CN101653425A - Arbidol hydrochloride medicament composition dispersible tablets and preparation method thereof - Google Patents
Arbidol hydrochloride medicament composition dispersible tablets and preparation method thereof Download PDFInfo
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- CN101653425A CN101653425A CN200910307014A CN200910307014A CN101653425A CN 101653425 A CN101653425 A CN 101653425A CN 200910307014 A CN200910307014 A CN 200910307014A CN 200910307014 A CN200910307014 A CN 200910307014A CN 101653425 A CN101653425 A CN 101653425A
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Abstract
The invention relates to arbidol hydrochloride medicament composition dispersible tablets and a preparation method thereof. The arbidol hydrochloride medicament composition dispersible tablets consistof 80-120 parts by weight of arbidol hydrochloride, 170-210 parts by weight of microcrystalline cellulose, 46-66 parts by weight of lactose, 15-25 parts by weight of starch, 2-4 parts by weight of carboxymethyl, 0.2-0.8 parts by weight of citric acid, 20-30 parts by weight of CMC-Na, proper amount of 50% PVP ethanol, 1-3 parts by weight of aerosil and 1-3 parts by weight of magnesium stearate. The substrates of arbidol hydrochloride medicament composition dispersible tablets have good appearance, hardness and dispersion uniformity.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to arbidol hydrochloride medicament composition, specifically is a kind of arbidol hydrochloride medicament composition dispersible tablets and preparation method thereof.
Background technology
Arbidol HCl (ArbidolHydrochloride) chemistry is called-6-bromo-4-dimethylaminomethyl-5-hydroxyl-1-methyl-2-benzene sulfidomethyl indole-3-carboxylic acid carbethoxy hydrochloride monohydrate, be a kind of interferon inducer, immunostimulant and anti-influenza virus medicament.Its chemical structural formula is as follows:
It is to having A, and the antiviral activity of the antigenic influenza virus of Type B is the most remarkable, can suppress A, Type B influenza virus duplicating in cell culture medium by selectivity.Arbidol HCl has immunoregulation effect simultaneously, can induce the generation interferon, activating macrophage improves the resistance of body to viral infection, is to be used for the treatment of the influenza that A, Type B virus cause and the novel antiviral medicine of acute respiratory viral infection.By the research and development of full Russia chemical pharmacy institute, in 1993 through the approval of Russian pharmacology committee in Russia's listing, dosage form is a tablet, now obtains licence in 28 countries.
The animal pharmacokinetics experiment shows that it is rapid that rat oral gavage gives arbidol HCl (150mg/kg) post-absorption, blood plasma t
MaxBe 20min, t
1/2Be 6.7h.Because the arbidol HCl half-life is shorter, in order to reach optimum therapeuticing effect, common arbidol HCl tablet or capsule need administration 3-4 time every day when clinical application, and each 200mg makes troubles for patient's medication.Therefore, be necessary to study the novel form of arbidol HCl.
Chinese patent ZL03159222.8 discloses a kind of slow releasing tablet of arbidol HCl.Because arbidol HCl is water-soluble hardly, therefore can be prepared into hydrogel matrix slow releasing tablet and waxiness matrix sustained release tablet.In hydrogel matrix tablet, hydrophilic gel matrix material proportion in prescription is 10～90%, preferred hydroxypropyl emthylcellulose, and shared part by weight preferably 15～50% in prescription, adopt common wet granulation technology.In the waxiness matrix sustained release tablet, waxiness framework material proportion in prescription is 5～80%, the preferably glycerine behenate, and shared part by weight preferably 10～40% in prescription, adopt direct compression, wet granulation, fusing or melt granulation technology.But because arbidol HCl is insoluble in water, absorption is limited by its stripping, and making slow releasing preparation might not be favourable.In addition, clinical practice slow releasing preparation treatment disease, the motility that dosage is regulated reduces, if run into certain special circumstances (as big side reaction occurring), often can not stop treatment at once; And the design of slow releasing preparation based on the average power mathematic(al) parameter of healthy population, is worked as morbid state often, when pharmaceutical in vivo dynamics characteristic changes to some extent, and can not the flexible dosage regimen; In addition, prepare the related equipment of slow releasing preparation and the cost of technology than the conventional formulation costliness.
As seen, arbidol HCl is made slow releasing preparation and nonideal selection." preparation process of Abiduoer dispersible tablet and quality research " (referring to Ding Feng, Li Dan, Xu becomes, Zhou Qin " preparation process of Abiduoer dispersible tablet and quality research; " Jiangsu pharmacy and clinical research " were rolled up for the 5th phase in 2004 the 12nd) preparation process and the quality of Abiduoer dispersible tablet are studied.Its prescription is Abiduoer 100g, and 2% ethyl cellulose alcoholic solution is an amount of, microcrystalline Cellulose 65g, crospolyvinylpyrrolidone 80g, starch 65g, mannitol 23g, steviosin 13g, aspartame 4g, bitterness masking agent 5g, micropowder silica gel 10g, magnesium stearate 4g, water is an amount of, makes 1000.But adopt the Abiduoer dispersible tablet of this prescription preparation to place 10 days under 60 ℃ of conditions, the slice, thin piece outward appearance is slightly yellow, and related substance exceeds standard; At relative humidity is to place 5 days under 92.5% condition, and weightening finish surpasses 5%, and as seen this Abiduoer dispersible tablet is stable bad.
The inventor is prepared into the dispersion sheet with it after having carried out a large amount of tests, and has good dispersive property and the stripping property of Geng Gao, and has good stability.
Summary of the invention
First purpose of the present invention is to provide a kind of arbidol hydrochloride medicament composition dispersible tablets, and this medicament combination dispersible tablet has good dispersive property and the stripping property of Geng Gao, and has good stability.
