CN105395517B - A kind of dutasteride's soft capsule preparation and its preparation technology - Google Patents
A kind of dutasteride's soft capsule preparation and its preparation technology Download PDFInfo
- Publication number
- CN105395517B CN105395517B CN201510920214.5A CN201510920214A CN105395517B CN 105395517 B CN105395517 B CN 105395517B CN 201510920214 A CN201510920214 A CN 201510920214A CN 105395517 B CN105395517 B CN 105395517B
- Authority
- CN
- China
- Prior art keywords
- soft capsule
- dutasteride
- preparation
- content
- gelatin
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Classifications
-
- 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
- A61K9/4858—Organic compounds
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
Abstract
The invention discloses a kind of dutasteride's soft capsule preparation, including soft capsule and content, content prescription is：Dutasteride's raw material 0.5g；Labraso 200g ~ 250g；Unigly GO 102S 30g ~ 60g；Median chain triglyceride oil 50g ~ 100g；2,6 BHT 0.02g ~ 0.05g.Dutasteride's soft capsule of the present invention, the accumulation dissolution rate of dissolution 5 minutes can be significantly improved, improve dissolution efficiency of the main ingredient in the preceding period；It is good with good stability, product appearance quality.
Description
Technical field
The present invention relates to technical field of medicine, and in particular to a kind of dutasteride's soft capsule preparation and its prepares work
Skill.
Background technology
Dutasteride is a kind of 5 alpha reductase inhibitors, and 5 alpha-reductases have two hypotypes, i.e. I types and II types, I type isodynamic enzymes
Reproductive system is played a role, II type isodynamic enzymes mainly act on the testosterone conversion of skin and liver.Dutasteride is to suppressing I types
The effect of 5 alpha-reductases is 60 times of Finasteride, and the effect to II types is also very strong, and dutasteride can suppress testosterone and be changed into dihydro
Testosterone (DHT), and then suppress male DHT generation, therefore suppress the growth of BPH prostate.Before being clinically mainly used in
The treatment of row adenoncus, male pattern alopecia, alopecia seborrheica, hereditary alopecia.
Dutasteride's formulation of listing is soft capsule, and trade name AVODART Anfus reach, be dutasteride is dissolved in it is pungent
With the mixture of Butylated Hydroxytoluene in sour mono diglycerides, then it is filled into soft capsule and obtains；But its dissolution rate is not high or external molten
Outlet is undesirable.
It is public in a kind of disclosed CN103655470A, entitled dutasteride's self-emulsion composition Chinese patent
The method that dutasteride is prepared into micro emulsion is opened, in that patent, using median chain triglyceride oil as oil phase, polyoxyethylene hydrogen
Change castor oil 40 is emulsifying agent, and propane diols is assistant for emulsifying agent.The patent, which discloses micro emulsion composition, can be prepared into hard shell capsules, flexible glue
Capsule, oral liquid formulations or tablet.After soft capsule preparation is prepared into, because propane diols adds in soft capsule content
Add, it is easy to cause pharmaceutical active compounds to migrate to rubber during drying and storage, so as to influence the stabilization of preparation
Property and bioavilability.
Because addition propane diols can migrate on pharmaceutical activity, preparation stability and bioavilability have certain influence,
Therefore the dissolved corrosion for the soft capsule preparation for being not added with propane diols using conventional selection is preferable, and conventional thinner can not significantly change
The dissolution rate of the kind soft capsule containing dutasteride, its dissolution rate at 45 minutes are difficult to reach more than 80%.Such as
In Chinese patent literature disclosed in CN103830201A, glycerol caprylate is with median chain triglyceride oil mixed solution as oily item system
Standby soft capsule, can preferably improve dutasteride's dissolution rate and stability, can particularly improve the period such as preceding 35 before dissolution
The dissolution rate of minute.But a microemulsion method used in CN103655470A, it has been not added with propane diols；Prepared degree he
Male amine is from micro emulsion solid pharmaceutical preparation with listing dutasteride's soft capsule (trade name：) and the patent comparing embodiment 3 AVODART
Preparation, dissolved corrosion is suitable in the 0.1mol/L hydrochloric acid solutions containing 2% lauryl sodium sulfate.As can be seen here, preparation is worked as
When prescription differs, there is considerable influence to the dissolved corrosion of main ingredient.
