CN109674762A - A kind of composition capsule of dutasteride and hair growth - Google Patents
A kind of composition capsule of dutasteride and hair growth Download PDFInfo
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- CN109674762A CN109674762A CN201910164118.0A CN201910164118A CN109674762A CN 109674762 A CN109674762 A CN 109674762A CN 201910164118 A CN201910164118 A CN 201910164118A CN 109674762 A CN109674762 A CN 109674762A
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- dutasteride
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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
- 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
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
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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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/14—Drugs for dermatological disorders for baldness or alopecia
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Abstract
The invention discloses a kind of dutasteride and contain the composition capsule of dutasteride.Contain dutasteride 0.125mg in the simple grain capsule of dutasteride of the present invention, contains dutasteride 0.125mg, minoxidil 0.3-0.4mg in the simple grain capsule of composition capsule.The simple grain effective dose that the present invention passes through reduction dutasteride at double, do not influence dutasteride be used in, the treatments of the BPH patients of severe symptomatic (single takes four), it can be used in combination again with low dose of application method with minoxidil, effectively treat male androgen alopecia.The composition capsule being prepared simultaneously is directly administered orally, can effective hair growth.
Description
Technical field
The present invention relates to a kind of dutasteride's soft capsules, and the composition glue prepared using dutasteride and minoxidil
Capsule.
Background technique
Dutasteride (dutrsteride), chemical name are N- { 2,5- bis- (trifluoromethyl) phenyl } -3- carbonyl -4- nitrogen
- 5 α of miscellaneous hero ammonium--17 β of androstane -1- alkene-formamide, have chemical structure shown in formula 1, are that GlaxoSmithKline PLC (GSK) company opens
A kind of drug for prevention and treatment benign prostate hyperplasia of hair obtains FDA approval in June, 2003 and lists in the U.S.,
It is approved within 2011 to enter China.Dutasteride belongs to 5 alpha reductase inhibitors, and can inhibit 2 kind of 5 α of I type and II type simultaneously
The drug of reductase.Dutasteride is rapider compared with the effect of Fei Nata hero peace, and effect is more significant, the advantage with double inhibition.
It is found in the research of dutasteride's curative effect of medication, due to the 5 alpha-reductase inhibiting effect that it has, male can be reduced
Property type take off the trichomadesis of originator (male androgen alopecia), and can promote hair growth.But not to its hair growth into
The research of the further curative effect of row and safety.
Domestic patient in the case where no obvious curative effects, can attempt to take tool using Fei Nata hero peace progress alopeciaing therapeutic
There is the dutasteride of stronger 5 alpha-reductase inhibitory effect to carry out alopeciaing therapeutic.But since the commercial product of dutasteride is
The capsule of 0.5mg, main function are to reduce acute urine as used in, the BPH patients of severe symptomatic
The risk of retention (AUR) and operation, thereby increases and it is possible to increase the risk of high-grade prostate cancer.The inseparability of capsule, so that
The once used amount of dutasteride can not be reduced, safety and drug effect can not ensure.
Summary of the invention
The purpose of the invention is to provide a kind of capsule that can be used in male androgen alopeciaing therapeutic.
In order to achieve the above object, male containing his is spent in simple grain capsule the present invention provides a kind of dutasteride's soft capsule
Amine 0.125mg.
Preferably, the content of dutasteride's soft capsule uses dutasteride's self-microemulsifying system.
Wherein, dutasteride's self-microemulsifying system includes dutasteride, oil phase solvent, emulsifier and assistant for emulsifying agent.
Oil phase solvent uses the mixture of sad certain herbaceous plants with big flowers acid glycerol three ester and Monoolein；Emulsifier uses Tween-20
With the mixture of PEG-50 rilanit special；Assistant for emulsifying agent uses Transcultol P；
Specifically, the content of every 1000 dutasteride's soft capsules contains following components: dutasteride 0.125g, octanoic acid
Certain herbaceous plants with big flowers acid glycerol three ester 20-30g, Monoolein 30-40g, Tween-20 70-90g, PEG-50 rilanit special 70-100g,
Transcultol P 30-40g, DBPC 2,6 ditertiary butyl p cresol 0.01-0.02g.
Preferably, the weight ratio of oil phase solvent, emulsifier and assistant for emulsifying agent is 25:60:15.
Optimal, the content of every 1000 dutasteride's soft capsules contains following each component: dutasteride 0.125g, pungent
Sour certain herbaceous plants with big flowers acid glycerol three ester 27g, Monoolein 38g, Tween-20 77g, PEG-50 rilanit special 79g, Transcultol
P 39g, DBPC 2,6 ditertiary butyl p cresol 0.01g.
