CN103462927A - Preparation method for daytime-taken softgel for treating cold - Google Patents
Preparation method for daytime-taken softgel for treating cold Download PDFInfo
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- CN103462927A CN103462927A CN2013103605497A CN201310360549A CN103462927A CN 103462927 A CN103462927 A CN 103462927A CN 2013103605497 A CN2013103605497 A CN 2013103605497A CN 201310360549 A CN201310360549 A CN 201310360549A CN 103462927 A CN103462927 A CN 103462927A
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Abstract
The invention discloses a preparation method for a daytime-taken softgel for treating a cold. The preparation method comprises the following steps: A, preparation of a gelatin liquor: dissolving plasticizer in water, adding into a gelatin melting tank, adding gelatin, stirring to dissolve, adding coloring agent into water, stirring uniformly to obtain a pigment solution, adding the pigment solution into an obtained gelatin solution, stirring and vacuumizing to exhaust air bubbles, so as to obtain the gelatin liquor; B, preparation of contents: adding mixed polyethylene glycol and polyhydric alcohol into polyvidone, stirring to dissolve, adding acetaminophen, stirring to obtain a suspension, adding into a proportioning tank, vacuumizing, filling with inert gas, heating to dissolve, cooling, adding dextromethorphan hydrobromide and phenylephrine hydrochloride, vacuumizing, and keeping the temperature to dissolve, so as to obtain a content solution; C preparation of the softgel: adding the gelatin liquor and the content solution into a pelleting machine respectively, pelleting, drying, pellet plastering and packaging. The invention aims to provide the preparation method for the daytime-taken softgel which is used for treating the cold, and is simple in process, convenient to manufacture and good in product stability.
Description
Technical field
The present invention relates to a kind of preparation method of daily treatment GANMAO RUANJIAONANG.
Background technology
Flu is as a kind of common respiratory tract disease, and the symptom of its performance is mainly headache, heating, cough, nasal obstruction, rhinorrhea, allergy etc.The medicine that is generally used for treating these symptoms comprises: antipyretic analgesic acetaminophen, cough medicine are dextromethorphan hydrobromide, decongestant drug phenylephrine hydrochloride.
Because these medicines have different character and stability, produce the compound preparation product containing above medicine, and to make medicine wherein all stable be effectively a challenge.Existing complicated process of preparation, and the product stability prepared is poor.Therefore, the technique of the existing daily treatment GANMAO RUANJIAONANG for the manufacture of containing these medicines awaits further perfect.
Summary of the invention
The objective of the invention is, in order to overcome weak point of the prior art, provides a kind of technique simple, easy to make, the preparation method of the daily treatment GANMAO RUANJIAONANG that product stability is good.
In order to achieve the above object, the present invention adopts following scheme:
A kind of preparation method of daily treatment GANMAO RUANJIAONANG is characterized in that comprising the following steps:
The preparation of A, gelatin solution
Plasticizer is water-soluble, in adding glue tank and be heated to 40~80 ℃, add gelatin, 60~80 ℃ of lower stirring and dissolving, coloring agent is added to the water, stirs, obtain pigment solution, pigment solution is added in gelatin solution, stir and the vacuumizing and exhausting bubble, obtain gelatin solution;
B, content preparation
By Polyethylene Glycol, polyhydric alcohol mixes and adds the polyvidone stirring and dissolving, after adding acetyl aminophenol to stir into suspension, adds in Agitation Tank, be filled with inert gas shielding after evacuation, be heated to 50 ℃~90 ℃ dissolvings, after acetaminophen dissolves, be cooled to below 40 ℃, add dextromethorphan hydrobromide and phenylephrine hydrochloride, evacuation, keep fluid temperature dissolving below 40 ℃, obtains content solution;
C, soft capsule preparation
Content medicinal liquid in gelatin solution in steps A and step B is added respectively in pellet press, adjust loading amount and rubber thickness, pelleting, drying, smear ball, packing.
The preparation method of a kind of daily treatment GANMAO RUANJIAONANG as above, is characterized in that in step B being cooled to below 40 ℃ after acetaminophen dissolves, add dextromethorphan hydrobromide and, phenylephrine hydrochloride, also add antioxidant.
The preparation method of a kind of daily treatment GANMAO RUANJIAONANG as above, is characterized in that the plasticizer described in steps A is one or more the mixture in glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400.
The preparation method of a kind of daily treatment GANMAO RUANJIAONANG as above, is characterized in that the coloring agent described in steps A is FD& C Yellow No.6, FD& One or both in C Red No.40.FD& wherein; C Yellow No.6, FD& C RedNo.40 all belongs to commercially available prod.
