CN106580913A - Trelagliptin succinate soft capsule preparation and preparation process thereof - Google Patents

Trelagliptin succinate soft capsule preparation and preparation process thereof Download PDF

Info

Publication number
CN106580913A
CN106580913A CN201710000247.7A CN201710000247A CN106580913A CN 106580913 A CN106580913 A CN 106580913A CN 201710000247 A CN201710000247 A CN 201710000247A CN 106580913 A CN106580913 A CN 106580913A
Authority
CN
China
Prior art keywords
soft capsule
lieting
gelatin
content
love song
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.)
Pending
Application number
CN201710000247.7A
Other languages
Chinese (zh)
Inventor
王雪峰
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Foshan City Teng Rui Medicine Technology Co Ltd
Original Assignee
Foshan City Teng Rui Medicine Technology Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Foshan City Teng Rui Medicine Technology Co Ltd filed Critical Foshan City Teng Rui Medicine Technology Co Ltd
Priority to CN201710000247.7A priority Critical patent/CN106580913A/en
Publication of CN106580913A publication Critical patent/CN106580913A/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention discloses a trelagliptin succinate soft capsule preparation, which comprises a soft capsule and a content, wherein the components in the content prescription comprise 0.5-1 g of a trelagliptin succinate raw material, 200-250 g of labrasol, 30-60 g of polyglycerol oleate, 50-100 g of medium chain triglyceride, and 0.02-0.05 g of 2,6-di-tert-butyl p-cresol. The trelagliptin succinate soft capsule of the present invention has characteristics of significantly improved dissolution rate, good stability, and good appearance quality.

