CN107898768A - A kind of tolvaptan soft capsule preparation and its preparation process - Google Patents
A kind of tolvaptan soft capsule preparation and its preparation process Download PDFInfo
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- CN107898768A CN107898768A CN201711272586.7A CN201711272586A CN107898768A CN 107898768 A CN107898768 A CN 107898768A CN 201711272586 A CN201711272586 A CN 201711272586A CN 107898768 A CN107898768 A CN 107898768A
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- soft capsule
- tolvaptan
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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
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
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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
- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. gelatin
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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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- 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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- General Health & Medical Sciences (AREA)
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- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of tolvaptan soft capsule preparation, including soft capsule and content, content prescription is:Tolvaptan raw material 0.01g ~ 0.1g;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 tolvaptan 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 tolvaptan soft capsule preparation and its prepares work
Skill.
Background technology
Tolvaptan is a kind of selective-βreceivingblockor for having vasorelaxation action concurrently, is mainly used for treating primary
Hypertension and chronic heart failure.It has the advantages that evident in efficacy, medication is convenient, adverse reaction is few, be one it is new have before
The antihypertensive drugs on way, is approved listing in Germany first in 1997 and is used to treat essential hypertension.Since this product tolvaptan is simultaneous
There is the advantages of Cardioprotective and blood vessel dilatation, be predicted to be one of following " ten big cookles " with good market future.
The characteristics of this product:
(1)Tolvaptan lack endogenous against sympathetic and membrane stabilizing action, but can by from vascular endothelia discharge nitric oxide and
Play it and expand blood vessel function, can mainly cause the expansion of human body the back of the hand or forearm blood vessel endothelium.
(2)This product is without obvious negative inotropic action, on the contrary, tolvaptan has heart function certain protective effect, can drop
Low cardiac preload, maintains or reduces afterload.Tolvaptan can make decreased heart rate at the same time, reduce Left ventricular end diastolic pressure, increase
Add stroke volume, be held essentially constant the cardiac output of cardiac, tolvaptan especially heart failure patient is more
Substantially.To left ventricular hypertrophy in essential hypertension patient, this product can improve left ventricular hypertrophy.
(3)Tolvaptan can effectively control blood pressure.Clinical studies show this product can produce good antihypertensive effect, one
1 5mg can substantially reduce vertical position or clinostatism diastolic pressure.During continued treatment, blood pressure rise or drug resistant sign there are no.Paddy-
The advantages of peak is than being almost 90% anti-hypertension, this show tolvaptan can almost in whole 24 hours period effectively
Blood pressure is controlled, daily medication is once.
(4)Dosage is low, few side effects.1 5mg of this product one day has good tolerance, and adverse reaction rate is small
In the nifedipine or metoprolol of 2 times on the one, the latter has during receiving atenolol or enalapril is treated causes impotence
Or the report of hypogona dism, and this product does not have then.In addition, the tired sensation of the patient for receiving atenolol treatment gradually aggravates,
And this product then no abnormality seen.In addition, the more conventional beta-blocker such as the adverse reaction of tolvaptan such as drowsiness and coldness of extremities
Gently.Especially it is appreciated that the report occurred using postural hypotension is had no after this product.
(5)Tolvaptan has cooperative effect when being combined with Hydrochioro.
The content of the invention
The object of the present invention is to provide a kind of tolvaptan soft capsule preparation.
In order to achieve the above object, a kind of tolvaptan soft capsule preparation is provided in one embodiment of the present of invention, including it is soft
Capsule and content, content prescription are:
Tolvaptan raw material 0.01g ~ 0.1g;
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:
Tolvaptan raw material 0.01g;
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:
Tolvaptan raw material 0.02g;
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:
Tolvaptan raw material 0.03g;
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 tolvaptan 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 tolvaptan 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 tolvaptan 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 tolvaptan 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
Tolvaptan soft capsule preparation content prescription:
Tolvaptan raw material 0.05g;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 tolvaptan 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
Tolvaptan soft capsule preparation content prescription:
Tolvaptan raw material 0.01g;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 tolvaptan 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
Tolvaptan soft capsule preparation content prescription:
Tolvaptan raw material 0.02g;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 tolvaptan 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
Tolvaptan soft capsule preparation content prescription:
Tolvaptan raw material 0.03g;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 tolvaptan 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
Tolvaptan soft capsule preparation content prescription:
Tolvaptan raw material 0.1g;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 tolvaptan 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 tolvaptan soft capsule preparation, including soft capsule and content, it is characterised in that:The content prescription is:
The g of tolvaptan raw material 0.01g ~ 0.1;
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:
Tolvaptan raw material 0.01g;
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:
Tolvaptan raw material 0.1g;
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:
Tolvaptan raw material 0.02g;
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 tolvaptan 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 tolvaptan 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 tolvaptan 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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CN201711272586.7A CN107898768A (en) | 2017-12-06 | 2017-12-06 | A kind of tolvaptan soft capsule preparation and its preparation process |
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Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102114001A (en) * | 2009-12-30 | 2011-07-06 | 北京德众万全医药科技有限公司 | Orally administered solid preparation containing tolvaptan |
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 CN201711272586.7A patent/CN107898768A/en active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102114001A (en) * | 2009-12-30 | 2011-07-06 | 北京德众万全医药科技有限公司 | Orally administered solid preparation containing tolvaptan |
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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Application publication date: 20180413 |