CN107184952A - A kind of lisinopril compound preparation and preparation method thereof - Google Patents
A kind of lisinopril compound preparation and preparation method thereof Download PDFInfo
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- CN107184952A CN107184952A CN201710440753.8A CN201710440753A CN107184952A CN 107184952 A CN107184952 A CN 107184952A CN 201710440753 A CN201710440753 A CN 201710440753A CN 107184952 A CN107184952 A CN 107184952A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/05—Dipeptides
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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
- A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2063—Proteins, e.g. gelatin
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Abstract
The invention belongs to biomedicine technical field, and in particular to a kind of lisinopril compound preparation and preparation method thereof.For existing Lisinopril Tablets in Chinese Volunteers when for diabetes mellitus hyperpietic, the problem of antihypertensive effect is bad, the present invention provides a kind of lisinopril compound preparation, including following components：10 20 parts of lisinopril, 10 20 parts of gliquidone, 100 500 parts of auxiliary material.Its preparation method is：Softwood A is made in lisinopril and pan feeding, softwood B is made in gliquidone and auxiliary material；Same dose softwood A and softwood B are taken, uniform tabletting forms tablet, is placed in the lactose solution that concentration is 80 90% and soaks 3 5h, lisinopril compound preparation is produced after drying.Lisinopril compound preparation prepared by the present invention can first reduce blood sugar concentration, in blood glucose hypotensive under normal circumstances, and more preferably, its preparation method is simple, is adapted to promote the use of for effect.
Description
Technical field
The invention belongs to biomedicine technical field, and in particular to a kind of lisinopril compound preparation and preparation method thereof.
Background technology
Lisinopril is the lysine derivative of enalaprilat, and belonging to has the suppression of third generation Angiotensin-Converting
Agent, can suppress the activity of Angiotensin-Converting, make the concentration of angiotensinⅡ and aldosterone and reduce, and raise plasma renin
Activity, causes peripheral vascular expansion and vascular resistence to decline, so as to produce pressure reduction effect.
Lisinopril has remarkable antihypertensive effect, effectively control 24h blood pressures, and the result of dynamic hematometry is shown, one day
Sustainable a more than 24h of anti-hypertension effect, is not adversely affected simultaneously for the Circadian variation of heart rate and blood pressure.Rely
Promise Puli also has good Renoprotective Effect, effectively reduces Urine proteins, improves renal function, is that hypertension complicated with diabetes mellitus is controlled
Treat choice drug.
But when facing the hyperpietic with diabetes, common Prinivil is difficult to effectively drop in decompression
Blood glucose, the effect for being depressured maintenance is also poor, easily gos up after drug withdrawal, dosage increase.
The content of the invention
The technical problem to be solved in the present invention is：Existing Lisinopril Tablets in Chinese Volunteers is difficult when for diabetes mellitus hyperpietic
With blood pressure and blood sugar with drop, the problem of antihypertensive effect is bad.
The present invention solve technical problem technical scheme be：A kind of lisinopril compound preparation and preparation method thereof is provided.
The lisinopril compound preparation of the present invention, including following components：10-20 parts of lisinopril, gliquidone 10-20
Part, 100-500 parts of auxiliary material.
It is preferred that, above-mentioned lisinopril compound preparation, including following components：10-20 parts of lisinopril, gliquidone 10-
20 parts, 150-350 parts of auxiliary material.
Further, in above-mentioned lisinopril compound preparation, the auxiliary material includes excipients, disintegrant, lubricant, hydrotropy
At least one of agent, flavouring or adhesive.
Further, in above-mentioned lisinopril compound preparation, the auxiliary material be lactose, starch, dextrin, microcrystalline cellulose,
At least one of PVP, gelatin, superfine silica gel powder or polyethylene glycol.
It is preferred that, in above-mentioned lisinopril compound preparation, the auxiliary material is lactose, starch, dextrin, microcrystalline cellulose, poly-
Tie up the mixture of ketone, gelatin, superfine silica gel powder and polyethylene glycol.
