CN107982267A - A kind of razaxaban soft capsule preparation and its preparation process - Google Patents
A kind of razaxaban soft capsule preparation and its preparation process Download PDFInfo
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- CN107982267A CN107982267A CN201711455515.0A CN201711455515A CN107982267A CN 107982267 A CN107982267 A CN 107982267A CN 201711455515 A CN201711455515 A CN 201711455515A CN 107982267 A CN107982267 A CN 107982267A
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- soft capsule
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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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
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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
- A61K9/4858—Organic compounds
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Abstract
The invention discloses a kind of razaxaban soft capsule preparation, including soft capsule and content, content prescription is：Razaxaban raw material 0.2g ~ 1.0g；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 razaxaban 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 razaxaban soft capsule preparation and its prepares work
Skill.
Background technology
Razaxaban（Rivaroxaban）It is global first oral direct Xa factor inhibitor, it is public by Bayer/Johnson ＆ Johnson
Department develops.In October, 2008, gets the Green Light listing in Canada and European Union, trade name Xarelto.2009 March, U.S.
FDA consultative committees of state have agreed to that razaxaban clinical data has good benefit-Hazard ratio.At present, razaxaban exists
Multiple countries and regions such as Canada, European Union, South America, China, Australia obtain registration approval, and the second half year in 2009 is in
State has held listing meeting, and trade name is visitd auspicious appropriate.
Mechanism of action
Xa factor is the common across point for the interior external source path that fibrin ferment is formed, and passes through razaxaban selective depression Xa factor
Block the explosion sample enlarge-effect of fibrin ferment generation, more efficient, safely inhibition thrombosis.Researches show that the medicine can compete
Property, optionally directly suppress Xa factor, can also suppress factor combined enzyme agent.
Pharmacokinetics
Work after administration rapid, 2.5~4.0h reaches peak serum concentration (Cmax) after administration.The medicine bioavilability is high, its end
Last half-life period is 5.7~9.2h.Food can increase the absorption of razaxaban.Razaxaban is mainly drained through following approach:66%
By renal route, wherein about 36% is discharged with prototype from urine;Also 28% through excrement/bile excretion.
Clinical characters：
Heparin and warfarin etc. establish the status of its traditional anticoagulant in long-term clinical test and clinical practice.But heparin
For parenteral, compliance is poor, is not suitable for long-time service.Warfarin and a variety of foods and drug interaction, therapeutic domain
It is narrow, need periodic monitoring.Compared with heparin and warfarin, razaxaban only needs daily once as oral formulations
Reach therapeutic effect, have it is convenient to take, work it is rapid, the generation of phlebothrombosis can be substantially reduced, and do not increase bleeding
Rate, dosage, the convenience without routine monitoring need not be adjusted by not only having, and phase interaction hardly occurs with food and medicine
With can take at the same time, the features such as security is higher, future sales market prospects are considerable.
The content of the invention
The object of the present invention is to provide a kind of razaxaban soft capsule preparation.
In order to achieve the above object, a kind of razaxaban soft capsule preparation is provided in one embodiment of the present of invention, including it is soft
Capsule and content, content prescription are：
Razaxaban raw material 0.2g ~ 1.0g；
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：
Razaxaban raw material 0.2g；
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：
Razaxaban raw material 0.4g；
Labraso 220g；
Unigly GO 102S 45g；
Median chain triglyceride oil 75g；
DBPC 2,6 ditertiary butyl p cresol 0.03g.
In the preferred solution of the present invention, content prescription is：
Razaxaban raw material 0.8g；
Labraso 230g；
Unigly GO 102S 45g；
Median chain triglyceride oil 75g；
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 razaxaban 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 razaxaban bulk pharmaceutical chemicals and 2,6-di-tert-butyl p-cresol of recipe quantity are added after heating, continue to stir evenly
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 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 razaxaban 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 razaxaban soft capsule of the present invention, can significantly improve the accumulation dissolution rate of dissolution 5 minutes, improve main ingredient in the preceding time
The dissolution efficiency of section；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
Razaxaban soft capsule preparation content prescription：
Razaxaban raw material 0.2g；Labraso 220g；
Unigly GO 102S 4g；Median chain triglyceride oil 7g；
DBPC 2,6 ditertiary butyl p cresol 0.03g.
