CN107496370A - A kind of Sildenafil citrate tablets agent composition and preparation method thereof - Google Patents

A kind of Sildenafil citrate tablets agent composition and preparation method thereof Download PDF

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Publication number
CN107496370A
CN107496370A CN201710631623.2A CN201710631623A CN107496370A CN 107496370 A CN107496370 A CN 107496370A CN 201710631623 A CN201710631623 A CN 201710631623A CN 107496370 A CN107496370 A CN 107496370A
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weight
coating
sildenafil citrate
parts
label
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CN107496370B (en
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齐慧
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HAINAN XIANTONG PHARMACEUTICAL Co Ltd
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HAINAN XIANTONG PHARMACEUTICAL Co Ltd
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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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention provides a kind of Sildenafil citrate tablets agent and preparation method thereof, the Sildenafil citrate tablets agent includes label and coating；The material of the label is sildenafil citrate, microcrystalline cellulose, pregelatinized starch, Ac-Di-Sol, magnesium stearate, silica, carboxyrnethyl starch sodium；The label is made of compressing dry granulation.This technique has very big superiority compared with the prior art, and operation is simpler, and the equipment used is few, with short production cycle, less energy consumption, can reduce production cost, can meet to commercially produce.

Description

A kind of Sildenafil citrate tablets agent composition and preparation method thereof
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, and in particular to a kind of Sildenafil citrate tablets agent group Compound and preparation method thereof.
Background technology
Silaenafil is a kind of medicine of oral medication erectile dysfunction.In natural environment, i.e., adjoint sexual stimulus, it Pass through the erection function for increasing the CBF of penis to recover impaired.The physiological mechanism of telotism is related to the moon during sexual stimulus The release of stem cavernous body intracellular nitric oxide (NO).NO activates guanylate cyclase, causes cyclic guanosine monophosphate (cGMP) level to increase, So that smooth muscle relaxation in cavernous body, blood flows into.Silaenafil is 5 type phosphodiesterases of cGMP specificity in cavernous body (PDE5) effective and selective depressant, in cavernous body, PDE5 causes cGMP to decompose.Silaenafil is to erecing with outer The effect of enclosing.Silaenafil does not have direct relexation in vitro human corpus cavernosum, but effectively enhances pines of the NO to the tissue Relaxation acts on.When NO/cGMP paths are activated, such as generation sexual stimulus, cavernous body cGMP can be increased by suppressing PDE5 by silaenafil Level.Therefore silaenafil needs sexual stimulus to produce expected pharmacological action.
Tablet means the disc-shaped that medicine suppresses after uniformly being mixed with proper auxiliary materials or the solid pharmaceutical preparation of special-shaped sheet, Due to its dosage is accurate, content uniformly, because small volume, densification, influenceed by outside air, light, water grading factors it is smaller, If necessary can by be coated protect, so chemical stability is good, carry, transport, take it is more convenient；The mechanization of production, Automaticity is higher, and yield is big, cost and price are relatively low；Different types of various tablets can be made, such as scattered (quick-acting) Piece, controlled release (long-acting) piece, enteric coated tablets, chewable tablets and buccal tablet etc., to meet the needs of different clinical treatments, turn into current One of formulation being most widely used, method for preparing tablet thereof includes granulating tabletting process and direct compression method is divided into direct powder compression Method and half dry type granulation method.
Main during China's tablet manufacturing at present to select granulating tabletting process, direct compression method is due to traditional former, auxiliary material Many-sided limited reason such as matter and production equipment does not obtain a wide range of popularization and application, but as China's medicine in recent years is related Industry development is rapid, and from supplementary material performance improvement and pharmaceutical equipment, there occurs rapid development, such as high speed tablet press are automatic The constantly improve of filling technique is forced, promotes the development of direct powder compression, it is direct according to document announcement developed country powder The kind of pressed disc method is up to more than 60%, is one of tablet prefered method, and direct pressed powder eliminates granulating process, step Suddenly so that technique is simpler, and production equipment species is less, and production power consumption reduces, and the production cycle shortens, is produced into so as to reduce This, due to avoiding heating and influence of the moisture to supplementary material, direct tablet compressing technique can improve the quality of medicine, particularly end-on Heat, chance water unstable medicine have special benefits, do not have pelletization in direct compression method technique, so after disintegration of tablet, particle Relatively carefully, the advantages that dissolution surface area is big, and dissolution rate is very fast.