The preparation method of a kind of daily treatment GANMAO RUANJIAONANG as above, is characterized in that the Polyethylene Glycol described in step B is one or more the mixture in Macrogol 200, PEG400, Macrogol 600.
The preparation method of a kind of daily treatment GANMAO RUANJIAONANG as above, it is characterized in that the polyhydric alcohol described in step B be in propylene glycol, glycerol one or both.
The preparation method of a kind of daily treatment GANMAO RUANJIAONANG as above, is characterized in that the polyvidone described in step B is one or more mixture in 30 POVIDONE K 30 BP/USP 12,30 POVIDONE K 30 BP/USP 17,30 POVIDONE K 30 BP/USP 25, PVPK29/32, PVP K30.
The preparation method of a kind of daily treatment GANMAO RUANJIAONANG as above, 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, propyl gallate.
The preparation method of a kind of daily treatment GANMAO RUANJIAONANG as above, it is characterized in that noble gas described in step B be nitrogen, helium one or both.
In sum, beneficial effect of the present invention:
In the present invention, acetaminophen belongs to ntipyretic analgesic medicine commonly used, dextromethorphan hydrobromide belongs to antitussive medicine commonly used, phenylephrine hydrochloride belongs to congestion medicine commonly used, and the symptoms such as the headache that these medicines cause flu, heating, cough, nasal obstruction, rhinorrhea, allergy have definite curative effect.
The present invention is containing the soft capsule good looking appearance of acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride, and compliance is strong; Because the acetaminophen in soft capsule, dextromethorphan hydrobromide and phenylephrine hydrochloride are liquid, be beneficial to absorption, onset is faster.
Content reasonable mixture ratio in the daily GANMAO RUANJIAONANG of the present invention, design ingenious, good stability, good effect.
Technique of the present invention is simple, easy to make, and the product stability of producing is high.
The specific embodiment
Below in conjunction with the specific embodiment, the present invention is described further:
Embodiment 1
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, and 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 polyvidone is 30 POVIDONE K 30 BP/USP 12; Described plasticizer is glycerol.
Can prepare by following technique by soft capsule of the present invention:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, by its adding glue tank and be heated to 40 ℃, add gelatin, stirring and dissolving more than 60 ℃, standby;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Polyvidone is added to stirring and dissolving in above-mentioned mixed liquor.Acetaminophen is added in above-mentioned solution, after stirring into suspension, it is added in Agitation Tank, evacuation is filled with the helium protection after forming negative pressure, is heated to dissolve more than 50 ℃.After acetaminophen dissolves, acetaminophen solution is cooled to below 40 ℃.Add dextromethorphan hydrobromide, phenylephrine hydrochloride, evacuation, keep fluid temperature below 40 ℃, dissolves.Medicinal liquid is standby.
3, soft capsule preparation:
By the content medicinal liquid, gelatin solution adds respectively in pellet press, adjusts loading amount and rubber thickness, pelleting, and drying, smear ball, packing.
Embodiment 2
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, and described content comprises following component by weight percentage:
Wherein said soft capsule rubber is composed of the following components by weight percentage:
Gelatin 90%
Plasticizer 5%
Purified water 5%.
The mixture that wherein said Polyethylene Glycol is Macrogol 200, PEG400.The mixture that described polyhydric alcohol is propylene glycol, glycerol.The mixture that described polyvidone is 30 POVIDONE K 30 BP/USP 12,30 POVIDONE K 30 BP/USP 17,30 POVIDONE K 30 BP/USP 25.The mixture that described plasticizer is glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400.
Can prepare by following technique by soft capsule of the present invention:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, by its adding glue tank and be heated to 60 ℃, add gelatin, stirring and dissolving more than 70 ℃, standby;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Polyvidone is added to stirring and dissolving in above-mentioned mixed liquor.Acetaminophen is added in above-mentioned solution, after stirring into suspension, it is added in Agitation Tank, evacuation is filled with nitrogen after forming negative pressure, is heated to dissolve more than 60 ℃.After acetaminophen dissolves, acetaminophen solution is cooled to below 40 ℃.Add dextromethorphan hydrobromide, phenylephrine hydrochloride, evacuation, keep fluid temperature below 40 ℃, dissolves.Medicinal liquid is standby.
3, soft capsule preparation:
By the content medicinal liquid, gelatin solution adds respectively in pellet press, adjusts loading amount and rubber thickness, pelleting, and drying, smear ball, packing.
