrointestinal drug and the crude drug effect that multiplies each other of drug effect separately that is good for the stomach.
And pharmaceutical composition of the present invention because the people of the such restriction sugar of diabetes picked-up takes them easily, has with the selection of Therapeutic Method extensively, and the expansion and contraction of taking medicine rises to main huge effect.
And, according to the manufacture method of pharmaceutical composition of the present invention, can make by cheap simple equipments ground.In addition, eliminated the maximization problem of so-called tablet, made the supply of various dosage forms such as powder beyond the tablet or granule become possibility.
Claims (4)
1, improved the pharmaceutical composition of taking sense, wherein contained sucralfate and be selected from least a crude drug of Cortex cinnamomi japonici (Ramulus Cinnamomi), Fructus Amomi, Flos Caryophylli, Rhizoma Zingiberis Recens, Fructus Foeniculi, Radix Gentianae, Pericarpium Citri Reticulatae, Pericarpium Zanthoxyli and Radix Curcumae, by the mixing or the dry pelletizing method manufacturing of the powder pulverized.
2, the pharmaceutical composition of claim 1 record, wherein above-mentioned crude drug are that comminuted powder below the 500 μ m uses with particle diameter.
3, the pharmaceutical composition of claim 1 or 2 records, wherein the combined amount of above-mentioned crude drug with respect to 1 weight portion sucralfate, is 0.2～2 weight portion.
4, the pharmaceutical composition of any record of claim 1～3 is characterized in that using the dry granulation method.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2002346393A JP2004175757A (en) | 2002-11-28 | 2002-11-28 | Medicinal composition |
| JP346393/2002 | 2002-11-28 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1504185A CN1504185A (en) | 2004-06-16 |
| CN1330378C true CN1330378C (en) | 2007-08-08 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2003101186813A Expired - Lifetime CN1330378C (en) | 2002-11-28 | 2003-11-28 | Medicine composition |
Country Status (5)
| Country | Link |
|---|---|
| JP (1) | JP2004175757A (en) |
| KR (1) | KR20040047588A (en) |
| CN (1) | CN1330378C (en) |
| HK (1) | HK1065477A1 (en) |
| TW (1) | TW200507876A (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4950551B2 (en) * | 2006-04-25 | 2012-06-13 | 興和株式会社 | Gastrointestinal mucosa protective agent |
| CN101507770B (en) * | 2008-07-18 | 2011-01-05 | 天津生机集团股份有限公司 | Traditional Chinese medicine composite for treating horse spasm hernia |
| JP6317190B2 (en) * | 2014-06-17 | 2018-04-25 | エスエス製薬株式会社 | Gastrointestinal drug |
| CN105944104B (en) * | 2016-06-17 | 2018-12-14 | 上海凯宝药业股份有限公司 | A kind of pharmaceutical composition for treating digestive tract ulcer |
| KR102428859B1 (en) * | 2020-05-29 | 2022-08-04 | 동성제약주식회사 | Pharmaceutical composition for oral administration to prevent or treat diseases of the digestive system with safety |
| CN115177593B (en) * | 2022-08-08 | 2023-08-25 | 锦州奥鸿药业有限责任公司 | Glutamine granule and preparation method thereof |
| CN117298086B (en) * | 2023-11-29 | 2024-03-08 | 中国中医科学院中药研究所 | Application of sofalcone in preparation of medicines for preventing and/or treating NLRP3 inflammatory corpuscle mediated diseases |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1114885A (en) * | 1994-05-17 | 1996-01-17 | 内蒙古自治区高等院校科技开发集团赤峰公司 | External-use medicine powder for health care, nourishing kidney and clearing brain |
| JP2000103746A (en) * | 1994-10-27 | 2000-04-11 | Takeda Chem Ind Ltd | Molded product and its production |
| CN1254520A (en) * | 1999-11-01 | 2000-05-31 | 济南联合大学 | Compound oil-resin flavouring |
| JP2000191517A (en) * | 1998-12-24 | 2000-07-11 | Lion Corp | Granular composition whose unpalatable taste is masked and its production |
| CN1287488A (en) * | 1998-04-01 | 2001-03-14 | 中外制药株式会社 | Preventives for alcoholic gastritis |
-
2002
- 2002-11-28 JP JP2002346393A patent/JP2004175757A/en active Pending
-
2003
- 2003-11-14 TW TW092132009A patent/TW200507876A/en not_active IP Right Cessation
- 2003-11-14 KR KR1020030080560A patent/KR20040047588A/en not_active Application Discontinuation
- 2003-11-28 CN CNB2003101186813A patent/CN1330378C/en not_active Expired - Lifetime
-
2004
- 2004-10-21 HK HK04108298A patent/HK1065477A1/en not_active IP Right Cessation
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1114885A (en) * | 1994-05-17 | 1996-01-17 | 内蒙古自治区高等院校科技开发集团赤峰公司 | External-use medicine powder for health care, nourishing kidney and clearing brain |
| JP2000103746A (en) * | 1994-10-27 | 2000-04-11 | Takeda Chem Ind Ltd | Molded product and its production |
| CN1287488A (en) * | 1998-04-01 | 2001-03-14 | 中外制药株式会社 | Preventives for alcoholic gastritis |
| JP2000191517A (en) * | 1998-12-24 | 2000-07-11 | Lion Corp | Granular composition whose unpalatable taste is masked and its production |
| CN1254520A (en) * | 1999-11-01 | 2000-05-31 | 济南联合大学 | Compound oil-resin flavouring |
Also Published As
| Publication number | Publication date |
|---|---|
| TWI343818B (en) | 2011-06-21 |
| KR20040047588A (en) | 2004-06-05 |
| JP2004175757A (en) | 2004-06-24 |
| CN1504185A (en) | 2004-06-16 |
| HK1065477A1 (en) | 2005-02-25 |
| TW200507876A (en) | 2005-03-01 |
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