CN103655529B - Composition and soft capsule for resisting histamine and promoting sleep - Google Patents
Composition and soft capsule for resisting histamine and promoting sleep Download PDFInfo
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- CN103655529B CN103655529B CN201310554296.7A CN201310554296A CN103655529B CN 103655529 B CN103655529 B CN 103655529B CN 201310554296 A CN201310554296 A CN 201310554296A CN 103655529 B CN103655529 B CN 103655529B
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- soft capsule
- polyethylene glycol
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- polyhydric alcohol
- solution
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- 239000007901 soft capsule Substances 0.000 title claims abstract description 80
- 239000000203 mixture Substances 0.000 title claims abstract description 63
- NTYJJOPFIAHURM-UHFFFAOYSA-N Histamine Chemical compound NCCC1=CN=CN1 NTYJJOPFIAHURM-UHFFFAOYSA-N 0.000 title abstract description 14
- 229960001340 histamine Drugs 0.000 title abstract description 7
- 230000001737 promoting effect Effects 0.000 title 1
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 46
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 46
- 150000005846 sugar alcohols Polymers 0.000 claims abstract description 46
- 108010010803 Gelatin Proteins 0.000 claims abstract description 42
- 239000008273 gelatin Substances 0.000 claims abstract description 42
- 229920000159 gelatin Polymers 0.000 claims abstract description 42
- 235000019322 gelatine Nutrition 0.000 claims abstract description 42
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 42
- 239000004014 plasticizer Substances 0.000 claims abstract description 26
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 24
- 239000003086 colorant Substances 0.000 claims abstract description 17
- 239000008213 purified water Substances 0.000 claims abstract description 5
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 72
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 69
- 238000003756 stirring Methods 0.000 claims description 43
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 36
- 238000002360 preparation method Methods 0.000 claims description 31
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical group OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 27
- 229960003511 macrogol Drugs 0.000 claims description 27
- 239000003963 antioxidant agent Substances 0.000 claims description 23
- 230000003078 antioxidant effect Effects 0.000 claims description 23
- 239000007788 liquid Substances 0.000 claims description 20
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims description 19
- JLFNLZLINWHATN-UHFFFAOYSA-N pentaethylene glycol Chemical compound OCCOCCOCCOCCOCCO JLFNLZLINWHATN-UHFFFAOYSA-N 0.000 claims description 19
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 18
- 239000000049 pigment Substances 0.000 claims description 14
- 238000000034 method Methods 0.000 claims description 11
- 239000003292 glue Substances 0.000 claims description 10
- 238000004806 packaging method and process Methods 0.000 claims description 10
- 239000008188 pellet Substances 0.000 claims description 10
- 238000013019 agitation Methods 0.000 claims description 9
- 229910052757 nitrogen Inorganic materials 0.000 claims description 9
- 239000000725 suspension Substances 0.000 claims description 9
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical group [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 claims description 7
- 235000010262 sodium metabisulphite Nutrition 0.000 claims description 7
- 230000001387 anti-histamine Effects 0.000 abstract description 27
- 239000000739 antihistaminic agent Substances 0.000 abstract description 27
- 230000000147 hypnotic effect Effects 0.000 abstract description 24
- 206010011224 Cough Diseases 0.000 abstract description 6
- 206010020751 Hypersensitivity Diseases 0.000 abstract description 4
- 208000026935 allergic disease Diseases 0.000 abstract description 4
- 230000007815 allergy Effects 0.000 abstract description 4
- 208000027776 Extrapyramidal disease Diseases 0.000 abstract description 3
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 abstract description 3
- 201000003152 motion sickness Diseases 0.000 abstract description 3
- 238000005728 strengthening Methods 0.000 abstract description 2
- CIVCELMLGDGMKZ-UHFFFAOYSA-N 2,4-dichloro-6-methylpyridine-3-carboxylic acid Chemical compound CC1=CC(Cl)=C(C(O)=O)C(Cl)=N1 CIVCELMLGDGMKZ-UHFFFAOYSA-N 0.000 abstract 2
- 229960000525 diphenhydramine hydrochloride Drugs 0.000 abstract 2
- 208000018737 Parkinson disease Diseases 0.000 abstract 1
- 230000000954 anitussive effect Effects 0.000 abstract 1
- 229940124584 antitussives Drugs 0.000 abstract 1
- 230000001914 calming effect Effects 0.000 abstract 1
- 239000011248 coating agent Substances 0.000 abstract 1
- 238000000576 coating method Methods 0.000 abstract 1
