CN103070847B - A kind of preparation method of Docusate sodium soft capsule - Google Patents
A kind of preparation method of Docusate sodium soft capsule Download PDFInfo
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- CN103070847B CN103070847B CN201310018344.0A CN201310018344A CN103070847B CN 103070847 B CN103070847 B CN 103070847B CN 201310018344 A CN201310018344 A CN 201310018344A CN 103070847 B CN103070847 B CN 103070847B
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Abstract
The invention discloses a kind of preparation method of Docusate sodium soft capsule, comprise: the preparation of A, red gelatin liquid: plasticizer is soluble in water, be heated to 40 ~ 80 DEG C in added glue tank, add gelatin, stirring and dissolving, obtain gelatin solution, coloring agent I is added to the water, stirs, add in gelatin solution, stir and vacuumizing and exhausting bubble, for subsequent use; The preparation of B, white gelatin solution: added by additive in enough water, colloid mill is uniformly dispersed, obtains solution I, and plasticizer is soluble in water, be heated to 40 ~ 80 DEG C by solution I and adding of plasticizer solution glue tank, add gelatin, stirring and dissolving, after solution is complete, vacuumizing and exhausting steeps, for subsequent use; C, content are prepared: in the polyglycol solution of docusate sodium, add polyhydric alcohol, mix under 30 ~ 50 ° of C, for subsequent use; Prepared by D, soft capsule: add in pellet press feed hopper by the content medicinal liquid in step C, adjustment loading amount and rubber thickness, and pelleting is dry, smears ball, packaging.
Description
Technical field
The present invention relates to a kind of preparation method 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.The technique of existing preparation Docusate sodium soft capsule is relatively complicated, is unfavorable for producing.
Summary of the invention
The object of the invention is to overcome weak point of the prior art, providing a kind of technique simple, for the preparation of the method for Docusate sodium soft capsule.
In order to achieve the above object, the present invention adopts following scheme:
A kind of preparation method of Docusate sodium soft capsule, this Docusate sodium soft capsule includes the double-colored soft capsule rubber be made up of red gelatin liquid and white gelatin solution, at described double-colored soft capsule rubber built with docusate sodium content, it is characterized in that this preparation method comprises the following steps:
The preparation of A, red gelatin liquid
Plasticizer is soluble in water, be heated to 40 ~ 80 DEG C in added glue tank, add gelatin, stirring and dissolving at 60 ~ 80 DEG C, obtain gelatin solution, 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;
The preparation of B, white gelatin solution
Added by additive in enough water, colloid mill is uniformly dispersed, and obtains solution I, and plasticizer is soluble in water, be heated to 40 ~ 80 DEG C by solution I and adding of plasticizer solution glue tank, add gelatin, stirring and dissolving at 60 ~ 80 DEG C, after solution is complete, vacuumizing and exhausting steeps, for subsequent use;
C, content are prepared
In the polyglycol solution of docusate sodium, add polyhydric alcohol, mix under 30 ~ 50 ° of C, for subsequent use;
Prepared by D, soft capsule
Content medicinal liquid in step C is added in pellet press feed hopper, adjustment loading amount and rubber thickness, pelleting, dry, smear ball, packaging.
The preparation method of a kind of Docusate sodium soft capsule as above, is characterized in that the coloring agent I described in steps A 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: Roha Dyechem Pvt.Ltd buys.
The preparation method of a kind of Docusate sodium soft capsule as above, it is characterized in that described plasticizer is glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400, Macrogol 600, one or more the mixture in polyethylene glycol-800.
The preparation method of a kind of Docusate sodium soft capsule as above, it is characterized in that the additive described in step B be in titanium dioxide, calcium carbonate or Pulvis Talci in one or more mixture.
The preparation method of a kind of Docusate sodium soft capsule as above, it is characterized in that the polyhydric alcohol described in step C be in propylene glycol, glycerol one or both.
The preparation method of a kind of Docusate sodium soft capsule as above, is characterized in that the polyglycol solution of docusate sodium described in step C is immersed in 40 ~ 70 ° of C in Polyethylene Glycol by docusate sodium and dissolves gained.
In sum, beneficial effect of the present invention:
In the present invention, preparation method technique is simple, easy to operate, the Docusate sodium soft capsule good looking appearance prepared, and compliance is strong; Because the docusate sodium in soft capsule is liquid, be beneficial to and enter feces and onset, onset is faster; Product 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.
