CN1857263A - Soft capsule composition containing zine gluconate, Ibuprofen and chlorphenamine maleate - Google Patents
Soft capsule composition containing zine gluconate, Ibuprofen and chlorphenamine maleate Download PDFInfo
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- CN1857263A CN1857263A CN 200610038794 CN200610038794A CN1857263A CN 1857263 A CN1857263 A CN 1857263A CN 200610038794 CN200610038794 CN 200610038794 CN 200610038794 A CN200610038794 A CN 200610038794A CN 1857263 A CN1857263 A CN 1857263A
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- ibuprofen
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Abstract
The present invention relates to medicine preparation, and especially a kind of soft capsule composition containing zinc gluconate, Ibuprofen and chlorphenamine maleate as active components. The composition consists of active component 1 weight portion, dispersant medium 0.8-3.0 weight portions, surfactant 0.02-0.3 weight portions and suspending agent 0.01-1.0 weight portion. The composition has homogeneous dispersion of medicine component and stable quality.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of capsule composition, it contains zinc gluconate, ibuprofen and chlorphenamine maleate is active component.
Background technology
Flu is a kind of common respiratory tract disease, occurs symptoms such as sneeze, watery nasal discharge, nasal obstruction, cough, heating, headache usually, has a strong impact on patient's operate as normal and life.Zinc gluconate can induce endogenous interferon, strengthens the human immunologic function, and can suppress influenza virus, rhinovirus, herpes simplex virus etc. and duplicate, and also has significant antitussive, antiasthmatic effect through clinical confirmation zinc gluconate in addition; Ibuprofen is potent actasal thing, belongs to the PG synthetase inhibitors, and its analgesia, refrigeration function are stronger than aspirin, Phenylbutazone or acetaminophen; Chlorphenamine maleate is an antihistaminic, has antiallergic and eliminates the effect of nasal obstruction mucositis symptom.The effect of share of three medicines is collaborative mutually, plays the effect for the treatment of both the principal and secondary aspects of a disease.Three's compound preparation is in clinical practice at present, and dosage form has tablet, granule.Limited dosage form has limited the extensive use of this compound medicine.
Summary of the invention
The invention discloses the compound soft capsule preparation that contains these three kinds of medicines of zinc gluconate, ibuprofen and chlorphenamine maleate.Under the suitable prerequisite of assurance principal agent dosage, by selecting adjuvant and formulation method for use, medicine is wrapped in the soft capsule with liquid form, therefore can be absorbed rapidly at oral back medicine, rapid-action, bioavailability is than conventional tablet, granule height.Simultaneously, this product can provide the possibility of a kind of renewal, better dosage form selection for doctor and patient as a kind of novel form.
Considering to select suitable disperse medium under the medicine effective dose, these three kinds of medicines of the necessary energy of used disperse medium homodisperse, and can keep medicinal liquid stable.By test, relatively the disperse medium of Shi Heing is a vegetable oil, and vegetable oil is optimal to be soybean oil.The inventor also attempts in test using Polyethylene Glycol to make disperse medium, but result of the test shows that above-mentioned three kinds of medicines can not dissolve fully in Polyethylene Glycol, even if be prepared into suspension, layering appears in medicinal liquid after placing 24 hours, is not suitable for making soft capsule.
Also to add an amount of surfactant in the medicinal liquid, by test, relatively the surfactant of Shi Heing is selected from one or more combination of tween, lecithin, glycerol, and the weight ratio of itself and active constituents of medicine is 0.02-0.3: 1, be preferably 0.04-0.25: 1.The inventor found through experiments, and surfactant adds very little, and it is inhomogeneous that medicine is disperseed, and causes the soft gelatin pharmaceutical loading amount deviation that finally makes excessive, is not suitable for medicinal; And surfactant adds too much, can make medicinal liquid floccule occur, is not suitable as medicinal equally.Abundant moistening according to selected suitable surfactant of the present invention and suitable weight specific energy thereof are guaranteed active medicine is scattered in the middle of the disperse medium medicine equably.