Another object of the present invention is to provide the preparation method of arbidol hydrochloride medicament composition dispersible tablets of the present invention, this method is simple.
For realizing first purpose of the present invention, the present invention adopts following technical scheme:
A kind of arbidol hydrochloride medicament composition dispersible tablets, wherein, described arbidol HCl compositions dispersible tablet is made 1000 by following component:
Arbidol HCl 80-120 weight portion
Microcrystalline Cellulose 170-210 weight portion
Lactose 46-66 weight portion
Starch 15-25 weight portion
Stevioside 2-4 weight portion
Citric acid 0.2-0.8 weight portion
Carboxymethyl starch sodium 20-30 weight portion
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 1-3 weight portion
Magnesium stearate 1-3 weight portion;
Preferably, arbidol hydrochloride medicament composition dispersible tablets of the present invention is made 1000 by following component:
Arbidol HCl 90-110 weight portion
Microcrystalline Cellulose 180-200 weight portion
Lactose 50-62 weight portion
Starch 18-22 weight portion
Stevioside 2.5-3.5 weight portion
Citric acid 0.3-0.7 weight portion
Carboxymethyl starch sodium 22-28 weight portion
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 1.5-2.5 weight portion
Magnesium stearate 1.5-2.5 weight portion;
More preferably, arbidol hydrochloride medicament composition dispersible tablets of the present invention is made 1000 by following component:
Arbidol HCl 100 weight portions
Microcrystalline Cellulose 190 weight portions
Lactose 56 weight portions
Starch 20 weight portions
Stevioside 3 weight portions
Citric acid 0.5 weight portion
Carboxymethyl starch sodium 25 weight portions
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 2 weight portions
Magnesium stearate 2 weight portions.
For realizing second purpose of the present invention, the present invention adopts following technical scheme:
A kind of preparation method of arbidol hydrochloride medicament composition dispersible tablets, this method comprises the steps:
1) with raw material arbidol HCl and microcrystalline cellulose excipients, lactose, starch, stevioside, citric acid and carboxymethyl starch sodium pulverize separately, sieve;
2) take by weighing arbidol HCl, microcrystalline Cellulose, lactose, starch and 50% carboxymethyl starch sodium mix homogeneously by recipe quantity, sieve, mix homogeneously obtains mixture;
3) with step 2) resulting mixture adds an amount of 5% polyvidone alcoholic solution system soft material, crosses the sieve series wet granular, drying, 20 order granulate are pressed recipe quantity and are added remaining 50% carboxymethyl starch sodium, stevioside, citric acid, Pulvis Talci and magnesium stearate, mixing, tabletting, promptly.
According to the preparation method of aforesaid arbidol HCl dispersible tablet, wherein, sieving described in the step 1) to crossing 80-120 mesh sieve, preferred 100 mesh sieves.
Sieving according to the preparation method of aforesaid arbidol HCl dispersible tablet, wherein, step 2) was the 40-80 mesh sieve, preferred 60 mesh sieves.
According to the preparation method of aforesaid arbidol HCl dispersible tablet, wherein, the drying described in the step 3) is at 65-75 ℃ of dry 2.5-3.5 hour.
According to the preparation method of aforesaid arbidol hydrochloride medicament composition dispersible tablets, wherein, step 2) describedly before sieving in was mixed under the condition of rotating speed 35～55 commentariess on classics/min, preferred 45 commentaries on classics/min mixing 5-15 minute.
According to the preparation method of aforesaid arbidol hydrochloride medicament composition dispersible tablets, wherein, step 2) sieves the described blended mixing velocity in back under the condition of rotating speed 25～35 commentaries on classics/min, preferred 30 commentaries on classics/min, to mix 1～5min in.
Below be detailed description of the present invention:
At first, the invention provides a kind of arbidol hydrochloride medicament composition dispersible tablets, this dispersible tablet is made 1000 by following component:
Arbidol HCl 80-120 weight portion
Microcrystalline Cellulose 170-210 weight portion
Lactose 46-66 weight portion
Starch 15-25 weight portion
Stevioside 2-4 weight portion
Citric acid 0.2-0.8 weight portion
Carboxymethyl starch sodium 20-30 weight portion
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 1-3 weight portion
Magnesium stearate 1-3 weight portion.
" preparation process of Abiduoer dispersible tablet and quality research " (referring to Ding Feng, Li Dan, Xu becomes, Zhou Qin " preparation process of Abiduoer dispersible tablet and quality research; " Jiangsu pharmacy and clinical research " were rolled up for the 5th phase in 2004 the 12nd) preparation process and the quality of Abiduoer dispersible tablet are studied.Its prescription is Abiduoer 100g, and 2% ethyl cellulose alcoholic solution is an amount of, microcrystalline Cellulose 65g, crospolyvinylpyrrolidone 80g, starch 65g, mannitol 23g, steviosin 13g, aspartame 4g, bitterness masking agent 5g, micropowder silica gel 10g, magnesium stearate 4g, water is an amount of, makes 1000.But adopt the Abiduoer dispersible tablet of this prescription preparation to place 10 days under 60 ℃ of conditions, the slice, thin piece outward appearance is slightly yellow, and related substance exceeds standard; At relative humidity is to place 5 days under 92.5% condition, and weightening finish surpasses 5%, and as seen this Abiduoer dispersible tablet is stable bad.
The arbidol hydrochloride medicament composition dispersible tablets of preparation was placed 10 days under 60 ℃ of conditions and be to place 5 days under 92.5% condition at relative humidity and adopt the present invention to write out a prescription, and increasing weight only is 2%, and as seen it has good stability.