It is furthermore preferred that in above-mentioned lisinopril compound preparation, in the auxiliary material, lactose is 10-100 parts, and starch is 10-30
Part, 20-70 parts of dextrin, 10-100 parts of microcrystalline cellulose, 10-20 parts of PVP, 20-30 parts of gelatin, 10-20 parts of superfine silica gel powder,
30-50 parts of polyethylene glycol.
Present invention also offers a kind of preparation method of above-mentioned lisinopril compound preparation, comprise the following steps：
A, lisinopril is dissolved in the PVP aqueous solution that concentration is 5-10%, adds starch, gelatin and suitable quantity of water,
Stir and softwood A is made, place 20-24h at room temperature；
B, gliquidone, dextrin, microcrystalline cellulose and superfine silica gel powder are uniformly mixed after, add polyethylene glycol,
Stirring, it is standby that softwood B is made；
C, the softwood B for taking the softwood A and step b of same dose step a preparations to prepare, uniform tabletting form tablet, are placed in
Concentration produces lisinopril compound preparation to soak 3-5h in 80-90% lactose solution after drying.
Wherein, in the preparation method of above-mentioned lisinopril compound preparation, water content is 10- in the softwood A described in step a
15%.
Wherein, in the preparation method of above-mentioned lisinopril compound preparation, the softwood B water content described in step b is 7-
10%.
Wherein, in the preparation method of above-mentioned lisinopril compound preparation, the tableting pressure described in step c is 10-
20Mpa, pelletizing temperature is 20-25 DEG C.
Wherein, in the preparation method of above-mentioned lisinopril compound preparation, drying temperature described in step c is 30-50 DEG C.
Beneficial effects of the present invention are：The present invention chooses lisinopril and gliquidone prepares compound preparation, on the one hand solves
The problem of hypertension of having determined, blood glucose can be effectively on the other hand controlled again, both medicines play synergy, and gliquidone exists
2-2.5h starts release after medication, and then 6-8h releases work lisinopril after the tablet has been ingested, take the lisinopril compound of the present invention
During preparation, blood glucose is first controlled before decompression, blood pressure is more stable more easy to control.The preparation method of the present invention is simple to operate, equipment
It is required that it is low, suitably promote the use of.
Embodiment
The invention provides a kind of lisinopril compound preparation, including following components：10-20 parts of lisinopril, lattice row quinoline
10-20 parts of ketone, 100-500 parts of auxiliary material.
It is preferred that, above-mentioned lisinopril compound preparation, including following components：10-20 parts of lisinopril, gliquidone 10-
20 parts, 150-350 parts of auxiliary material.
Further, in above-mentioned lisinopril compound preparation, the auxiliary material includes excipients, disintegrant, lubricant, hydrotropy
At least one of agent, flavouring or adhesive.
Further, in above-mentioned lisinopril compound preparation, the auxiliary material be lactose, starch, dextrin, microcrystalline cellulose,
At least one of PVP, gelatin, superfine silica gel powder or polyethylene glycol.
It is preferred that, in above-mentioned lisinopril compound preparation, the auxiliary material is lactose, starch, dextrin, microcrystalline cellulose, poly-
Tie up the mixture of ketone, gelatin, superfine silica gel powder and polyethylene glycol.
It is furthermore preferred that in above-mentioned lisinopril compound preparation, in the auxiliary material, lactose is 10-100 parts, and starch is 10-30
Part, 20-70 parts of dextrin, 10-100 parts of microcrystalline cellulose, 10-20 parts of PVP, 20-30 parts of gelatin, 10-20 parts of superfine silica gel powder,
30-50 parts of polyethylene glycol.