- 210000004877 mucosa Anatomy 0.000 abstract 1
- 230000002265 prevention Effects 0.000 abstract 1
- GUGOEEXESWIERI-UHFFFAOYSA-N Terfenadine Chemical compound C1=CC(C(C)(C)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 GUGOEEXESWIERI-UHFFFAOYSA-N 0.000 description 21
- 235000006708 antioxidants Nutrition 0.000 description 20
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 12
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 12
- 230000000694 effects Effects 0.000 description 11
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 7
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 7
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 7
- 239000000600 sorbitol Substances 0.000 description 7
- 239000004255 Butylated hydroxyanisole Substances 0.000 description 6
- 235000019282 butylated hydroxyanisole Nutrition 0.000 description 6
- CZBZUDVBLSSABA-UHFFFAOYSA-N butylated hydroxyanisole Chemical compound COC1=CC=C(O)C(C(C)(C)C)=C1.COC1=CC=C(O)C=C1C(C)(C)C CZBZUDVBLSSABA-UHFFFAOYSA-N 0.000 description 6
- 229940043253 butylated hydroxyanisole Drugs 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 4
- 239000004471 Glycine Substances 0.000 description 4
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 description 4
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 description 4
- 238000006243 chemical reaction Methods 0.000 description 4
- 206010022437 insomnia Diseases 0.000 description 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 3
- 229930195725 Mannitol Natural products 0.000 description 3
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 description 3
- 230000018044 dehydration Effects 0.000 description 3
- 238000006297 dehydration reaction Methods 0.000 description 3
- 239000000594 mannitol Substances 0.000 description 3
- 235000010355 mannitol Nutrition 0.000 description 3
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- 210000000621 bronchi Anatomy 0.000 description 2
- 229960000520 diphenhydramine Drugs 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 230000002792 vascular Effects 0.000 description 2
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 description 1
- 206010012442 Dermatitis contact Diseases 0.000 description 1
- 208000019872 Drug Eruptions Diseases 0.000 description 1
- 102000003834 Histamine H1 Receptors Human genes 0.000 description 1
- 108090000110 Histamine H1 Receptors Proteins 0.000 description 1
- 208000006877 Insect Bites and Stings Diseases 0.000 description 1
- 208000003251 Pruritus Diseases 0.000 description 1
- 206010039085 Rhinitis allergic Diseases 0.000 description 1
- 208000024780 Urticaria Diseases 0.000 description 1
- 229930003268 Vitamin C Natural products 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 230000000172 allergic effect Effects 0.000 description 1
- 201000010105 allergic rhinitis Diseases 0.000 description 1
- 230000003042 antagnostic effect Effects 0.000 description 1
- 230000001139 anti-pruritic effect Effects 0.000 description 1
- 239000003908 antipruritic agent Substances 0.000 description 1
- 208000010668 atopic eczema Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000003153 cholinolytic effect Effects 0.000 description 1
- 208000010247 contact dermatitis Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 125000003630 glycyl group Chemical group [H]N([H])C([H])([H])C(*)=O 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 125000003071 maltose group Chemical group 0.000 description 1
- 229960003742 phenol Drugs 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 230000016160 smooth muscle contraction Effects 0.000 description 1
- 230000024883 vasodilation Effects 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
The invention discloses an antihistaminic and sleep-promoting composition and a soft capsule, wherein the composition comprises the following components in percentage by weight: 5-45% of diphenhydramine hydrochloride, 30-90% of polyethylene glycol and 1-25% of polyalcohol. Soft capsules: comprises a soft capsule rubber and contents, wherein the contents comprise the following components in percentage by weight: 5-45% of diphenhydramine hydrochloride, 30-90% of polyethylene glycol and 1-25% of polyalcohol; and (3) soft capsule coating: 50-90% of gelatin, 5-70% of plasticizer, 5-15% of purified water and 0-0.5% of colorant. The invention aims to provide a composition which has simple components, is stable and effective, can quickly dissolve and absorb histamine and can promote sleep; and a soft capsule containing the above antihistaminic and sleep-promoting composition. The soft capsule of the invention is suitable for the allergy of skin mucosa, the prevention and treatment of motion sickness, Parkinson's disease and extrapyramidal symptoms, has the functions of calming, hypnosis and strengthening antitussive, and is suitable for treating cough caused by cold or allergy.