" preparation process of Abiduoer dispersible tablet and quality research " (referring to Ding Feng, Li Dan, Xu becomes, Zhou Qin " preparation process of Abiduoer dispersible tablet and quality research; " Jiangsu pharmacy and clinical research "; 2004 the 12nd the 5th phases of volume) preparation technology of the Abiduoer dispersible tablet that provides is: the Abiduoer raw material was pulverized 100 mesh sieves in advance; make binding agent system soft material; mistake 30 mesh sieves granulation; 60 ℃ of oven dry with an amount of 2% ethyl cellulose (7cp) alcoholic solution, cross 30 mesh sieve granulate, be granule 1; Other gets microcrystalline Cellulose, crospolyvinylpyrrolidone, starch, mannitol, steviosin, aspartame, bitterness masking agent mixing, crosses 100 mesh sieves, makes binding agent system soft material with suitable quantity of water, crossing 30 mesh sieves granulates, 30 mesh sieve granulate are crossed in 60 ℃ of oven dry, are granule 2.With granule 1 and granule 2 mix homogeneously, again with the crospolyvinylpyrrolidone that adds, micropowder silica gel, magnesium stearate mix homogeneously, measure content, qualified back is heavy according to the cubage sheet, and tabletting is promptly.
Arbidol HCl dispersible tablet provided by the present invention, disintegrate fully in 2 minutes and 20 seconds average time, and can cross No. 2 sieves (two appendix IA of Chinese Pharmacopoeia version in 2005), accumulation stripping percentage rate can reach 100% (adopting Chinese Pharmacopoeia appendix XC dissolution determination method second method) in the time of 2 minutes.
For the present invention clearly is described, below carry out some explanations with regard to thinking of the present invention earlier.
Dispersible tablet of the present invention (dispersible tablets), claim water dispersion tablet (water dis-persibletablets) again, mean a kind of tablet of meeting the even stickiness suspension of water rapid disintegrate formation, dispersible tablet has the advantage of tablet and liquid preparation concurrently, that is: taking convenience, absorb soon, bioavailability height and untoward reaction are little etc.
The active component of dispersible tablet, regulation is generally arranged, therefore, the research that the present invention is carried out to the branch assembly with regard to integral formula to the stripping and the dispersion effect of described dispersible tablet, dispersible tablet of the present invention, require to meet behind the water as soon as possible that disintegrate becomes granule, and form uniform suspension, so design of components is important.
At first, the kind of disintegrating agent and consumption are most important to disintegrate, the result of extraction of dispersible tablet, from composition, the most frequently used have carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (L-HPC), cross-linked carboxymethyl cellulose sodium (cCMC-Na), a crospolyvinylpyrrolidone (PVPP) etc.
Prior art shows that the difference on the disintegrating agent consumption also may produce diametrically opposite effect to the disintegrate behavior of dispersible tablet.As a kind of quickly disintegrated efficiently CMS-Na, the influence to disintegration of tablet when its consumption is 1%-2% is not obvious; Can obviously accelerate disintegrate during 3%-7%, 8%-10% has postponed disintegrate on the contrary.
Studies show that several disintegrating agents with different performance are united use, adjust its composition or consumption separately, can reach better disintegrate effect at active component.
It is low that " Chinese pharmaceutic adjuvant " mentions the microcrystalline Cellulose swellbility, is not suitable for using as disintegrating agent.Yet the present invention is unexpected to be found, uses high carboxymethyl starch sodium of swellbility and microcrystalline Cellulose combination collocation to use, and can well improve dispersing uniformity and dissolution rate.
Analysis may be the contour swelling material of carboxymethyl starch sodium in aqueous solution after the disintegrate, the Colloidal fluid of formation is wrapped in the outside of drug particles, has hindered the further stripping of granule Chinese medicine powder.
And the present invention uses microcrystalline Cellulose and carboxymethyl starch sodium combination collocation, and not only the dispersing uniformity time lacks, and the effective ingredient dissolution rate is fast.
In addition, note also the ratio of control microcrystalline Cellulose and carboxymethyl starch sodium, when large percentage, can not reach good dispersion effect, jitter time has exceeded the state-promulgated pharmacopoeia standard.
In addition, the suitable composition of binding agent and other filler and ratio are influential to the disintegrate of dispersible tablet.
Among the present invention, select for use 5% polyvidone alcoholic solution as binding agent, as long as its consumption can satisfy the amount that supplementary material can reach the system soft material, this point is that art technology can both be expected.Consumption according to 5% used polyvidone alcoholic solution of the concrete prescription of arbidol HCl compositions dispersible tablet of the present invention is 30-60ml.
Based on described consideration, the present invention is in order to obtain the best prescription combination of described dispersible tablet, is kind and best proportioning or the consumption that index adopts quadrature, method for designing screening disintegrating agent such as even with substrate's appearance, hardness, dispersing uniformity and stripping.Test is found, when the arbidol hydrochloride medicament composition dispersible tablets that is provided consist of that arbidol HCl 80-120 weight portion, microcrystalline Cellulose 170-210 weight portion, lactose 46-66 weight portion, starch 15-25 weight portion, stevioside 2-4 weight portion, citric acid 0.2-0.8 weight portion, carboxymethyl starch sodium 20-30 weight portion, 5% polyvidone alcoholic solution are an amount of, when micropowder silica gel 1-3 weight portion and magnesium stearate 1-3 weight portion, its substrate's appearance of prepared arbidol hydrochloride medicament composition dispersible tablets, hardness and dispersing uniformity are all good.When the arbidol hydrochloride medicament composition dispersible tablets that is provided consist of that arbidol HCl 90-110 weight portion, microcrystalline Cellulose 180-200 weight portion, lactose 50-62 weight portion, starch 18-22 weight portion, stevioside 2.5-3.5 weight portion, citric acid 0.3-0.7 weight portion, carboxymethyl starch sodium 22-28 weight portion, 5% polyvidone alcoholic solution are an amount of, when micropowder silica gel 1.5-2.5 weight portion and magnesium stearate 1.5-2.5 weight portion, its substrate's appearance of prepared arbidol hydrochloride medicament composition dispersible tablets, hardness and dispersing uniformity are all better.When the arbidol hydrochloride medicament composition dispersible tablets that is provided consist of that arbidol HCl 100 weight portions, microcrystalline Cellulose 190 weight portions, lactose 56 weight portions, starch 20 weight portions, stevioside 3 weight portions, citric acid 0.5 weight portion, carboxymethyl starch sodium 25 weight portions, 5% polyvidone alcoholic solution are an amount of, when micropowder silica gel 2 weight portions and magnesium stearate 2 weight portions, its substrate's appearance of prepared arbidol hydrochloride medicament composition dispersible tablets, hardness and dispersing uniformity are all good.