Present invention also offers a kind of preparation method of above-mentioned lisinopril compound preparation, comprise the following steps：
A, lisinopril is dissolved in the PVP aqueous solution that concentration is 5-10%, adds starch, gelatin and suitable quantity of water,
Stir and softwood A is made, place 20-24h at room temperature；
B, gliquidone, dextrin, microcrystalline cellulose and superfine silica gel powder are uniformly mixed after, add polyethylene glycol,
Stirring, it is standby that softwood B is made；
C, the softwood B for taking the softwood A and step b of same dose step a preparations to prepare, uniform tabletting form tablet, are placed in
Concentration produces lisinopril compound preparation to soak 3-5h in 80-90% lactose solution after drying.
Wherein, in the preparation method of above-mentioned lisinopril compound preparation, water content is 10- in the softwood A described in step a
15%.
Wherein, in the preparation method of above-mentioned lisinopril compound preparation, the softwood B water content described in step b is 7-
10%.
Wherein, in the preparation method of above-mentioned lisinopril compound preparation, the tableting pressure described in step c is 10-
20Mpa, pelletizing temperature is 20-25 DEG C.
Wherein, in the preparation method of above-mentioned lisinopril compound preparation, drying temperature described in step c is 30-50 DEG C.
Lisinopril is a kind of ACEI1 of high tissue affinity.Pharmacology (1) is depressured：This product is hydrolyzed to benzene in liver, and that is general
Li La, as a kind of emulative angiotensin converting enzyme inhibitor, prevention angiotensin i-converting is angiotensins
II, reduces vascular resistence, and Aldosterone Secretion is reduced, and plasma renin activity increases.Benazeprilat also suppresses the drop of bradykinin
Solution, also reduces vascular resistence, produces antihypertensive effect.(2) cardiac load is lowered：Around this product expansion artery and vein, reduction
Vascular resistence or cardiac afterload, reduction pulmonary capillaries are snapped or cardiac preload, pulmonary vascular resistance are also reduced, so as to improve
Cardiac output, makes exercise tolerance and time lengthening.2. toxicity rat and mouse sustained oral Benazepril 2 years, dosage is daily
150mg/kg, does not have found that this product has carcinogenicity.(dosage is calculated by mg/kg, is 110 times of mankind's research on maximum utilized quantity；By mg/m2
Calculate, be 18 times and 9 times of mankind's research on maximum utilized quantity).Though in bacteria test, the mammalian cell still cultivated in vitro
Do not find that this product has mutagenicity in experiment.Female, male Oral Administration in Rats Benazepril, dosage is daily 50-150mg/kg, is not sent out
Existing this product influence fecundity.(dosage is calculated by mg/kg, is 37~375 times of mankind's research on maximum utilized quantity；Calculated by mg/m2,
For 6~60 times of mankind's research on maximum utilized quantity).
Gliquidone is second generation sulfonylureas oral hypoglycemic.Its mechanism of action and other oral sulfonylureas hypoglycemic agents
Identical, in treatment early stage to promote based on endogenous insulin secretion, its main function is to improve after being treated through a period of time
Sensitiveness of the surrounding tissue to insulin.It can promote pancreatic islet B cell excreting insulin, and prerequisite is B cell
Also certain synthesis and the function of excreting insulin；Can also be by increasing portal vein insulin level or making to liver is direct
With suppression hepatic glycogenolytic and gluconeogenesis, liver generation and output glucose are reduced；It may also increase outside pancreas and organize to pancreas
The sensitiveness of island element and the utilization (may be mainly by being acted on after acceptor) of sugar.
Gliquidone oral absorption is fast, oral rear 2~3 hours blood concentration peakings, and the duration, will up to 8 hours
Gliquidone is prepared into uniform compound preparation with lisinopril, and blood glucose can be controlled before depressor dissolution comes into force in normal water
Flat, antihypertensive effect is more preferable, it is adaptable to the hyperpietic of diabetes, it is to avoid patient takes decompression in the case where blood glucose is high
Medicine, aggravates burden of liver, and antihypertensive effect is bad.
Explanation is further explained to the embodiment of the present invention below by embodiment, but does not indicate that and sends out this
Bright protection domain is limited in described in embodiment in scope.
