CN111840240A - Finasteride preparation and application thereof - Google Patents
Finasteride preparation and application thereof Download PDFInfo
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- CN111840240A CN111840240A CN202010471903.3A CN202010471903A CN111840240A CN 111840240 A CN111840240 A CN 111840240A CN 202010471903 A CN202010471903 A CN 202010471903A CN 111840240 A CN111840240 A CN 111840240A
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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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—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
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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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
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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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
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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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/08—Drugs for disorders of the urinary system of the prostate
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Abstract
The invention belongs to the technical field of medicines, and discloses a finasteride preparation which comprises a tablet core and an enteric coating, wherein the tablet core comprises the following raw and auxiliary materials in parts by weight: 5 parts of finasteride, 83 parts of lactose, 10g of microcrystalline cellulose, 10 parts of sodium alginate, 20 parts of ethyl cellulose, 20 parts of hydroxypropyl cellulose and 2 parts of sodium stearyl fumarate. The finasteride preparation has good slow release effect and uniform release speed.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a finasteride preparation and application thereof.
Background
Molecules of finasterideFormula is C23H36N2O2The molecular weight is 327.55, the chemical name is 17 beta- (N-tertiary butyl amino formyl) -4-aza-5 alpha-androst-1-ene-3-ketone, and the specific structural formula is as follows:
finasteride tablets are conventional western medicine preparations for treating prostatic hyperplasia, and finasteride is a 4-aza steroid compound which is a specific inhibitor of intracellular enzyme-II type 5 a-reductase in the process of metabolizing testosterone into stronger dihydrotestosterone. While benign prostatic hyperplasia, or prostatic hypertrophy, is dependent on the conversion of testosterone to dihydrotestosterone within the prostate. The medicine can effectively reduce dihydrotestosterone in blood and prostate. Finasteride has no affinity for the androgen receptor. Finasteride belongs to the 5 alpha reductase inhibitors, which improve symptoms by inhibiting the conversion of testosterone to Dihydrotestosterone (DHT), reducing prostate volume, increasing urine flow rate, preventing the progression of Benign Prostatic Hyperplasia (BPH), through its hormonal mechanism of action.
The prior patent technology of the applicant improves the dissolution rate and the content uniformity by optimizing the components, the content and the process of the prescription finasteride, the impurity content is lower than that of the original preparation, the effect of the preparation is verified by a pilot test, and the next production can be carried out.
"CN 108379236A" discloses a finasteride sustained-release tablet, which is prepared from the following raw materials: 100 mg of phospholipid, 40-70mg of glyceride, 50-60mg of ethanol, 2-5mg of finasteride, 10-50mg of superfine silica gel powder, 20-60mg of chitosan, 20-60mg of adhesive, 2-10mg of low-substituted hydroxypropyl cellulose, 0.5-5 mg of lubricant and 0.2-2 mg of sweetener; the preparation method comprises the following steps: mixing phospholipid, glyceride and finasteride; adding ethanol and mixing uniformly; adding silica gel micropowder, chitosan and adhesive, and mixing; granulating by a wet method; drying; adding low-substituted hydroxypropyl cellulose, lubricant and sweetener, and mixing; the tablet has obvious slow release effect and uniform release speed, and can reduce the administration times.
Disclosure of Invention
In order to optimize a prescription finasteride preparation, the invention provides a finasteride preparation and application thereof.
The invention is realized by the following technical scheme.
A finasteride formulation comprising a core and an enteric coating.
Specifically, the tablet core comprises the following raw and auxiliary materials in parts by weight: 5 parts of finasteride, 83 parts of lactose, 10g of microcrystalline cellulose, 10 parts of sodium alginate, 20 parts of ethyl cellulose, 20 parts of hydroxypropyl cellulose and 2 parts of sodium stearyl fumarate.
Further, the preparation method of the enteric coating comprises the following steps: 50 parts of hydroxypropyl methyl cellulose phthalate, 20 parts of polyethylene glycol, 10 parts of cetyl alcohol and 2 parts of lauryl sodium sulfate are dissolved in water, and then 18 parts of talcum powder is added to obtain the enteric coating.