Arbidol hydrochloride medicament composition dispersible tablets provided by the present invention can be with reference to the preparation method preparation of any dispersible tablet of prior art, those skilled in the art can prepare this arbidol hydrochloride medicament composition dispersible tablets by simple experiment in conjunction with the prior art of self grasping after reading the present invention.But in order further to improve the quality of this arbidol hydrochloride medicament composition dispersible tablets, further improve and disperse result of extraction, the present invention provides a kind of preferred manufacturing procedure simultaneously:
1) with raw material arbidol HCl and microcrystalline cellulose excipients, lactose, starch, stevioside, citric acid and carboxymethyl starch sodium pulverize separately, sieve;
2) take by weighing arbidol HCl, microcrystalline Cellulose, lactose, starch and 50% carboxymethyl starch sodium mix homogeneously by recipe quantity, sieve, mix homogeneously obtains mixture;
3) with step 2) resulting mixture adds an amount of 5% polyvidone alcoholic solution system soft material, crosses the sieve series wet granular, drying, 20 order granulate are pressed recipe quantity and are added remaining 50% carboxymethyl starch sodium, stevioside, citric acid, Pulvis Talci and magnesium stearate, mixing, tabletting, promptly.
According to the preparation method of aforesaid arbidol HCl dispersible tablet, wherein, sieving described in the step 1) to crossing 80-120 mesh sieve, preferred 100 mesh sieves.
Sieving according to the preparation method of aforesaid arbidol HCl dispersible tablet, wherein, step 2) was the 80-120 mesh sieve, preferred 60 mesh sieves.
Pulverizing back gained material is the aggregation of different sized particles, and the purpose of sieving is in order to obtain the material than uniform particle size.This all has an important meaning smoothly to the quality of the pharmaceutical preparations and preparation production.The present invention has carried out strict control to related sieving in the different step, has guaranteed the quality of product.
According to the preparation method of aforesaid arbidol HCl dispersible tablet, wherein, the drying described in the step 3) is at 65-75 ℃ of dry 2.5-3.5 hour.
According to the preparation method of aforesaid arbidol hydrochloride medicament composition dispersible tablets, wherein, step 2) describedly before sieving in was mixed under the condition of rotating speed 35～55 commentariess on classics/min, preferred 45 commentaries on classics/min mixing 5-15 minute.
According to the preparation method of aforesaid arbidol hydrochloride medicament composition dispersible tablets, wherein, step 2) sieves the described blended mixing velocity in back under the condition of rotating speed 25～35 commentaries on classics/min, preferred 30 commentaries on classics/min, to mix 1～5min in.
Married operation is a purpose with the content uniformity, uses very extensive in the preparation production process.Mixing resultant directly influences the presentation quality and the inherent quality of preparation.Rotating speed and the incorporation time of the present invention when mixing tested, discovery is being carried out certain control to mixing rotating speed in the preparation method and incorporation time, after promptly adopting the present invention above-mentioned rotating speed and incorporation time, the dissolution of product has obtained correspondingly improving, and when further to mix rotating speed and incorporation time carry out preferred after, its dissolution reaches best.
Compared with prior art, the present invention has following beneficial effect:
(1) dispersing uniformity of arbidol hydrochloride medicament composition dispersible tablets of the present invention, dissolution Abiduoer dispersible tablet more of the prior art are good;
(2) the preparation method simple possible of arbidol hydrochloride medicament composition dispersible tablets of the present invention is fit to large-scale production.
The specific embodiment
Below be the specific embodiment of the present invention, described embodiment is in order to further describe the present invention, rather than restriction the present invention.
Embodiment 1
1, prescription:
Arbidol HCl 100g
Microcrystalline Cellulose 190.0g
Lactose 56.0g
Starch 20.0g
Stevioside 3.0g
Citric acid 0.5g
Carboxymethyl starch sodium 25g
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 2.0g
Magnesium stearate 2.0g
Make 1000
2, preparation technology:
1) with raw material arbidol HCl and microcrystalline cellulose excipients, lactose, starch, stevioside, citric acid and carboxymethyl starch sodium pulverize separately, sieve;
2) take by weighing arbidol HCl, microcrystalline Cellulose, lactose, starch and 50% carboxymethyl starch sodium mix homogeneously by recipe quantity, sieve, mix homogeneously obtains mixture;
3) with step 2) resulting mixture adds an amount of 5% polyvidone alcoholic solution system soft material, crosses the sieve series wet granular, drying, 20 order granulate are pressed recipe quantity and are added remaining 50% carboxymethyl starch sodium, stevioside, citric acid, Pulvis Talci and magnesium stearate, mixing, tabletting, promptly.