Description
Technical field
The present invention relates to the compositions of a kind of antihistamine and hypnotic, the invention still further relates to a kind of soft capsule comprising said composition.
Background technology
Due to social pressure and environment bad, many people have the worry of insomnia.8 one-tenth experiences having insomnia are about had through investigation modern.
For insomnia so, using antihistaminic as the medicament of effective ingredient, also general medicine or need not the improving water flood pharmaceutical compositions of prescription list is utilized as, in order to reduce transient insomnia symptom in the American-European countries such as the U.S., Britain, Germany, Canada, Japan.
But, have a sleepless night according to its state, have sleep obstacle, form miscellaneous is waken up or to be wakeeed up in advance etc. in obstacle of sleeping soundly, midway.For insomniac miscellaneous like this, existing antihistaminic not only prescription is complicated, and during as improving water flood pharmaceutical compositions, fails to obtain sufficient effect.
And user is in the existing antihistaminic process of use, body is comparatively obvious to the reaction of histamine, to bronchus, nose, skin, gastrointestinal vascular reaction than stronger, has certain side effect.So the compositions of existing antihistamine and hypnotic awaits further improvement.
Summary of the invention
The object of the invention is to overcome weak point of the prior art, provide a kind of component simple, effectively stable, stripping absorbs the compositions of antihistamine and hypnotic fast;
Another object of the present invention is to provide a kind of soft capsule containing the compositions of above-mentioned antihistamine and hypnotic.Soft capsule of the present invention is applicable to Mucocutaneous allergy, the control of motion sickness, parkinson and extrapyramidal symptoms, calmness, hypnosis, strengthens the effect of cough medicine, is applicable to treatment flu or irritated cough caused.
In order to achieve the above object, the present invention adopts following scheme:
A compositions for antihistamine and hypnotic, is characterized in that comprising following component by weight percentage:
Diphhydramine hydrochloride 5 ~ 45%
Polyethylene Glycol 30 ~ 90%
Polyhydric alcohol 1 ~ 25%.
The compositions of a kind of antihistamine as above and hypnotic, is characterized in that comprising following component by weight percentage:
The compositions of a kind of antihistamine as above and hypnotic, is characterized in that described Polyethylene Glycol is one or more the mixture in Macrogol 200, PEG400, Macrogol 600.
The compositions of a kind of antihistamine as above and hypnotic, it is characterized in that described polyhydric alcohol be in propylene glycol, glycerol one or both.
The compositions of a kind of antihistamine as above and hypnotic, it is characterized in that described antioxidant is one or more mixture in 2,6-di-tert-butyl-4-methy phenol, Butylated hydroxyanisole, vitamin C, sodium pyrosulfite, glycine, citric acid.
A kind of soft capsule of the present invention, is characterized in that: include soft capsule rubber and be wrapped in the content in described soft capsule rubber, described content comprises following component by weight percentage:
Diphhydramine hydrochloride 5 ~ 45%
Polyethylene Glycol 30 ~ 90%
Polyhydric alcohol 1 ~ 25%;
Wherein said soft capsule rubber is composed of the following components by weight percentage:
A kind of soft capsule as above, is characterized in that described plasticizer is one or more the mixture in glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400.
A kind of soft capsule as above, is characterized in that described coloring agent is one or both in D & CYellowNo.10, FD & CBlueNo.1.
In sum, beneficial effect of the present invention:
This present composition can compete the histamine H1-receptor blocked on target cell, thus produces the effect of antagonizing histamine.Reach and reduce body to the reaction of histamine.Eliminate the various allergic symptom caused by histamine release, weaken histamine to bronchus, nose, skin, gastrointestinal vascular reaction, also have the slight effect suppressing smooth muscle contraction.Diphenhydramine has central inhibitory action concurrently, has calmness, improves the effects such as dizzy, Nausea and vomiting.This medicine also has cholinolytic, reduces blood capillary and oozes out, detumescence, effect such as antipruritic grade.This product also has the effect strengthening cough medicine.
Diphenhydramine is made soft capsule and contribute to its stripping release in human body, accelerate onset speed.In addition, soft capsule dosage form good looking appearance, can increase pill taker's compliance.