The present invention also provides a kind of composition capsule of hair growth, in simple grain capsule containing dutasteride 0.125mg,
Minoxidil 0.3-0.4mg.
Specifically, the content of every 1000 composition capsules contains following components: dutasteride 0.125g, minoxidil
0.3-0.4g, sad certain herbaceous plants with big flowers acid glycerol three ester 20-30g, Monoolein 30-40g, Tween-20 70-90g, PEG-50 hydrogenation
Castor oil 70-100g, Transcultol P 30-40g, DBPC 2,6 ditertiary butyl p cresol 0.01-0.02g.
Optimal, the content of every 1000 composition softs contains following each component: dutasteride 0.125g, minot
Ground that 0.3-0.4g, sad certain herbaceous plants with big flowers acid glycerol three ester 30g, Monoolein 40g, Tween-20 75g, PEG-50 rilanit special
75g, Transcultol P 30g, DBPC 2,6 ditertiary butyl p cresol 0.01g.
The present invention has the advantage that compared with prior art
1, the present invention by double reduce dutasteride simple grain effective dose, i.e., do not influence dutasteride be used in, again
The treatment (single takes four) of the BPH patients of symptom is spent, and can be with low dose of application method
It is used in combination with minoxidil, effectively treats male androgen alopecia.
2, the content of soft capsule uses self-emulsifying microemulsion medication system, and medicament storage is more stable, and can effectively improve life
Object availability.
3, the present invention has studied the oral preparation consumption proportion of dutasteride and minoxidil, avoids minoxidil tincture
The inconvenience of externally applied drug and peculiar smell also ensure curative effect while facilitating progress alopeciaing therapeutic.
Specific embodiment
The present invention is described in detail combined with specific embodiments below.
Embodiment 1
Dutasteride's soft capsule preparation: with the component proportion of the standby dutasteride's preparation AVODART of Ge Lansu corporation
1/4 preparation dutasteride's soft capsule.
Embodiment 2
The preparation of dutasteride's soft capsule:
Content composition: dutasteride 0.125g, sad certain herbaceous plants with big flowers acid glycerol three ester 30g, Monoolein 35g, Tween-20
70g, PEG-50 rilanit special 78g, Transcultol P 35g, DBPC 2,6 ditertiary butyl p cresol 0.02g；
Preparation method: sad certain herbaceous plants with big flowers acid glycerol three ester, the Monoolein, Tween-20, PEG-50 hydrogenation castor of formula ratio are taken
Sesame oil, Transcultol P, are warming up to 40-45 DEG C and stir evenly, and the dutasteride and 2 of formula ratio, 6- di-t-butyl pair is added
Cresols is uniformly mixed, and emulsification obtains stable content rapidly, prepares soft capsule 1000.
It after storage 6 months, measures its main ingredient and moves to content in capsule shells, be 0.7%.
Embodiment 3
The preparation of dutasteride's soft capsule:
Content forms dutasteride 0.125g, sad certain herbaceous plants with big flowers acid glycerol three ester 27g, Monoolein 38g, Tween-20
77g, PEG-50 rilanit special 79g, Transcultol P 39g, DBPC 2,6 ditertiary butyl p cresol 0.01g；Using embodiment 2
Method prepare soft capsule 1000.
It after storage 6 months, measures its main ingredient and moves to content in capsule shells, be 0.8%.
Embodiment 4: dutasteride's Stability of Soft Capsules test
The stability for the soft capsule being prepared in measurement embodiment 1,2,3.
The soft capsule that each embodiment is prepared is placed in 25 DEG C of progress long-time stability experiments, carries out accelerating in 40 DEG C real
It tests, as a result as shown in the table:
1 study on the stability experimental result of table
Embodiment 5: dutasteride's soft capsule Dissolution Rate Testing
1, dutasteride's soft capsule that Example 1,2,3 is prepared carries out the dissolution in vitro comparison in water
Test method: it using the basket method in " Chinese Pharmacopoeia " 2015 editions the 4th dissolution rates and drug release determination method, takes respectively
Test specimen is measured, and dissolution medium is 900mL water, and revolving speed is 50 turns/min；
Respectively at 5,10,15,20,30,45,60,90min timing sampling 5mL；
The content of dutasteride in sampling sample is measured with HPLC method (100 μ L of sample volume)；HPLC testing conditions are equal are as follows: benzene
Base silane bonded silica gel column (205 × 4.6mm, 5 μm)；Mobile phase: acetonitrile-methanol-water (40:20:35)；Detection wavelength:
240nm；Flow velocity: 1.0mL/min.