Because the effective dose of three active medicines is very big in the capsule composition among the present invention, also needs to add suitable suspending agent, improve the stability of medicinal liquid.By test, relatively the suspending agent of Shi Heing is selected from Cera Flava, hydrogenated vegetable oil, stearic one or more combination, and the weight ratio of itself and active constituents of medicine is 0.01-1.0: 1, be preferably 0.05-0.7: 1.Above-mentioned suitable suspending agent and suitable weight specific energy messenger drug liquid suspendible thereof are uniform and stable, and the soft capsule that makes character before the deadline can not change.And suspending agent adds very little, can make medicinal liquid layering occur after placing a period of time; Same add too much suspending agent then can the mobile variation of messenger drug liquid, be not suitable for being introduced into pellet press compacting soft capsule.
As everyone knows, soft capsule has release, absorbs rapidly, bioavailability is high, advantages such as taking convenience, but whether the disperse medium of selecting for use in the soft capsule is suitable, soft capsule is formed and the proportioning of each adjuvant component directly has influence on the stability of soft capsule.Therefore, finding the pharmaceutic adjuvant of suitable zinc gluconate, ibuprofen and chlorphenamine maleate compound medicine and ratio of adjuvant is key technology of the present invention.
Based on above-mentioned result of the test, compound capsules compositions of the present invention mainly contains following component and weight ratio:
Active component 1
Disperse medium 0.8-3.0
Surfactant 0.02-0.3
Suspending agent 0.01-1.0
Wherein active component is the compositions of zinc gluconate, ibuprofen and chlorphenamine maleate, and weight ratio is 1: 1.2-2: 0.02-0.2.
Above-mentioned soft capsule preparation, wherein the weight ratio of each material is preferably:
Active component 1
Disperse medium 1.2-2.0
Surfactant 0.04-0.25
Suspending agent 0.05-0.7
Wherein active component zinc gluconate, ibuprofen and chlorphenamine maleate weight ratio are preferably 1: 1.5: 0.02.
In the above-mentioned soft capsule, disperse medium preferably vegetable oil wherein.
In the above-mentioned soft capsule, the preferred soybean oil of vegetable oil wherein.
In the above-mentioned soft capsule, wherein surfactant is preferably from one or more combination of tween, lecithin, glycerol.
In the above-mentioned soft capsule, wherein suspending agent is selected from Cera Flava, hydrogenated vegetable oil, stearic one or more combination.
The specific embodiment
Embodiment 1
Constituent content (mg/ grain)
Zinc gluconate 100.0
Ibuprofen 150.0
Chlorphenamine maleate 2.0
Soybean oil 400.0
Tween 80 20.0
Lecithin 12.0
Cera Flava 20.0
Amount to 704.0mg
Preparation method
Soft capsule content: the amount by 1000 of preparations feeds intake.Disperse medium is heated to 50 ℃, and surfactant takes by weighing by required unit of weight, stirs to add mix homogeneously, add zinc gluconate, ibuprofen and chlorphenamine maleate more in proportion, add the suspending agent that takes by weighing by required unit of weight then, stir, form uniform and stable medicinal liquid.Medicinal liquid is introduced the soft capsule pellet press, be prepared into soft capsule according to the soft capsule preparation method of routine.
Embodiment 2
Constituent content (mg/ grain)
Zinc gluconate 100.0
Ibuprofen 150.0
Chlorphenamine maleate 2.0
Soybean oil 300.0
Tween 80 20.0
Lecithin 20.0
Hydrogenated oil and fat 200.0
Cera Flava 10.0
Amount to 802.0mg
Preparation method is with embodiment 1.