Detailed description of the invention
Below in conjunction with detailed description of the invention, the present invention is described further:
The present invention prepares the method for Docusate sodium soft capsule, this Docusate sodium soft capsule includes the double-colored soft capsule rubber be made up of red gelatin liquid and white gelatin solution, at described double-colored soft capsule rubber built with docusate sodium content, wherein in Docusate sodium soft capsule finished product, docusate sodium content is composed of the following components by weight percentage:
Docusate sodium 10% ~ 50%
Polyethylene Glycol 35% ~ 90%
Polyhydric alcohol 1% ~ 15%;
Red rubber is made up of following component by weight percentage:
White rubber is made up of following component by weight percentage:
This preparation method comprises the following steps:
The preparation of A, red gelatin liquid
Plasticizer is soluble in water, be heated to 40 ~ 80 DEG C in added glue tank, add gelatin, stirring and dissolving at 60 ~ 80 DEG C, obtain gelatin solution, 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; Wherein the weight ratio of water and gelatin is 0.8 ~ 1.2:1.
The preparation of B, white gelatin solution
Added by additive in enough water, colloid mill is uniformly dispersed, and obtains solution I, and plasticizer is soluble in water, be heated to 40 ~ 80 DEG C by solution I and adding of plasticizer solution glue tank, add gelatin, stirring and dissolving at 60 ~ 80 DEG C, after solution is complete, vacuumizing and exhausting steeps, for subsequent use; Wherein the weight ratio of water and gelatin is 0.8 ~ 1.2:1.
C, content are prepared
Docusate sodium is soaked in Polyethylene Glycol, is heated to 30 ~ 70 ° of C and makes dissolving, add polyhydric alcohol, mixing, for subsequent use; Wherein the content of each component is by weight percentage:
Prepared by D, soft capsule
Content medicinal liquid in step C and white gelatin solution and red gelatin liquid are added in pellet press respectively, adjustment loading amount and rubber thickness, pelleting, dry, smear ball, packaging.
Wherein said coloring agent I is one or more the mixture in D & C Red, FD & C Red, FD & C Yellow.Described plasticizer is glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400, Macrogol 600, one or more the mixture in polyethylene glycol-800.Described additive is one or more the mixture in titanium dioxide, calcium carbonate or Pulvis Talci.Described polyhydric alcohol be in propylene glycol, glycerol one or both.
Embodiment 1
The present invention prepares the method for Docusate sodium soft capsule, this Docusate sodium soft capsule includes the double-colored soft capsule rubber be made up of red gelatin liquid and white gelatin solution, at described double-colored soft capsule rubber built with docusate sodium content, wherein in Docusate sodium soft capsule finished product, docusate sodium content is composed of the following components by weight percentage:
Docusate sodium 10%
Polyethylene Glycol 80%
Polyhydric alcohol 15%;
Red rubber is made up of following component by weight percentage:
White rubber is made up of following component by weight percentage:
This preparation method comprises the following steps:
The preparation of A, red gelatin liquid
Plasticizer is soluble in water, be heated to 40 DEG C in added glue tank, add gelatin, stirring and dissolving at 60 DEG C, obtain gelatin solution, 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; Wherein the weight ratio of water and gelatin is 0.8:1.
The preparation of B, white gelatin solution
Added by additive in enough water, colloid mill is uniformly dispersed, and obtains solution I, and plasticizer is soluble in water, is heated to 40 DEG C, adds gelatin, stirring and dissolving at 60 DEG C by solution I and adding of plasticizer solution glue tank, and after solution is complete, vacuumizing and exhausting steeps, for subsequent use; Wherein the weight ratio of water and gelatin is 0.8:1.
C, content are prepared
In the polyglycol solution of docusate sodium, add polyhydric alcohol, mix under 50 ° of C, for subsequent use;
Prepared by D, soft capsule
Content medicinal liquid in step C and white gelatin solution and red gelatin liquid are added in pellet press respectively, adjustment loading amount and rubber thickness, pelleting, dry, smear ball, packaging.
Wherein said coloring agent I is one or more the mixture in D & C Red, FD & C Red, FD & C Yellow.Described plasticizer is glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400, Macrogol 600, one or more the mixture in polyethylene glycol-800.Described additive is one or more the mixture in titanium dioxide, calcium carbonate or Pulvis Talci.Described polyhydric alcohol be in propylene glycol, glycerol one or both.