Measurement result: embodiment 1 prepare soft capsule maximum dissolution rate be 11%, the degree that embodiment 2,3 is prepared he
Male amine soft capsule reaches 100% in 30 minutes dissolution rates, and dissolution rate significantly improves.
2, dutasteride's soft capsule that Example 1,2,3 is prepared carries out the dissolution in vitro comparison in hydrochloric acid
Test method: it using the basket method in " Chinese Pharmacopoeia " 2015 editions the 4th dissolution rates and drug release determination method, takes respectively
Test specimen is measured, and dissolution medium is the hydrochloric acid of 900mL0.1mol/L, and revolving speed is 50 turns/min；
Respectively at 5,10,15,20,30,45,60,90min timing sampling 5mL；
The content of dutasteride in sampling sample is measured with HPLC method (100 μ L of sample volume)；HPLC testing conditions are equal are as follows: benzene
Base silane bonded silica gel column (205 × 4.6mm, 5 μm)；Mobile phase: acetonitrile-methanol-water (40:20:35)；Detection wavelength:
240nm；Flow velocity: 1.0mL/min.
Measurement result: embodiment 1 prepare soft capsule maximum dissolution rate be 13%, the degree that embodiment 2,3 is prepared he
Male amine soft capsule reaches 100% in 30 minutes dissolution rates, and dissolution rate significantly improves.
Embodiment 6
Composition capsule preparation:
Content composition: dutasteride 0.125g, minoxidil 0.3-0.4g, sad certain herbaceous plants with big flowers acid glycerol three ester 30g, glycerol list
Oleate 40g, Tween-20 75g, PEG-50 rilanit special 75g, Transcultol P 30g, 2,6- di-t-butyl are to first
Phenol 0.01g；
Complex capsule preparation: sad certain herbaceous plants with big flowers acid glycerol three ester, the Monoolein, Tween-20, PEG-50 hydrogen of formula ratio are taken
Change castor oil, Transcultol P, be warming up to 40-45 DEG C and stir evenly, be added the dutasteride of formula ratio, minoxidil and
2,6-di-tert-butyl p-cresol is uniformly mixed, and emulsification obtains stable content rapidly, prepares soft capsule 1000.
After storage 6 months, measures its main ingredient and move to content in capsule shells, dutasteride 0.7%, minoxidil are
0.8%.And investigation 6 months is stored at 25 DEG C to the content being prepared, no medicine crystal is precipitated, no lamination hair
It is raw.
And the dissolution in vitro in water and in hydrochloric acid is carried out to composition capsule using the method for embodiment 5 and is tested, 30
The dissolution rate of minute dutasteride and minoxidil reaches 100%.
7 safety testing of embodiment
The oral preparation as treatment hypertension of minoxidil, in composition capsule of the invention, although once used amount
Far below the dosage (2.5mg/ times) for blood pressure lowering, but still needs to the blood pressure that may cause to it reduction and carry out safety investigation.
The content being prepared in the embodiment of the present invention 6 is taken to be grouped gastric infusion, daily administration to healthy rat
Once, each dosage according to main ingredient minoxidil content 0.0006mg/Kg, 0.0008mg/Kg, 0.001mg/Kg,
0.002mg/Kg is grouped administration, and detects rat tail artery systolic pressure weekly, detects surrounding altogether, does not there is significant change.
8 hair growth effect example of embodiment
Carry out alopeciaing therapeutic:
Patient's selection: it has been diagnosed as the sex patient of 18 to 60 years old of androgenetic alopecia, according to gender, age
Section, is divided into treatment group 1, treatment group 2, treatment group 3, contrast groups 1 and contrast groups 2.
Treatment group 1: the soft capsule that embodiment 1 is prepared is taken orally: 1 tablet/time, once a day；And combine 5% meter
Promise your tincture carry out the partial smearing in alopecia area, twice daily.
Treatment group 2: the soft capsule that embodiment 3 is prepared is taken orally: 1 tablet/time, once a day；And combine 5% meter
Promise your tincture carry out the partial smearing in alopecia area, twice daily.
Treatment group 3: the composition soft that embodiment 6 is prepared is taken orally: 1 tablet/time, once a day；
Contrast groups 1: the partial smearing in alopecia area is carried out only with 5% minoxidil in minoxidil tincture, twice daily.
Contrast groups 2: oral Finasteride 1mg/ days, and the partial smearing in 5% minoxidil in minoxidil tincture progress alopecia area is combined, often
Day is twice.
In patient's initial diagnosis, alopecia area is marked, and uses simple hand-held at interval of a period of time after administration
Hair image analyzer carries out the average thickness of 5 hairs around the unit area number of hairs statistics and alopecia area in alopecia area
It calculates.