Embodiment 3
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, and described content comprises following component by weight percentage:
Wherein said soft capsule rubber is composed of the following components by weight percentage:
The mixture that wherein said Polyethylene Glycol is Macrogol 200, PEG400, Macrogol 600.Described polyhydric alcohol is propylene glycol.The mixture that described polyvidone is 30 POVIDONE K 30 BP/USP 12,30 POVIDONE K 30 BP/USP 17,30 POVIDONE K 30 BP/USP 25, PVPK29/32, PVP K30.
Described plasticizer is maltose alcohol.Described coloring agent is FD& C Yellow No.6.
Can prepare by following technique by soft capsule of the present invention:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, by its adding glue tank and be heated to 70 ℃, add gelatin, stirring and dissolving more than 80 ℃.Coloring agent is added to the water, stirs, obtain pigment solution, pigment solution is added in gelatin solution, stir and the vacuumizing and exhausting bubble, standby;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Polyvidone is added to stirring and dissolving in above-mentioned mixed liquor.Acetaminophen is added in above-mentioned solution, after stirring into suspension, it is added in Agitation Tank, evacuation is filled with nitrogen after forming negative pressure, is heated to dissolve more than 90 ℃.After acetaminophen dissolves, acetaminophen solution is cooled to below 40 ℃.Add dextromethorphan hydrobromide, phenylephrine hydrochloride, evacuation, keep fluid temperature below 40 ℃, dissolves.Medicinal liquid is standby.
3, soft capsule preparation:
By the content medicinal liquid, gelatin solution adds respectively in pellet press, adjusts loading amount and rubber thickness, pelleting, and drying, smear ball, packing.
Embodiment 4
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, and 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 polyvidone is PVP K30.The mixture that described plasticizer is glycerol, sorbitol.Described coloring agent is FD& C RedNo.40.
Can prepare by following technique by soft capsule of the present invention:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, by its adding glue tank and be heated to 60 ℃, add gelatin, stirring and dissolving more than 60 ℃.Coloring agent is added to the water, stirs, obtain pigment solution, pigment solution is added in gelatin solution, stir and the vacuumizing and exhausting bubble, standby;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Polyvidone is added to stirring and dissolving in above-mentioned mixed liquor.Acetaminophen is added in above-mentioned solution, after stirring into suspension, it is added in Agitation Tank, evacuation is filled with nitrogen after forming negative pressure, is heated to dissolve more than 50 ℃.After acetaminophen dissolves, acetaminophen solution is cooled to below 40 ℃.Add dextromethorphan hydrobromide, phenylephrine hydrochloride, evacuation, keep fluid temperature below 40 ℃, dissolves.Medicinal liquid is standby.
3, soft capsule preparation:
By the content medicinal liquid, gelatin solution adds respectively in pellet press, adjusts loading amount and rubber thickness, pelleting, and drying, smear ball, packing.
Embodiment 5
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, and described content comprises following component by weight percentage:
Wherein said soft capsule rubber is composed of the following components by weight percentage:
The mixture that wherein said Polyethylene Glycol is Macrogol 200, PEG400, Macrogol 600.The mixture that described polyhydric alcohol is propylene glycol, glycerol.The mixture that described polyvidone is 30 POVIDONE K 30 BP/USP 12,30 POVIDONE K 30 BP/USP 17,30 POVIDONE K 30 BP/USP 25, PVPK29/32, PVP K30.The mixture that described plasticizer is glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400.Described coloring agent is FD& C Yellow No.6, FD& The mixture of C RedNo.40.
Can prepare by following technique by soft capsule of the present invention:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, by its adding glue tank and be heated to 70 ℃, add gelatin, stirring and dissolving more than 70 ℃.Coloring agent is added to the water, stirs, obtain pigment solution, pigment solution is added in gelatin solution, stir and the vacuumizing and exhausting bubble, standby;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Polyvidone is added to stirring and dissolving in above-mentioned mixed liquor.Acetaminophen is added in above-mentioned solution, after stirring into suspension, it is added in Agitation Tank, evacuation is filled with nitrogen after forming negative pressure, is heated to dissolve more than 60 ℃.After acetaminophen dissolves, acetaminophen solution is cooled to below 40 ℃.Add dextromethorphan hydrobromide, phenylephrine hydrochloride, evacuation, keep fluid temperature below 40 ℃, dissolves.Medicinal liquid is standby.
3, soft capsule preparation:
By the content medicinal liquid, gelatin solution adds respectively in pellet press, adjusts loading amount and rubber thickness, pelleting, and drying, smear ball, packing.
Embodiment 6
Soft capsule of the present invention, include soft capsule rubber and be wrapped in the content in described soft capsule rubber, and 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 polyvidone is 30 POVIDONE K 30 BP/USP 25.Described plasticizer is Macrogol 200.Described coloring agent is FD& C Yellow No.6, FD& The mixture of C RedNo.40.