Embodiment 2
1, prescription:
Arbidol HCl 80g
Microcrystalline Cellulose 170g
Lactose 46g
Starch 15g
Stevioside 2g
Citric acid 0.2g
Carboxymethyl starch sodium 20g
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 1g
Magnesium stearate 1g
Make 1000
2, preparation technology:
1) with raw material arbidol HCl and microcrystalline cellulose excipients, lactose, starch, stevioside, citric acid and carboxymethyl starch sodium pulverize separately, cross 100 mesh sieves;
2) take by weighing arbidol HCl, microcrystalline Cellulose, lactose, starch and 50% carboxymethyl starch sodium mix homogeneously by recipe quantity, cross 60 mesh sieves, mix homogeneously obtains mixture;
3) with step 2) resulting mixture adds an amount of 5% polyvidone alcoholic solution system soft material, crosses the sieve series wet granular, 75 ℃ of dryings 3.5 hours, 20 order granulate are pressed recipe quantity and are added remaining 50% carboxymethyl starch sodium, stevioside, citric acid, Pulvis Talci and magnesium stearate, mixing, tabletting, promptly.
Embodiment 3
1, prescription:
Arbidol HCl 120g
Microcrystalline Cellulose 210g
Lactose 66g
Starch 25g
Stevioside 4g
Citric acid 0.8g
Carboxymethyl starch sodium 30g
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 3g
Magnesium stearate 3g
Make 1000
2, preparation technology:
1) with raw material arbidol HCl and microcrystalline cellulose excipients, lactose, starch, stevioside, citric acid and carboxymethyl starch sodium pulverize separately, cross 100 mesh sieves;
2) take by weighing arbidol HCl, microcrystalline Cellulose, lactose, starch and 50% carboxymethyl starch sodium mix homogeneously by recipe quantity, cross 60 mesh sieves, mix homogeneously obtains mixture;
3) with step 2) resulting mixture adds an amount of 5% polyvidone alcoholic solution system soft material, crosses the sieve series wet granular, 65 ℃ of dryings 2.5 hours, 20 order granulate are pressed recipe quantity and are added remaining 50% carboxymethyl starch sodium, stevioside, citric acid, Pulvis Talci and magnesium stearate, mixing, tabletting, promptly.
Embodiment 4
1, prescription:
Arbidol HCl 110g
Microcrystalline Cellulose 200g
Lactose 58g
Starch 23g
Stevioside 2.8g
Citric acid 0.6g
Carboxymethyl starch sodium 28g
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 1.8g
Magnesium stearate 1.8g
Make 1000
2, preparation technology:
1) with raw material arbidol HCl and microcrystalline cellulose excipients, lactose, starch, stevioside, citric acid and carboxymethyl starch sodium pulverize separately, cross 100 mesh sieves;
2) take by weighing arbidol HCl, microcrystalline Cellulose, lactose, starch and 50% carboxymethyl starch sodium mix homogeneously by recipe quantity, cross 60 mesh sieves, mix homogeneously obtains mixture;
3) with step 2) resulting mixture adds an amount of 5% polyvidone alcoholic solution system soft material, crosses the sieve series wet granular, 68 ℃ of dryings 2.8 hours, 20 order granulate are pressed recipe quantity and are added remaining 50% carboxymethyl starch sodium, stevioside, citric acid, Pulvis Talci and magnesium stearate, mixing, tabletting, promptly.
Embodiment 5
1, prescription:
Arbidol HCl 90g
Microcrystalline Cellulose 180g
Lactose 50g
Starch 18g
Stevioside 2.5g
Citric acid 0.3g
Carboxymethyl starch sodium 22g
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 1.5g
Magnesium stearate 1.5g
Make 1000
2, preparation technology:
1) with raw material arbidol HCl and microcrystalline cellulose excipients, lactose, starch, stevioside, citric acid and carboxymethyl starch sodium pulverize separately, cross 100 mesh sieves;
2) taking by weighing arbidol HCl, microcrystalline Cellulose, lactose, starch and 50% carboxymethyl starch sodium by recipe quantity mixed 10 minutes under the condition of rotating speed 45 commentaries on classics/min, mix homogeneously is crossed 60 mesh sieves, mixes 3 minutes under the condition of rotating speed 45 commentaries on classics/min again, mix homogeneously obtains mixture;
3) with step 2) resulting mixture adds an amount of 5% polyvidone alcoholic solution system soft material, crosses the sieve series wet granular, 68 ℃ of dryings 2.8 hours, 20 order granulate are pressed recipe quantity and are added remaining 50% carboxymethyl starch sodium, stevioside, citric acid, Pulvis Talci and magnesium stearate, mixing, tabletting, promptly.
Embodiment 6
1, prescription:
Arbidol HCl 100g
Microcrystalline Cellulose 190.0g
Lactose 56.0g
Starch 20.0g
Stevioside 3.0g
Citric acid 0.5g
Carboxymethyl starch sodium 25g
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 2.0g
Magnesium stearate 2.0g
Make 1000
2, preparation technology:
1) with raw material arbidol HCl and microcrystalline cellulose excipients, lactose, starch, stevioside, citric acid and carboxymethyl starch sodium pulverize separately, cross 100 mesh sieves;
2) taking by weighing arbidol HCl, microcrystalline Cellulose, lactose, starch and 50% carboxymethyl starch sodium by recipe quantity mixed 15 minutes under the condition of rotating speed 35 commentaries on classics/min, mix homogeneously is crossed 60 mesh sieves, mixes 5 minutes under the condition of rotating speed 25 commentaries on classics/min again, mix homogeneously obtains mixture;
3) with step 2) resulting mixture adds an amount of 5% polyvidone alcoholic solution system soft material, crosses the sieve series wet granular, 68 ℃ of dryings 2.8 hours, 20 order granulate are pressed recipe quantity and are added remaining 50% carboxymethyl starch sodium, stevioside, citric acid, Pulvis Talci and magnesium stearate, mixing, tabletting, promptly.
