CN107898770A - A kind of Zaltoprofen soft capsule preparation and its preparation process - Google Patents
A kind of Zaltoprofen soft capsule preparation and its preparation process Download PDFInfo
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- CN107898770A CN107898770A CN201711273892.2A CN201711273892A CN107898770A CN 107898770 A CN107898770 A CN 107898770A CN 201711273892 A CN201711273892 A CN 201711273892A CN 107898770 A CN107898770 A CN 107898770A
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- soft capsule
- zaltoprofen
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
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Abstract
The invention discloses a kind of Zaltoprofen soft capsule preparation, including soft capsule and content, content prescription is：Zaltoprofen raw material 0.1g ~ 0.5g；Labraso 200g ~ 250g；Unigly GO 102S 30g ~ 60g；Median chain triglyceride oil 50g ~ 100g；2,6 di-tert-butyl p-cresol 0.02g ~ 0.05g.The Zaltoprofen soft capsule of the present invention, can significantly improve the accumulation dissolution rate of dissolution 5 minutes, improve dissolution efficiency of the main ingredient in the preceding period；With good stability, product appearance quality is good.
Description
Technical field
The present invention relates to technical field of medicine, and in particular to a kind of Zaltoprofen soft capsule preparation and its preparation
Technique.
Background technology
Developed by Japanese Chemiphar companies, in a kind of potent non-steroidal anti-inflammatory in Japanese Initial Public Offering in 1993, town
Bitterly, alexipyretic this product selectively acting is in inflammation part, and to other organs such as stomach and kidney without effect, with similar drugs such as Nabumetone
Raw, brufen is compared, and has the characteristics that efficient, stomach Small side effects, thus quite by favorable comment on Japan Clinic.
This product analgesic activity and to acute inflammation act on it is stronger, and to chronic inflammation act on it is weaker.Mechanism of action is system
The activity of epoxidase, reduces prostaglandin synthesis, blocks inflammatory mediator and work.Oral gastrointestinal absorption is good, in blood plasma
Drug concentration linearly increases, and peak time is 1~1.5h.Repetitively administered has no medicine savings property.The original shape medicine of last reign of a dynasty medicine
Thing is about the 1%~3% of dosage, including the total excretion rate of metabolin is about 82%.Digestive tract ulcer, blood disease, serious hepatic and renal function
Obstacle, serious cardiac insufficiency, disables this product and aspirin-sensitive person.There is alimentary canal to burst history, blood disease, hepatic and renal function is not
Quan Zhe, has allergies bronchial asthma person to use with caution.To chronic disease, long term administration should periodically carry out blood urine routine and liver function inspection
Look into.Acute patient applies this product, is used in combination if necessary with antimicrobial.
The content of the invention
The object of the present invention is to provide a kind of Zaltoprofen soft capsule preparation.
In order to achieve the above object, a kind of Zaltoprofen soft capsule preparation is provided in one embodiment of the present of invention, including
Soft capsule and content, content prescription are：
Zaltoprofen raw material 0.1g ~ 0.5g；
Labraso 200g~250g；
Unigly GO 102S 30g~60g；
Median chain triglyceride oil 50g~100g；
DBPC 2,6 ditertiary butyl p cresol 0.02g~0.05g.
In the preferred solution of the present invention, content prescription is：
Zaltoprofen raw material 0.1g；
Labraso 220g~240g；
Unigly GO 102S 40g~50g；
Median chain triglyceride oil 60g~90g；
DBPC 2,6 ditertiary butyl p cresol 0.03g~0.04g.
In the preferred solution of the present invention, content prescription is：
Zaltoprofen raw material 0.5g；
Labraso 220g；
Unigly GO 102S 45g；
Median chain triglyceride oil 75g；
DBPC 2,6 ditertiary butyl p cresol 0.035g.
In the preferred solution of the present invention, content prescription is：
Zaltoprofen raw material 0.2g；
Labraso 235g；
Unigly GO 102S 48g；
Median chain triglyceride oil 78g；
DBPC 2,6 ditertiary butyl p cresol 0.04g.
In the preferred solution of the present invention, the prescription of soft capsule is：
Gelatin 140mg~180mg；
Glycerine 70mg~100mg；
Yellow ferric oxide 0.1mg~0.4mg；
Titanium dioxide 1mg~3mg.
In the preferred solution of the present invention, the prescription of soft capsule is：
Gelatin 160mg；
Glycerine 80mg；
Yellow ferric oxide 0.29mg；
Titanium dioxide 2mg.