Embodiment 1 prepares lisinopril compound preparation with the inventive method
The formula of the lisinopril compound preparation is constituted：10 parts of lisinopril, 10 parts of gliquidone, lactose is 100
Part, starch is 30 parts, 70 parts of dextrin, 100 parts of microcrystalline cellulose, 20 parts of PVP, 30 parts of gelatin, 20 parts of superfine silica gel powder, poly- second
50 parts of glycol.
Specific preparation method operation is as follows：
A, lisinopril is dissolved in the PVP aqueous solution that concentration is 5%, adds starch, gelatin and suitable quantity of water, stir
Mix and softwood A is uniformly made, place 20h at room temperature；
B, gliquidone, dextrin, microcrystalline cellulose and superfine silica gel powder are uniformly mixed after, add polyethylene glycol,
Stirring, it is standby that softwood B is made；
C, the softwood B for taking the softwood A and step b of same dose step a preparations to prepare, uniform tabletting form tablet, are placed in
Concentration produces lisinopril compound preparation to soak 3h in 80% lactose solution after drying.
Embodiment 2 prepares lisinopril compound preparation with the inventive method
The formula of the lisinopril compound preparation is constituted：20 parts of lisinopril, 20 parts of gliquidone, lactose is 10
Part, starch is 10 parts, 20 parts of dextrin, 10 parts of microcrystalline cellulose, 10 parts of PVP, 20 parts of gelatin, 10 parts of superfine silica gel powder, poly- second two
30 parts of alcohol.
Specific preparation method operation is as follows：
A, lisinopril is dissolved in the PVP aqueous solution that concentration is 10%, adds starch, gelatin and suitable quantity of water, stir
Mix and softwood A is uniformly made, place 24h at room temperature；
B, gliquidone, dextrin, microcrystalline cellulose and superfine silica gel powder are uniformly mixed after, add polyethylene glycol,
Stirring, it is standby that softwood B is made；
C, the softwood B for taking the softwood A and step b of same dose step a preparations to prepare, uniform tabletting form tablet, are placed in
Concentration produces lisinopril compound preparation to soak 5h in 90% lactose solution after drying.
Embodiment 3 prepares lisinopril compound preparation with the inventive method
The formula of the lisinopril compound preparation is constituted：15 parts of lisinopril, 15 parts of gliquidone, lactose is 50
Part, starch is 20 parts, 50 parts of dextrin, 50 parts of microcrystalline cellulose, 20 parts of PVP, 20 parts of gelatin, 20 parts of superfine silica gel powder, poly- second two
40 parts of alcohol.
Specific preparation method operation is as follows：
A, lisinopril is dissolved in the PVP aqueous solution that concentration is 10%, adds starch, gelatin and suitable quantity of water, stir
Mix and softwood A is uniformly made, place 24h at room temperature；
B, gliquidone, dextrin, microcrystalline cellulose and superfine silica gel powder are uniformly mixed after, add polyethylene glycol,
Stirring, it is standby that softwood B is made；
C, the softwood B for taking the softwood A and step b of same dose step a preparations to prepare, uniform tabletting form tablet, are placed in
Concentration produces lisinopril compound preparation to soak 5h in 90% lactose solution after drying.
Three kinds of lisinopril compound preparations that embodiment is prepared are tested with commercially available Prinivil, are examined
Dissolution rate is examined, it is as a result as shown in table 1 below.
The lisinopril compound preparation and common Prinivil prepared in embodiment by the inventive method is carried out
Dissolution determination, instrument：ZRS-4 medicament dissolution instruments, rotating speed：50 revs/min, surveyed respectively at 0.5,1,2,4,8,12,24h samplings
It is fixed.Assay method：Using ultraviolet spectrophotometry, Detection wavelength 286nm.
The different lisinopril dissolution rate of table 1
It can be seen that by dissolution rate, in lisinopril compound preparation of the invention, gliquidone can reach in 2h or so
More than 97%, can be effectively hypoglycemic.Until during lisinopril dissolution, blood sugar concentration is decreased, antihypertensive effect is more preferable.