Description

A kind of succinum love song Ge Lieting soft capsule preparations and its preparation technology
Technical field
The present invention relates to technical field of medicine, and in particular to a kind of succinum love song Ge Lieting soft capsule preparations and its Preparation technology.
Background technology
Bent Ge Lieting(Trelagliptin succinate), researched and developed by military field and Furiex, on 7 days March in 2015 City, trade name:Zafatek.Bent Ge Lieting is a kind of super long effective DPP IV(DPP-4)Inhibitor, by selectivity, holds Continuous property suppresses DPP-4, and so as to control blood sugar level, once, and similar DPP-4 inhibitor needs daily mouth to Weekly administration on market Take once, the medication advantage of Zafatek undoubtedly will provide more convenient therapeutic choice for diabeticss, be expected to significantly change The convenience and compliance of kind patient.
Bent Ge Lieting is a kind of weekly DPP IV (DPP-4) inhibitor, can cause incretin (Glucagon-like-peptide-1(GLP-1)With diabetes dependency pancreotropic hormone polypeptide(GIP)Inactivation, and islets of langerhans drop in this 2 kinds of intestinal Element plays an important role in blood glucose regulation.Suppress DPP-4, by increasing capacitance it is possible to increase blood sugar level dependency insulin secretion, from And control blood sugar level.
World Health Organization's report of 2011 points out that the whole world has about 3.5 hundred million people to suffer from diabetes, it was reported that China Just have more than 100,000,000 diabeticss.DPP-IV inhibitor is a class novel diabetes medicine, has been listed including sitagliptin, dimension Ge Lieting, BMS-477118, Li Gelieting, Egelieting etc., wherein the sitagliptin annual sales amount of first listing is beautiful more than 4,000,000,000 Unit, other similar drugs not yet have an outstanding behaviours due to homogeneity, and song Ge Lieting as it is first can realize once in a week to The small molecule diabetes medicament of medicine, is expected to have outstanding behaviours in keen competition
Treating diabetes correlation global medical is spent up to 548,000,000,000 dollars within 2013, accounts for the 11.6% of global medical expenditure, it is contemplated that By 2035, the global medical related to diabetes spent and is up to 627,300,000,000 dollars.Counted according to IMS, global diabetes Pharmaceutical market scale broke through 40,000,000,000 dollars in 2012, had reached 42,400,000,000 dollars, and rate of increase has reached 8.2%, is higher than Global pharmaceutical market speedup, in global drug market position is ranked fourth.With global diabeticss number and sickness rate not The continuous propulsion of disconnected soaring and new drug development, diabetic market scale will dilatation year by year.
The content of the invention
It is an object of the invention to provide a kind of succinum love song Ge Lieting soft capsule preparations.
It is, up to above-mentioned purpose, a kind of succinum love song Ge Lieting soft capsule preparations to be provided in one embodiment of the present of invention, Including soft capsule and content, content prescription is:
Succinum love song Ge Lieting 0.5~1g of raw material;
Caprylocaproyl Macrogolglycerides 200g~250g;
Polyglycerol acrylate 30g~60g;
Medium chain Triglyceride 50g~100g;
DBPC 2,6 ditertiary butyl p cresol 0.02g~0.05g.
In one preferred version of the present invention, content prescription is:
Succinum love song Ge Lieting raw material 0.5g;
Caprylocaproyl Macrogolglycerides 220g~240g;
Polyglycerol acrylate 40g~50g;
Medium chain Triglyceride 60g~90g;
DBPC 2,6 ditertiary butyl p cresol 0.03g~0.04g.
In one preferred version of the present invention, content prescription is:
Succinum love song Ge Lieting raw material 0.5g;
Caprylocaproyl Macrogolglycerides 220g;
Polyglycerol acrylate 45g;
Medium chain Triglyceride 75g;
DBPC 2,6 ditertiary butyl p cresol 0.035g.
In one preferred version of the present invention, content prescription is:
Succinum love song Ge Lieting raw material 1g;
Caprylocaproyl Macrogolglycerides 235g;
Polyglycerol acrylate 48g;
Medium chain Triglyceride 78g;
DBPC 2,6 ditertiary butyl p cresol 0.04g.
In one preferred version of the present invention, the prescription of soft capsule is:
Gelatin 140mg~180mg;
Glycerol 70mg~100mg;
Yellow ferric oxide 0.1mg~0.4mg;
Titanium dioxide 1mg~3mg.
In one preferred version of the present invention, the prescription of soft capsule is:
Gelatin 160mg;
Glycerol 80mg;
Yellow ferric oxide 0.29mg;
Titanium dioxide 2mg.
In one preferred version of the present invention, the prescription of soft capsule is:
Gelatin 150mg;
Glycerol 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 succinum love song Ge Lieting soft capsule preparations, including with Lower step:
(1) content is prepared:Caprylocaproyl Macrogolglycerides, polyglycerol acrylate and the medium chain triglyceride three for taking recipe quantity is sour Ester stirs, and the succinum love song Ge Lieting crude drug and 2,6 ditertiary butyl p cresol of recipe quantity are added after intensification, continues to stir Room temperature is down to after mixing uniformly, content is obtained;
(2) soft capsule is prepared:It is uniformly mixed in glycerol addition water the being placed in glue tank for taking recipe quantity, is subsequently adding what is sieved Titanium dioxide and yellow ferric oxide mix homogeneously, are subsequently adding gelatin and are heated to 60 DEG C~80 DEG C;Continue to stir to gelatin It is completely dissolved;Vacuum is opened after Gelatin makes glue deaerate, and degassing is lowered the temperature after finishing;
(3) pill:Inside Contents Fill to soft capsule, will shape, be dried using soft capsule, obtain pastille soft capsule.
In one preferred version of the present invention, Caprylocaproyl Macrogolglycerides, polyglycerol acrylate and medium chain triglyceride Three acid esters stir, and succinum love song Ge Lieting crude drug and 2,6 ditertiary butyl p cresol are added after being warming up to 40 DEG C.
In one preferred version of the present invention, the capsule severe edema due to hypofunction of the spleen of pastille soft capsule is divided into 8%~12%.
The polyglycerol acrylate of the present invention is bought in the product polyglycerol acrylate of the good method lion of France.
In sum, the present invention has advantages below:
The succinum love song Ge Lieting soft capsules of the present invention, can significantly improve the dissolution accumulation dissolution of 5 minutes, improve principal agent and exist The dissolution efficiency of front time period;With good stability, product appearance quality is good.Secondly the present invention is by the excellent of component Change and select, reduce harmful effect of the Propylene Glycol to principal agent migration, stability, dissolution and bioavailability.
Specific embodiment
Embodiment 1
Succinum love song Ge Lieting soft capsule preparation content prescriptions:
Succinum love song Ge Lieting raw material 0.5g;Caprylocaproyl Macrogolglycerides 220g;
Polyglycerol acrylate 45g;Medium chain Triglyceride 75g;
DBPC 2,6 ditertiary butyl p cresol 0.035g.
Soft capsule prescription:
Gelatin 160mg;Glycerol 80mg;
Yellow ferric oxide 0.29mg;Titanium dioxide 2mg.
Preparation method:
(1) content is prepared:Caprylocaproyl Macrogolglycerides, polyglycerol acrylate and the medium chain triglyceride three for taking recipe quantity is sour Ester stirs, and is warmed up to after 40 DEG C and adds the succinum love song Ge Lieting crude drug and 2,6 ditertiary butyl p cresol of recipe quantity, Continue to stir 1h to room temperature is down to after uniform, obtain content;
(2) soft capsule is prepared:It is uniformly mixed in glycerol addition water the being placed in glue tank for taking recipe quantity, was subsequently adding 80 mesh The titanium dioxide and yellow ferric oxide mix homogeneously of sieve, is subsequently adding gelatin and is 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 Lower the temperature 60 DEG C after finishing, stand standby after 24h;
(3) pill:Encapsulating machine is heated after being debugged to sprinkler body;Adjustment revolving die pressure, is advisable with just extruding soft gelatin capsule, Pressure is avoided to cross conference mold damage.Loading amount regulation is carried out, sampling detection extrudes crack quality, outward appearance, the content weight of soft gelatin capsule, Adjust in time, till meeting the requirements;Cylinder is opened, by the soft gelatin capsule sizing of compacting;The soft gelatin capsule of compacting is determined in cylinder Take out after type, be placed in 30 DEG C, be dried 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
Succinum love song Ge Lieting soft capsule preparation content prescriptions:
Succinum love song Ge Lieting raw material 0.5g;Caprylocaproyl Macrogolglycerides 225g;
Polyglycerol acrylate 50g;Medium chain Triglyceride 72g;
DBPC 2,6 ditertiary butyl p cresol 0.038g.
Soft capsule prescription:
Gelatin 160mg;Glycerol 80mg;
Yellow ferric oxide 0.25mg;Titanium dioxide 2.2mg.
Preparation method:
(1) content is prepared:Caprylocaproyl Macrogolglycerides, polyglycerol acrylate and the medium chain triglyceride three for taking recipe quantity is sour Ester stirs, and is warmed up to after 40 DEG C and adds the succinum love song Ge Lieting crude drug and 2,6 ditertiary butyl p cresol of recipe quantity, Continue to stir 1h to room temperature is down to after uniform, obtain content;