The content of the invention
The invention discloses a kind of Sildenafil citrate tablets agent and preparation method thereof, the Sildenafil citrate tablets agent bag Include label and coating；
The material of the label is as follows：
The parts by weight of sildenafil citrate 35.12~105.36,
The parts by weight of microcrystalline cellulose 62~186,
The parts by weight of pregelatinized starch 35~105,
The parts by weight of Ac-Di-Sol 6~18,
The parts by weight of magnesium stearate 1~3,
Silica 2-6 parts by weight,
The parts by weight of carboxyrnethyl starch sodium 5.5~16.5
The label is made of compressing dry granulation.
It is described coating raw material be：
It is coated pre-mixing agent 4.5-13.5 parts by weight
95% ethanol 4.5-13.5 parts by weight
Purified water 18.0-54.0 parts by weight
The coating pre-mixing agent refers to available commercially available prod, such as polyvinyl alcohol, titanium dioxide, talcum powder, phosphatide (soybean Phosphatide), hydroxypropyl methylcellulose composition product grade be 295W680000 coating pre-mixing agent, can be coated by Shanghai Ka Lekang Technology Co., Ltd. provides.
The preparation method of Sildenafil citrate tablets agent of the present invention, comprises the following steps：
1. label preparation technology
It is standby that label material is crossed into 60 eye mesh screens, sildenafil citrate, microcrystalline cellulose is weighed, wherein takes 1/3-2/3 Amount Ac-Di-Sol and carboxyrnethyl starch sodium, pregelatinized starch are put in three-dimensional mixer and mixed；In dry granulating machine On to said mixture material carry out precompressed；Precompressed material is put into attrition grinding and granulation on Fastgranulatemachine；By unsanctioned Grain is crushed and by 24 eye mesh screen again, and remaining Ac-Di-Sol, carboxyrnethyl starch sodium, hard is added in above-mentioned material Fatty acid magnesium, silica, mixing；Tabletting.
2. it is coated preparation technology
Take label to be coated, take film coating pre-mix dose：95% ethanol：Purified water=1:1:4 materials are put in agitator, stirring Time, 40min was standby.Coating parameter：55 DEG C of EAT, 40 DEG C of piece bed tempertaure；Coating pan revolution：Start 2 hours 1r/min, Middle 2r/min, terminate 2r/min；Coating solution usage amount：With solids basis weightening 2%；Produce Tablets composition.
Brief description of the drawings
Fig. 1：Sildenafil citrate tablets stripping curve comparison diagram
Tablets composition can realize following technique effect：
1st, the composition of Sildenafil citrate tablets agent of the invention is formed reasonable, and lmpurities are few, in stripping curve, have Had a clear superiority in terms of closing the index such as material and tablet uniformity.
2nd, the compressing dry granulation that the present invention uses refers to be well mixed medicine with partial supplementary material after rear precompressed through phase Corresponding device pulverizes and sieves rear with remaining auxiliary materials and mixing direct tablet compressing method, and silaenafil raw material is unstable, illumination, height Apt to deteriorate under temperature, super-humid conditions, medicine easily turns yellow after especially meeting water, compared with existing wet granulation production technology, adopts With the process do not pelletized in dry granulation tabletting production technology with the aqueous solution, also without the process of heat drying, so production The controllable stabilization of drug quality out.
3rd, this technique has very big superiority compared with the prior art, and operation is simpler, and the equipment used is few, production week Phase is short, less energy consumption, can reduce production cost, can meet to commercially produce.
Embodiment 1：
Preparation technology：It is standby that label material is crossed into 60 eye mesh screens, weighs sildenafil citrate, microcrystalline cellulose, pre- glue Change starch, take 2/3 recipe quantity Ac-Di-Sol and carboxyrnethyl starch sodium to put and mix 20min in three-dimensional mixer； Precompressed is carried out to said mixture material on dry granulating machine；Precompressed material is put on Fastgranulatemachine attrition grinding and by 20 mesh Screen cloth is pelletized；Unsanctioned particle is crushed again and by 24 eye mesh screens, remaining cross-linked carboxymethyl is added in above-mentioned material Sodium cellulosate, carboxyrnethyl starch sodium, magnesium stearate, silica, mixing；Tabletting；Take label to be coated, take film coating pre-mix dose： 95% ethanol：Purified water=1:1:4 materials are put in agitator, and mixing time 40min is standby.Coating parameter：55 DEG C of EAT, 40 DEG C of piece bed tempertaure；Coating pan revolution：Start 2 hours 1r/min, middle 2r/min, terminate 2r/min；Coating solution usage amount：With Solids basis weightening 2%；Produce Tablets composition.