Claims (11)
1. lisinopril compound preparation, it is characterised in that including following components：10-20 parts of lisinopril, gliquidone 10-20
Part, 100-500 parts of auxiliary material.
2. lisinopril compound preparation according to claim 1, it is characterised in that including following components：Lisinopril 10-
20 parts, 10-20 parts of gliquidone, 150-350 parts of auxiliary material.
3. lisinopril compound preparation according to claim 1, it is characterised in that：The auxiliary material includes excipients, disintegration
At least one of agent, lubricant, cosolvent, flavouring or adhesive.
4. lisinopril compound preparation according to claim 1, it is characterised in that：The auxiliary material is lactose, starch, paste
At least one of essence, microcrystalline cellulose, PVP, gelatin, superfine silica gel powder or polyethylene glycol.
5. lisinopril compound preparation according to claim 1, it is characterised in that：The auxiliary material is lactose, starch, paste
Essence, microcrystalline cellulose, PVP, gelatin, the mixture of superfine silica gel powder and polyethylene glycol.
6. lisinopril compound preparation according to claim 1, it is characterised in that：In the auxiliary material, lactose is 10-100
Part, starch is 10-30 parts, and 20-70 parts of dextrin, 10-100 parts of microcrystalline cellulose, 10-20 parts of PVP, 20-30 parts of gelatin is micro-
10-20 parts of powder silica gel, 30-50 parts of polyethylene glycol.
7. the preparation method of the lisinopril compound preparation described in claim any one of 1-6, it is characterised in that including following step
Suddenly：
A, lisinopril is dissolved in the PVP aqueous solution that concentration is 5-10%, adds starch, gelatin and suitable quantity of water, stirring
It is uniform that softwood A is made, place 20-24h at room temperature；
B, gliquidone, dextrin, microcrystalline cellulose and superfine silica gel powder are uniformly mixed after, add polyethylene glycol, stir
Softwood B uniformly is made standby；
C, the softwood B for taking the softwood A and step b of same dose step a preparations to prepare, uniform tabletting form tablet, are placed in concentration
To soak 3-5h in 80-90% lactose solution, lisinopril compound preparation is produced after drying.
8. the preparation method of lisinopril compound preparation according to claim 7, it is characterised in that：Described in step a
Water content is 10-15% in softwood A.
9. the preparation method of lisinopril compound preparation according to claim 7, it is characterised in that：Described in step b
Softwood B water content is 7-10%.
10. the preparation method of lisinopril compound preparation according to claim 7, it is characterised in that：Described in step c
Tableting pressure is 10-20Mpa, and pelletizing temperature is 20-25 DEG C.
11. the preparation method of lisinopril compound preparation according to claim 7, it is characterised in that：Done described in step c
Dry temperature is 30-50 DEG C.
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| CN105944079A (en) * | 2016-05-05 | 2016-09-21 | 成都易胜科生物科技有限公司 | Safe and effective anti-hypertensive drug compound preparation |
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2017
- 2017-06-13 CN CN201710440753.8A patent/CN107184952A/en active Pending
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| CN1822820A (en) * | 2003-07-28 | 2006-08-23 | 雷迪实验室有限公司 | Treatment and prevention of cardiovascular events |
| CN1583173A (en) * | 2004-06-06 | 2005-02-23 | 李军生 | Serial medicines for hypertension and method for research, application and production |
| CN101024082A (en) * | 2007-04-06 | 2007-08-29 | 张士东 | Compounded medicine for wholely preventing and treating cardio-cerebral blood vessel diseases and use thereof |
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| CN105920024A (en) * | 2016-04-27 | 2016-09-07 | 荆燕 | Acarbose-containing compound preparation for treating diabetes mellitus complicated essential hypertension and preparation method thereof |
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| Title |
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| 余元勋等主编: "《中国分子糖尿病学》", 30 April 2016, 安徽科学技术出版社 * |
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