The content of the invention
It is an object of the invention to provide a kind of dutasteride's soft capsule preparation.
For the above-mentioned purpose, a kind of dutasteride's soft capsule preparation is provided in one embodiment of the present of invention, including it is soft
Capsule and content, content prescription are：
Dutasteride's raw material 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 scheme of the present invention, content prescription is：
Dutasteride's raw material 0.5g；
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 scheme of the present invention, content prescription is：
Dutasteride's 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 scheme of the present invention, content prescription is：
Dutasteride's raw material 0.5g；
Labraso 235g；
Unigly GO 102S 48g；
Median chain triglyceride oil 78g；
DBPC 2,6 ditertiary butyl p cresol 0.04g.
In the preferred scheme 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 scheme of the present invention, the prescription of soft capsule is：
Gelatin 160mg；
Glycerine 85mg；
Yellow ferric oxide 0.28mg；
Titanium dioxide 2mg.
In the preferred scheme of the present invention, the prescription of soft capsule is：
Gelatin 155mg；
Glycerine 92mg；
Yellow ferric oxide 0.3mg；
Titanium dioxide 2.5mg.
Another object of the present invention is to improve a kind of technique for preparing dutasteride's soft capsule preparation, including following step
Suddenly：
(1) content is prepared：Take the Labraso, Unigly GO 102S and medium chain triglyceride of recipe quantity
Three acid esters are stirred, and the dutasteride's bulk drug and BHT of recipe quantity are added after heating, continues to stir
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 added
The titanium dioxide and yellow ferric oxide of sieve are well mixed, and are then added gelatin and are heated to 60 DEG C~80 DEG C；Continue stirring extremely
Gelatin is completely dissolved；Vacuum is opened after Gelatin makes glue deaerate, and cools after degassing；
(3) pill：Using soft capsule by inside Contents Fill to soft capsule, sizing, dry, obtain drug containing flexible glue
Capsule.
In the preferred scheme of the present invention, Labraso, Unigly GO 102S and medium chain triglyceride
Three acid esters are stirred, and dutasteride's bulk drug and BHT are added after being warming up to 40 DEG C.
In the preferred scheme 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 of the present invention is bought in the product Unigly GO 102S of the good method lion of France.
In summary, the present invention has advantages below：
Dutasteride's soft capsule of the present invention, the accumulation dissolution rate of dissolution 5 minutes can be significantly improved, improve main ingredient preceding
The dissolution efficiency of period；It is good with good stability, product appearance quality.Secondly the present invention passes through the optimization to component
Selection, reduces harmful effect of the propane diols to main ingredient migration, stability, dissolution rate and bioavailability.
Brief description of the drawings
Fig. 1 is the one of embodiment of the present invention and commercially available prod dissolution rate contrast table.
Embodiment
Embodiment 1
Dutasteride's soft capsule preparation content prescription：
Dutasteride's raw material 0.5g；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 85mg；
Yellow ferric oxide 0.28mg；Titanium dioxide 2mg.
Preparation method：
(1) content is prepared：Take the Labraso, Unigly GO 102S and medium chain triglyceride of recipe quantity
Three acid esters stir, and are warming up to the dutasteride's bulk drug and BHT that recipe quantity is added after 40 DEG C, after
Continuous stirring 1h obtains content to room temperature is down to after uniformly；
(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 added
The titanium dioxide and yellow ferric oxide of 80 mesh sieves are well mixed, and are then added gelatin and are heated to 70 DEG C；Continue to stir 1h extremely
Gelatin stops stirring after being completely dissolved；Vacuum is opened after Gelatin keeps vacuum bag -0.09Mpa to make glue degassing 30min, takes off
Cool 60 DEG C after gas, it is standby after standing 24h；
(3) pill：Encapsulating machine heats after being debugged to sprinkler body；Revolving die pressure is adjusted, just to extrude capsule and pill
It is advisable, avoids pressure from crossing conference mold damage.Loading amount regulation is carried out, sampling detection extrudes crack quality, outward appearance, the content of capsule and pill
Thing weight, is adjusted in time, untill meeting the requirements；Roller is opened, the capsule and pill of compacting is shaped；The capsule and pill of compacting is being rolled
Taken out after cylinder sizing, be placed in 30 DEG C, dried in below RH50% environment, 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
Divide at 8%~12%, stop drying.