Embodiment 2：
Preparation technology：Taking label component materials, 60 eye mesh screens excessively are standby respectively, take recipe quantity sildenafil citrate, crystallite Cellulose, pregelatinized starch, 1/3 recipe quantity Ac-Di-Sol and carboxyrnethyl starch sodium is taken to put 3 D multi-directional mixer Middle mixing 20min, the precompressed in above-mentioned material addition dry granulating machine, put Fastgranulatemachine whole grain by material and cross 20 eye mesh screens, 24 eye mesh screens will not crushed again by particle, mix, add remaining Ac-Di-Sol and carboxyrnethyl starch sodium, Silica, magnesium stearate are well mixed, tabletting；Take label to be coated, take film coating pre-mix dose：95% ethanol：Purified water= 1:1:4 materials are put in agitator, and mixing time 40min is standby.Coating parameter：55 DEG C of EAT, 40 DEG C of piece bed tempertaure；Coating Pot revolution：Start 2 hours 1r/min, middle 2r/min, terminate 2r/min；Coating solution usage amount：With solids basis weightening 2%； Produce Tablets composition.
Embodiment 3：
Preparation technology：Taking label component materials, 60 eye mesh screens excessively are standby respectively, take recipe quantity sildenafil citrate, crystallite Cellulose, pregelatinized starch, the Ac-Di-Sol of recipe quantity 2/3 and the carboxyrnethyl starch sodium of 1/3 recipe quantity is taken to put three Tie up and 20min is mixed in multidirectional mixer, add precompressed in dry granulating machine in above-mentioned material, material is put into Fastgranulatemachine whole grain Cross 20 eye mesh screens, will not crushed 24 eye mesh screens again by particle, mix, add remaining Ac-Di-Sol and Carboxyrnethyl starch sodium, silica, magnesium stearate are well mixed, tabletting；Take label to be coated, take film coating pre-mix dose：95% second Alcohol：Purified water=1:1:4 materials are put in agitator, and mixing time 40min is standby.Coating parameter：55 DEG C of EAT, piece bed temperature 40 DEG C of degree；Coating pan revolution：Start 2 hours 1r/min, middle 2r/min, terminate 2r/min；Coating solution usage amount：With solid content Meter weightening 2%；Produce Tablets composition.
Embodiment 4：
Preparation technology：Taking label component materials, 60 eye mesh screens excessively are standby respectively, take recipe quantity sildenafil citrate, crystallite Cellulose, pregelatinized starch, Ac-Di-Sol are put in 3 D multi-directional mixer and mix 20min, add in above-mentioned material Enter precompressed in dry granulating machine, material is put into Fastgranulatemachine whole grain and crosses 20 eye mesh screens, will not crushed 24 again by particle Eye mesh screen, mixing, addition carboxyrnethyl starch sodium, silica, magnesium stearate are well mixed, tabletting；Take label to be coated, take film bag Clothing pre-mixing agent：95% ethanol：Purified water=1:1:4 materials are put in agitator, and mixing time 40min is standby.Coating parameter：Air intake 55 DEG C of temperature, 40 DEG C of piece bed tempertaure；Coating pan revolution：Start 2 hours 1r/min, middle 2r/min, terminate 2r/min；Coating solution Usage amount：With solids basis weightening 2%；Produce Tablets composition.
On above-described embodiment and comparative example, by production time, quality versus, (relevant material, content, dissolution are bent respectively Line) result of study see the table below：
Experimental example 1, embodiment and comparative example production hour contrast
Table：Embodiment collects with the contrast of comparative example production hour
Process Embodiment 1 Embodiment 2 Embodiment 3 Embodiment 4 Comparative example
Sieving 40 minutes 40 minutes 40 minutes 40 minutes 40 minutes
Mixing 30 minutes 30 minutes 30 minutes 30 minutes 30 minutes
Precompressed 30 minutes 30 minutes 30 minutes 30 minutes -
Granulation - - - - 30 minutes
Dry - - - - 150 minutes
Whole grain 30 minutes 30 minutes 30 minutes 30 minutes 30 minutes
It is total mixed 30 minutes 30 minutes 30 minutes 30 minutes 30 minutes
Tabletting 60 minutes 60 minutes 60 minutes 60 minutes 60 minutes
Coating 60 minutes 60 minutes 60 minutes 60 minutes 60 minutes
Production hour 280 minutes 280 minutes 280 minutes 280 minutes 430 minutes
It will be compared the production time, the production hour of embodiment 1 to embodiment 4 is 280 minutes, comparative example Man-hour is 430 minutes, hence it is evident that embodiment production hour is less than using conventional normal wet granulation comparative example man-hour, due to dry method system Grain has removed drying process less with existing frequently-used wet granulation contrast, so while the production time is reduced, can also save drop Consumption reduces production cost.