Further, the preparation process of the preparation comprises the following steps:
1) treating raw materials and auxiliary materials: crushing the raw and auxiliary materials and sieving the crushed raw and auxiliary materials with a 100-mesh sieve;
2) preparing materials: weighing the processed raw and auxiliary materials according to the weight ratio;
3) preparing a soft material: pre-mixing the prepared raw and auxiliary materials except the sodium stearyl fumarate in a mixer for 20 minutes, then adding purified water with the amount of the prescription, and continuously stirring for 30 minutes to obtain a qualified soft material;
4) preparing wet granules: feeding the prepared soft material into a swing type granulator to prepare wet granules;
5) and (3) drying: uniformly feeding the wet granules into a hot air circulating oven, and drying by blowing at 50-60 ℃ for 8 hours to ensure that the water content of the dry granules reaches about 1.0-3.0%;
6) Straightening: putting the dried granules into a swing type granulator, and granulating through a 16-mesh iron screen to obtain granules with uniform sizes;
7) total mixing: placing the whole granules into a three-dimensional motion mixer, adding sodium stearyl fumarate with the formula amount, setting the rotating speed to be 6-8 r/min, and mixing for 5 minutes to uniformly mix the granules;
8) tabletting: putting a stamping die, cleaning and disinfecting, and calculating the weight of the tablet; weighing the tablet weight once every 10 minutes in the tabletting process, ensuring that the tablet weight difference is within an allowable range, and observing the appearance of the tablet at any time;
9) coating with a film coat: coating the prepared sustained-release tablet core with enteric coating solution;
10) packaging: packaging with aluminum plastic, and warehousing after passing inspection.
Preferably, the wet granulation is screened with a 20 mesh nylon screen.
The technical scheme of the invention has the following beneficial effects:
the skeleton material is hydroxypropyl methylcellulose, the filling agent is lactose, the influence on the drug release is minimal, the slow release material is selected from ethyl cellulose and sodium alginate, and the weight ratio of the ethyl cellulose to the sodium alginate is 2: 1. The enteric material hydroxypropyl methyl cellulose phthalate has higher mechanical strength and gastric acid resisting capability, can effectively prevent the coating film from cracking, and the pore-forming agent is polyethylene glycol, so that the tablet can form a tiny drug release channel in gastric juice, and the drug can be released in the stomach. The hexadecanol is used as a plasticizer, and the prepared enteric coating has good toughness and is not easy to damage. Talcum powder is used as antisticking agent, and sodium dodecyl sulfate is used as surfactant.
Compared with a comparative preparation, the release speed is average and slow, the dissolution efficiency is more stable, all indexes reach the standard, and the stability of the preparation meets the requirement.
Drawings
FIG. 1: release of example 1 and comparative examples 1-3.
Detailed Description
In order to make those skilled in the art better understand the technical solutions in the present application, the present invention will be described more clearly and completely below with reference to specific embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The starting materials or reagents used in the present invention are commercially available unless otherwise specified.
Example 1
Prescription:
finasteride 5g
Lactose 83g
Microcrystalline cellulose 10g
Sodium alginate 10g
Ethyl cellulose 20g
Hydroxypropyl cellulose 20g
Proper amount of purified water
Sodium stearyl fumarate 2g
1000 tablets
Operating process and process conditions
1, treating raw materials and auxiliary materials: the raw and auxiliary materials are subjected to outsourcing treatment and then are crushed and sieved by a 100-mesh sieve.
2, preparing materials: weighing the processed raw and auxiliary materials according to the prescription requirement
3, soft material preparation: and (3) premixing the prepared raw and auxiliary materials in a mixer for 20 minutes, adding purified water according to the prescription amount, and continuously stirring for 30 minutes to obtain a qualified soft material.
4, preparing wet granules: and (3) feeding the prepared soft material into a swing granulator to prepare wet granules. The granules were made using a 20 mesh nylon screen.
5, drying: and uniformly feeding the wet granules into a hot air circulating oven, and drying by blowing at 50-60 ℃ for 8 hours to ensure that the water content of the dry granules reaches about 1.0-3.0%.
6, finishing the grains: and putting the dried granules into a swing type granulator, and granulating through a 16-mesh iron screen to obtain granules with uniform sizes.
7 total mixing: placing the whole granules into a three-dimensional motion mixer, adding sodium stearyl fumarate with the amount of the prescription, setting the rotating speed to be 6-8 r/min, and mixing for 5 minutes to uniformly mix the granules.
8, tabletting: and (4) putting a stamping die, and cleaning and disinfecting. The tablet weight was calculated from the particle content detected in the laboratory. The filling amount is adjusted, and then the pressure is adjusted, so that the weight, hardness, friability, appearance and the like of the pressed tablets meet the quality requirements. The tablet weight is weighed every 10 minutes in the tabletting process, the difference of the tablet weight is ensured to be within an allowable range, and the appearance of the tablets is observed at any time.