Embodiment 2
Dutasteride's soft capsule preparation content prescription：
Dutasteride's raw material 0.5g；Labraso 225g；
Unigly GO 102S 50g；Median chain triglyceride oil 72g；
DBPC 2,6 ditertiary butyl p cresol 0.038g.
Soft capsule prescription：
Gelatin 165mg；Glycerine 83mg；
Yellow ferric oxide 0.27mg；Titanium dioxide 2.2mg.
Preparation method：
(1) content is prepared：Take the Labraso, Unigly GO 102S and medium chain triglyceride of recipe quantity
Three acid esters stir, and are warming up to the dutasteride's bulk drug and BHT that recipe quantity is added after 40 DEG C, after
Continuous stirring 1h obtains content to room temperature is down to after uniformly；
(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 added
The titanium dioxide and yellow ferric oxide of 80 mesh sieves are well mixed, and are then added gelatin and are heated to 70 DEG C；Continue to stir 1h extremely
Gelatin stops stirring after being completely dissolved；Vacuum is opened after Gelatin keeps vacuum bag -0.09Mpa to make glue degassing 30min, takes off
Cool 60 DEG C after gas, it is standby after standing 24h；
(3) pill：Encapsulating machine heats after being debugged to sprinkler body；Revolving die pressure is adjusted, just to extrude capsule and pill
It is advisable, avoids pressure from crossing conference mold damage.Loading amount regulation is carried out, sampling detection extrudes crack quality, outward appearance, the content of capsule and pill
Thing weight, is adjusted in time, untill meeting the requirements；Roller is opened, the capsule and pill of compacting is shaped；The capsule and pill of compacting is being rolled
Taken out after cylinder sizing, be placed in 30 DEG C, dried in below RH50% environment, 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
Divide at 8%~12%, stop drying.
Embodiment 3
Dutasteride's soft capsule preparation content prescription：
Dutasteride's raw material 0.5g；Labraso 220g；
Unigly GO 102S 45g；Median chain triglyceride oil 75g；
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 medium chain triglyceride of recipe quantity
Three acid esters stir, be warming up to after 40 DEG C add recipe quantity dutasteride's bulk drug continue stir 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 added
The titanium dioxide and yellow ferric oxide of 80 mesh sieves are well mixed, and are then added gelatin and are heated to 70 DEG C；Continue to stir 1h extremely
Gelatin stops stirring after being completely dissolved；Vacuum is opened after Gelatin keeps vacuum bag -0.09Mpa to make glue degassing 30min, takes off
Cool 60 DEG C after gas, it is standby after standing 24h；
(3) pill：Encapsulating machine heats after being debugged to sprinkler body, and control temperature is at 35 DEG C；Revolving die pressure is adjusted,
It is advisable with just extruding capsule and pill, avoids pressure from crossing conference mold damage.Loading amount regulation is carried out, sampling detection extrudes the crack of capsule and pill
Quality, outward appearance, content weight, are adjusted, untill meeting the requirements in time；Roller is opened, the capsule and pill of compacting is shaped；Will
The capsule and pill of compacting takes out after roller sizing, is placed in 30 DEG C, is dried in below RH50% environment, and the capsule skin of sampling detection at any time
Moisture, when the capsule severe edema due to hypofunction of the spleen point is 8%~12%, stop drying.
Embodiment 4
Dutasteride's soft capsule preparation content prescription：
Dutasteride's raw material 0.5g；Labraso 220g；
Unigly GO 102S 45g；Median chain triglyceride oil 75g；
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 medium chain triglyceride of recipe quantity
Three acid esters stir, and are warming up to dutasteride's bulk drug that recipe quantity is added after 40 DEG C and butylated hydroxy anisole BHA 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 added
The titanium dioxide and yellow ferric oxide of 80 mesh sieves are well mixed, and are then added gelatin and are heated to 70 DEG C；Continue to stir 1h extremely
Gelatin stops stirring after being completely dissolved；Vacuum is opened after Gelatin keeps vacuum bag -0.09Mpa to make glue degassing 30min, takes off
Cool 60 DEG C after gas, it is standby after standing 24h；
(3) pill：Encapsulating machine heats after being debugged to sprinkler body；Revolving die pressure is adjusted, just to extrude capsule and pill
It is advisable, avoids pressure from crossing conference mold damage.Loading amount regulation is carried out, sampling detection extrudes crack quality, outward appearance, the content of capsule and pill
Thing weight, is adjusted in time, untill meeting the requirements；Roller is opened, the capsule and pill of compacting is shaped；The capsule and pill of compacting is being rolled
Taken out after cylinder sizing, be placed in 30 DEG C, dried in below RH50% environment, 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
Divide at 8%~12%, stop drying.