Embodiment 2
The present invention prepares the method for Docusate sodium soft capsule, this Docusate sodium soft capsule includes the double-colored soft capsule rubber be made up of red gelatin liquid and white gelatin solution, at described double-colored soft capsule rubber built with docusate sodium content, wherein in Docusate sodium soft capsule finished product, docusate sodium content is composed of the following components by weight percentage:
Docusate sodium 50%
Polyethylene Glycol 35%
Polyhydric alcohol 15%;
Red rubber is made up of following component by weight percentage:
White rubber is made up of following component by weight percentage:
This preparation method comprises the following steps:
The preparation of A, red gelatin liquid
Plasticizer is soluble in water, be heated to 80 DEG C in added glue tank, add gelatin, stirring and dissolving at 80 DEG C, obtain gelatin solution, 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; Wherein the weight ratio of water and gelatin is 1.2:1.
The preparation of B, white gelatin solution
Added by additive in enough water, colloid mill is uniformly dispersed, and obtains solution I, and plasticizer is soluble in water, is heated to 80 DEG C, adds gelatin, stirring and dissolving at 80 DEG C by solution I and adding of plasticizer solution glue tank, and after solution is complete, vacuumizing and exhausting steeps, for subsequent use; Wherein the weight ratio of water and gelatin is 1.2:1.
C, content are prepared
Docusate sodium is soaked in Polyethylene Glycol, is heated to 40 ° of C and makes dissolving, add polyhydric alcohol, mix under 40 ° of C, for subsequent use;
Prepared by D, soft capsule
Content medicinal liquid in step C and white gelatin solution and red gelatin liquid are added in pellet press respectively, adjustment loading amount and rubber thickness, pelleting, dry, smear ball, packaging.
Wherein said coloring agent I is one or more the mixture in D & C Red, FD & C Red, FD & C Yellow.Described plasticizer is glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400, Macrogol 600, one or more the mixture in polyethylene glycol-800.Described additive is one or more the mixture in titanium dioxide, calcium carbonate or Pulvis Talci.Described polyhydric alcohol be in propylene glycol, glycerol one or both.
Embodiment 3
The present invention prepares the method for Docusate sodium soft capsule, this Docusate sodium soft capsule includes the double-colored soft capsule rubber be made up of red gelatin liquid and white gelatin solution, at described double-colored soft capsule rubber built with docusate sodium content, wherein in Docusate sodium soft capsule finished product, docusate sodium content is composed of the following components by weight percentage:
Docusate sodium 30%
Polyethylene Glycol 60%
Polyhydric alcohol 10%;
Red rubber is made up of following component by weight percentage:
White rubber is made up of following component by weight percentage:
This preparation method comprises the following steps:
The preparation of A, red gelatin liquid
Plasticizer is soluble in water, be heated to 80 DEG C in added glue tank, add gelatin, stirring and dissolving at 80 DEG C, obtain gelatin solution, 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; Wherein the weight ratio of water and gelatin is 1:1.
The preparation of B, white gelatin solution
Added by additive in enough water, colloid mill is uniformly dispersed, and obtains solution I, and plasticizer is soluble in water, is heated to 80 DEG C, adds gelatin, stirring and dissolving at 80 DEG C by solution I and adding of plasticizer solution glue tank, and after solution is complete, vacuumizing and exhausting steeps, for subsequent use; Wherein the weight ratio of water and gelatin is 1:1.
C, content are prepared
In the polyglycol solution of docusate sodium, add polyhydric alcohol, make it dissolve under 30 ° of C, add polyhydric alcohol, mixing, for subsequent use;
Prepared by D, soft capsule
Content medicinal liquid in step C and white gelatin solution and red gelatin liquid are added in pellet press respectively, adjustment loading amount and rubber thickness, pelleting, dry, smear ball, packaging.
Wherein said coloring agent I is one or more the mixture in D & C Red, FD & C Red, FD & C Yellow.Described plasticizer is glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400, Macrogol 600, one or more the mixture in polyethylene glycol-800.Described additive is one or more the mixture in titanium dioxide, calcium carbonate or Pulvis Talci.Described polyhydric alcohol be in propylene glycol, glycerol one or both.
Embodiment 4
The present invention prepares the method for Docusate sodium soft capsule, this Docusate sodium soft capsule includes the double-colored soft capsule rubber be made up of red gelatin liquid and white gelatin solution, at described double-colored soft capsule rubber built with docusate sodium content, wherein in Docusate sodium soft capsule finished product, docusate sodium content is composed of the following components by weight percentage:
This preparation method comprises the following steps:
The preparation of A, red gelatin liquid
Plasticizer is soluble in water, be heated to 80 DEG C in added glue tank, add gelatin, stirring and dissolving at 80 DEG C, obtain gelatin solution, 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; Wherein the weight ratio of water and gelatin is 1:1.
