CN113694035A - Preparation method of sildenafil tablets - Google Patents

Preparation method of sildenafil tablets Download PDF

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Publication number
CN113694035A
CN113694035A CN202111174057.XA CN202111174057A CN113694035A CN 113694035 A CN113694035 A CN 113694035A CN 202111174057 A CN202111174057 A CN 202111174057A CN 113694035 A CN113694035 A CN 113694035A
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sildenafil
plant biomass
source material
carbon source
mixing
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CN202111174057.XA
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Chinese (zh)
Inventor
郝静梅
朱靓
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Cpu Pharma Co ltd
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Cpu Pharma Co ltd
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Priority to CN202111174057.XA priority Critical patent/CN113694035A/en
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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
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6921—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere
    • A61K47/6923—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere the form being an inorganic particle, e.g. ceramic particles, silica particles, ferrite or synsorb
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1664—Compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

Abstract

The invention belongs to the field of medicine preparation, and particularly relates to a preparation method of sildenafil tablets, which comprises the following steps: carbonizing plant biomass to obtain a carbon source material; mixing and granulating sildenafil and a carbon source material to obtain carbon-supported sildenafil particles; and mixing the carbon-carried sildenafil granules with hydroxypropyl methyl cellulose, drying and tabletting to obtain the sildenafil tablet. The preparation method of the invention stabilizes the release speed of sildenafil, realizes the sustained release of the drug and reduces the side effect.

