CN103070846B - Docusate sodium soft capsule - Google Patents
Docusate sodium soft capsule Download PDFInfo
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- CN103070846B CN103070846B CN201310017981.6A CN201310017981A CN103070846B CN 103070846 B CN103070846 B CN 103070846B CN 201310017981 A CN201310017981 A CN 201310017981A CN 103070846 B CN103070846 B CN 103070846B
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Abstract
The invention discloses a docusate sodium soft capsule which comprises a soft capsule rubber skin and docusate sodium solution packaged in the soft capsule shell. The docusate sodium soft capsule is characterized in that the docusate sodium solution consists of the following components in percentage by weight: 10% to 50% of docusate sodium, 35% to 90% of polyethylene glycol and 0% to 15% of polyhydric alcohol; the soft capsule shell comprises a red shell and a white shell; the red rubber skin consists of the following components in percentage by weight: 45% to 80% of gelatin, 10% to 40% of plasticizer, 0.01% to 0.4% of colorant I and 5% to 15% of water; and the white shell consists of the following components in percentage by weight: 45% to 80% of gelatin, 10% to 40% of plasticizer, 0.1% to 4.0% of additive and 5% to 15% of water. The invention aims to overcome the defects in the prior art and provide the docusate sodium soft capsule which comprises simple components and has strong adaptability and high response speed.
Description
Technical field
The present invention relates to a kind of Docusate sodium soft capsule.
Background technology
Chronic functional constipation is one of comparatively common clinically digestive tract illness, is that times of defecation reduces or feces drying is difficult to resolve caused by knot, rectum and abnormal anal function.Local and general malaise chronic constipation can cause local and General Symptoms, as stickness in bitter taste, mouth, upper abdomen distension, two side of body distending pain, belch, also can there is inappetence in some patients, lethargy, dizzy weak, general malaise, headache, insomnia etc., constipation can cause the harm of body local, directly causes anal and intestinal disease, if treat not in time, by the quality of life of serious harm patient.Therefore, keep fecal water, increase the better method that feces containment is treatment senile constipation.Clinical adopted bulk-forming let out medicine as Macrogol 4000 and lubricity let out the mouthfeel of medicine as liquid paraffin etc. poor, act on weak, and the malabsorption of vitamin A, D, K and calcium, phosphorus can be caused; And life-time service zest lets out medicine as Chinese herb rhubarb or similar composition, patient can be caused the dependency of medicine, intestinal wall nerve can be damaged again, cause melanosis coli, and then may colon cancer be caused, be not suitable for long-term taking.
Summary of the invention
The object of the invention is to overcome weak point of the prior art, providing a kind of component simple, strong adaptability, the rapid-action Docusate sodium soft capsule being used for the treatment of constipation.
In order to achieve the above object, the present invention adopts following scheme:
A kind of Docusate sodium soft capsule, includes soft capsule rubber and is wrapped in the docusate sodium solution in described soft capsule rubber, it is characterized in that described docusate sodium solution is composed of the following components by weight percentage:
Docusate sodium 10% ~ 50%
Polyethylene Glycol 35% ~ 90%
Polyhydric alcohol 0% ~ 15%;
Described soft capsule rubber includes red rubber and white rubber; Described red rubber is composed of the following components by weight percentage:
Described white rubber is composed of the following components by weight percentage:
A kind of Docusate sodium soft capsule as above, is characterized in that described docusate sodium solution is composed of the following components by weight percentage:
Docusate sodium 15% ~ 40%
Polyethylene Glycol 40% ~ 80%
Polyhydric alcohol 3% ~ 10%.
A kind of Docusate sodium soft capsule as above, is characterized in that described red rubber is composed of the following components by weight percentage:
Described white rubber is composed of the following components by weight percentage:
A kind of Docusate sodium soft capsule as above, is characterized in that described Polyethylene Glycol is that average molecular mass is from 200 to 600 daltonian Polyethylene Glycol.
A kind of Docusate sodium soft capsule as above, it is characterized in that described polyhydric alcohol be in propylene glycol, glycerol one or both.
A kind of Docusate sodium 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, Macrogol 600, polyethylene glycol-800.
A kind of Docusate sodium soft capsule as above, is characterized in that described coloring agent I is one or more the mixture in D & C Red, FD & C Red, FD & C Yellow.In the present invention, D & C Red, FD & C Red, FD & C Yellow are commercially available prod, can buy from Beijing Orient Kai Er Trade Co., Ltd. and obtain, also can from manufacturer: RohaDyechem Pvt.Ltd buys.