In the preferred solution of the present invention, the prescription of soft capsule is：
Gelatin 150mg；
Glycerine 90mg；
Yellow ferric oxide 0.35mg；
Titanium dioxide 2.5mg.
Another object of the present invention is to improve a kind of technique for preparing Zaltoprofen soft capsule preparation, including following step
Suddenly：
(1) content is prepared：Take the Labraso, Unigly GO 102S and the acid of medium chain triglyceride three of recipe quantity
Ester stirs evenly, and the Zaltoprofen bulk pharmaceutical chemicals and 2,6-di-tert-butyl p-cresol of recipe quantity are added after heating, and it is equal to continue stirring
Room temperature is down to after even, obtains content；
(2) soft capsule is prepared：Take the glycerine of recipe quantity to add in water being placed in glue tank to be uniformly mixed, then add sieving
Titanium dioxide and yellow ferric oxide are uniformly mixed, and are then added gelatin and are heated to 60 DEG C~80 DEG C；Continue stirring to gelatin
It is completely dissolved；Vacuum is opened after Gelatin makes glue deaerate, and cools down after degassing；
(3) pill：Using soft capsule by inside Contents Fill to soft capsule, sizing, drying, obtain pastille soft capsule.
In the preferred solution of the present invention, Labraso, Unigly GO 102S and medium chain triglyceride
Three acid esters stir evenly, and Zaltoprofen bulk pharmaceutical chemicals and 2,6-di-tert-butyl p-cresol are added after being warming up to 40 DEG C.
In the preferred solution of the present invention, the capsule severe edema due to hypofunction of the spleen of pastille soft capsule is divided into 8%~12%.
The Unigly GO 102S purchase of the present invention is in the product Unigly GO 102S of the good method lion of France.
In conclusion the present invention has the following advantages：
The Zaltoprofen soft capsule of the present invention, can significantly improve the accumulation dissolution rate of dissolution 5 minutes, improve main ingredient when preceding
Between section dissolution efficiency；With good stability, product appearance quality is good.Secondly the present invention is selected by the optimization to component
Select, reduce harmful effect of the propane diols to main ingredient migration, stability, dissolution rate and bioavailability.
Embodiment
Embodiment 1
Zaltoprofen soft capsule preparation content prescription：
Zaltoprofen raw material 0.1g；Labraso 220g；
Unigly GO 102S 45g；Median chain triglyceride oil 75g；
DBPC 2,6 ditertiary butyl p cresol 0.035g.
Soft capsule prescription：
Gelatin 160mg；Glycerine 80mg；
Yellow ferric oxide 0.29mg；Titanium dioxide 2mg.
Preparation method：
(1) content is prepared：Take the Labraso, Unigly GO 102S and the acid of medium chain triglyceride three of recipe quantity
Ester stirs evenly, and is warming up to the Zaltoprofen bulk pharmaceutical chemicals and 2,6-di-tert-butyl p-cresol that recipe quantity is added after 40 DEG C, continues
Stirring 1h to uniformly after be down to room temperature, obtain content；
(2) soft capsule is prepared：Take the glycerine of recipe quantity to add in water being placed in glue tank to be uniformly mixed, then add 80 mesh
The titanium dioxide and yellow ferric oxide of sieve are uniformly mixed, and are then added gelatin and are heated to 70 DEG C；Continue to stir 1h to gelatin
Stop stirring after being completely dissolved；Vacuum is opened after Gelatin keeps vacuum bag -0.09Mpa to make glue degassing 30min, has deaerated
Cool down 60 DEG C after finishing, it is spare after standing 24h；
(3) pill：Encapsulating machine heats sprinkler body after being debugged；Revolving die pressure is adjusted, is advisable with just extruding capsule and pill,
Pressure is avoided to cross conference mold damage.Loading amount adjusting is carried out, sampling detection extrudes the crack quality, appearance, content weight of capsule and pill,
Adjust in time, untill meeting the requirements；Roller is opened, the capsule and pill of compacting is shaped；The capsule and pill of compacting is determined in roller
Taken out after type, be placed in 30 DEG C, it is dry in the environment of below RH50%, and the sampling detection capsule severe edema due to hypofunction of the spleen point at any time, when the capsule severe edema due to hypofunction of the spleen point exists
When 8%~12%, stop drying.
Embodiment 2
Zaltoprofen soft capsule preparation content prescription：
Zaltoprofen raw material 0.2g；Labraso 225g；
Unigly GO 102S 50g；Median chain triglyceride oil 72g；
DBPC 2,6 ditertiary butyl p cresol 0.038g.
Soft capsule prescription：
Gelatin 160mg；Glycerine 80mg；
Yellow ferric oxide 0.25mg；Titanium dioxide 2.2mg.
Preparation method：
(1) content is prepared：Take the Labraso, Unigly GO 102S and the acid of medium chain triglyceride three of recipe quantity
Ester stirs evenly, and is warming up to the Zaltoprofen bulk pharmaceutical chemicals and 2,6-di-tert-butyl p-cresol that recipe quantity is added after 40 DEG C, continues
Stirring 1h to uniformly after be down to room temperature, obtain content；
(2) soft capsule is prepared：Take the glycerine of recipe quantity to add in water being placed in glue tank to be uniformly mixed, then add 80 mesh
The titanium dioxide and yellow ferric oxide of sieve are uniformly mixed, and are then added gelatin and are heated to 70 DEG C；Continue to stir 1h to gelatin
Stop stirring after being completely dissolved；Vacuum is opened after Gelatin keeps vacuum bag -0.09Mpa to make glue degassing 30min, has deaerated
Cool down 60 DEG C after finishing, it is spare after standing 24h；
(3) pill：Encapsulating machine heats sprinkler body after being debugged；Revolving die pressure is adjusted, is advisable with just extruding capsule and pill,
Pressure is avoided to cross conference mold damage.Loading amount adjusting is carried out, sampling detection extrudes the crack quality, appearance, content weight of capsule and pill,
Adjust in time, untill meeting the requirements；Roller is opened, the capsule and pill of compacting is shaped；The capsule and pill of compacting is determined in roller
Taken out after type, be placed in 30 DEG C, it is dry in the environment of below RH50%, and the sampling detection capsule severe edema due to hypofunction of the spleen point at any time, when the capsule severe edema due to hypofunction of the spleen point exists
When 8%~12%, stop drying.
Embodiment 3
Zaltoprofen soft capsule preparation content prescription：
Zaltoprofen raw material 0.3g；Labraso 220g；
Unigly GO 102S 45g；Median chain triglyceride oil 75g；
Soft capsule prescription：
Gelatin 161mg；Glycerine 85mg；
Yellow ferric oxide 0.27mg；Titanium dioxide 2mg.
Preparation method：
(1) content is prepared：Take the Labraso, Unigly GO 102S and the acid of medium chain triglyceride three of recipe quantity
Ester stirs evenly, be warming up to after 40 DEG C add recipe quantity Zaltoprofen bulk pharmaceutical chemicals continue stir 1h to uniformly after be down to room
Temperature, obtains content；
(2) soft capsule is prepared：Take the glycerine of recipe quantity to add in water being placed in glue tank to be uniformly mixed, then add 80 mesh
The titanium dioxide and yellow ferric oxide of sieve are uniformly mixed, and are then added gelatin and are heated to 70 DEG C；Continue to stir 1h to gelatin
Stop stirring after being completely dissolved；Vacuum is opened after Gelatin keeps vacuum bag -0.09Mpa to make glue degassing 30min, has deaerated
Cool down 60 DEG C after finishing, it is spare after standing 24h；
(3) pill：Encapsulating machine heats sprinkler body after being debugged, and control temperature is at 35 DEG C；Revolving die pressure is adjusted, with firm
Extruding capsule and pill well is advisable, and avoids pressure from crossing conference mold damage.Loading amount adjusting is carried out, sampling detection extrudes the crack matter of capsule and pill
Amount, appearance, content weight, adjust, untill meeting the requirements in time；Roller is opened, the capsule and pill of compacting is shaped；Will pressure
The capsule and pill of system takes out after roller sizing, is placed in 30 DEG C, is dried in the environment of below RH50%, and the capsule severe edema due to hypofunction of the spleen of sampling detection at any time
Point, when the capsule severe edema due to hypofunction of the spleen point is 8%~12%, stop drying.
Embodiment 4
Zaltoprofen soft capsule preparation content prescription：
Zaltoprofen raw material 0.4g；Labraso 210g；
Unigly GO 102S 40g；Median chain triglyceride oil 70g；
Butylated hydroxy anisole BHA0.035g.
Soft capsule prescription：
Gelatin 160mg；Glycerine 85mg；
Yellow ferric oxide 0.28mg；Titanium dioxide 2mg.
Preparation method：
(1) content is prepared：Take the Labraso, Unigly GO 102S and the acid of medium chain triglyceride three of recipe quantity
Ester stirs evenly, and is warming up to the Zaltoprofen bulk pharmaceutical chemicals of addition recipe quantity and butylated hydroxy anisole BHA after 40 DEG C and continues to stir
Mix 1h to uniformly after be down to room temperature, obtain content；
(2) soft capsule is prepared：Take the glycerine of recipe quantity to add in water being placed in glue tank to be uniformly mixed, then add 80 mesh
The titanium dioxide and yellow ferric oxide of sieve are uniformly mixed, and are then added gelatin and are heated to 70 DEG C；Continue to stir 1h to gelatin
Stop stirring after being completely dissolved；Vacuum is opened after Gelatin keeps vacuum bag -0.09Mpa to make glue degassing 30min, has deaerated
Cool down 60 DEG C after finishing, it is spare after standing 24h；
(3) pill：Encapsulating machine heats sprinkler body after being debugged；Revolving die pressure is adjusted, is advisable with just extruding capsule and pill,
Pressure is avoided to cross conference mold damage.Loading amount adjusting is carried out, sampling detection extrudes the crack quality, appearance, content weight of capsule and pill,
Adjust in time, untill meeting the requirements；Roller is opened, the capsule and pill of compacting is shaped；The capsule and pill of compacting is determined in roller
Taken out after type, be placed in 30 DEG C, it is dry in the environment of below RH50%, and the sampling detection capsule severe edema due to hypofunction of the spleen point at any time, when the capsule severe edema due to hypofunction of the spleen point exists
When 8%~12%, stop drying.
Embodiment 5
Zaltoprofen soft capsule preparation content prescription：
Zaltoprofen raw material 0.5g；Labraso 225g；
Unigly GO 102S 46g；Median chain triglyceride oil 75g；
Sodium pyrosulfite 0.036g.
Soft capsule prescription：
Gelatin 160mg；Glycerine 85mg；
Yellow ferric oxide 0.28mg；Titanium dioxide 2mg.
Preparation method：
(1) content is prepared：Take the Labraso, Unigly GO 102S and the acid of medium chain triglyceride three of recipe quantity
Ester stirs evenly, and is warming up to the Zaltoprofen bulk pharmaceutical chemicals and sodium pyrosulfite that recipe quantity is added after 40 DEG C, continues to stir 1h extremely
Room temperature is down to after uniformly, obtains content；
(2) soft capsule is prepared：Take the glycerine of recipe quantity to add in water being placed in glue tank to be uniformly mixed, then add 80 mesh
The titanium dioxide and yellow ferric oxide of sieve are uniformly mixed, and are then added gelatin and are heated to 70 DEG C；Continue to stir 1h to gelatin
Stop stirring after being completely dissolved；Vacuum is opened after Gelatin keeps vacuum bag -0.09Mpa to make glue degassing 30min, has deaerated
Cool down 60 DEG C after finishing, it is spare after standing 24h；
(3) pill：Encapsulating machine heats sprinkler body after being debugged, and control temperature is at 35 DEG C；Revolving die pressure is adjusted, with firm
Extruding capsule and pill well is advisable, and avoids pressure from crossing conference mold damage.Loading amount adjusting is carried out, sampling detection extrudes the crack matter of capsule and pill
Amount, appearance, content weight, adjust, untill meeting the requirements in time；Roller is opened, the capsule and pill of compacting is shaped；Will pressure
The capsule and pill of system takes out after roller sizing, is placed in 30 DEG C, is dried in the environment of below RH50%, and the capsule severe edema due to hypofunction of the spleen of sampling detection at any time
Point, when the capsule severe edema due to hypofunction of the spleen point is 8%~12%, stop drying.
Claims (10)
1. a kind of Zaltoprofen soft capsule preparation, including soft capsule and content, it is characterised in that：The content prescription
For：
The g of Zaltoprofen raw material 0.1g ~ 0.5；
Labraso 200g ~ 250g；
Unigly GO 102S 30g ~ 60g；
Median chain triglyceride oil 50g ~ 100g；
DBPC 2,6 ditertiary butyl p cresol 0.02g ~ 0.05g.
2. soft capsule preparation as claimed in claim 1, it is characterised in that：The content prescription is：
Zaltoprofen raw material 0.1g；
Labraso 220g ~ 240g；
Unigly GO 102S 40g ~ 50g；
Median chain triglyceride oil 60g ~ 90g；
DBPC 2,6 ditertiary butyl p cresol 0.03g ~ 0.04g.
3. soft capsule preparation as claimed in claim 1, it is characterised in that：The content prescription is：
Zaltoprofen raw material 0.5g；
Labraso 220g；
Unigly GO 102S 45g；
Median chain triglyceride oil 75g；
DBPC 2,6 ditertiary butyl p cresol 0.035g.
4. soft capsule preparation as claimed in claim 1, it is characterised in that：The content prescription is：
Zaltoprofen raw material 0.3.0g；
Labraso 235g；
Unigly GO 102S 48g；
Median chain triglyceride oil 78g；
DBPC 2,6 ditertiary butyl p cresol 0.04g.
5. soft capsule preparation as claimed in claim 1, it is characterised in that the prescription of the soft capsule is：
Gelatin 140mg ~ 180mg；
Glycerine 70mg ~ 100mg；
Yellow ferric oxide 0.1mg ~ 0.4mg；
Titanium dioxide 1mg ~ 3mg.
6. soft capsule preparation as claimed in claim 5, it is characterised in that the prescription of the soft capsule is：
Gelatin 160mg；
Glycerine 80mg；
Yellow ferric oxide 0.29mg；
Titanium dioxide 2mg.
7. soft capsule preparation as claimed in claim 5, it is characterised in that the prescription of the soft capsule is：
Gelatin 152mg；
Glycerine 92mg；
Yellow ferric oxide 0.35mg；
Titanium dioxide 2.5mg.
8. preparing the technique of any Zaltoprofen soft capsule preparation in claim 1 ~ 7, comprise the following steps：
（1）Prepare content：Take the Labraso, Unigly GO 102S and the acid of medium chain triglyceride three of recipe quantity
Ester stirs evenly, and the Zaltoprofen bulk pharmaceutical chemicals and 2,6-di-tert-butyl p-cresol of recipe quantity are added after heating, and it is equal to continue stirring
Room temperature is down to after even, obtains content；
（2）Prepare soft capsule：Take the glycerine of recipe quantity to add in water being placed in glue tank to be uniformly mixed, then add sieving
Titanium dioxide and yellow ferric oxide are uniformly mixed, and are then added gelatin and are heated to 60 DEG C ~ 80 DEG C；It is complete to gelatin to continue stirring
Fully dissolved；Vacuum is opened after Gelatin makes glue deaerate, and cools down after degassing；
（3）Pill：Using soft capsule by inside Contents Fill to soft capsule, sizing, drying, obtain pastille soft capsule.
9. preparation process as claimed in claim 8, it is characterised in that：The Labraso, polyglycereol
Oleate and median chain triglyceride oil stir evenly, and Zaltoprofen bulk pharmaceutical chemicals and 2,6- di-t-butyl are added after being warming up to 40 DEG C
Paracresol.
10. preparation process as claimed in claim 8, it is characterised in that：The capsule severe edema due to hypofunction of the spleen of the pastille soft capsule is divided into 8% ~ 12%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711273892.2A CN107898770A (en) | 2017-12-06 | 2017-12-06 | A kind of Zaltoprofen soft capsule preparation and its preparation process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711273892.2A CN107898770A (en) | 2017-12-06 | 2017-12-06 | A kind of Zaltoprofen soft capsule preparation and its preparation process |
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| Publication Number | Publication Date |
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| CN107898770A true CN107898770A (en) | 2018-04-13 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
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| CN201711273892.2A Pending CN107898770A (en) | 2017-12-06 | 2017-12-06 | A kind of Zaltoprofen soft capsule preparation and its preparation process |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101278932A (en) * | 2007-04-05 | 2008-10-08 | 贾盈 | Sustained release medicinal compositions containing Zaltoprofen, preparation method and application thereof |
| CN105395517A (en) * | 2015-12-11 | 2016-03-16 | 成都华宇制药有限公司 | Dutasteride soft capsule preparation and preparation process thereof |
-
2017
- 2017-12-06 CN CN201711273892.2A patent/CN107898770A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101278932A (en) * | 2007-04-05 | 2008-10-08 | 贾盈 | Sustained release medicinal compositions containing Zaltoprofen, preparation method and application thereof |
| CN105395517A (en) * | 2015-12-11 | 2016-03-16 | 成都华宇制药有限公司 | Dutasteride soft capsule preparation and preparation process thereof |
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