Embodiment 3
Constituent content (mg/ grain)
Zinc gluconate 100.0
Ibuprofen 150.0
Chlorphenamine maleate 2.0
Soybean oil 350.0
Lecithin 10.5
Hydrogenated oil and fat 100.0
Stearic acid 28.0
Amount to 740.5mg
Embodiment 3
Constituent content (mg/ grain)
Zinc gluconate 100.0
Ibuprofen 150.0
Chlorphenamine maleate 2.0
Soybean oil 530.0
Glycerol 53.0
Lecithin 10.6
Cera Flava 53.0
Amount to 898.6mg
Preparation method is with embodiment 1.
Embodiment 4
Constituent content (mg/ grain)
Zinc gluconate 100.0
Ibuprofen 150.0
Chlorphenamine maleate 2.0
Soybean oil 450.0
Glycerol 50.0
Hydrogenated oil and fat 150.0
Amount to 902.0mg.
Claims (6)
1, a kind of capsule composition of compound recipe cold medicine is made up of soft capsule rubber and the pharmaceutical composition that is wrapped in the rubber, it is characterized in that described pharmaceutical composition mainly contains following material and weight ratio:
Active component 1
Disperse medium 0.8～3.0
Surfactant 0.02～0.3
Suspending agent 0.01～1.0
Wherein active component and weight ratio are zinc gluconate: ibuprofen: chlorphenamine maleate=1: 1.2～2: 0.02～0.2.
2, the capsule composition of claim 1, wherein the weight ratio of each material is:
Active component 1
Disperse medium 1.2～2.0
Surfactant 0.04～0.25
Suspending agent 0.05～0.7
Wherein the weight ratio of active component is a zinc gluconate: ibuprofen: chlorphenamine maleate=1: 1.5: 0.02.
3, claim 1 or 2 capsule composition, wherein disperse medium is a vegetable oil.
4, the capsule composition of claim 3, wherein vegetable oil is a soybean oil.
5, claim 1 or 2 capsule composition, wherein surfactant is one or more in tween, lecithin, the glycerol.
6, claim 1 or 2 capsule composition, wherein suspending agent is one or more in Cera Flava, hydrogenated vegetable oil, the stearic acid.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100387946A CN100404031C (en) | 2006-03-13 | 2006-03-13 | Soft capsule composition containing zine gluconate, Ibuprofen and chlorphenamine maleate |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100387946A CN100404031C (en) | 2006-03-13 | 2006-03-13 | Soft capsule composition containing zine gluconate, Ibuprofen and chlorphenamine maleate |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1857263A true CN1857263A (en) | 2006-11-08 |
| CN100404031C CN100404031C (en) | 2008-07-23 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2006100387946A Expired - Fee Related CN100404031C (en) | 2006-03-13 | 2006-03-13 | Soft capsule composition containing zine gluconate, Ibuprofen and chlorphenamine maleate |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102283824A (en) * | 2011-06-24 | 2011-12-21 | 南京中医药大学 | Medicinal composition and soft capsule preparation for treating influenza |
| WO2019205030A1 (en) * | 2018-04-25 | 2019-10-31 | 人福普克药业（武汉）有限公司 | Amantadine hydrochloride soft capsule and preparation method therefor |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6387400B1 (en) * | 2000-08-29 | 2002-05-14 | R.P. Scherer Technologies, Inc. | Process for preparing pharmaceutical compositions for use with soft gelatin formulations |
-
2006
- 2006-03-13 CN CNB2006100387946A patent/CN100404031C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102283824A (en) * | 2011-06-24 | 2011-12-21 | 南京中医药大学 | Medicinal composition and soft capsule preparation for treating influenza |
| CN102283824B (en) * | 2011-06-24 | 2013-03-27 | 南京中医药大学 | Medicinal composition and soft capsule preparation for treating influenza |
| WO2019205030A1 (en) * | 2018-04-25 | 2019-10-31 | 人福普克药业（武汉）有限公司 | Amantadine hydrochloride soft capsule and preparation method therefor |
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| Publication number | Publication date |
|---|---|
| CN100404031C (en) | 2008-07-23 |
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