Experimental example 2, embodiment and comparative example quality versus study
Relevant substance method：
Chemicals and reagent：Ammonium acetate：Analyze pure rank；Sodium 1-octanesulfonate：Analyze pure rank；Acetonitrile：Efficient liquid phase Chromatogram rank；Water：Milli-Q ranks
The preparation of buffer solution：About 15.43g ammonium acetates are weighed, are put in the beaker containing 1000mL water, ultrasonic dissolution.
The preparation of mobile phase A：700mL buffer solutions and 300mL acetonitriles are mixed, adds 100mg sodium 1-octanesulfonates, ultrasound Dissolving.Filtered, and deaerated by 0.45 μm of membrane filter.
The preparation of Mobile phase B：300mL buffer solutions and 700mL acetonitriles are mixed, adds 100mg sodium 1-octanesulfonates, ultrasound Dissolving.Filtered, and deaerated by 0.45 μm of membrane filter.
The preparation of dilution：500mL buffer solutions and 500mL acetonitriles are mixed, adds 100mg sodium 1-octanesulfonates, ultrasound is molten Solution.Filtered, and deaerated by 0.45 μm of membrane filter.
Chromatographic condition：
Table：Embodiment material relevant with comparative example, content balance collect
By 60 DEG C of comparative example and embodiment high temperature accelerate 10 days relevant material Comparative results find comparative example single contaminants with Total miscellaneous increase is obvious, illustrates that dry granulation process is advantageous to improve the stability of drug quality, after comparative example accelerates with embodiment Content is substantially without significant change.
Experimental example 3, embodiment and comparative example and original grind the contrast of sample stripping curve
Medicine " viagra " is ground to Sildenafil citrate tablets embodiment 1 to embodiment 4, comparative example and original to exist Stripping curve comparative study in medium in 0.01mol/L hydrochloric acid.
Stripping curve method：
Dissolution medium：0.01mol/L hydrochloric acid volumes：900ml；Device：Basket method；Rotating speed：100rpm；
Temperature：37℃±0.5℃；Sample time：5th, sample within 10,15,20,30,45 minutes；Sample volume：
Per sub-sampling 10ml, while supplement corresponding dissolution medium 10ml；Detection method：UV, wavelength 292nm
It is prepared by solution：
Reference substance solution：Separately take sildenafil citrate reference substance appropriate, it is accurately weighed, add dissolution medium to dissolve and quantify Dilution is made in every 1ml containing about the μ g of silaenafil 27 solution.
It is prepared by test sample：
In each stripping rotor, 900ml dissolution mediums are separately added into.Reserving the time of abundance makes dissolution medium balance to 37 DEG C ± 0.5 DEG C, adjustment rotating speed to 100rpm, 1 tablet is put into each basket, reduction is installed in dissolution medium, starter.
Respectively at 5,10,15,20,30,45 minutes, dissolution is taken out from dissolution medium surface to the centre position turned at the top of basket Medium decoction 10ml and fluid infusion 10ml, using membrane filtration, discard appropriate primary filtrate, subsequent filtrate is standby.
Stripping curve (Fig. 1) is compared, the f of embodiment 3 and embodiment 42Similar factors are all higher than 85,
Show and the former sample that grinds has good similitude, the similar factors of comparative example have substantially for 56 and embodiment contrast Gap.
Comparative example in above-mentioned experimental example is prepared by the following method：
Preparation technology：The HPMC of formula ratio is dissolved in the aqueous solution that water is made 4%, by the sildenafil citrate of formula ratio (140.5mg/ pieces are equivalent to silaenafil 100mg) is placed in wet mixing pelletizer, opens stirring and shearing, adds formula ratio The HPMC aqueous solution, softwood processed, wet granular processed in 16 mesh oscillating granulators is put, wet granular is put in fluidized bed dryer and dried, done Dry temperature is 45 ± 5 DEG C, is dried to moisture below 2.5%, by above-mentioned particle by 16 eye mesh screen whole grains, by above-mentioned particle with matching somebody with somebody Excipient, disintegrant and the lubricant just measured are added in high efficient mixer and are well mixed, and intermediate detection, tabletting, will premix Agent is configured to 15% homogeneous aqueous solution, coating, and coating pre-mixing agent is configured into coating solution uniformly sprays in tablet surface, makes It is unilateral to form uniform film-coating
In summary, because embodiment does not use water or other solvents as bonding in granulating process using dry granulation Agent is pelletized, also the process without heat drying, so embodiment quality in relevant material, content and stripping curve investigation project It is more stably and controllable, while ingredient in tablets is formed rationally compared with conventional wet lay granulating process in embodiment, with short production cycle, energy Consumption is few, and Recipe more meets and commercially produced in embodiment.

