CN103462927B - A kind of preparation method of daily treatment GANMAO RUANJIAONANG - Google Patents
A kind of preparation method of daily treatment GANMAO RUANJIAONANG Download PDFInfo
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- CN103462927B CN103462927B CN201310360549.7A CN201310360549A CN103462927B CN 103462927 B CN103462927 B CN 103462927B CN 201310360549 A CN201310360549 A CN 201310360549A CN 103462927 B CN103462927 B CN 103462927B
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Abstract
The invention discloses a kind of preparation method of daily treatment GANMAO RUANJIAONANG, comprise the following steps: the preparation of A, gelatin solution: plasticizer is water-soluble, in adding glue tank, add gelatin stirring and dissolving, coloring agent is added to the water, stirs, obtain pigment solution and add in gelatin solution, stir and vacuumizing and exhausting bubble, obtain gelatin solution; B, content are prepared: by Polyethylene Glycol, polyhydric alcohol mixing adds polyvidone stirring and dissolving, add after acetyl aminophenol stirs into suspension, add in Agitation Tank, after evacuation, be filled with noble gas, heating for dissolving, cooling, adds dextromethorphan hydrobromide and phenylephrine hydrochloride, evacuation, insulation degree dissolves, and obtains content solution; Prepared by C, soft capsule: gelatin solution and content medicinal liquid are added respectively in pellet press, pelleting, dry, smears ball, packaging.The object of this invention is to provide a kind of technique simple, easy to make, the preparation method of the daily treatment GANMAO RUANJIAONANG that product stability is good.
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 being generally used for treating these symptoms comprises: antipyretic analgesic acetaminophen, cough medicine and dextromethorphan hydrobromide, decongestant drug phenylephrine hydrochloride.
Because these medicines have different character and stability, produce containing the compound preparation product of 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 existing technique for the manufacture of the daily treatment GANMAO RUANJIAONANG containing these medicines awaits perfect further.
Summary of the invention
The object of the invention is to overcome weak point of the prior art, providing 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 preparation method for daily treatment GANMAO RUANJIAONANG, is characterized in that comprising the following steps:
The preparation of A, gelatin solution
Plasticizer is water-soluble, be heated to 40 ~ 80 DEG C in adding glue tank, add gelatin, stirring and dissolving at 60 ~ 80 DEG C, coloring agent is added to the water, stirs, obtain pigment solution, pigment solution is added in gelatin solution, stir and vacuumizing and exhausting bubble, obtain gelatin solution;
B, content are prepared
By Polyethylene Glycol, polyhydric alcohol mixing adds polyvidone stirring and dissolving, adds after acetyl aminophenol stirs into suspension, adds in Agitation Tank, inert gas shielding is filled with after evacuation, be heated to 50 DEG C ~ 90 DEG C dissolvings, after acetaminophen dissolves, be cooled to less than 40 DEG C, add dextromethorphan hydrobromide and phenylephrine hydrochloride, evacuation, keeps fluid temperature to dissolve below 40 DEG C, obtains content solution;
Prepared by C, soft capsule
Gelatin solution in steps A and the content medicinal liquid in step B are added in pellet press respectively, adjustment loading amount and rubber thickness, pelleting, dry, smear ball, packaging.
The preparation method of a kind of daily treatment GANMAO RUANJIAONANG as above, it is characterized in that in step B until acetaminophen dissolve after, be cooled to less than 40 DEG C, add dextromethorphan hydrobromide and, phenylephrine hydrochloride, also adds 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 one or both in FD & C Yellow No.6, FD & C Red No.40.Wherein FD & C Yellow No.6, FD & C RedNo.40 all belong 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 conventional ntipyretic analgesic medicine, dextromethorphan hydrobromide belongs to conventional antitussive medicine, phenylephrine hydrochloride belongs to conventional congestion medicine, and these medicines have definite curative effect to the symptom such as headache, heating, cough, nasal obstruction, rhinorrhea, allergy caused of catching a cold.
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, designs ingenious, good stability, good effect.
Present invention process is simple, and easy to make, the product stability produced is high.
Detailed description of the invention
Below in conjunction with detailed description of the invention, 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, 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.