Embodiment 7
1, prescription:
Arbidol HCl 100g
Microcrystalline Cellulose 190.0g
Lactose 56.0g
Starch 20.0g
Stevioside 3.0g
Citric acid 0.5g
Carboxymethyl starch sodium 25g
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 2.0g
Magnesium stearate 2.0g
Make 1000
2, preparation technology:
1) with raw material arbidol HCl and microcrystalline cellulose excipients, lactose, starch, stevioside, citric acid and carboxymethyl starch sodium pulverize separately, cross 100 mesh sieves;
2) taking by weighing arbidol HCl, microcrystalline Cellulose, lactose, starch and 50% carboxymethyl starch sodium by recipe quantity mixed 5 minutes under the condition of rotating speed 55 commentaries on classics/min, mix homogeneously is crossed 60 mesh sieves, mixes 1 minute under the condition of rotating speed 35 commentaries on classics/min again, mix homogeneously obtains mixture;
3) with step 2) resulting mixture adds an amount of 5% polyvidone alcoholic solution system soft material, crosses the sieve series wet granular, 68 ℃ of dryings 2.8 hours, 20 order granulate are pressed recipe quantity and are added remaining 50% carboxymethyl starch sodium, stevioside, citric acid, Pulvis Talci and magnesium stearate, mixing, tabletting, promptly.
Embodiment 8
1, prescription:
Arbidol HCl 100g
Microcrystalline Cellulose 190.0g
Lactose 56.0g
Starch 20.0g
Stevioside 3.0g
Citric acid 0.5g
Carboxymethyl starch sodium 25g
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 2.0g
Magnesium stearate 2.0g
Make 1000
2, preparation technology:
1) with raw material arbidol HCl and microcrystalline cellulose excipients, lactose, starch, stevioside, citric acid and carboxymethyl starch sodium pulverize separately, cross 100 mesh sieves;
2) taking by weighing arbidol HCl, microcrystalline Cellulose, lactose, starch and 50% carboxymethyl starch sodium by recipe quantity mixed 10 minutes under the condition of rotating speed 45 commentaries on classics/min, mix homogeneously is crossed 60 mesh sieves, mixes 3 minutes under the condition of rotating speed 45 commentaries on classics/min again, mix homogeneously obtains mixture;
3) with step 2) resulting mixture adds an amount of 5% polyvidone alcoholic solution system soft material, crosses the sieve series wet granular, 68 ℃ of dryings 2.8 hours, 20 order granulate are pressed recipe quantity and are added remaining 50% carboxymethyl starch sodium, stevioside, citric acid, Pulvis Talci and magnesium stearate, mixing, tabletting, promptly.
Test example 1
This test example is screened the prescription of arbidol HCl dispersible tablet composition of the present invention.The selection result sees Table 1.
Table 1
| The prescription numbering | ??1 | ??2 | ??3 | ??4 | ??5 | ??6 | ??7 |
| Arbidol HCl | ??75g | ??80g | ??90g | ??100g | ??110g | ??120g | ??125g |
| Microcrystalline Cellulose | ??165g | ??170g | ??180g | ??190g | ??200g | ??210g | ??212g |
| Lactose | ??45g | ??46g | ??50g | ??56g | ??62g | ??66g | ??68g |
| Starch | ??13g | ??15g | ??18g | ??20g | ??22g | ??25g | ??28g |
| Stevioside | ??1.5g | ??2g | ??2.5g | ??3.0g | ??3.5g | ??4g | ??4.5g |
| Citric acid | ??0.1g | ??0.2g | ??0.3g | ??0.5g | ??0.7g | ??0.8g | ??1.0g |
| Carboxymethyl starch sodium | ??18g | ??20g | ??22g | ??25g | ??28g | ??30g | ??32g |
| 5% polyvidone ethanol | In right amount | In right amount | In right amount | In right amount | In right amount | In right amount | In right amount |
| Micropowder silica gel | ??0.8g | ??1g | ??1.5g | ??2.0g | ??2.5g | ??3g | ??3.5g |
| Magnesium stearate | ??0.8g | ??1g | ??1.5g | ??2.0g | ??2.5g | ??3g | ??3.5g |
| Substrate's appearance | Difference | Good | Better | Well | Better | Good | Difference |
| Hardness | Difference | Good | Better | Well | Better | Good | Difference |
| Dispersing uniformity | Difference | Good | Better | Well | Better | Good | Difference |
| Medicine stripping in 45 minutes | ??78.7％ | ??94.5％ | ??96.8％ | ??99.9％ | ??96.7％ | ??94.6％ | ??77.6％ |
From above-mentioned screening test as can be seen, consist of arbidol HCl 80-120 weight portion when the arbidol hydrochloride medicament composition dispersible tablets that is provided, microcrystalline Cellulose 170-210 weight portion, lactose 46-66 weight portion, starch 15-25 weight portion, stevioside 2-4 weight portion, citric acid 0.2-0.8 weight portion, carboxymethyl starch sodium 20-30 weight portion, 5% polyvidone alcoholic solution is an amount of, when micropowder silica gel 1-3 weight portion and magnesium stearate 1-3 weight portion, its substrate's appearance of prepared arbidol hydrochloride medicament composition dispersible tablets, hardness and dispersing uniformity are all good.When the arbidol hydrochloride medicament composition dispersible tablets that is provided consist of that arbidol HCl 90-110 weight portion, microcrystalline Cellulose 180-200 weight portion, lactose 50-62 weight portion, starch 18-22 weight portion, stevioside 2.5-3.5 weight portion, citric acid 0.3-0.7 weight portion, carboxymethyl starch sodium 22-28 weight portion, 5% polyvidone alcoholic solution are an amount of, when micropowder silica gel 1.5-2.5 weight portion and magnesium stearate 1.5-2.5 weight portion, its substrate's appearance of prepared arbidol hydrochloride medicament composition dispersible tablets, hardness and dispersing uniformity are all better.When the arbidol hydrochloride medicament composition dispersible tablets that is provided consist of that arbidol HCl 100 weight portions, microcrystalline Cellulose 190 weight portions, lactose 56 weight portions, starch 20 weight portions, stevioside 3 weight portions, citric acid 0.5 weight portion, carboxymethyl starch sodium 25 weight portions, 5% polyvidone alcoholic solution are an amount of, when micropowder silica gel 2 weight portions and magnesium stearate 2 weight portions, its substrate's appearance of prepared arbidol hydrochloride medicament composition dispersible tablets, hardness and dispersing uniformity are all good.