A kind of Docusate sodium soft capsule as above, is characterized in that described additive is one or more the mixture in titanium dioxide, calcium carbonate, Pulvis Talci.
A kind of Docusate sodium soft capsule as above, is characterized in that described Polyethylene Glycol is PEG400.
A kind of Docusate sodium soft capsule as above, is characterized in that described coloring agent I is the mixture of D & CRed and FD & C Red.
In sum, beneficial effect of the present invention:
In the present invention, docusate sodium belongs to emollient laxative, for substantially non-absorbent anion surfactant, it can reduce the surface tension of feces, water and fat is made to be easy to infiltrate in excrement block, make it softening, be convenient to discharge, it can act on intestinal mucosa again, enteral moisture is secreted, is specially adapted to the short term therapy that defecation can not be exerted oneself.
Docusate sodium soft capsule good looking appearance of the present invention, compliance is strong; Because the docusate sodium in soft capsule is liquid, be beneficial to and enter feces and onset, onset is faster.
Detailed description of the invention
Below in conjunction with detailed description of the invention, the present invention is described further:
Embodiment 1
Docusate sodium soft capsule of the present invention, include soft capsule rubber and be wrapped in the docusate sodium solution in described soft capsule rubber, described docusate sodium solution is composed of the following components by weight percentage:
Docusate sodium 10%
Macrogol 200 90%
Described soft capsule rubber includes red rubber and white rubber; Described red rubber is composed of the following components by weight percentage:
Described white rubber is composed of the following components by weight percentage:
Prepare Docusate sodium soft capsule of the present invention, comprise the following steps:
1, the preparation of red gelatin liquid:
Plasticizer is soluble in water, be heated to 40 ° of C in added glue tank, add gelatin, stirring and dissolving under 60 ° of C.Coloring agent I 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, the preparation of white gelatin solution:
Added by titanium dioxide in enough water, colloid mill is uniformly dispersed, and obtains solution I.Plasticizer is soluble in water, obtain solution II, will be heated to 40 ° of C in solution I and adding of solution II glue tank.Add gelatin, stirring and dissolving under 60 ° of C.After solution is complete, vacuumizing and exhausting steeps, for subsequent use.
3, content preparation:
Docusate sodium is soaked in Polyethylene Glycol, is heated to 40 ° of C and dissolves, mixing, for subsequent use;
4, soft capsule preparation:
By content medicinal liquid, red gelatin liquid and white gelatin solution add in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Embodiment 2
Docusate sodium soft capsule of the present invention, include soft capsule rubber and be wrapped in the docusate sodium solution in described soft capsule rubber, described docusate sodium solution is composed of the following components by weight percentage:
Docusate sodium 20%
PEG400 70%
Propylene glycol 10%;
Described soft capsule rubber includes red rubber and white rubber; Described red rubber is composed of the following components by weight percentage:
Described white rubber is composed of the following components by weight percentage:
Prepare Docusate sodium soft capsule of the present invention, comprise the following steps:
1, the preparation of red gelatin liquid:
Plasticizer is soluble in water, be heated to 50 ° of C in added glue tank, add gelatin, stirring and dissolving under 70 ° of C.Coloring agent I 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, the preparation of white gelatin solution:
Added by calcium carbonate in enough water, colloid mill is uniformly dispersed, and obtains solution I.Plasticizer is soluble in water, obtain solution II, will be heated to 60 ° of C in solution I and adding of solution II glue tank.Add gelatin, stirring and dissolving under 70 ° of C.After solution is complete, vacuumizing and exhausting steeps, for subsequent use.
3, content preparation:
Docusate sodium is soaked in Polyethylene Glycol, is heated to 60 ° of C and dissolves, add polyhydric alcohol, mixing, for subsequent use;
4, soft capsule preparation:
By content medicinal liquid, red gelatin liquid and white gelatin solution add in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Embodiment 3
Docusate sodium soft capsule of the present invention, include soft capsule rubber and be wrapped in the docusate sodium solution in described soft capsule rubber, described docusate sodium solution is composed of the following components by weight percentage:
Docusate sodium 30%
Macrogol 600 65%
Glycerol 5%;
Described soft capsule rubber includes red rubber and white rubber; Described red rubber is composed of the following components by weight percentage:
Described white rubber is composed of the following components by weight percentage:
Prepare Docusate sodium soft capsule of the present invention, comprise the following steps:
1, the preparation of red gelatin liquid:
Plasticizer is soluble in water, be heated to 60 ° of C in added glue tank, add gelatin, stirring and dissolving under 75 ° of C.Coloring agent I 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, the preparation of white gelatin solution:
Added by Pulvis Talci in enough water, colloid mill is uniformly dispersed, and obtains solution I.Plasticizer is soluble in water, obtain solution II, will be heated to 50 ° of C in solution I and adding of solution II glue tank.Add gelatin, stirring and dissolving under 65 ° of C.After solution is complete, vacuumizing and exhausting steeps, for subsequent use.