(2) soft capsule is prepared:It is uniformly mixed in glycerol addition water the being placed in glue tank for taking recipe quantity, was subsequently adding 80 mesh The titanium dioxide and yellow ferric oxide mix homogeneously of sieve, is subsequently adding gelatin and is 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 Lower the temperature 60 DEG C after finishing, stand standby after 24h;
(3) pill:Encapsulating machine is heated after being debugged to sprinkler body;Adjustment revolving die pressure, is advisable with just extruding soft gelatin capsule, Pressure is avoided to cross conference mold damage.Loading amount regulation is carried out, sampling detection extrudes crack quality, outward appearance, the content weight of soft gelatin capsule, Adjust in time, till meeting the requirements;Cylinder is opened, by the soft gelatin capsule sizing of compacting;The soft gelatin capsule of compacting is determined in cylinder Take out after type, be placed in 30 DEG C, be dried 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
Succinum love song Ge Lieting soft capsule preparation content prescriptions:
Succinum love song Ge Lieting raw material 1g;Caprylocaproyl Macrogolglycerides 250g;
Polyglycerol acrylate 55g;Medium chain Triglyceride 85g;
Soft capsule prescription:
Gelatin 161mg;Glycerol 85mg;
Yellow ferric oxide 0.27mg;Titanium dioxide 2mg.
Preparation method:
(1) content is prepared:Caprylocaproyl Macrogolglycerides, polyglycerol acrylate and the medium chain triglyceride three for taking recipe quantity is sour Ester stirs, and the succinum love song Ge Lieting crude drug that recipe quantity is added after being warmed up to 40 DEG C continues to stir 1h to being down to after uniform Room temperature, obtains content;
(2) soft capsule is prepared:It is uniformly mixed in glycerol addition water the being placed in glue tank for taking recipe quantity, was subsequently adding 80 mesh The titanium dioxide and yellow ferric oxide mix homogeneously of sieve, is subsequently adding gelatin and is 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 Lower the temperature 60 DEG C after finishing, stand standby after 24h;
(3) pill:Encapsulating machine is heated after being debugged to sprinkler body, and control temperature is at 35 DEG C;Adjustment revolving die pressure, with firm Extrude soft gelatin capsule well to be advisable, it is to avoid pressure crosses conference mold damage.Loading amount regulation is carried out, sampling detection extrudes the crack matter of soft gelatin capsule Amount, outward appearance, content weight, adjust in time, till meeting the requirements;Cylinder is opened, by the soft gelatin capsule sizing of compacting;Will pressure The soft gelatin capsule of system takes out after cylinder 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
Succinum love song Ge Lieting soft capsule preparation content prescriptions:
Succinum love song Ge Lieting raw material 1g;Caprylocaproyl Macrogolglycerides 290g;
Polyglycerol acrylate 80g;Medium chain Triglyceride 90g;
Butylated hydroxyanisole BHA0.035g.
Soft capsule prescription:
Gelatin 160mg;Glycerol 85mg;
Yellow ferric oxide 0.28mg;Titanium dioxide 2mg.
Preparation method:
(1) content is prepared:Caprylocaproyl Macrogolglycerides, polyglycerol acrylate and the medium chain triglyceride three for taking recipe quantity is sour Ester stirs, be warmed up to after 40 DEG C add recipe quantity succinum love song Ge Lieting crude drug and Butylated hydroxyanisole BHA after Continuous stirring 1h obtains content to room temperature is down to after uniform;
(2) soft capsule is prepared:It is uniformly mixed in glycerol addition water the being placed in glue tank for taking recipe quantity, was subsequently adding 80 mesh The titanium dioxide and yellow ferric oxide mix homogeneously of sieve, is subsequently adding gelatin and is 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 Lower the temperature 60 DEG C after finishing, stand standby after 24h;
(3) pill:Encapsulating machine is heated after being debugged to sprinkler body;Adjustment revolving die pressure, is advisable with just extruding soft gelatin capsule, Pressure is avoided to cross conference mold damage.Loading amount regulation is carried out, sampling detection extrudes crack quality, outward appearance, the content weight of soft gelatin capsule, Adjust in time, till meeting the requirements;Cylinder is opened, by the soft gelatin capsule sizing of compacting;The soft gelatin capsule of compacting is determined in cylinder Take out after type, be placed in 30 DEG C, be dried 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
Succinum love song Ge Lieting soft capsule preparation content prescriptions:
Succinum love song Ge Lieting raw material 0.5g;Caprylocaproyl Macrogolglycerides 225g;