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 razaxaban bulk pharmaceutical chemicals and 2,6-di-tert-butyl p-cresol that recipe quantity is added after 40 DEG C, 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 2
Razaxaban soft capsule preparation content prescription：
Razaxaban raw material 0.4g；Labraso 225g；
Unigly GO 102S 50g；Median chain triglyceride oil 72g；
DBPC 2,6 ditertiary butyl p cresol 0.032g.
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 razaxaban bulk pharmaceutical chemicals and 2,6-di-tert-butyl p-cresol that recipe quantity is added after 40 DEG C, 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 3
Razaxaban soft capsule preparation content prescription：
Razaxaban raw material 0.6g；Labraso 220g；
Unigly GO 102S 42g；Median chain triglyceride oil 72g；
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 razaxaban bulk pharmaceutical chemicals 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 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
Razaxaban soft capsule preparation content prescription：
Razaxaban raw material 0.8g；Labraso 211g；
Unigly GO 102S 41g；Median chain triglyceride oil 71g；
Butylated hydroxy anisole BHA0.032g.
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 razaxaban bulk pharmaceutical chemicals of addition recipe quantity and butylated hydroxy anisole BHA after 40 DEG C and continues 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 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
Razaxaban soft capsule preparation content prescription：
Razaxaban raw material 1.0g；Labraso 225g；
Unigly GO 102S 46g；Median chain triglyceride oil 72g；
Sodium pyrosulfite 0.034g.
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 razaxaban bulk pharmaceutical chemicals and sodium pyrosulfite that recipe quantity is added after 40 DEG C, continues to stir 1h to equal
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 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 razaxaban soft capsule preparation, including soft capsule and content, it is characterised in that：The content prescription is：
The g of razaxaban raw material 0.2g ~ 1.0；
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：
Razaxaban raw material 0.8g；
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：
Razaxaban raw material 1.2g；
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：
Razaxaban raw material 1.5g；
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 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 razaxaban 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 razaxaban bulk pharmaceutical chemicals and 2,6-di-tert-butyl p-cresol of recipe quantity are added after heating, continue to stir evenly
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 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 razaxaban bulk pharmaceutical chemicals and 2,6- di-t-butyl pair are added after being warming up to 40 DEG C
Cresols.
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%.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201711455515.0A CN107982267A (en) | 2017-12-28 | 2017-12-28 | A kind of razaxaban soft capsule preparation and its preparation process |
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| CN201711455515.0A CN107982267A (en) | 2017-12-28 | 2017-12-28 | A kind of razaxaban soft capsule preparation and its preparation process |
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| CN105616379A (en) * | 2014-11-12 | 2016-06-01 | 天津汉瑞药业有限公司 | Stable rivaroxaban capsule pharmaceutical composition |
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| 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 |
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Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103550165A (en) * | 2013-10-19 | 2014-02-05 | 浙江华海药业股份有限公司 | Medicinal composition containing rivaroxaban and preparation method thereof |
| CN103705520A (en) * | 2013-12-27 | 2014-04-09 | 华润赛科药业有限责任公司 | Method for preparing rivaroxaban solid composition |
| CN105616379A (en) * | 2014-11-12 | 2016-06-01 | 天津汉瑞药业有限公司 | Stable rivaroxaban capsule pharmaceutical composition |
| CN105287414A (en) * | 2015-10-21 | 2016-02-03 | 南京百迪尔生物医药有限公司 | Solid drug composition containing rivaroxaban and preparation method 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 |
| 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 |
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Application publication date: 20180504 |