Can prepare by following technique by soft capsule of the present invention:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, by its adding glue tank and be heated to 60 ℃, add gelatin, stirring and dissolving more than 60 ℃.Coloring agent is added to the water, stirs, obtain pigment solution, pigment solution is added in gelatin solution, stir and the vacuumizing and exhausting bubble, standby;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Polyvidone is added to stirring and dissolving in above-mentioned mixed liquor.Acetaminophen is added in above-mentioned solution, after stirring into suspension, it is added in Agitation Tank, evacuation is filled with nitrogen after forming negative pressure, is heated to dissolve more than 50 ℃.After acetaminophen dissolves, acetaminophen solution is cooled to below 40 ℃.Add dextromethorphan hydrobromide, phenylephrine hydrochloride, evacuation, keep fluid temperature below 40 ℃, dissolves.Medicinal liquid is standby.
3, soft capsule preparation:
By the content medicinal liquid, gelatin solution adds respectively in pellet press, adjusts loading amount and rubber thickness, pelleting, and drying, smear ball, packing.
Claims (10)
1. the preparation method of a daily treatment GANMAO RUANJIAONANG is characterized in that comprising the following steps:
The preparation of A, gelatin solution
Plasticizer is water-soluble, in adding glue tank and be heated to 40~80 ℃, add gelatin, 60~80 ℃ of lower stirring and dissolving, obtain gelatin solution;
B, content preparation
By Polyethylene Glycol, polyhydric alcohol mixes and adds the polyvidone stirring and dissolving, after adding acetyl aminophenol to stir into suspension, adds in Agitation Tank, be filled with inert gas shielding after evacuation, be heated to 50 ℃~90 ℃ dissolvings, after acetaminophen dissolves, be cooled to below 40 ℃, add dextromethorphan hydrobromide and phenylephrine hydrochloride, evacuation, keep fluid temperature dissolving below 40 ℃, obtains content solution;
C, soft capsule preparation
Content medicinal liquid in gelatin solution in steps A and step B is added respectively in pellet press, adjust loading amount and rubber thickness, pelleting, drying, smear ball, packing.
2. the preparation method of a kind of daily treatment GANMAO RUANJIAONANG according to claim 1, it is characterized in that in steps A adding gelatin, after 60~80 ℃ of lower stirring and dissolving, coloring agent is added to the water, stir, obtain pigment solution, pigment solution is added in gelatin solution, stir and the vacuumizing and exhausting bubble, obtain gelatin solution.
3. the preparation method of a kind of daily treatment GANMAO RUANJIAONANG according to claim 1, is characterized in that in step B being cooled to below 40 ℃ after acetaminophen dissolves, and adds dextromethorphan hydrobromide, and phenylephrine hydrochloride, also add antioxidant.
4. the preparation method of a kind of daily treatment GANMAO RUANJIAONANG according to claim 1, is characterized in that the plasticizer described in steps A is one or more the mixture in glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400.
5. the preparation method of a kind of daily treatment GANMAO RUANJIAONANG according to claim 1, is characterized in that the coloring agent described in steps A is FD& C Yellow No.6, FD& One or both in C RedNo.40.
6. the preparation method of a kind of daily treatment GANMAO RUANJIAONANG according to claim 1, is characterized in that the Polyethylene Glycol described in step B is one or more the mixture in Macrogol 200, PEG400, Macrogol 600.
7. the preparation method of a kind of daily treatment GANMAO RUANJIAONANG according to claim 1, it is characterized in that the polyhydric alcohol described in step B be in propylene glycol, glycerol one or both.
8. the preparation method of a kind of daily treatment GANMAO RUANJIAONANG according to claim 1, is characterized in that the polyvidone described in step B is one or more mixture in 30 POVIDONE K 30 BP/USP 12,30 POVIDONE K 30 BP/USP 17,30 POVIDONE K 30 BP/USP 25, PVPK29/32, PVP K30.
9. the preparation method of a kind of daily treatment GANMAO RUANJIAONANG according to claim 3, 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, propyl gallate.
10. the preparation method of a kind of daily treatment GANMAO RUANJIAONANG according to claim 1, it is characterized in that noble gas described in step B be nitrogen, helium one or both.
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Citations (1)
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CN1615866A (en) * | 2004-09-21 | 2005-05-18 | 石家庄制药集团欧意药业有限公司 | Anti-cold medicine soft capsule and its preparing method |
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CN1615866A (en) * | 2004-09-21 | 2005-05-18 | 石家庄制药集团欧意药业有限公司 | Anti-cold medicine soft capsule and its preparing method |
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