Description

Preparation method of sildenafil tablets
Technical Field
The invention belongs to the field of medicine preparation, and particularly relates to a preparation method of sildenafil tablets.
Background
Sildenafil can take effect within a very short time after oral administration, the peak value of blood concentration can be reached within 30 minutes to two hours after oral administration on an empty stomach, the blood pressure is more obviously influenced at high blood concentration, cardiac events are easily induced, abnormal color vision can be caused, and the elimination half-life period of sildenafil and metabolites thereof is about 4 hours. There is therefore a need for a sildenafil formulation capable of sustained release, improving the duration of drug action, and reducing side effects.
Disclosure of Invention
The invention mainly provides a preparation method capable of carrying out rapid processing and continuous production on Chinese honeylocust fruit rice. The technical scheme is as follows:
a method for preparing sildenafil tablets, comprising the steps of: carbonizing plant biomass to obtain a carbon source material; mixing and granulating sildenafil and a carbon source material to obtain carbon-supported sildenafil particles; and mixing the carbon-carried sildenafil granules with hydroxypropyl methyl cellulose, drying and tabletting to obtain the sildenafil tablet.
Further, the weight ratio of the sildenafil to the carbon source material is 1: (1-5); the weight ratio of the sum of the weights of the sildenafil and the carbon source material to the hydroxypropyl methylcellulose is 1: (0.2-0.5).
Further, the method comprises the following steps:
(1) preparing plant biomass into powder, and then roasting and carbonizing twice to obtain a carbon source material;
(2) adding the carbon source material obtained in the step (1) and sildenafil in a prescription amount into water, mixing and stirring for 1-2 h at a speed of 100-200 r/min, and granulating to obtain sildenafil mixed particles;
(3) adding hydroxypropyl methylcellulose into equal weight of water in alcohol, simultaneously adding 2 times of water in volume of the alcohol, and stirring thoroughly to obtain mixed solution;
(4) and (3) placing the sildenafil mixed granules obtained in the step (2) into the mixed solution obtained in the step (3), mixing with auxiliary materials, drying, and tabletting to obtain sildenafil tablets.
Further, the preparation of the carbon source material comprises the following steps: crushing plant biomass, soaking and washing the plant biomass with water, drying the plant biomass, sieving the plant biomass with a 200-mesh sieve, placing the plant biomass in a nitrogen atmosphere for primary roasting, cooling the plant biomass, mixing the plant biomass with phosphoric acid, placing the plant biomass in the nitrogen atmosphere for secondary roasting, washing the plant biomass to be neutral, and drying the plant biomass to obtain the carbon source material.
Further, the primary roasting is carried out for 2-4 hours at the temperature of 750-900 ℃.
Further, the secondary roasting is carried out for 0.5-1.5 hours at 800-950 ℃.
Further, the weight ratio of the plant biomass after primary roasting to phosphoric acid is 1: 2 to 5.
Further, the mixing and drying in the step (4) is to stir at the speed of 30-50 r/min for 60-90 min at the temperature of 45-60 ℃.
Further, the plant biomass comprises one of corn stover, corn cobs, peanut shells, sugar cane bagasse, and wood.
By adopting the scheme, the method has the following advantages:
1. the invention stabilizes the release speed of sildenafil by wrapping hydroxypropyl methylcellulose and loading by using a carbon source material, realizes the sustained release of the drug and reduces side effects.
2. The carbon source material disclosed by the invention is porous and large in specific surface area, can adsorb part of sildenafil, avoids all medicines from being released and absorbed at one time, and forms a controlled release effect.
3. The hydroxypropyl methyl cellulose is coated outside the sildenafil mixed particles, so that the problem that the traditional coated tablet loses the slow release effect after being chewed by mistake is solved, and the tablet is safer and more reliable.
4. The carbon source material is derived from plant biomass, is easy to obtain and low in cost, is harmless to human bodies, and greatly reduces the introduction of other chemical preparations compared with common coated tablets.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, 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.
Example 1
(1) Crushing corncobs, soaking and washing the corncobs by using water, drying the corncobs, sieving the dried corncobs by using a 200-mesh sieve, roasting the corncobs for 3 hours at 800 ℃ in a nitrogen atmosphere, cooling the roasted corncobs, mixing the cooled corncobs with 3 times of phosphoric acid by weight, roasting the mixture for 1 hour at 800 ℃ in the nitrogen atmosphere, washing the mixture to be neutral, and drying the mixture to obtain a carbon source material;
(2) adding 75g of the carbon source material obtained in the step (1) and 25g of sildenafil into water, mixing and stirring for 1-2 h at a speed of 100-200 r/min, and granulating to obtain sildenafil mixed particles;