The preparation of B, white gelatin solution
Added by additive in enough water, colloid mill is uniformly dispersed, and obtains solution I, and plasticizer is soluble in water, is heated to 80 DEG C, adds gelatin, stirring and dissolving at 80 DEG C by solution I and adding of plasticizer solution glue tank, and after solution is complete, vacuumizing and exhausting steeps, for subsequent use; Wherein the weight ratio of water and gelatin is 1:1.
C, content are prepared
Docusate sodium is soaked in Polyethylene Glycol, is heated to 30 ° of C and makes dissolving, add polyhydric alcohol, mix under 50 ° of C, for subsequent use;
Prepared by D, soft capsule
Content medicinal liquid in step C and white gelatin solution and red gelatin liquid are added in pellet press respectively, adjustment loading amount and rubber thickness, pelleting, dry, smear ball, packaging.
Wherein said coloring agent I is one or more the mixture in D & C Red, FD & C Red, FD & C Yellow.Described plasticizer is glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400, Macrogol 600, one or more the mixture in polyethylene glycol-800.Described additive is one or more the mixture in titanium dioxide, calcium carbonate or Pulvis Talci.Described polyhydric alcohol be in propylene glycol, glycerol one or both.
Claims (1)
1. the present invention prepares the method for Docusate sodium soft capsule, this Docusate sodium soft capsule includes the double-colored soft capsule rubber be made up of red gelatin liquid and white gelatin solution, at described double-colored soft capsule rubber built with docusate sodium content, wherein in Docusate sodium soft capsule finished product, docusate sodium content is composed of the following components by weight percentage:
Docusate sodium 50%
Polyethylene Glycol 35%
Polyhydric alcohol 15%;
Red rubber is composed of the following components by weight percentage:
White rubber is composed of the following components by weight percentage:
This preparation method comprises the following steps:
The preparation of A, red gelatin liquid
Plasticizer is soluble in water, be heated to 80 DEG C in added glue tank, add gelatin, stirring and dissolving at 80 DEG C, obtain gelatin solution, 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; Wherein the weight ratio of water and gelatin is 1.2:1;
The preparation of B, white gelatin solution
Added by additive in enough water, colloid mill is uniformly dispersed, and obtains solution I, and plasticizer is soluble in water, is heated to 80 DEG C, adds gelatin, stirring and dissolving at 80 DEG C by solution I and adding of plasticizer solution glue tank, and after solution is complete, vacuumizing and exhausting steeps, for subsequent use; Wherein the weight ratio of water and gelatin is 1.2:1;
C, content are prepared
Docusate sodium is soaked in Polyethylene Glycol, is heated to 40 DEG C and makes dissolving, add polyhydric alcohol, mix at 40 DEG C, for subsequent use;
Prepared by D, soft capsule
Content medicinal liquid in step C and white gelatin solution and red gelatin liquid are added in pellet press respectively, adjustment loading amount and rubber thickness, pelleting, dry, smear ball, packaging;
Wherein said coloring agent I is one or more the mixture in D & C Red, FD & C Red, FD & C Yellow; Described plasticizer is glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400, Macrogol 600, one or more the mixture in polyethylene glycol-800; Described additive is one or more the mixture in titanium dioxide, calcium carbonate or Pulvis Talci; Described polyhydric alcohol be in propylene glycol, glycerol one or both.
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| EP3422871A1 (en) | 2016-03-01 | 2019-01-09 | Kraft Foods Group Brands LLC | Pelletized colorants comprising a pigment-protein complex and food products including the same |
| CN108524464A (en) * | 2018-05-17 | 2018-09-14 | 安士制药（中山）有限公司 | A kind of preparation method of Simethicone soft capsule |
| CN112675146A (en) * | 2021-01-13 | 2021-04-20 | 湖南华纳大药厂股份有限公司 | Doku sodium micro-pills and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20060095081A (en) * | 2005-02-25 | 2006-08-30 | 보람제약주식회사 | Transparent solution and soft capsule formulation of laxative formulation |
| CN101810336A (en) * | 2010-04-30 | 2010-08-25 | 广东仙乐制药有限公司 | Chewable soft capsules and method for preparing same |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20060095081A (en) * | 2005-02-25 | 2006-08-30 | 보람제약주식회사 | Transparent solution and soft capsule formulation of laxative formulation |
| CN101810336A (en) * | 2010-04-30 | 2010-08-25 | 广东仙乐制药有限公司 | Chewable soft capsules and method for preparing same |
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