Patient 50 using initial diagnosis as androgenetic alopecia compare test, according to gender, age bracket, are divided into and controlling
Treatment group 1, treatment group 2, treatment group 3, contrast groups 1 and contrast groups 2, every group 10, after a period of time is administered, statistics calculates every group of trouble
The increased average value of person's number of hairs and the increased average value of hair thickness, as a result as shown in the table.
2 each group patient of table carries out the Contrast on effect after alopeciaing therapeutic
It from the point of view of upper table, is taken orally using dutasteride's soft capsule of the present invention, and combines 5% minoxidil in minoxidil tincture carry out office
Portion's treatment has apparent curative effect to promotion hair growth.
3 each group patient of table carries out the Contrast on effect after alopeciaing therapeutic
As can be seen from the above table, due to the self-emulsifying microemulsion drug system that the capsule for preparing in embodiment 3 uses, drug it is molten
The effect that out-degree will be generated much higher than the drug dissolution of the dutasteride's soft capsule prepared in embodiment 1, hair growth
The effect being much better than in embodiment 1.Due to dutasteride and minoxidil oral combination medication in embodiment 6, better than part
Medication absorption of drugs has curative effect the most apparent to promotion hair growth, and oral medication is convenient, carries
It is more convenient.
Claims (9)
1. a kind of dutasteride's soft capsule, it is characterised in that: contain dutasteride 0.125mg in simple grain capsule.
2. dutasteride's soft capsule according to claim 1, it is characterised in that: the content of dutasteride's soft capsule
Using dutasteride's self-microemulsifying system.
3. dutasteride's soft capsule according to claim 2, it is characterised in that: dutasteride's self-microemulsifying system packet
Include dutasteride, oil phase solvent, emulsifier and assistant for emulsifying agent.
4. dutasteride's soft capsule according to claim 3, it is characterised in that: the oil phase solvent is sweet using sad certain herbaceous plants with big flowers acid
The mixture of oily three esters and Monoolein；The emulsifier uses the mixture of Tween-20 and PEG-50 rilanit special；
The assistant for emulsifying agent uses Transcultol P；The content of every 1000 dutasteride's soft capsules contains following components: spending him
Male amine 0.125g, sad certain herbaceous plants with big flowers acid glycerol three ester 20-30g, Monoolein 30-40g, Tween-20 70-90g, PEG-50 hydrogen
Change castor oil 70-100g, Transcultol P 30-40g, DBPC 2,6 ditertiary butyl p cresol 0.01-0.02g.
5. dutasteride's soft capsule according to claim 4, it is characterised in that: the oil phase solvent, emulsifier and help cream
The weight ratio of agent is 25:60:15.
6. dutasteride's soft capsule according to claim 5, it is characterised in that: every 1000 dutasteride's soft capsules it is interior
It is tolerant to contain following each component: dutasteride 0.125g, sad certain herbaceous plants with big flowers acid glycerol three ester 27g, Monoolein 38g, Tween-20
77g, PEG-50 rilanit special 79g, Transcultol P 39g, DBPC 2,6 ditertiary butyl p cresol 0.01g.
7. a kind of composition capsule of hair growth, it is characterised in that: contain dutasteride 0.125mg, minot in simple grain capsule
Ground that 0.3-0.4mg.
8. composition capsule according to claim 7, it is characterised in that: the content of every 1000 composition capsules contains
Following components: dutasteride 0.125g, minoxidil 0.3-0.4g, sad certain herbaceous plants with big flowers acid glycerol three ester 20-30g, Monoolein
30-40g, Tween-20 70-90g, PEG-50 rilanit special 70-100g, Transcultol P 30-40g, the tertiary fourth of 2,6- bis-
Base paracresol 0.01-0.02g.
9. composition capsule according to claim 8, it is characterised in that: the content of every 1000 composition softs contains
There is following each component: dutasteride 0.125g, minoxidil 0.3-0.4g, sad certain herbaceous plants with big flowers acid glycerol three ester 30g, Monoolein
40g, Tween-20 75g, PEG-50 rilanit special 75g, Transcultol P 30g, DBPC 2,6 ditertiary butyl p cresol
0.01g。
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910164118.0A CN109674762A (en) | 2019-03-05 | 2019-03-05 | A kind of composition capsule of dutasteride and hair growth |
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| CN201910164118.0A CN109674762A (en) | 2019-03-05 | 2019-03-05 | A kind of composition capsule of dutasteride and hair growth |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112067737A (en) * | 2020-09-27 | 2020-12-11 | 江苏知原药业有限公司 | Method for detecting antioxidant in minoxidil foaming agent |
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Application publication date: 20190426 |