Polyglycerol acrylate 46g;Medium chain Triglyceride 75g;
Sodium pyrosulfite 0.036g.
Soft capsule prescription:
Gelatin 160mg;Glycerol 85mg;
Yellow ferric oxide 0.28mg;Titanium dioxide 2mg.
Preparation method:
(1) content is prepared:Caprylocaproyl Macrogolglycerides, polyglycerol acrylate and the medium chain triglyceride three for taking recipe quantity is sour Ester stirs, and is warmed up to after 40 DEG C and adds the succinum love song Ge Lieting crude drug and sodium pyrosulfite of recipe quantity, continues to stir 1h obtains content to room temperature is down to after uniform;
(2) soft capsule is prepared:It is uniformly mixed in glycerol addition water the being placed in glue tank for taking recipe quantity, was subsequently adding 80 mesh The titanium dioxide and yellow ferric oxide mix homogeneously of sieve, is subsequently adding gelatin and is 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 Lower the temperature 60 DEG C after finishing, stand standby after 24h;
(3) pill:Encapsulating machine is heated after being debugged to sprinkler body, and control temperature is at 35 DEG C;Adjustment revolving die pressure, with firm Extrude soft gelatin capsule well to be advisable, it is to avoid pressure crosses conference mold damage.Loading amount regulation is carried out, sampling detection extrudes the crack matter of soft gelatin capsule Amount, outward appearance, content weight, adjust in time, till meeting the requirements;Cylinder is opened, by the soft gelatin capsule sizing of compacting;Will pressure The soft gelatin capsule of system takes out after cylinder 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 succinum love song Ge Lieting soft capsule preparations, including soft capsule and content, it is characterised in that:At the content Fang Wei:
Succinum love song Ge Lieting 0.5 ~ 1g of raw material;
Caprylocaproyl Macrogolglycerides 200g ~ 250g;
Polyglycerol acrylate 30g ~ 60g;
Medium chain Triglyceride 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:
Succinum love song Ge Lieting raw material 0.5g;
Caprylocaproyl Macrogolglycerides 220g ~ 240g;
Polyglycerol acrylate 40g ~ 50g;
Medium chain Triglyceride 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:
Succinum love song Ge Lieting raw material 0.5g;
Caprylocaproyl Macrogolglycerides 220g;
Polyglycerol acrylate 45g;
Medium chain Triglyceride 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:
Succinum love song Ge Lieting raw material 1g;
Caprylocaproyl Macrogolglycerides 235g;
Polyglycerol acrylate 48g;
Medium chain Triglyceride 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;
Glycerol 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;
Glycerol 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;
Glycerol 92mg;
Yellow ferric oxide 0.35mg;
Titanium dioxide 2.5mg.
8. the technique for preparing arbitrary succinum love song Ge Lieting soft capsule preparations in claim 1 ~ 7, comprises the following steps:
(1)Prepare content:Caprylocaproyl Macrogolglycerides, polyglycerol acrylate and the medium chain triglyceride three for taking recipe quantity is sour Ester stirs, and the succinum love song Ge Lieting crude drug and 2,6 ditertiary butyl p cresol of recipe quantity are added after intensification, continues to stir Room temperature is down to after mixing uniformly, content is obtained;
(2)Prepare soft capsule:It is uniformly mixed in glycerol addition water the being placed in glue tank for taking recipe quantity, is subsequently adding what is sieved Titanium dioxide and yellow ferric oxide mix homogeneously, are subsequently adding gelatin and are heated to 60 DEG C ~ 80 DEG C;Continue to stir complete to gelatin CL;Vacuum is opened after Gelatin makes glue deaerate, and degassing is lowered the temperature after finishing;
(3)Pill:Inside Contents Fill to soft capsule, will shape, be dried using soft capsule, obtain pastille soft capsule.
9. preparation technology as claimed in claim 8, it is characterised in that:The Caprylocaproyl Macrogolglycerides, polyglycereol Oleate and Medium chain Triglyceride stir, and succinum love song Ge Lieting crude drug and the uncle of 2,6- bis- are added after being warming up to 40 DEG C Butyl paracresol.
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%.
CN201710000247.7A 2017-01-02 2017-01-02 Trelagliptin succinate soft capsule preparation and preparation process thereof Pending CN106580913A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201710000247.7A CN106580913A (en) 2017-01-02 2017-01-02 Trelagliptin succinate soft capsule preparation and preparation process thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201710000247.7A CN106580913A (en) 2017-01-02 2017-01-02 Trelagliptin succinate soft capsule preparation and preparation process thereof

