CN107898771A - A kind of ranolazine soft capsule preparation and its preparation process - Google Patents
A kind of ranolazine soft capsule preparation and its preparation process Download PDFInfo
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- CN107898771A CN107898771A CN201711283706.3A CN201711283706A CN107898771A CN 107898771 A CN107898771 A CN 107898771A CN 201711283706 A CN201711283706 A CN 201711283706A CN 107898771 A CN107898771 A CN 107898771A
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- soft capsule
- ranolazine
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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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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Abstract
The invention discloses a kind of ranolazine soft capsule preparation, including soft capsule and content, content prescription is：Ranolazine raw material 0.5g ~ 1.5g；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 ranolazine 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 ranolazine soft capsule preparation and its prepares work
Skill.
Background technology
Ranolazine has antianginal and function of resisting myocardial ischemia, its specific mechanism of action is unclear.Researches show that
It can partly suppress fatty acid oxidation, but can also influence the electrical conduction of heart at the same time, cause the QT interval related with dosage to be prolonged
It is long.Ranolazine be only limited to take the antianginal drugs such as long acting nitrate, calcium ion channel blocker and beta 2 receptor retarding agent without
The patient of effect uses.Clinical test shows that the effect that male patient takes ranolazine is better than women, and head occurs in long-term use
The adverse reactions such as dizzy, headache, constipation and nausea.
Ranolazine is a kind of new chemical entities compound, is the first treatment chronic angina medicine that FDA ratifies over 10 years.
Different from existing antianginal drug, ranolazine is partial fatty acid oxidation enzyme inhibitor, on heart rate and blood pressure without influence, can be had
Effect ground allevating angina pectoris, and do not change other kinetic parameters of medicine, the quality of life of patient with angina pectoris can be improved.According to U.S.
About 6,800,000 people are diagnosed with angina pectoris to the estimation U.S. of heart association of state every year, and Chinese patients number is up to more than 4 000
Ten thousand, therefore ranolazine has very big market development potential.
The content of the invention
The object of the present invention is to provide a kind of ranolazine soft capsule preparation.
In order to achieve the above object, a kind of ranolazine soft capsule preparation is provided in one embodiment of the present of invention, including flexible glue
Capsule and content, content prescription are：
Ranolazine raw material 0.5g ~ 1.5g；
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：
Ranolazine 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 solution of the present invention, content prescription is：
Ranolazine raw material 1g；
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：
Ranolazine raw material 1.5g；
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 ranolazine soft capsule preparation, is comprised the following steps：
(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 ranolazine bulk pharmaceutical chemicals and 2,6-di-tert-butyl p-cresol of recipe quantity are added after heating, are continued after stirring evenly
Room temperature is down to, 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 ranolazine 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 ranolazine soft capsule of the present invention, can significantly improve the accumulation dissolution rate of dissolution 5 minutes, improve main ingredient in the preceding period
Dissolution efficiency；With good stability, product appearance quality is good.Secondly the present invention is by the optimum choice to component,
Reduce harmful effect of the propane diols to main ingredient migration, stability, dissolution rate and bioavailability.
Embodiment
Embodiment 1
Ranolazine soft capsule preparation content prescription：
Ranolazine raw material 0.5g；Labraso 200g；
Unigly GO 102S 45g；Median chain triglyceride oil 70g；
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 ranolazine bulk pharmaceutical chemicals and 2,6-di-tert-butyl p-cresol that recipe quantity is added after 40 DEG C, 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 2
Ranolazine soft capsule preparation content prescription：
Ranolazine raw material 1.0g；Labraso 220g；
Unigly GO 102S 50g；Median chain triglyceride oil 72g；
DBPC 2,6 ditertiary butyl p cresol 0.03g.
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 ranolazine bulk pharmaceutical chemicals and 2,6-di-tert-butyl p-cresol that recipe quantity is added after 40 DEG C, 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 3
Ranolazine soft capsule preparation content prescription：
Ranolazine raw material 1.5g；Labraso 227g；
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 ranolazine bulk pharmaceutical chemicals continue stir 1h to uniformly after be down to room temperature, obtain
To 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
Ranolazine soft capsule preparation content prescription：
Ranolazine raw material 0.8g；Labraso 213g；
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 ranolazine 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
Ranolazine soft capsule preparation content prescription：
Ranolazine raw material 0.6g；Labraso 215g；
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 ranolazine bulk pharmaceutical chemicals and sodium pyrosulfite that recipe quantity is added after 40 DEG C, continues to stir 1h to uniform
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.
Claims (10)
1. a kind of ranolazine soft capsule preparation, including soft capsule and content, it is characterised in that：The content prescription is：
The g of ranolazine raw material 0.5g ~ 1.5；
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：
Ranolazine 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：
Ranolazine raw material 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：
Ranolazine 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 ranolazine 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 ranolazine bulk pharmaceutical chemicals and 2,6-di-tert-butyl p-cresol of recipe quantity are added after heating, are continued after stirring evenly
Room temperature is down to, 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 ranolazine bulk pharmaceutical chemicals and 2,6- di-t-butyl are added after being warming up to 40 DEG C to first
Phenol.
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 |
|---|---|---|---|
| CN201711283706.3A CN107898771A (en) | 2017-12-07 | 2017-12-07 | A kind of ranolazine soft capsule preparation and its preparation process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711283706.3A CN107898771A (en) | 2017-12-07 | 2017-12-07 | A kind of ranolazine soft capsule preparation and its preparation process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107898771A true CN107898771A (en) | 2018-04-13 |
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ID=61864906
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711283706.3A Pending CN107898771A (en) | 2017-12-07 | 2017-12-07 | A kind of ranolazine soft capsule preparation and its preparation process |
Country Status (1)
| Country | Link |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101066253A (en) * | 2007-06-07 | 2007-11-07 | 北京本草天源药物研究院 | Slow releasing ranolazine tablet |
| 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
- 2017-12-07 CN CN201711283706.3A patent/CN107898771A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101066253A (en) * | 2007-06-07 | 2007-11-07 | 北京本草天源药物研究院 | Slow releasing ranolazine tablet |
| 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 |
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