Test example 2
This test example is to investigate the influence to dissolution of mixing rotating speed among the preparation technology of the present invention and incorporation time.
Dissolution determination method: get this product, according to dissolution method (two appendix XC second methods of Chinese Pharmacopoeia version in 2005), with 0.1molL
-1, operation in accordance with the law during 30min, is got solution and is filtered, and precision is measured subsequent filtrate 1ml, puts in the 10ml measuring bottle, adds 0.1molL
-1Acetum be diluted to scale, as need testing solution; Other gets the about 11.1mg of arbidol HCl reference substance that measures moisture content, and accurate the title decides, and puts in the 100ml measuring bottle, adds an amount of 0.1molL
-1Acetum be diluted to scale, shake up, precision is measured 1ml and is put in the 10ml measuring bottle, adds 0.1molL
-1Acetum be diluted to scale, shake up, in contrast product solution.Get above-mentioned two kinds of solution, measure trap at 314nm wavelength place, calculate, and the result be multiply by 1.035 promptly get every stripping quantity according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2005 A).Limit is 70% of a labelled amount, should be up to specification.Check result sees Table 2.
Table 2, arbidol HCl dispersible tablet checkout facility result
| The embodiment numbering | Dispersing uniformity | Dissolution (%) |
| Embodiment 1 | Disintegrate fully in 2 minutes and 20 seconds average time, and can be by No. 2 sieves | ??101.5 |
| Embodiment 8 | Disintegrate fully in 2 minutes and 15 seconds average time, and can be by No. 2 sieves | ??102.5 |
| Embodiment 7 | Disintegrate fully in 2 minutes and 10 seconds average time, and can be by No. 2 sieves | ??102.0 |
| Embodiment 6 | Disintegrate fully in 2 minutes and 8 seconds average time, and can be by No. 2 sieves | ??102.1 |
As can be seen from the above table, the preparation method of arbidol hydrochloride medicament composition dispersible tablets of the present invention has certain influence to the dissolution of medicine, the dissolution of the product of the embodiment of the invention 1 is 99.3%, after the mixing rotating speed in the preparation method and incorporation time are carried out certain control, the dissolution of product correspondingly improves, and to mix rotating speed and incorporation time carry out preferred after, its dissolution is best.
Test example 3
This test example relates to influence factor's test of arbidol hydrochloride medicament composition dispersible tablets.
1, exposure experiments to light prepares a batch sample (lot number 080115) according to the method for embodiment 1 and removes outer package, and is with the luminosity irradiation of 4500Lx ± 500Lx, respectively at the 5th day and the 10th day every index of sampling and measuring, all up to specification.
2, hot test prepares a batch sample (lot number 080115) according to the method for embodiment 1 and removes outer package, respectively at placing in 40 ℃, the 60 ℃ constant temperature ovens, respectively at the 5th day and the 10th day every index of sampling and measuring.Placed 10 days under 40 ℃ as a result, the 60 ℃ conditions, every index is all up to specification.
3, high humility test prepares a batch sample (lot number 080115) according to the method for embodiment 1 and removes outer package, in 25 ℃, relative humidity was that 75% and 25 ℃, relative humidity are to place under 92.5% the condition, respectively at the 5th day and the 10th day every index of sampling and measuring.Placed 10 days under relative humidity 75% condition as a result, every index is all up to specification; At relative humidity is to place 5 days under 92.5% condition, and weightening finish 2% is so this product should be stored in hermetic container.
4, accelerated test prepares 3 batch samples (lot number 080115,080116,080117) by simulation listing packing according to the method for embodiment 1, in 40 ± 2 ℃ of temperature, relative humidity 75 ± 5% is placed, respectively at the 1st, 2,3,6 month every index of sampling and measuring, the every index of result is all up to specification, the results are shown in following table 3.
Table 3, accelerated test result
5, long term test prepares 3 batch samples (lot number 080115,080116,080117) by simulation listing packing by the method for embodiment 1, in room temperature (25 ± 2 ℃ of temperature, relative humidity 60 ± 10%) places naturally, respectively at the 3rd, 6,9,12,18,24,36 month every index of sampling and measuring, the every index of result is all up to specification, the results are shown in following table 4.
Table 4, long-term test results
Product to other embodiment of the present invention has also carried out above-mentioned identical test, and the result of its acquisition is similar.
Comparative example 1
Compare to the prepared arbidol HCl compositions dispersible tablet of the embodiment of the invention 1 with according to the accumulation dissolution of the Abiduoer dispersible tablet (title reference substance) of the method preparation of " preparation process of Abiduoer dispersible tablet and quality research " (referring to " Jiangsu pharmacy and clinical research ", 2004 the 12nd the 5th phases of volume).