In the present invention, diphhydramine hydrochloride belongs to conventional antihistaminic, Mucocutaneous allergy, as urticaria, vasodilation, allergic rhinitis, skin pruritus, drug eruption, to insect bite disease and contact dermatitis also effective; The control of motion sickness, has stronger town to tell effect; Parkinson and extrapyramidal symptoms; Calmness, hypnosis; Strengthen the effect of cough medicine, be applicable to treatment flu or irritated cough caused.
Content reasonable mixture ratio in diphhydramine hydrochloride soft capsule of the present invention, designs ingenious, good stability, good effect.
Detailed description of the invention
Below in conjunction with detailed description of the invention, the present invention is described further:
Embodiment 1
The compositions of antihistamine of the present invention and hypnotic, comprises following component by weight percentage:
Diphhydramine hydrochloride 12.5%
Polyethylene Glycol 75.5%
Polyhydric alcohol 12%
Wherein said Polyethylene Glycol is PEG400; Described polyhydric alcohol is propylene glycol.Embodiment 2
The compositions of antihistamine of the present invention and hypnotic, comprises following component by weight percentage:
Diphhydramine hydrochloride 12.5%
Polyethylene Glycol 80.0%
Polyhydric alcohol 7.5%
Wherein said Polyethylene Glycol is Macrogol 200; Described polyhydric alcohol is the mixture of glycerol and propylene glycol.
Embodiment 3
The compositions of antihistamine of the present invention and hypnotic, comprises following component by weight percentage:
Diphhydramine hydrochloride 12.5%
Polyethylene Glycol 77.5%
Polyhydric alcohol 10%
Wherein said Polyethylene Glycol is the mixture of Macrogol 200 and PEG400.Described polyhydric alcohol is the mixture of propylene glycol and glycerol.
Embodiment 4
The compositions of antihistamine of the present invention and hypnotic, comprises following component by weight percentage:
Diphhydramine hydrochloride 5%
Polyethylene Glycol 90%
Polyhydric alcohol 5%
Wherein said Polyethylene Glycol is PEG400; Described polyhydric alcohol is propylene glycol.
Embodiment 5
The compositions of antihistamine of the present invention and hypnotic, comprises following component by weight percentage:
Diphhydramine hydrochloride 9%
Polyethylene Glycol 90%
Polyhydric alcohol 1%
Wherein said Polyethylene Glycol is Macrogol 200; Described polyhydric alcohol is the mixture of glycerol and propylene glycol.
Embodiment 6
The compositions of antihistamine of the present invention and hypnotic, comprises following component by weight percentage:
Diphhydramine hydrochloride 45%
Polyethylene Glycol 30%
Polyhydric alcohol 25%
Wherein said Polyethylene Glycol is the mixture of Macrogol 200 and PEG400.Described polyhydric alcohol is the mixture of propylene glycol and glycerol.
Embodiment 7
The compositions of antihistamine of the present invention and hypnotic, comprises following component by weight percentage:
Diphhydramine hydrochloride 20%
Polyethylene Glycol 70%
Polyhydric alcohol 10%
Wherein said Polyethylene Glycol is Macrogol 600; Described polyhydric alcohol is the mixture of propylene glycol and glycerol.
Embodiment 8
The compositions of antihistamine of the present invention and hypnotic, comprises following component by weight percentage:
Diphhydramine hydrochloride 30%
Polyethylene Glycol 45%
Polyhydric alcohol 25%
Wherein said Polyethylene Glycol is Macrogol 600; Described polyhydric alcohol is the mixture of propylene glycol and glycerol.
Embodiment 9
The compositions of antihistamine of the present invention and hypnotic, comprises following component by weight percentage:
Wherein said Polyethylene Glycol is the mixture of Macrogol 200, PEG400 and Macrogol 600.Described polyhydric alcohol is propylene glycol.Described antioxidant is the mixture of 2,6-di-tert-butyl-4-methy phenol, Butylated hydroxyanisole.
Embodiment 10
The compositions of antihistamine of the present invention and hypnotic, comprises following component by weight percentage:
Wherein said Polyethylene Glycol is Macrogol 600; Described polyhydric alcohol is glycerol; Described antioxidant is glycine, citric acid, ascorbic mixture.
Embodiment 11
The compositions of antihistamine of the present invention and hypnotic, comprises following component by weight percentage:
Wherein said Polyethylene Glycol is the mixture of Macrogol 200, PEG400 and Macrogol 600.Described polyhydric alcohol is the mixture of propylene glycol and glycerol.Described antioxidant is the mixture of 2,6-di-tert-butyl-4-methy phenol, Butylated hydroxyanisole, sodium pyrosulfite.