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 40 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.Polyvidone is added stirring and dissolving in above-mentioned mixed liquor.Added by acetaminophen in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with helium protection after forming negative pressure, be heated to more than 50 DEG C dissolvings.After acetaminophen dissolves, acetaminophen solution is cooled to less than 40 DEG C.Add dextromethorphan hydrobromide, phenylephrine hydrochloride, evacuation, keep fluid temperature below 40 DEG C, dissolve.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 2
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 90%
Plasticizer 5%
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 polyvidone is the mixture of 30 POVIDONE K 30 BP/USP 12,30 POVIDONE K 30 BP/USP 17,30 POVIDONE K 30 BP/USP 25.Described plasticizer is the mixture of glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400.
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 70 DEG C stirring and dissolving, for subsequent use;
2, content preparation:
By Polyethylene Glycol, polyhydric alcohol mixes.Polyvidone is added stirring and dissolving in above-mentioned mixed liquor.Added by acetaminophen in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with nitrogen, is heated to more than 60 DEG C dissolvings after forming negative pressure.After acetaminophen dissolves, acetaminophen solution is cooled to less than 40 DEG C.Add dextromethorphan hydrobromide, phenylephrine hydrochloride, evacuation, keep fluid temperature below 40 DEG C, dissolve.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 3
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 polyvidone is the mixture of 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.
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 70 DEG C in added glue tank, add gelatin, more than 80 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.Polyvidone is added stirring and dissolving in above-mentioned mixed liquor.Added by acetaminophen in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with nitrogen, is heated to more than 90 DEG C dissolvings after forming negative pressure.After acetaminophen dissolves, acetaminophen solution is cooled to less than 40 DEG C.Add dextromethorphan hydrobromide, phenylephrine hydrochloride, evacuation, keep fluid temperature below 40 DEG C, dissolve.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 4
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 polyvidone is PVP K30.Described plasticizer is the mixture of glycerol, sorbitol.Described coloring agent is FD & C RedNo.40.
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.Polyvidone is added stirring and dissolving in above-mentioned mixed liquor.Added by acetaminophen 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 acetaminophen dissolves, acetaminophen solution is cooled to less than 40 DEG C.Add dextromethorphan hydrobromide, phenylephrine hydrochloride, evacuation, keep fluid temperature below 40 DEG C, dissolve.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 5
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 polyvidone is the mixture of 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 the mixture of glycerol, sorbitol, partial dehydration sorbitol, maltose alcohol, mannitol, propylene glycol, Macrogol 200, PEG400.Described coloring agent is the mixture of FD & C Yellow No.6, FD & C RedNo.40.
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 70 DEG C in added glue tank, add gelatin, more than 70 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.Polyvidone is added stirring and dissolving in above-mentioned mixed liquor.Added by acetaminophen in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with nitrogen, is heated to more than 60 DEG C dissolvings after forming negative pressure.After acetaminophen dissolves, acetaminophen solution is cooled to less than 40 DEG C.Add dextromethorphan hydrobromide, phenylephrine hydrochloride, evacuation, keep fluid temperature below 40 DEG C, dissolve.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 6
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 polyvidone is 30 POVIDONE K 30 BP/USP 25.Described plasticizer is Macrogol 200.Described coloring agent is the mixture of FD & C Yellow No.6, FD & C RedNo.40.
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.Polyvidone is added stirring and dissolving in above-mentioned mixed liquor.Added by acetaminophen 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 acetaminophen dissolves, acetaminophen solution is cooled to less than 40 DEG C.Add dextromethorphan hydrobromide, phenylephrine hydrochloride, evacuation, keep fluid temperature below 40 DEG C, dissolve.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 preparation method for daily treatment GANMAO RUANJIAONANG, is characterized in that described soft capsule, and 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 polyvidone is 30 POVIDONE K 30 BP/USP 12; Described plasticizer is glycerol;
Following technique preparation:
1, the preparation of gelatin solution:
Plasticizer is soluble in water, be heated to 40 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; Polyvidone is added stirring and dissolving in above-mentioned mixed liquor; Added by acetaminophen in above-mentioned solution, after stirring into suspension, added in Agitation Tank, evacuation is filled with helium protection after forming negative pressure, be heated to more than 50 DEG C dissolvings; After acetaminophen dissolves, acetaminophen solution is cooled to less than 40 DEG C; Add dextromethorphan hydrobromide, phenylephrine hydrochloride, evacuation, keep fluid temperature below 40 DEG C, dissolve; 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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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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