Publications (1)

Publication Number Publication Date
CN106580913A true CN106580913A (en) 2017-04-26

Family

ID=58582294

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201710000247.7A Pending CN106580913A (en) 2017-01-02 2017-01-02 Trelagliptin succinate soft capsule preparation and preparation process thereof

Country Status (1)

Country Link
CN (1) CN106580913A (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104825413A (en) * 2015-05-25 2015-08-12 浙江华海药业股份有限公司 Oral tablet containing trelagliptin succinate 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

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104825413A (en) * 2015-05-25 2015-08-12 浙江华海药业股份有限公司 Oral tablet containing trelagliptin succinate 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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Similar Documents

Publication Publication Date Title
JP2006016395A (en) Pharmaceutical formulation for safe administration of drug used for treatment of drug dependency and method for obtaining pharmaceutical formulation
CN103285398B (en) Compound preparation containing DPP-IV (dipeptidyl peptidase-IV) inhibitor and type-II diabetes medicine and preparation method thereof
JP7060589B2 (en) A drug preparation containing polyethylene glycol loxonate and a method for producing the same.
CN104840415A (en) Long-acting controlled release liposome gel combination containing blood sugar reducing active component, and preparation method thereof
CN101601659B (en) Glutathione enteric-coated pellet and preparation method thereof
WO2013169007A1 (en) Sustained-release complex preparations for treating diabetes with improved drug compliance and method for preparing same
CN106580913A (en) Trelagliptin succinate soft capsule preparation and preparation process thereof
CN107982241B (en) Potassium sodium dehydroandroan drographolide succinate enteric preparation and preparation method thereof
CN106619567A (en) Trelagliptin succinate rapid-release pellet preparation and preparation method thereof
CN107260697A (en) A kind of Metformin hydrochloride controlled release tablet and preparation method thereof
CN100537593C (en) Glycyrrhizic acid double salt and preparation thereof
CN103565774A (en) Glipizide controlled release composition as well as preparation method thereof
CN107982268A (en) A kind of tolvaptan preparation and its application
JP2024518060A (en) Pharmaceutical composition for treating hyperlipidemia and preparation method thereof
CN1775208A (en) Liver-tonifying formulation prepared from silymarin and its preparing method
CN102755302A (en) Delayed release preparation containing safe and reliable plasticizer and preparation method thereof
CN104840480B (en) Metformin/folic acid/vitamin B12New application of pharmaceutical composition
CN105769796B (en) A kind of pharmaceutical preparation and preparation method thereof containing vildagliptin and Metformin hydrochloride
CN103622930B (en) Metformin hydrochloride slow release preparation and preparation method thereof
CN105796503A (en) Saxagliptin micro-pill and preparation method thereof
CN106667954A (en) Diacerein soft capsule preparation and preparation process thereof
CN106860424A (en) A kind of Tadalafei fast release micropill preparation, preparation method
CN101502516B (en) Glipizide enteric-coated formulation composition and method for preparing the same
CN111184703B (en) Arsenic trioxide slow-release pill and preparation method thereof
CN101584754A (en) Medicinal preparation used for liver and gallbladder diseases and preparation method thereof

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
WD01 Invention patent application deemed withdrawn after publication
WD01 Invention patent application deemed withdrawn after publication

Application publication date: 20170426