9, coating a film coat: dissolving 50 parts of hydroxypropyl methyl cellulose phthalate enteric material, 20 parts of polyethylene glycol, 10 parts of cetyl alcohol and 2 parts of sodium dodecyl sulfate in water, and then adding 18 parts of talcum powder to obtain enteric coating liquid; the prepared sustained-release tablet core is coated with enteric coating.
10, packaging: packaging with aluminum plastic, and warehousing after passing inspection.
Comparative example 1
Prescription:
finasteride 5g
Lactose 83g
Microcrystalline cellulose 10g
Ethyl cellulose 30g
Hydroxypropyl cellulose 20g
Proper amount of purified water
Sodium stearyl fumarate 2g
1000 tablets
Comparative example 2
Prescription:
finasteride 5g
Lactose 83g
Microcrystalline cellulose 10g
Sodium alginate 30g
Hydroxypropyl cellulose 20g
Proper amount of purified water
Sodium stearyl fumarate 2g
1000 tablets
Comparative example 3
Prescription:
finasteride 5g
Lactose 83g
Microcrystalline cellulose 10g
Sodium alginate 10g
Sodium carboxymethylcellulose 20g
Hydroxypropyl cellulose 20g
Proper amount of purified water
Sodium stearyl fumarate 2g
1000 tablets
Example 2
Firstly, stability test:
the stability study was performed using finasteride prepared in example 1 and the stability of the formulation prepared by this formulation process was examined for 8 months at 35 ℃ and 80% relative humidity. The content determination method comprises the following steps of respectively determining in 0 th month, 2 th month, 4 th month, 6 th month and 8 th month:
the test instrument: high performance liquid chromatograph: shimadzu LC-20AT/SPD-20A/SIL-20A
Numbering: FX-PC-013 electronic balance: sartorius CP225D
Mobile phase: acetonitrile-water (50:50)
A chromatographic column: UnitaryC18 (4.6X 250mm,5 μ l)
Column temperature: 30 deg.C
Flow rate: 1.0ml/min
Detection wavelength: 210nm
Sample introduction amount: 20 mu l
The test process comprises the following steps:
test solution: taking 20 tablets of the product, precisely weighing (calculating average tablet weight), grinding, taking a proper amount of fine powder (about 10mg equivalent to finasteride), placing in a 100ml measuring flask, adding a proper amount of mobile phase, shaking to dissolve finasteride and dilute to scale, shaking uniformly, filtering, and taking the subsequent filtrate as a sample solution.
Control solution: precisely weighing about 10mg of finasteride reference substance, placing into a 100ml measuring flask, adding mobile phase, dissolving and diluting to scale, and shaking.
System applicability test solution: dissolving finasteride and impurity I with mobile phase, diluting to obtain solution containing finasteride 0.1mg and impurity I0.01 mg, and shaking.
And precisely measuring 20 mul of system applicability test solution, injecting the solution into a liquid chromatograph, recording the chromatogram, wherein the number of theoretical plates is not less than 3000 according to the finasteride peak, and the separation degree between finasteride and the impurity I peak is in accordance with the regulation.
The results of the content measurement are shown in Table 1.
TABLE 1
| Time of the month | Traits | |
| 0 | White or off-white | 100 |
| 2 | White or off-white | 100 |
| 4 | White or off-white | 99.8 |
| 6 | White or off-white | 99.7 |
| 8 | White or off-white | 99.7 |
The stability test results show that after 8-month accelerated tests of the finasteride preparation in example 1, all indexes of the finasteride preparation reach the standard, and the stability of the finasteride preparation meets the requirements.
II, in-vitro release determination:
the release rates of example 1 and comparative examples 1-3 were tested at 1,2,4,8,16, and 24 hours, respectively, as shown in fig. 1. As shown in fig. 1, compared with the comparative preparation, the finasteride preparation of example 1 has a slow release rate, a more stable dissolution efficiency, all indexes of the preparation reach the standard, and the stability of the preparation meets the requirement.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (7)
1. A finasteride formulation comprising a core and an enteric coating.
2. The preparation as claimed in claim 1, wherein the tablet core comprises the following raw and auxiliary materials in parts by weight: 5 parts of finasteride, 83 parts of lactose, 10g of microcrystalline cellulose, 10 parts of sodium alginate, 20 parts of ethyl cellulose, 20 parts of hydroxypropyl cellulose and 2 parts of sodium stearyl fumarate.