3, content preparation:
Docusate sodium is soaked in Polyethylene Glycol, is heated to 45 ° of C and dissolves, add polyhydric alcohol, mixing, for subsequent use;
4, soft capsule preparation:
By content medicinal liquid, red gelatin liquid and white gelatin solution add in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Embodiment 4
Docusate sodium soft capsule of the present invention, include soft capsule rubber and be wrapped in the docusate sodium solution in described soft capsule rubber, described docusate sodium solution is composed of the following components by weight percentage:
Docusate sodium 40%
The mixture 45% of Macrogol 200 and PEG400
The mixture 15% of propylene glycol, glycerol;
Described soft capsule rubber includes red rubber and white rubber; Described red rubber is composed of the following components by weight percentage:
Described white rubber is composed of the following components by weight percentage:
Prepare Docusate sodium soft capsule of the present invention, comprise the following steps:
1, the preparation of red gelatin liquid:
Plasticizer is soluble in water, be heated to 55 ° of C in added glue tank, add gelatin, stirring and dissolving under 70 ° of C.Coloring agent I 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, the preparation of white gelatin solution:
Added by titanium dioxide in enough water, colloid mill is uniformly dispersed, and obtains solution I.Plasticizer is soluble in water, obtain solution II, will be heated to 45 ° of C in solution I and adding of solution II glue tank.Add gelatin, stirring and dissolving under 80 ° of C.After solution is complete, vacuumizing and exhausting steeps, for subsequent use.
3, content preparation:
Docusate sodium is soaked in Polyethylene Glycol, is heated to 65 ° of C and dissolves, add polyhydric alcohol, mixing, for subsequent use;
4, soft capsule preparation:
By content medicinal liquid, red gelatin liquid and white gelatin solution add in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Embodiment 5
Docusate sodium soft capsule of the present invention, include soft capsule rubber and be wrapped in the docusate sodium solution in described soft capsule rubber, described docusate sodium solution is composed of the following components by weight percentage:
Docusate sodium 50%
The mixture 35% of Macrogol 200, PEG400 and Macrogol 600
Glycerol 15%;
Described soft capsule rubber includes red rubber and white rubber; Described red rubber is composed of the following components by weight percentage:
Gelatin 80%
The mixture 10% of glycerol, sorbitol
The mixture 0.02% of D & C Red No.33, FD & C Red No.40, FD & C Yellow No.6
Water 9.8%;
Described white rubber is composed of the following components by weight percentage:
Prepare Docusate sodium soft capsule of the present invention, comprise the following steps:
1, the preparation of red gelatin liquid:
Plasticizer is soluble in water, be heated to 50 ° of C in added glue tank, add gelatin, stirring and dissolving under 70 ° of C.Coloring agent I 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, the preparation of white gelatin solution:
Added by titanium dioxide in enough water, colloid mill is uniformly dispersed, and obtains solution I.Plasticizer is soluble in water, obtain solution II, will be heated to 60 ° of C in solution I and adding of solution II glue tank.Add gelatin, stirring and dissolving under 80 ° of C.After solution is complete, vacuumizing and exhausting steeps, for subsequent use.
3, content preparation:
Docusate sodium is soaked in Polyethylene Glycol, is heated to 50 ° of C and dissolves, add polyhydric alcohol, mixing, for subsequent use;
4, soft capsule preparation:
By content medicinal liquid, red gelatin liquid and white gelatin solution add in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Embodiment 6
Docusate sodium soft capsule of the present invention, include soft capsule rubber and be wrapped in the docusate sodium solution in described soft capsule rubber, described docusate sodium solution is composed of the following components by weight percentage:
Docusate sodium 10%
PEG400 87%
Propylene glycol 3%;
Described soft capsule rubber includes red rubber and white rubber; Described red rubber is composed of the following components by weight percentage:
Described white rubber is composed of the following components by weight percentage:
Prepare Docusate sodium soft capsule of the present invention, comprise the following steps:
1, the preparation of red gelatin liquid:
Plasticizer is soluble in water, be heated to 60 ° of C in added glue tank, add gelatin, stirring and dissolving under 70 ° of C.Coloring agent I 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, the preparation of white gelatin solution:
Added by titanium dioxide in enough water, colloid mill is uniformly dispersed, and obtains solution I.Plasticizer is soluble in water, obtain solution II, will be heated to 60 ° of C in solution I and adding of solution II glue tank.Add gelatin, stirring and dissolving under 70 ° of C.After solution is complete, vacuumizing and exhausting steeps, for subsequent use.