(3) adding 30g of hydroxypropyl methyl cellulose into equal weight of water in alcohol, simultaneously adding 2 times of water in volume of the alcohol, and fully stirring to obtain a mixed solution;
(4) putting the sildenafil mixed granules obtained in the step (2) into the mixed liquid obtained in the step (3), adding 3g of magnesium stearate, stirring at the speed of 40r/min at 50 ℃ for 80min, and tabletting to obtain 1000 sildenafil tablets.
Example 2
(1) Crushing corncobs, soaking and washing the corncobs by using water, drying the corncobs, sieving the dried corncobs by using a 200-mesh sieve, roasting the corncobs for 3 hours at 750 ℃ in a nitrogen atmosphere, cooling the roasted corncobs, mixing the cooled corncobs with 3 times of phosphoric acid by weight, roasting the mixture for 1 hour at 800 ℃ in the nitrogen atmosphere, washing the mixture to be neutral, and drying the mixture to obtain a carbon source material;
(2) adding 75g of the carbon source material obtained in the step (1) and 25g of sildenafil into water, mixing and stirring at 150r/min for 1h, and granulating to obtain sildenafil mixed particles;
(3) adding 30g of hydroxypropyl methyl cellulose into equal weight of water in alcohol, simultaneously adding 2 times of water in volume of the alcohol, and fully stirring to obtain a mixed solution;
(4) putting the sildenafil mixed granules obtained in the step (2) into the mixed liquid obtained in the step (3), adding 3g of magnesium stearate, stirring at the speed of 40r/min at 50 ℃ for 80min, and tabletting to obtain 1000 sildenafil tablets.
Example 3
(1) Crushing corncobs, soaking and washing the corncobs by using water, drying the corncobs, sieving the dried corncobs by using a 200-mesh sieve, roasting the corncobs for 3 hours at 800 ℃ in a nitrogen atmosphere, cooling the roasted corncobs, mixing the cooled corncobs with 3 times of phosphoric acid by weight, roasting the mixture for 1 hour at 800 ℃ in the nitrogen atmosphere, washing the mixture to be neutral, and drying the mixture to obtain a carbon source material;
(2) adding 25g of the carbon source material obtained in the step (1) and 25g of sildenafil into water, mixing and stirring at 150r/min for 1h, and granulating to obtain sildenafil mixed particles;
(3) adding 15g of hydroxypropyl methyl cellulose into equal weight of water in alcohol, simultaneously adding 2 times of water in volume of the alcohol, and fully stirring to obtain a mixed solution;
(4) putting the sildenafil mixed granules obtained in the step (2) into the mixed liquid obtained in the step (3), adding 3g of magnesium stearate, stirring at the speed of 40r/min at 50 ℃ for 80min, and tabletting to obtain 1000 sildenafil tablets.
Example 4
(1) Crushing corncobs, soaking and washing the corncobs by using water, drying the corncobs, sieving the dried corncobs by using a 200-mesh sieve, roasting the corncobs for 3 hours at 800 ℃ in a nitrogen atmosphere, cooling the roasted corncobs, mixing the cooled corncobs with 3 times of phosphoric acid by weight, roasting the mixture for 1 hour at 800 ℃ in the nitrogen atmosphere, washing the mixture to be neutral, and drying the mixture to obtain a carbon source material;
(2) adding 75g of the carbon source material obtained in the step (1) and 25g of sildenafil into water, mixing and stirring at 150r/min for 1h, and granulating to obtain sildenafil mixed particles;
(3) adding 30g of hydroxypropyl methyl cellulose into equal weight of water in alcohol, simultaneously adding 2 times of water in volume of the alcohol, and fully stirring to obtain a mixed solution;
(4) and (3) putting the sildenafil mixed granules obtained in the step (2) into the mixed liquid obtained in the step (3), adding 3g of magnesium stearate, stirring at the temperature of 50 ℃ at the speed of 40r/min for 60min, and tabletting to obtain 1000 sildenafil tablets.
Examples sample testing:
the dissolution rate of each example was tested according to XC first method, appendix of the second part of the Chinese pharmacopoeia. Samples of each example are respectively placed in 900mL of dissolution medium prepared from hydrochloric acid solution with the concentration of 1mol/L, 10mL of dissolution medium is sampled at the rotating speed of 50r/min for 5min and 15min respectively, and 10mL of dissolution medium is supplemented at the same time. And taking a proper amount of sildenafil reference substance, precisely weighing, dissolving with 0.01mol/L hydrochloric acid, and diluting into 20ug/ml sildenafil solution as a reference substance solution. Taking the two solutions, respectively measuring absorbance at 292nm by spectrophotometry, and calculating the elution amount of each tablet. The results are shown in table 1 below:
table 1: dissolution rate
Figure BDA0003294303480000061
According to the table, the dissolution rate of each example of the invention is about 90% at 5min and 94% at 15min, which shows that each example has better controlled release effect. Example 4 it can be seen that the encapsulation process of hydroxypropyl methylcellulose has a significant effect on the dissolution of the sample. Example 3 can see that the content of the carbon source material has a more significant effect on the subsequent dissolution rate of the sample.
Various other modifications and changes may be made by those skilled in the art based on the above-described technical solutions and concepts, and all such modifications and changes should fall within the scope of the claims of the present invention.