Embodiment 12
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, described content comprises following component by weight percentage:
Wherein said soft capsule rubber is composed of the following components by weight percentage:
Gelatin 50%
Plasticizer 45%
Purified water 5%.
Wherein said Polyethylene Glycol is PEG400; Described polyhydric alcohol be in propylene glycol, glycerol one or both.Described plasticizer is glycerol.Described antioxidant is the mixture of glycine, citric acid.
Soft capsule of the present invention can be prepared by following technique:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, be heated to 60 DEG C in added glue tank, add gelatin, more than 60 DEG C stirring and dissolving, for subsequent use;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Diphhydramine hydrochloride is added in above-mentioned solution, is heated to more than 50 DEG C dissolvings.After diphhydramine hydrochloride dissolves, be cooled to less than 40 DEG C, add antioxidant stirring and dissolving.Evacuation forms negative pressure, and except debubblizing, medicinal liquid is for subsequent use.
3, soft capsule preparation:
By content medicinal liquid, gelatin solution adds in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Embodiment 13
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, described content comprises following component by weight percentage:
Wherein said soft capsule rubber is composed of the following components by weight percentage:
Gelatin 80%
Plasticizer 15%
Purified water 5%
Wherein said Polyethylene Glycol is the mixture of Macrogol 200, PEG400.Described polyhydric alcohol is the mixture of propylene glycol, glycerol.Described plasticizer is the mixture of glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400.Described antioxidant is the mixture of 2,6-di-tert-butyl-4-methy phenol, Butylated hydroxyanisole, sodium pyrosulfite.
Soft capsule of the present invention can be prepared by following technique:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, be heated to 60 DEG C in added glue tank, add gelatin, more than 60 DEG C stirring and dissolving, for subsequent use;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Added by diphhydramine hydrochloride in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with nitrogen, is heated to more than 50 DEG C dissolvings after forming negative pressure.After diphhydramine hydrochloride dissolves, diphhydramine hydrochloride solution is cooled to less than 40 DEG C, adds antioxidant stirring and dissolving.Medicinal liquid is for subsequent use.
3, soft capsule preparation:
By content medicinal liquid, gelatin solution adds in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Embodiment 14
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, described content comprises following component by weight percentage:
Wherein said soft capsule rubber is composed of the following components by weight percentage:
Wherein said Polyethylene Glycol is the mixture of Macrogol 200, PEG400, Macrogol 600.Described polyhydric alcohol is propylene glycol.Described plasticizer is maltose alcohol.Described coloring agent is FD & CBlueNo.1.Described antioxidant is the mixture of glycine, citric acid.
Soft capsule of the present invention can be prepared by following technique:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, be heated to 60 DEG C in added glue tank, add gelatin, more than 60 DEG C stirring and dissolving.Coloring agent is added to the water, stirs, obtain pigment solution, pigment solution is added in gelatin solution, stir and vacuumizing and exhausting bubble, for subsequent use;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Added by diphhydramine hydrochloride in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with nitrogen, is heated to more than 50 DEG C dissolvings after forming negative pressure.After diphhydramine hydrochloride dissolves, diphhydramine hydrochloride solution is cooled to less than 40 DEG C, adds antioxidant stirring and dissolving.Medicinal liquid is for subsequent use.
3, soft capsule preparation:
By content medicinal liquid, gelatin solution adds in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Embodiment 15
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, described content comprises following component by weight percentage:
Wherein said soft capsule rubber is composed of the following components by weight percentage:
Wherein said Polyethylene Glycol is Macrogol 200.Described polyhydric alcohol be in propylene glycol, glycerol one or both.Described plasticizer is the mixture of glycerol, sorbitol.Described coloring agent is FD & CBlueNo.1.Described antioxidant is the mixture of 2,6-di-tert-butyl-4-methy phenol, Butylated hydroxyanisole.
Soft capsule of the present invention can be prepared by following technique:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, be heated to 60 DEG C in added glue tank, add gelatin, more than 60 DEG C stirring and dissolving.Coloring agent is added to the water, stirs, obtain pigment solution, pigment solution is added in gelatin solution, stir and vacuumizing and exhausting bubble, for subsequent use;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Added by diphhydramine hydrochloride in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with nitrogen, is heated to more than 50 DEG C dissolvings after forming negative pressure.After diphhydramine hydrochloride dissolves, solution is cooled to less than 40 DEG C, adds antioxidant stirring and dissolving.Medicinal liquid is for subsequent use.