3. The formulation of claim 1, wherein the enteric coating is prepared by a method comprising: 50 parts of hydroxypropyl methyl cellulose phthalate, 20 parts of polyethylene glycol, 10 parts of cetyl alcohol and 2 parts of lauryl sodium sulfate are dissolved in water, and then 18 parts of talcum powder is added to obtain the enteric coating.
4. The preparation according to claim 1, wherein the preparation process comprises:
1) treating raw materials and auxiliary materials: crushing the raw and auxiliary materials and sieving the crushed raw and auxiliary materials with a 100-mesh sieve;
2) preparing materials: weighing the processed raw and auxiliary materials according to the weight ratio;
3) preparing a soft material: pre-mixing the prepared raw and auxiliary materials except the sodium stearyl fumarate in a mixer for 20 minutes, then adding purified water with the amount of the prescription, and continuously stirring for 30 minutes to obtain a qualified soft material;
4) preparing wet granules: feeding the prepared soft material into a swing type granulator to prepare wet granules;
5) And (3) drying: uniformly feeding the wet granules into a hot air circulating oven, and drying by blowing at 50-60 ℃ for 8 hours to ensure that the water content of the dry granules reaches about 1.0-3.0%;
6) straightening: putting the dried granules into a swing type granulator, and granulating through a 16-mesh iron screen to obtain granules with uniform sizes;
7) total mixing: placing the whole granules into a three-dimensional motion mixer, adding sodium stearyl fumarate with the formula amount, setting the rotating speed to be 6-8 r/min, and mixing for 5 minutes to uniformly mix the granules;
8) tabletting: putting a stamping die, cleaning and disinfecting, and calculating the weight of the tablet; weighing the tablet weight once every 10 minutes in the tabletting process, ensuring that the tablet weight difference is within an allowable range, and observing the appearance of the tablet at any time;
9) coating with a film coat: coating the prepared sustained-release tablet core with enteric coating solution;
10) packaging: packaging with aluminum plastic, and warehousing after passing inspection.
5. The formulation of claim 4, wherein the wet granulation is screened with a 20 mesh nylon screen.
6. Use of a formulation according to any one of claims 1 to 5 for the treatment of prostatic hyperplasia.
7. Use of a formulation according to any one of claims 1 to 5 for male alopecia.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010471903.3A CN111840240A (en) | 2020-05-29 | 2020-05-29 | Finasteride preparation and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010471903.3A CN111840240A (en) | 2020-05-29 | 2020-05-29 | Finasteride preparation and application thereof |
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| Publication Number | Publication Date |
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| CN111840240A true CN111840240A (en) | 2020-10-30 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202010471903.3A Pending CN111840240A (en) | 2020-05-29 | 2020-05-29 | Finasteride preparation and application thereof |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20120137998A (en) * | 2011-06-14 | 2012-12-24 | 지엘팜텍 주식회사 | A dosage form with increased stability comprising tamsulosin and finasteride |
| EP2694038A2 (en) * | 2011-04-06 | 2014-02-12 | Sovic Brkicic Ljiljana | Pharmaceutical composition |
| US20150157572A1 (en) * | 2012-05-09 | 2015-06-11 | Western University Of Health Sciences | Proliposomal testosterone formulations |
| CN104940156A (en) * | 2015-06-09 | 2015-09-30 | 扬子江药业集团南京海陵药业有限公司 | Epalrestat enteric-coated and sustained-release tablets and preparation method thereof |
-
2020
- 2020-05-29 CN CN202010471903.3A patent/CN111840240A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2694038A2 (en) * | 2011-04-06 | 2014-02-12 | Sovic Brkicic Ljiljana | Pharmaceutical composition |
| KR20120137998A (en) * | 2011-06-14 | 2012-12-24 | 지엘팜텍 주식회사 | A dosage form with increased stability comprising tamsulosin and finasteride |
| US20150157572A1 (en) * | 2012-05-09 | 2015-06-11 | Western University Of Health Sciences | Proliposomal testosterone formulations |
| CN104940156A (en) * | 2015-06-09 | 2015-09-30 | 扬子江药业集团南京海陵药业有限公司 | Epalrestat enteric-coated and sustained-release tablets and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 唐静雯: "非那雄胺缓释片的稳定性研究", 《天津药学》 * |
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Application publication date: 20201030 |