Claims (7)

  1. A kind of 1. Sildenafil citrate tablets agent composition, it is characterised in that the label of the tablet composition
    Material is：
    The parts by weight of sildenafil citrate 35.12~105.36,
    The parts by weight of microcrystalline cellulose 62~186,
    The parts by weight of pregelatinized starch 35~105,
    The parts by weight of Ac-Di-Sol 6~18,
    The parts by weight of magnesium stearate 1~3,
    Silica 2-6 parts by weight,
    The parts by weight of carboxyrnethyl starch sodium 5.5~16.5.
  2. 2. a kind of Sildenafil citrate tablets agent composition as claimed in claim 1, it is characterised in that the tablet composition Label material is：
  3. A kind of 3. Sildenafil citrate tablets agent composition as claimed in claim 1 or 2, it is characterised in that the tablet composition Label be made of compressing dry granulation.
  4. A kind of 4. Sildenafil citrate tablets agent composition as described in claim 1,2 or 3, it is characterised in that the tablet composition Thing also includes coating, and the coating raw material is：
    It is coated pre-mixing agent 4.5-13.5 parts by weight
    95% ethanol 4.5-13.5 parts by weight
    Purified water 18.0-54.0 parts by weight.
  5. 5. a kind of Sildenafil citrate tablets agent composition as claimed in claim 4, it is characterised in that the tablet composition is also Including coating, the coating raw material is：
    It is coated the parts by weight of pre-mixing agent 4.50
    The parts by weight of 95% ethanol 4.50
    The parts by weight of purified water 18.00.
  6. A kind of 6. preparation method of Sildenafil citrate tablets agent composition as claimed in claim 3, it is characterised in that the party Method is：
    It is standby that label material is crossed into 60 eye mesh screens, sildenafil citrate, microcrystalline cellulose is weighed, wherein takes 1/3-2/3 amounts to hand over Connection sodium carboxymethylcellulose and carboxyrnethyl starch sodium, pregelatinized starch are put in three-dimensional mixer and mixed；It is right on dry granulating machine Said mixture material carries out precompressed；Precompressed material is put into attrition grinding and granulation on Fastgranulatemachine；By unsanctioned particle weight It is new to crush, remaining Ac-Di-Sol, carboxyrnethyl starch sodium, magnesium stearate, silica are added in above-mentioned material, is mixed Close；Tabletting.
    Label is coated, takes film coating pre-mix dose, 95% ethanol, purified water is put in agitator, and mixing time 40min is standby； Coating parameter：55 DEG C of EAT, 40 DEG C of piece bed tempertaure；Coating pan revolution：Start 2 hours 1r/min, middle 2r/min, terminate 2r/min；Coating solution usage amount：With solids basis weightening 2%；Produce tablet composition.
  7. A kind of 7. preparation method of Sildenafil citrate tablets agent composition as claimed in claim 6, it is characterised in that the party Method is：
    It is standby that label material is crossed into 60 eye mesh screens, sildenafil citrate, microcrystalline cellulose is weighed, pregelatinized starch, takes at 2/3 Side's amount Ac-Di-Sol and carboxyrnethyl starch sodium are put and 20min are mixed in three-dimensional mixer；It is right on dry granulating machine Said mixture material carries out precompressed；Precompressed material is put into attrition grinding on Fastgranulatemachine and pelletized by 20 eye mesh screens；Will not The particle passed through crushes and by 24 eye mesh screens, remaining Ac-Di-Sol, carboxylic first is added in above-mentioned material again Sodium starch, magnesium stearate, silica, mixing；Tabletting, coating；
    Art for coating is：Label is coated, takes film coating pre-mix dose, 95% ethanol, purified water is put in agitator, mixing time 40min is standby；Coating parameter：55 DEG C of EAT, 40 DEG C of piece bed tempertaure；Coating pan revolution：Start 2 hours 1r/min, it is middle 2r/min, terminate 2r/min；Coating solution usage amount：With solids basis weightening 2%.；Produce tablet composition.
CN201710631623.2A 2017-07-28 2017-07-28 Sildenafil citrate tablet composition and preparation method thereof Active CN107496370B (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113456604A (en) * 2021-07-08 2021-10-01 天地恒一制药股份有限公司 Sildenafil citrate orally disintegrating tablet and preparation method thereof

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