3, soft capsule preparation:
By content medicinal liquid, gelatin solution adds in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Embodiment 16
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, described content comprises following component by weight percentage:
Wherein said soft capsule rubber is composed of the following components by weight percentage:
Wherein said Polyethylene Glycol is the mixture of Macrogol 200, PEG400, Macrogol 600.Described polyhydric alcohol is the mixture of propylene glycol, glycerol.Described plasticizer is the mixture of glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400.Described coloring agent is FD & CBlueNo.1.Described antioxidant is the mixture of 2,6-di-tert-butyl-4-methy phenol, Butylated hydroxyanisole.
Soft capsule of the present invention can be prepared by following technique:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, be heated to 60 DEG C in added glue tank, add gelatin, more than 60 DEG C stirring and dissolving.Coloring agent is added to the water, stirs, obtain pigment solution, pigment solution is added in gelatin solution, stir and vacuumizing and exhausting bubble, for subsequent use;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Added by diphhydramine hydrochloride in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with nitrogen, is heated to more than 50 DEG C dissolvings after forming negative pressure.After diphhydramine hydrochloride dissolves, solution is cooled to less than 40 DEG C, add antioxidant stirring and dissolving, medicinal liquid is for subsequent use.
3, soft capsule preparation:
By content medicinal liquid, gelatin solution adds in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Embodiment 17
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, described content comprises following component by weight percentage:
Wherein said soft capsule rubber is composed of the following components by weight percentage:
Wherein said Polyethylene Glycol is PEG400.Described polyhydric alcohol be in propylene glycol, glycerol one or both.Described plasticizer is Macrogol 200.Described coloring agent is the mixture of D & CYellowNo.10, FD & CBlueNo.1.Described antioxidant is sodium pyrosulfite.
Soft capsule of the present invention can be prepared by following technique:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, be heated to 60 DEG C in added glue tank, add gelatin, more than 60 DEG C stirring and dissolving.Coloring agent is added to the water, stirs, obtain pigment solution, pigment solution is added in gelatin solution, stir and vacuumizing and exhausting bubble, for subsequent use;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Added by diphhydramine hydrochloride in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with nitrogen, is heated to more than 50 DEG C dissolvings after forming negative pressure.After diphhydramine hydrochloride dissolves, solution is cooled to less than 40 DEG C, add antioxidant stirring and dissolving, medicinal liquid is for subsequent use.
3, soft capsule preparation:
By content medicinal liquid, gelatin solution adds in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Embodiment 18
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, described content comprises following component by weight percentage:
Diphhydramine hydrochloride 15%
Polyethylene Glycol 83%
Polyhydric alcohol 2%
Wherein said soft capsule rubber is composed of the following components by weight percentage:
Gelatin 50%
Plasticizer 35%
Purified water 15%.
Wherein said Polyethylene Glycol is PEG400.Described polyhydric alcohol be in propylene glycol, glycerol one or both.Described plasticizer is Macrogol 200.
Soft capsule of the present invention can be prepared by following technique:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, be heated to 60 DEG C in added glue tank, add gelatin, more than 60 DEG C stirring and dissolving, stir and vacuumizing and exhausting bubble, for subsequent use;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Added by diphhydramine hydrochloride in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with nitrogen, is heated to more than 50 DEG C dissolvings after forming negative pressure.After diphhydramine hydrochloride dissolves, solution is cooled to less than 40 DEG C, medicinal liquid is for subsequent use.
3, soft capsule preparation:
By content medicinal liquid, gelatin solution adds in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Embodiment 19
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, described content comprises following component by weight percentage:
Wherein said soft capsule rubber is composed of the following components by weight percentage:
Wherein said Polyethylene Glycol is PEG400.Described polyhydric alcohol be in propylene glycol, glycerol one or both.Described plasticizer is Macrogol 200.Described coloring agent is the mixture of D & CYellowNo.10, FD & CBlueNo.1.Described antioxidant is sodium pyrosulfite.