Claims (9)

1. A method for preparing sildenafil tablets, which is characterized by comprising the following steps: carbonizing plant biomass to obtain a carbon source material; mixing and granulating sildenafil and a carbon source material to obtain carbon-supported sildenafil particles; and mixing the carbon-carried sildenafil granules with hydroxypropyl methyl cellulose, drying and tabletting to obtain the sildenafil tablet.
2. The method for preparing sildenafil tablets according to claim 1, wherein the weight ratio of sildenafil to the carbon source material is 1: (1-5); the weight ratio of the sum of the weights of the sildenafil and the carbon source material to the hydroxypropyl methylcellulose is 1: (0.2-0.5).
3. The process for preparing sildenafil tablets according to claim 1, comprising the steps of:
(1) preparing plant biomass into powder, and then roasting and carbonizing twice to obtain a carbon source material;
(2) adding the carbon source material obtained in the step (1) and sildenafil in a prescription amount into water, mixing and stirring for 1-2 h at a speed of 100-200 r/min, and granulating to obtain sildenafil mixed particles;
(3) adding hydroxypropyl methylcellulose into equal weight of water in alcohol, simultaneously adding 2 times of water in volume of the alcohol, and stirring thoroughly to obtain mixed solution;
(4) and (3) placing the sildenafil mixed granules obtained in the step (2) into the mixed solution obtained in the step (3), mixing with auxiliary materials, drying, and tabletting to obtain sildenafil tablets.
4. The method of preparing sildenafil tablets according to claim 1, wherein the preparation of the carbon source material comprises the steps of: crushing plant biomass, soaking and washing the plant biomass with water, drying the plant biomass, sieving the plant biomass with a 200-mesh sieve, placing the plant biomass in a nitrogen atmosphere for primary roasting, cooling the plant biomass, mixing the plant biomass with phosphoric acid, placing the plant biomass in the nitrogen atmosphere for secondary roasting, washing the plant biomass to be neutral, and drying the plant biomass to obtain the carbon source material.
5. The method for preparing sildenafil tablets according to claim 4, wherein the primary roasting is carried out at 750 to 900 ℃ for 2 to 4 hours.
6. The method for preparing sildenafil tablets according to claim 4, wherein the secondary roasting is carried out at 800 to 950 ℃ for 0.5 to 1.5 hours.
7. The method for preparing sildenafil tablets according to claim 4, wherein the weight ratio of the plant biomass to the phosphoric acid after the primary roasting is 1: 2 to 5.
8. The method for preparing sildenafil tablets according to claim 3, wherein the mixing and drying in the step (4) is performed by stirring at a speed of 30 to 50r/min at 45 to 60 ℃ for 60 to 90 min.
9. The method of preparing sildenafil tablets of claim 1, wherein the plant biomass comprises one of corn stover, corn cobs, peanut hulls, sugar cane bagasse, and wood.
CN202111174057.XA 2021-10-09 2021-10-09 Preparation method of sildenafil tablets Pending CN113694035A (en)

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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WO2017168174A1 (en) * 2016-04-02 2017-10-05 N4 Pharma Uk Limited New pharmaceutical forms of sildenafil
CN108685866A (en) * 2018-07-25 2018-10-23 江苏黄河药业股份有限公司 A kind of Gliclazide sustained-release tablet
CN108706585A (en) * 2018-07-18 2018-10-26 昆明理工大学 A kind of preparation method of big kenaf stalk activated charcoal
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CN104546779A (en) * 2013-10-14 2015-04-29 深圳海王药业有限公司 Sildenafil citrate tablet with high medicine loading and preparation method thereof
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WO2017168174A1 (en) * 2016-04-02 2017-10-05 N4 Pharma Uk Limited New pharmaceutical forms of sildenafil
CN108706585A (en) * 2018-07-18 2018-10-26 昆明理工大学 A kind of preparation method of big kenaf stalk activated charcoal
CN108685866A (en) * 2018-07-25 2018-10-23 江苏黄河药业股份有限公司 A kind of Gliclazide sustained-release tablet
CN111186836A (en) * 2018-11-14 2020-05-22 天津科技大学 Preparation method of corncob-based activated carbon
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