Method: get this product, according to dissolution method (two appendix XC second methods of Chinese Pharmacopoeia version in 2005), with 0.1molL
-1, operation in accordance with the law during 30min, is got solution and is filtered, and precision is measured subsequent filtrate 1ml, puts in the 10ml measuring bottle, adds 0.1molL
-1Acetum be diluted to scale, as need testing solution; Other gets the about 11.1mg of arbidol HCl reference substance that measures moisture content, and accurate the title decides, and puts in the 100ml measuring bottle, adds an amount of 0.1molL
-1Acetum be diluted to scale, shake up, precision is measured 1ml and is put in the 10ml measuring bottle, adds 0.1molL
-1Acetum be diluted to scale, shake up, in contrast product solution.Get above-mentioned two kinds of solution, measure trap at 314nm wavelength place, calculate, and the result be multiply by 1.035 promptly get every stripping quantity according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2005 A).Limit is 70% of a labelled amount, should be up to specification.Comparative result sees Table 5:
Table 5, comparative result
| Sample | Dispersing uniformity | Dissolution (%) |
| The present invention | Disintegrate fully in 2 minutes and 20 seconds average time, and can be by No. 2 sieves | ??102.4 |
| Reference substance | Disintegrate fully in 3 minutes average times, and can be by No. 2 sieves | ??100.3 |
As can be seen from the above table, adopt the dispersing uniformity and the dissolution of the arbidol HCl dispersible tablet of prescription of the present invention and preparation method preparation all to be better than reference substance.
Product to other embodiment of the present invention has also carried out this test, and its result is similar.
Claims (9)
1. an arbidol hydrochloride medicament composition dispersible tablets is characterized in that, described arbidol hydrochloride medicament composition dispersible tablets is made 1000 by following component:
Arbidol HCl 80-120 weight portion
Microcrystalline Cellulose 170-210 weight portion
Lactose 46-66 weight portion
Starch 15-25 weight portion
Stevioside 2-4 weight portion
Citric acid 0.2-0.8 weight portion
Carboxymethyl starch sodium 20-30 weight portion
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 1-3 weight portion
Magnesium stearate 1-3 weight portion.
2. arbidol hydrochloride medicament composition dispersible tablets according to claim 1 is characterized in that, described arbidol hydrochloride medicament composition dispersible tablets is made 1000 by following component:
Arbidol HCl 90-110 weight portion
Microcrystalline Cellulose 180-200 weight portion
Lactose 50-62 weight portion
Starch 18-22 weight portion
Stevioside 2.5-3.5 weight portion
Citric acid 0.3-0.7 weight portion
Carboxymethyl starch sodium 22-28 weight portion
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 1.5-2.5 weight portion
Magnesium stearate 1.5-2.5 weight portion.
3. arbidol hydrochloride medicament composition dispersible tablets according to claim 2 is characterized in that, described arbidol hydrochloride medicament composition dispersible tablets is made 1000 by following component:
Arbidol HCl 100 weight portions
Microcrystalline Cellulose 190 weight portions
Lactose 56 weight portions
Starch 20 weight portions
Stevioside 3 weight portions
Citric acid 0.5 weight portion
Carboxymethyl starch sodium 25 weight portions
5% polyvidone alcoholic solution is an amount of
Micropowder silica gel 2 weight portions
Magnesium stearate 2 weight portions.
4. the preparation method of claim 1 or 2 or 3 described arbidol hydrochloride medicament composition dispersible tablets is characterized in that this method comprises the steps:
1) with raw material arbidol HCl and microcrystalline cellulose excipients, lactose, starch, stevioside, citric acid and carboxymethyl starch sodium pulverize separately, sieve;
2) take by weighing arbidol HCl, microcrystalline Cellulose, lactose, starch and 50% carboxymethyl starch sodium mix homogeneously by recipe quantity, sieve, mix homogeneously obtains mixture;
3) with step 2) resulting mixture adds an amount of 5% polyvidone alcoholic solution system soft material, crosses the sieve series wet granular, drying, 20 order granulate are pressed recipe quantity and are added remaining 50% carboxymethyl starch sodium, stevioside, citric acid, Pulvis Talci and magnesium stearate, mixing, tabletting, promptly.
5. the preparation method of arbidol hydrochloride medicament composition dispersible tablets according to claim 4 is characterized in that, sieving to crossing 80-120 mesh sieve, preferred 100 mesh sieves described in the step 1).
6. the preparation method of arbidol hydrochloride medicament composition dispersible tablets according to claim 4 is characterized in that step 2) described in to sieve be the 40-80 mesh sieve, preferred 60 mesh sieves.
7. the preparation method of arbidol hydrochloride medicament composition dispersible tablets according to claim 4 is characterized in that, the drying described in the step 3) is at 65-75 ℃ of dry 2.5-3.5 hour.
8. the preparation method of arbidol hydrochloride medicament composition dispersible tablets according to claim 4 is characterized in that step 2) in describedly before sieving be mixed under the condition of rotating speed 35～55 commentariess on classics/min, preferred 45 commentaries on classics/min mixing 5-15 minute.
9. the preparation method of arbidol hydrochloride medicament composition dispersible tablets according to claim 4 is characterized in that step 2) in sieve the back described blended mixing velocity under the condition of rotating speed 25～35 commentaries on classics/min, preferred 30 commentaries on classics/min, to mix 1～5min.
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| CN105030710A (en) * | 2015-09-08 | 2015-11-11 | 湖北生物医药产业技术研究院有限公司 | Arbidol tablet |
| CN105030710B (en) * | 2015-09-08 | 2021-07-30 | 湖北生物医药产业技术研究院有限公司 | Arbidol tablet |
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| CN111202724A (en) * | 2020-02-16 | 2020-05-29 | 江苏艾立康药业股份有限公司 | Arbidol inhalation dry powder pharmaceutical composition and preparation method thereof |
| WO2023070985A1 (en) * | 2021-11-01 | 2023-05-04 | 石家庄四药有限公司 | Abidor hydrochloride tablet and preparation method therefor |
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