Soft capsule of the present invention can be prepared by following technique:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, be heated to 60 DEG C in added glue tank, add gelatin, more than 60 DEG C stirring and dissolving.Coloring agent is added to the water, stirs, obtain pigment solution, pigment solution is added in gelatin solution, stir and vacuumizing and exhausting bubble, for subsequent use;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Added by diphhydramine hydrochloride in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with nitrogen, is heated to more than 50 DEG C dissolvings after forming negative pressure.After diphhydramine hydrochloride dissolves, solution is cooled to less than 40 DEG C, add antioxidant stirring and dissolving, medicinal liquid is for subsequent use.
3, soft capsule preparation:
By content medicinal liquid, gelatin solution adds in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Embodiment 20
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, described content comprises following component by weight percentage:
Wherein said soft capsule rubber is composed of the following components by weight percentage:
Wherein said Polyethylene Glycol is PEG400.Described polyhydric alcohol be in propylene glycol, glycerol one or both.Described plasticizer is Macrogol 200.Described coloring agent is the mixture of D & CYellowNo.10, FD & CBlueNo.1.Described antioxidant is sodium pyrosulfite.
Soft capsule of the present invention can be prepared by following technique:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, be heated to 60 DEG C in added glue tank, add gelatin, more than 60 DEG C stirring and dissolving.Coloring agent is added to the water, stirs, obtain pigment solution, pigment solution is added in gelatin solution, stir and vacuumizing and exhausting bubble, for subsequent use;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Added by diphhydramine hydrochloride in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with nitrogen, is heated to more than 50 DEG C dissolvings after forming negative pressure.After diphhydramine hydrochloride dissolves, solution is cooled to less than 40 DEG C, add antioxidant stirring and dissolving, medicinal liquid is for subsequent use.
3, soft capsule preparation:
By content medicinal liquid, gelatin solution adds in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Claims (1)
1. a soft capsule, includes soft capsule rubber and is wrapped in the content in described soft capsule rubber, it is characterized in that described content comprises following component by weight percentage:
Diphhydramine hydrochloride 35%
Polyethylene Glycol 45%
Polyhydric alcohol 18%
Antioxidant 2%
Wherein said soft capsule rubber is composed of the following components by weight percentage:
Gelatin 70%
Plasticizer 24.5%
Purified water 5%
Coloring agent 0.5%;
Wherein said Polyethylene Glycol is PEG400; Described polyhydric alcohol be in propylene glycol, glycerol one or both; Described plasticizer is Macrogol 200; Described coloring agent is the mixture of D & CYellowNo.10, FD & CBlueNo.1; Described antioxidant is sodium pyrosulfite;
Described soft capsule is by following technique preparation:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, be heated to 60 DEG C in added glue tank, add gelatin, more than 60 DEG C stirring and dissolving; Coloring agent is added to the water, stirs, obtain pigment solution, pigment solution is added in gelatin solution, stir and vacuumizing and exhausting bubble, for subsequent use;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes; Added by diphhydramine hydrochloride in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with nitrogen, is heated to more than 50 DEG C dissolvings after forming negative pressure; After diphhydramine hydrochloride dissolves, solution is cooled to less than 40 DEG C, add antioxidant stirring and dissolving, medicinal liquid is for subsequent use;
3, soft capsule preparation:
By content medicinal liquid, gelatin solution adds in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201310554296.7A CN103655529B (en) | 2013-11-09 | 2013-11-09 | Composition and soft capsule for resisting histamine and promoting sleep |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310554296.7A CN103655529B (en) | 2013-11-09 | 2013-11-09 | Composition and soft capsule for resisting histamine and promoting sleep |
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| CN103655529B true CN103655529B (en) | 2016-02-03 |
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| CN104013608A (en) * | 2014-05-16 | 2014-09-03 | 安士制药（中山）有限公司 | Composition and soft capsule for alleviating cough |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2008184430A (en) * | 2007-01-30 | 2008-08-14 | Ss Pharmaceut Co Ltd | Soft capsule |
| CN103070846A (en) * | 2013-01-17 | 2013-05-01 | 安士制药（中山）有限公司 | Docusate sodium soft capsule |
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2013
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2008184430A (en) * | 2007-01-30 | 2008-08-14 | Ss Pharmaceut Co Ltd | Soft capsule |
| CN103070846A (en) * | 2013-01-17 | 2013-05-01 | 安士制药（中山）有限公司 | Docusate sodium soft capsule |
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| CN103655529A (en) | 2014-03-26 |
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