Embodiment 5
Dutasteride's soft capsule preparation content prescription：
Dutasteride's raw material 0.5g；Labraso 220g；
Unigly GO 102S 45g；Median chain triglyceride oil 75g；
Sodium pyrosulfite 0.035g.
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 medium chain triglyceride of recipe quantity
Three acid esters stir, and are warming up to the dutasteride's bulk drug and sodium pyrosulfite that recipe quantity is added after 40 DEG C, continue to stir 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 added
The titanium dioxide and yellow ferric oxide of 80 mesh sieves are well mixed, and are then added gelatin and are heated to 70 DEG C；Continue to stir 1h extremely
Gelatin stops stirring after being completely dissolved；Vacuum is opened after Gelatin keeps vacuum bag -0.09Mpa to make glue degassing 30min, takes off
Cool 60 DEG C after gas, it is standby after standing 24h；
(3) pill：Encapsulating machine heats after being debugged to sprinkler body, and control temperature is at 35 DEG C；Revolving die pressure is adjusted,
It is advisable with just extruding capsule and pill, avoids pressure from crossing conference mold damage.Loading amount regulation is carried out, sampling detection extrudes the crack of capsule and pill
Quality, outward appearance, content weight, are adjusted, untill meeting the requirements in time；Roller is opened, the capsule and pill of compacting is shaped；Will
The capsule and pill of compacting takes out after roller sizing, is placed in 30 DEG C, is dried in below RH50% environment, and the capsule skin of sampling detection at any time
Moisture, when the capsule severe edema due to hypofunction of the spleen point is 8%~12%, stop drying.
Comparative example 3~5 and embodiment 1 are contrasted, main ingredient moves to flexible glue wherein after storing 6 months for detection
The content of capsule.Averagely contain main ingredient 1.2% in capsule shells after 6 months in embodiment 1, i.e. migration amount reaches 1.2%, embodiment
Migration amount is more than 3% in 3~5；Migration amount can be substantially reduced after BHT is added as can be seen here so that drug component
Stability is more preferable.
Test example 1：Stability experiment
The soft capsule being prepared is placed in 25 DEG C of progress long-time stability experiments, Acceleration study is carried out in 40 DEG C.
The soft capsule that self-control sample is prepared using the method in embodiment 1 and prescription, commercially available prod is reached using Anfu；
Its stability and quality testing such as table 1：
Table 1：Study on the stability experimental result
Test example 2：Dissolution is tested
Dissolution medium：The hydrochloric acid solution of 0.1mol/L containing 2% lauryl sodium sulfate
Leaching temperature：37.5℃
Speed of agitator：50rpm
It is real using the dissolution rate of sample and commercial samples in HPLC methods measure embodiment 1 under above-mentioned leaching condition
Test, experimental result such as table 2 and Fig. 1
Table 2：Dissolution rate experimental result
As can be seen here, dutasteride's soft capsule that prescription disclosed by the invention and preparation technology are prepared, its stability
Slightly above commercially available prod；As can be seen that the soft capsule of the present invention before 5 minutes there is very high dissolution to imitate in dissolution experiment
Rate, compared to commercially available prod dissolved corrosion more rapidly, have faster work action time.
Claims (10)
1. a kind of dutasteride's soft capsule preparation, including soft capsule and content, it is characterised in that：The content prescription is：
Dutasteride's raw material 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.
2. soft capsule preparation as claimed in claim 1, it is characterised in that：The content prescription is：
Dutasteride's raw material 0.5g；
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：
Dutasteride's 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：
Dutasteride's raw material 0.5g；
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 85mg；
Yellow ferric oxide 0.28mg；
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 155mg；
Glycerine 92mg；
Yellow ferric oxide 0.3mg；
Titanium dioxide 2.5mg.