3, content preparation:
Docusate sodium is soaked in Polyethylene Glycol, is heated to 55 ° of C and dissolves, add polyhydric alcohol, mixing, for subsequent use;
4, soft capsule preparation:
By content medicinal liquid, red gelatin liquid and white gelatin solution add in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Claims (1)
1. a Docusate sodium soft capsule, includes soft capsule rubber and is wrapped in the docusate sodium solution in described soft capsule rubber, it is characterized in that described docusate sodium solution is composed of the following components by weight percentage:
Docusate sodium 50%
The mixture 35% of Macrogol 200, PEG400 and Macrogol 600
Glycerol 15%;
Described soft capsule rubber includes red rubber and white rubber; Described red rubber is composed of the following components by weight percentage:
Described white rubber is composed of the following components by weight percentage:
Prepare described Docusate sodium soft capsule, comprise the following steps:
The preparation of A, red gelatin liquid:
By soluble in water for the mixture of glycerol, sorbitol, be heated to 50 DEG C in added glue tank, add gelatin, stirring and dissolving at 70 DEG C; The mixture of D & C Red No.33, FD & C RedNo.40, FD & C Yellow No.6 is added to the water, stir, obtain pigment solution, pigment solution is added in gelatin solution, stir and vacuumizing and exhausting bubble, for subsequent use;
The preparation of B, white gelatin solution:
Added by titanium dioxide in enough water, colloid mill is uniformly dispersed, and obtains solution I; By increase maltose alcohol, mannitol, propylene glycol mixture soluble in water, obtain solution II, will be heated to 60 DEG C in solution I and adding of solution II glue tank; Add gelatin, stirring and dissolving at 80 DEG C; After solution is complete, vacuumizing and exhausting steeps, for subsequent use;
C, content are prepared:
Docusate sodium is soaked in Polyethylene Glycol, is heated to 50 DEG C of dissolvings, adds glycerol, mixing, for subsequent use;
Prepared by D, soft capsule:
By content medicinal liquid, red gelatin liquid and white gelatin solution add in pellet press respectively, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310017981.6A CN103070846B (en) | 2013-01-17 | 2013-01-17 | Docusate sodium soft capsule |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310017981.6A CN103070846B (en) | 2013-01-17 | 2013-01-17 | Docusate sodium soft capsule |
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| CN103070846A CN103070846A (en) | 2013-05-01 |
| CN103070846B true CN103070846B (en) | 2015-05-27 |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103655529B (en) * | 2013-11-09 | 2016-02-03 | 安士制药（中山）有限公司 | Composition and soft capsule for resisting histamine and promoting sleep |
| CN108354910A (en) * | 2018-05-17 | 2018-08-03 | 安士制药（中山）有限公司 | A kind of Simethicone soft capsule |
| CN108853051B (en) * | 2018-09-04 | 2020-12-18 | 安士制药（中山）有限公司 | Ursodeoxycholic acid soft capsule and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0032825A2 (en) * | 1980-01-18 | 1981-07-29 | MALLINCKRODT, INC.(a Missouri corporation) | Stabilized solutions of dioctyl calcium sulfosuccinate in corn oil |
| KR20060095081A (en) * | 2005-02-25 | 2006-08-30 | 보람제약주식회사 | Transparent solution and soft capsule formulation of laxative formulation |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000067747A1 (en) * | 1999-05-06 | 2000-11-16 | Warner-Lambert Company | Docusate hard gelatin capsules |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0032825A2 (en) * | 1980-01-18 | 1981-07-29 | MALLINCKRODT, INC.(a Missouri corporation) | Stabilized solutions of dioctyl calcium sulfosuccinate in corn oil |
| KR20060095081A (en) * | 2005-02-25 | 2006-08-30 | 보람제약주식회사 | Transparent solution and soft capsule formulation of laxative formulation |
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