8. preparing the technique of any dutasteride's 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 is stirred, and the dutasteride's bulk drug and BHT of recipe quantity are added after heating, continues to stir
After be down to room temperature, obtain 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 well 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 after degassing；
（3）Pill：Using soft capsule by inside Contents Fill to soft capsule, sizing, dry, obtain pastille soft capsule.
9. preparation technology as claimed in claim 8, it is characterised in that：The Labraso, polyglycereol
Oleate and median chain triglyceride oil are stirred, and dutasteride's bulk drug and 2,6- di-t-butyl pair are added after being warming up to 40 DEG C
Cresols.
10. preparation technology 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 |
|---|---|---|---|
| CN201510920214.5A CN105395517B (en) | 2015-12-11 | 2015-12-11 | A kind of dutasteride's soft capsule preparation and its preparation technology |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510920214.5A CN105395517B (en) | 2015-12-11 | 2015-12-11 | A kind of dutasteride's soft capsule preparation and its preparation technology |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN105395517A CN105395517A (en) | 2016-03-16 |
| CN105395517B true CN105395517B (en) | 2018-04-06 |
Family
ID=55461517
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510920214.5A Active CN105395517B (en) | 2015-12-11 | 2015-12-11 | A kind of dutasteride's soft capsule preparation and its preparation technology |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105395517B (en) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106822025A (en) * | 2017-01-02 | 2017-06-13 | 佛山市腾瑞医药科技有限公司 | A kind of Desloratadine soft capsule preparation and its preparation technology |
| CN106580913A (en) * | 2017-01-02 | 2017-04-26 | 佛山市腾瑞医药科技有限公司 | Trelagliptin succinate soft capsule preparation and preparation process thereof |
| CN106667953A (en) * | 2017-02-14 | 2017-05-17 | 佛山市腾瑞医药科技有限公司 | Apremilast soft capsule preparation and preparation process thereof |
| CN106667954A (en) * | 2017-02-14 | 2017-05-17 | 佛山市腾瑞医药科技有限公司 | Diacerein soft capsule preparation and preparation process thereof |
| CN106667955A (en) * | 2017-02-15 | 2017-05-17 | 佛山市腾瑞医药科技有限公司 | Minodronic acid soft capsule preparation and preparation technology thereof |
| CN106822028A (en) * | 2017-02-15 | 2017-06-13 | 佛山市腾瑞医药科技有限公司 | A kind of Tadalafei soft capsule preparation and its preparation technology |
| CN106667956A (en) * | 2017-02-16 | 2017-05-17 | 佛山市腾瑞医药科技有限公司 | Febuxostat soft capsule preparation and preparation technology thereof |
| CN109875973B (en) * | 2017-12-06 | 2021-09-03 | 南京恒生制药有限公司 | Dutasteride-containing soft capsule composition and preparation method thereof |
| CN107898770A (en) * | 2017-12-06 | 2018-04-13 | 佛山市腾瑞医药科技有限公司 | A kind of Zaltoprofen soft capsule preparation and its preparation process |
| CN107898768A (en) * | 2017-12-06 | 2018-04-13 | 佛山市腾瑞医药科技有限公司 | A kind of tolvaptan soft capsule preparation and its preparation process |
| CN107898769A (en) * | 2017-12-06 | 2018-04-13 | 佛山市腾瑞医药科技有限公司 | A kind of nebivolol hydrochloric acid soft capsule preparation and its preparation process |
| CN107898771A (en) * | 2017-12-07 | 2018-04-13 | 佛山市腾瑞医药科技有限公司 | A kind of ranolazine soft capsule preparation and its preparation process |
| CN107998100A (en) * | 2017-12-08 | 2018-05-08 | 佛山市腾瑞医药科技有限公司 | A kind of Febustat soft capsule preparation and its preparation process |
| CN107982267A (en) * | 2017-12-28 | 2018-05-04 | 佛山市腾瑞医药科技有限公司 | A kind of razaxaban soft capsule preparation and its preparation process |
| CN112569201A (en) * | 2019-09-27 | 2021-03-30 | 重庆华邦制药有限公司 | Dutasteride soft capsule and preparation method thereof |
| CN110613695A (en) * | 2019-10-23 | 2019-12-27 | 人福普克药业（武汉）有限公司 | Dutasteride soft capsule and preparation method thereof |
| CN111759821B (en) * | 2020-08-24 | 2021-10-08 | 四川奥邦投资有限公司 | Dutasteride soft capsule pharmaceutical composition |
| CN115300469B (en) * | 2022-08-11 | 2024-03-22 | 南京瑞孚医药科技有限公司 | Dutasteride composition |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103169712A (en) * | 2011-12-20 | 2013-06-26 | 重庆华邦制药有限公司 | Dutasteride preparation used for increasing bioavailability and preparation method |
| CN103479595A (en) * | 2012-06-13 | 2014-01-01 | 成都国弘医药有限公司 | Dutasteride-containing soft capsule |
| CN103830201A (en) * | 2012-11-20 | 2014-06-04 | 重庆医药工业研究院有限责任公司 | Dutasteride liquid soft capsules |
| CN104069084A (en) * | 2013-03-25 | 2014-10-01 | 重庆华邦制药有限公司 | Dutasteride soft capsule with stable quality |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2737528A1 (en) * | 2008-09-17 | 2010-03-25 | Mylan Laboratories, Inc. | Granulates, process for preparing them and pharmaceutical products containing them |
-
2015
- 2015-12-11 CN CN201510920214.5A patent/CN105395517B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103169712A (en) * | 2011-12-20 | 2013-06-26 | 重庆华邦制药有限公司 | Dutasteride preparation used for increasing bioavailability and preparation method |
| CN103479595A (en) * | 2012-06-13 | 2014-01-01 | 成都国弘医药有限公司 | Dutasteride-containing soft capsule |
| CN103830201A (en) * | 2012-11-20 | 2014-06-04 | 重庆医药工业研究院有限责任公司 | Dutasteride liquid soft capsules |
| CN104069084A (en) * | 2013-03-25 | 2014-10-01 | 重庆华邦制药有限公司 | Dutasteride soft capsule with stable quality |
Also Published As
| Publication number | Publication date |
|---|---|
| CN105395517A (en) | 2016-03-16 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN105395517B (en) | A kind of dutasteride's soft capsule preparation and its preparation technology | |
| EP1496871B1 (en) | Polysaccharide capsules and methods of preparation | |
| TWI472323B (en) | Aqueous composition for enteric hard capsule, method of preparing enteric hard capsule,and enteric hard capsule prepared using the method | |
| CN105395492B (en) | A kind of volatile oil solid self-emulsifying tablet and preparation method thereof | |
| CN104095830A (en) | Preparation method for mesylate dabigatran capsule | |
| CN107348304A (en) | Effervescent tablet containing Tea Polyphenols and curcumin and preparation method thereof | |
| JP2009524573A (en) | Low moisture hard capsule and method for producing the same | |
| EP3150201B1 (en) | Composite preparation comprising 5- -reductase inhibitor-containing film coating layer, and method for producing the composite preparation | |
| JP5795585B2 (en) | Film coating composition from solid powder compound | |
| CN107638333A (en) | A kind of Tea Polyphenols/chitosan particle and preparation method thereof | |
| CN102958514B (en) | Intraoral disintegration tablet | |
| CN103655470A (en) | Dutasteride self-microemulsion composition and preparation method thereof | |
| CN104721166A (en) | Butylphthalide liquid hard capsule preparation and preparation method thereof | |
| CN108578370A (en) | Lutein/lutein ester particle and preparation method thereof | |
| CN104490802B (en) | Rhodioside enteric coatel tablets and preparation method thereof | |
| KR102627892B1 (en) | Rapid release drug formulation of anticoagulant and method for manufacturing same | |
| EP2563160B1 (en) | Novel coating system | |
| CN107898771A (en) | A kind of ranolazine soft capsule preparation and its preparation process | |
| CN106667953A (en) | Apremilast soft capsule preparation and preparation process thereof | |
| CN105012275B (en) | Indapamide slow release agent preparation method | |
| CN106983752A (en) | A kind of preparation method of valsartan and Hydrochlorothiade capsule | |
| CN104288114B (en) | A kind of erlotinib Hydrochloride pharmaceutical composition without surfactant | |
| EP3773463B1 (en) | Skin care kit | |
| CN107998100A (en) | A kind of Febustat soft capsule preparation and its preparation process | |
| CN106822025A (en) | A kind of Desloratadine soft capsule preparation and its preparation technology |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |