CN102302474A - Orally administered danazol sustained-release capsule and preparation method thereof - Google Patents
Orally administered danazol sustained-release capsule and preparation method thereof Download PDFInfo
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- CN102302474A CN102302474A CN201110272088A CN201110272088A CN102302474A CN 102302474 A CN102302474 A CN 102302474A CN 201110272088 A CN201110272088 A CN 201110272088A CN 201110272088 A CN201110272088 A CN 201110272088A CN 102302474 A CN102302474 A CN 102302474A
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Abstract
The invention provides an orally administered danazol sustained-release capsule and a preparation method thereof. The orally administered danazol sustained-release capsule mainly comprises danazol and a sustained-release frame material, wherein the mass proportion of the danazol to the sustained-release frame material is 1:(0.32-2.1). The orally administered danazol sustained-release capsule also can comprise a thinning agent and a flow aid. The orally administered danazol sustained-release capsule provided by the invention has steady in-vitro release rate and in-vivo blood concentration, exhibits excellent sustained-release property; when applied in clinic, the administration frequency can be reduced, the orally administered danazol sustained-release capsule is convenient to administer, side effects can be reduced, and the orally administered danazol sustained-release capsule is particularly suitable for patients who take drugs for a long time.
Description
Technical field
The present invention relates to medical technical field, specifically, relate to a kind of oral slow-releasing preparation of hormone medicine, more particularly, relate to a kind of oral danazol slow releasing capsule and preparation method thereof.
Background technology
Danazol; Have another name called danazol, Danazol, DANAZOL, danazol, chemical name 17 α-pregnant steroid-2,4-diene-20-alkynes also (2; 3-d 〕 isoxazole-17 β alcohol; It is a kind of synthetic androgen, has weak androgenic activity, and protein assimilation and estrogenic antagonist are arranged; Belong to the GTH depressant, clinically be used for treating endometriosis, fibrocystic disease of breast, hereditary angioedema, gynaecomastia, sexual precosity, thrombocytopenic purpura, hemophilia and lupus erythematosus etc.
Existing commercially available danazol preparation is a danazol capsule, is a kind of capsule formulation of often releasing.Be used to treat endometriosis, oral 2 times of every day, 3 months is a course of treatment; The treatment fibrocystic disease of breast, oral 2 times of every day; The treatment hereditary angioedema, oral 3 times of every day, 2 months is a course of treatment; The treatment thrombocytopenic purpura, obey 2-4 every day, more than the January course of treatment.Because day clothes often, medicining cycle is long, and the patient feels inconvenience very much, very easily causes to miss, wrongly take, and influences therapeutic effect.In addition, form blood medicine peak valley phenomenon, untoward reaction such as headache, edema of lower limbs, hoarseness are happened occasionally because of taking normal release dosage form.Thereby the clinical oral slow-releasing preparation that presses for a kind of danazol after the patient takes this preparation, through the slow release of medicine, reduces medicining times, guarantees curative effect of medication, reduces adverse reaction rate.
Summary of the invention
The object of the present invention is to provide a kind of oral danazol slow releasing capsule, it can comprise danazol and slow release framework material, and the quality proportioning of said danazol and slow release framework material is 1:0.32-2.1.
Said sustained-release matrix material is hydrophilic framework material and/or hydrophobicity framework material; The quality proportioning of said danazol and hydrophilic framework material is 1:0.1-1.1; The quality proportioning of said danazol and hydrophobicity framework material is 1:0.08-0.9.
Said hydrophilic framework material is selected from least a in hypromellose K4M, hypromellose K10M, hypromellose E15, No. 3 resins of acrylic acid and the sodium carboxymethyl cellulose; Said hydrophobicity framework material is selected from least a in ethyl cellulose and the cellulose acetate-phthalate.
Oral danazol slow releasing capsule of the present invention can also comprise diluent and fluidizer, and wherein, said diluent is selected from least a in microcrystalline Cellulose, lactose and the mannitol; Said fluidizer is selected from least a in micropowder silica gel, magnesium stearate and the aluminium stearate; The quality proportioning of said danazol and diluent is 1:0.5-2.5; The quality proportioning of said fluidizer and capsule 's content total amount is 0.001-0.006:1.
According to one embodiment of the invention, said oral danazol slow releasing capsule comprises the following component of weight portion meter: danazol 26.9-42.4 part, hypromellose K4M 4.15-11.4 part, hypromellose K10M 2.1-4.3 part, hypromellose E15 3.8-4.2 part, No. 3 resin 5.1-5.8 of acrylic acid part, sodium carboxymethyl cellulose 4.24-14.2 part, microcrystalline Cellulose 14.8-26.9 part, ethyl cellulose 2.8-21.2 part, cellulose acetate-phthalate 3.8-4.2 part, mannitol 23.0-42.6 part, lactose 24-30.5 part.
More preferably, said oral danazol slow releasing capsule comprises the following component of weight portion meter: 36.9 parts of danazol, hypromellose K10M7.3 part, 7.3 parts of sodium carboxymethyl cellulose, 14.8 parts of microcrystalline Cellulose, 9.2 parts of ethyl celluloses, 24 parts of lactose.
More preferably, said oral danazol slow releasing capsule comprises the following component of weight portion meter: 41.5 parts of danazol, 4.15 parts of hypromellose K4M, 4.15 parts of hypromellose K10M, 16.6 parts of microcrystalline Cellulose, 6.2 parts of ethyl celluloses, 27.0 parts in mannitol.
More preferably, said oral danazol slow releasing capsule comprises the following component of weight portion meter: 41.5 parts of danazol, 6.2 parts of hypromellose K4M, 2.1 parts of hypromellose K10M, 16.6 parts of microcrystalline Cellulose, 5.2 parts of ethyl celluloses, 28.0 parts in mannitol.
The present invention also provides the method for preparing of above-mentioned oral danazol slow releasing capsule, and it mainly comprises following steps: take by weighing danazol and slow release framework material according to quality proportioning 1:0.32-2.1; And mixing promptly makes described oral danazol slow releasing capsule after crossing mesh sieve.
Particularly; Above-mentioned method for preparing comprises step: take by weighing danazol, hypromellose E15, hypromellose K4M, hypromellose K10M, microcrystalline Cellulose, sodium carboxymethyl cellulose, acrylic acid No. 3 resins, ethyl cellulose, cellulose acetate-phthalate, mannitol and lactose respectively according to proportioning, equivalent increases progressively mixing, crosses 200 mesh sieves; Process soft material with 10% starch slurry or 8% polyvinylpyrrolidone K25 ethanol liquid; 20 mesh sieves are granulated, and 50-60 ℃ of drying adds magnesium stearate or aluminium stearate or micropowder silica gel; Fill promptly makes described oral danazol slow releasing capsule.
The invention has the advantages that: the product that 1) makes has significant slow releasing function, can prevent that the quick stripping of medicine from discharging, thereby blood drug level is steady in the body, and the excursion of peak concentration and paddy concentration is dwindled greatly, the effective blood drug concentration prolongation of holding time.This slow releasing preparation is used for clinical avoiding frequently takes medicine, and makes things convenient for patient, reduces adverse reaction rate, thereby improves patient's compliance, helps it and is treated safely and effectively, has overcome the shortcoming of common danazol capsule; 2) each used component does not have specific (special) requirements, is easy to buy in a large number, and its preparation method is suitable for suitability for industrialized production.
The specific embodiment
Embodiment 1
Prescription (in weight portion)
26.9 parts of danazol
8.1 parts of hypromellose K4M
26.9 parts of microcrystalline Cellulose
5.4 parts of No. 3 resins of acrylic acid
32.3 parts in mannitol
0.54 part of magnesium stearate
Method for making
Take by weighing danazol, hypromellose K4M, microcrystalline Cellulose, No. 3 resins of acrylic acid and mannitol respectively according to above-mentioned prescription proportioning; Equivalent incremental method mixing is crossed 200 mesh sieves, processes soft material with 8% polyvinylpyrrolidone K25 ethanol liquid; 20 mesh sieves are granulated; 50-60 ℃ of drying adds magnesium stearate, is loaded in the capsule.
Embodiment 2
Prescription (in weight portion)
40.6 parts of danazol
4.06 parts of hypromellose E15
20.3 parts of ethyl celluloses
4.06 parts of cellulose acetate-phthalates
30.5 parts of lactose
0.4 part of magnesium stearate
Method for making
Take by weighing danazol, hypromellose E15, ethyl cellulose, cellulose acetate-phthalate and lactose respectively according to the prescription proportioning, equivalent incremental method mixing is crossed 200 mesh sieves; Process soft material with 10% starch slurry, 20 mesh sieves are granulated, 50-60 ℃ of drying; Add magnesium stearate, be loaded in the capsule.
Embodiment 3
Prescription (in weight portion)
42.4 parts of danazol
4.24 parts of hypromellose K10M
4.24 parts of sodium carboxymethyl cellulose
21.2 parts of ethyl celluloses
27.6 parts in mannitol
0.42 part of micropowder silica gel
Method for making
Take by weighing respectively and reach that azoles, Hydroxypropyl methylcellulose K10M, sodium carboxymethylcellulose, ethyl cellulose and sweet mellow wine according to the prescription proportioning, equivalent incremental method mixing is crossed 200 mesh sieves; Make softwood with 10% starch slurry, 20 mesh sieves are granulated, 50-60 ℃ of drying; Add superfine silica gel powder, be loaded in the capsule.
Embodiment 4
Prescription (in weight portion)
36.9 parts of danazol
7.3 parts of hypromellose K10M
7.3 parts of sodium carboxymethyl cellulose
14.8 parts of microcrystalline Cellulose
9.2 parts of ethyl celluloses
24.0 parts of lactose
0.37 part of magnesium stearate
Method for making
Take by weighing respectively and reach that azoles, Hydroxypropyl methylcellulose K10M, sodium carboxymethylcellulose, ethyl cellulose, microcrystalline cellulose and lactose according to the prescription proportioning; Equivalent incremental method mixing; Cross 200 mesh sieves; Make softwood with 10% starch slurry; 20 mesh sieves are granulated; 50-60 ℃ of drying adds dolomol, is loaded in the capsule.
Embodiment 5
Prescription (in weight portion)
38.3 parts of danazol
7.7 parts of hypromellose K4M
7.7 parts of sodium carboxymethyl cellulose
19.2 parts of microcrystalline Cellulose
3.8 parts of ethyl celluloses
23.0 parts in mannitol
0.38 part of aluminium stearate
Method for making
Take by weighing respectively and reach that azoles, Hydroxypropyl methylcellulose K4M, sodium carboxymethylcellulose, microcrystalline cellulose, ethyl cellulose and sweet mellow wine according to the prescription proportioning; Equivalent incremental method mixing; Cross 200 mesh sieves; Make softwood with 10% starch slurry; 20 mesh sieves are granulated; 50-60 ℃ of drying adds stearic acid aluminium, is loaded in the capsule.
Embodiment 6
Prescription (in weight portion)
28.4 parts of danazol
11.4 parts of hypromellose K4M
14.2 parts of sodium carboxymethyl cellulose
2.8 parts of ethyl celluloses
42.6 parts in mannitol
0.57 part of magnesium stearate
Method for making
Take by weighing respectively and reach that azoles, Hydroxypropyl methylcellulose K4M, sodium carboxymethylcellulose, ethyl cellulose and sweet mellow wine according to the prescription proportioning; Equivalent incremental method mixing; Cross 200 mesh sieves; Make softwood with 8% polyvinylpyrrolidone K25 ethanol liquid; 20 mesh sieves are granulated; 50-60 ℃ of drying adds dolomol, is loaded in the capsule.
Embodiment 7
Prescription (in weight portion)
41.5 parts of danazol
4.15 parts of hypromellose K4M
4.15 parts of hypromellose K10M
16.6 parts of microcrystalline Cellulose
6.2 parts of ethyl celluloses
27.0 parts in mannitol
0.41 part of micropowder silica gel
Method for making
Take by weighing danazol, hypromellose K4M, hypromellose K10M, microcrystalline Cellulose, ethyl cellulose and mannitol respectively according to the prescription proportioning; Equivalent incremental method mixing is crossed 200 mesh sieves, processes soft material with 10% starch slurry; 20 mesh sieves are granulated; 50-60 ℃ of drying adds micropowder silica gel, is loaded in the capsule.
Embodiment 8
Prescription (in weight portion)
41.5 parts of danazol
6.2 parts of hypromellose K4M
2.1 parts of hypromellose K10M
16.6 parts of microcrystalline Cellulose
5.2 parts of ethyl celluloses
28.0 parts in mannitol
0.41 part of magnesium stearate
Method for making
Take by weighing danazol, hypromellose K4M, hypromellose K10M, microcrystalline Cellulose, ethyl cellulose and mannitol respectively according to the prescription proportioning; Equivalent incremental method mixing is crossed 200 mesh sieves, processes soft material with 8% polyvinylpyrrolidone K25 ethanol liquid; 20 mesh sieves are granulated; 50-60 ℃ of drying adds magnesium stearate, is loaded in the capsule.
The mensuration of embodiment 9 release in vitro degree
Release in vitro degree according to following method working sample: get the inspection article,, press dissolution method first method according to two appendix X of Pharmacopoeia of People's Republic of China version in 2010 D; With 0.1mol/L hydrochloric acid-isopropyl alcohol (3: 2) is medium, and Revolution Per Minute 100 changes, in accordance with the law operation; In 0.5,1,2,3,4,5,6,7,8,9,10,11,12 hour; It is an amount of to get solution, with 0.45 μ m membrane filtration, in stripping rotor, replenishes the equivalent medium solution immediately; Get subsequent filtrate, quantitatively dilute with dissolution medium and process the solution that every 1ml contains danazol 20 μ g approximately; Other gets the danazol reference substance, and accurate the title decides, and adds medium dissolves, and quantitatively the solution that every 1ml contains danazol 20 μ g is approximately processed in dilution, gets above-mentioned two kinds of solution, uses ultraviolet visible spectrophotometry, measures absorbance respectively in the 285nm wavelength, calculates burst size.
The release degree of the different samples of measuring with said method is measured the result and is listed in table 1.
Table 1 danazol preparation release in vitro degree is measured the result
Visible by table 1, danazol capsule (normal release dosage form) discharged 85.3%, 1 hour in 0.5 hour and discharges 98.5%, showed that often to release the danazol capsule extracorporeal releasing speed very fast, in 1 hour near discharging fully.Adopt the prepared danazol slow releasing capsule of prescription of the present invention and method for preparing, its rate of release is controlled, performance slow release effect in various degree.The embodiment of the invention 2 discharged 16.1%, 4 hour in 1 hour and discharges release in 38.8%, 8 hour release 78.8% in 58.8%, 12 hour.Embodiment 4 discharged 22.5%, 4 hour in 1 hour and discharges release in 48.4%, 8 hour release 92.7% in 78.8%, 12 hour.Embodiment 7 discharged 25.1%, 4 hour in 1 hour and discharges release in 55.5%, 8 hour release 99.0% in 80.1%, 12 hour.Embodiment 8 discharged 28.9%, 4 hour in 1 hour and discharges release in 60.2%, 8 hour release 100.2% in 85.7%, 12 hour.Show and adopt prescription of the present invention and the prepared danazol slow releasing capsule of method for preparing, its rate of release is effectively controlled, and steadily slowly release shows slow release effect in various degree.
Determination of plasma concentration in embodiment 10 bodies
The present invention has carried out common danazol capsule and the embodiment of the invention 8 beasle dog body giving drugs into nose for the kinetics preliminary study, and the result lists in table 2.
Determination of plasma concentration result in the table 2 danazol preparation beasle dog body
Visible by table 2, common danazol capsule, 0.5 hour blood drug level 1.30 μ g/ml; 1.0 hour blood drug level 2.18 μ g/ml, 4 hours blood drug level 1.05 μ g/ml, 8 hours blood drug level 0.32 μ g/ml; 12 hours blood drug level 0.21 μ g/ml, 24 hours blood drug level 0.19 μ g/ml
c Max =2.18 μ g/ml,
T Max =1h; In the embodiment of the invention 8,0.5 hour blood drug level 0.56 μ g/ml, 1 hour blood drug level 0.87 μ g/ml; 4 hours blood drug level 1.65 μ g/ml, 8 hours blood drug level 1.22 μ g/ml, 12 hours blood drug level 0.92 μ g/ml; 24 hours blood drug level 0.65 μ g/ml
c Max =1.65 μ g/ml,
T Max =4h.Above data show, the oral common danazol capsule of animal, and blood drug level was peaking in 1 hour, reduced to below 50% of peak concentration in 4 hours, reduced in 8 hours and to reduce to about 10% of peak concentration in 14.7%, 12 hour of peak concentration, was tangible peak valley phenomenon; And the danazol slow releasing capsule of the oral embodiment of the invention 8 of animal, 4 hours blood drug level reaches peak value, and 1 hour is 52.7% of peak value; 8 hours is 73.9% of peak value; 12 hours is 55.8% of peak value, and blood drug level is steady, can keep higher blood drug level in a long time.
Though the present invention discloses as above with preferred embodiment; Right its is not that any person of ordinary skill in the field is in spirit that does not break away from the present invention and scope in order to qualification the present invention; When can doing a little change and improvement, so the present invention's protection domain defines when looking claim.
Claims (10)
1. an oral danazol slow releasing capsule is characterized in that, comprises danazol and slow release framework material, and the quality proportioning of said danazol and slow release framework material is 1:0.32-2.1.
2. oral danazol slow releasing capsule according to claim 1 is characterized in that, said sustained-release matrix material is hydrophilic framework material and/or hydrophobicity framework material;
The quality proportioning of said danazol and hydrophilic framework material is 1:0.1-1.1; The quality proportioning of said danazol and hydrophobicity framework material is 1:0.08-0.9.
3. oral danazol slow releasing capsule according to claim 2; It is characterized in that said hydrophilic framework material is selected from least a in hypromellose K4M, hypromellose K10M, hypromellose E15, No. 3 resins of acrylic acid and the sodium carboxymethyl cellulose; Said hydrophobicity framework material is selected from least a in ethyl cellulose and the cellulose acetate-phthalate.
4. oral danazol slow releasing capsule according to claim 3 is characterized in that, also comprises diluent and fluidizer, and wherein, said diluent is selected from least a in microcrystalline Cellulose, lactose and the mannitol; Said fluidizer is selected from least a in micropowder silica gel, magnesium stearate and the aluminium stearate;
The quality proportioning of said danazol and diluent is 1:0.5-2.5; The quality proportioning of said fluidizer and capsule 's content total amount is 0.001-0.006:1.
5. oral danazol slow releasing capsule according to claim 4; It is characterized in that said oral danazol slow releasing capsule comprises the following component of weight portion meter: danazol 26.9-42.4 part, hypromellose K4M 4.15-11.4 part, hypromellose K10M 2.1-4.3 part, hypromellose E15 3.8-4.2 part, No. 3 resin 5.1-5.8 of acrylic acid part, sodium carboxymethyl cellulose 4.24-14.2 part, microcrystalline Cellulose 14.8-26.9 part, ethyl cellulose 2.8-21.2 part, cellulose acetate-phthalate 3.8-4.2 part, mannitol 23.0-42.6 part, lactose 24-30.5 part.
6. oral danazol slow releasing capsule according to claim 5; It is characterized in that said oral danazol slow releasing capsule comprises the following component of weight portion meter: 36.9 parts of danazol, 7.3 parts of hypromellose K10M, 7.3 parts of sodium carboxymethyl cellulose, 14.8 parts of microcrystalline Cellulose, 9.2 parts of ethyl celluloses, 24.0 parts of lactose.
7. oral danazol slow releasing capsule according to claim 5; It is characterized in that said oral danazol slow releasing capsule comprises the following component of weight portion meter: 41.5 parts of danazol, 4.15 parts of hypromellose K4M, 4.15 parts of hypromellose K10M, 16.6 parts of microcrystalline Cellulose, 6.2 parts of ethyl celluloses, 27.0 parts in mannitol.
8. oral danazol slow releasing capsule according to claim 5; It is characterized in that said oral danazol slow releasing capsule comprises the following component of weight portion meter: 41.5 parts of danazol, 6.2 parts of hypromellose K4M, 2.1 parts of hypromellose K10M, 16.6 parts of microcrystalline Cellulose, 5.2 parts of ethyl celluloses, 28.0 parts in mannitol.
9. the method for preparing of the described oral danazol slow releasing capsule of claim 1 is characterized in that, comprises following steps:
Take by weighing danazol and slow release framework material according to quality proportioning 1:0.32-2.1;
And mixing promptly makes described oral danazol slow releasing capsule after crossing mesh sieve.
10. method for preparing according to claim 9 is characterized in that, specifically comprises step: take by weighing danazol, hypromellose E15, hypromellose K4M, hypromellose K10M, microcrystalline Cellulose, sodium carboxymethyl cellulose, acrylic acid No. 3 resins, ethyl cellulose, cellulose acetate-phthalate, mannitol and lactose respectively according to proportioning; Equivalent increases progressively mixing; Cross 200 mesh sieves, process soft material with 10% starch slurry or 8% polyvinylpyrrolidone K25 ethanol liquid, 20 mesh sieves are granulated; 50-60 ℃ of drying; Add magnesium stearate or aluminium stearate or micropowder silica gel, fill promptly makes described oral danazol slow releasing capsule.
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| CN201110272088A CN102302474A (en) | 2011-09-15 | 2011-09-15 | Orally administered danazol sustained-release capsule and preparation method thereof |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1449760A (en) * | 2003-04-10 | 2003-10-22 | 上海医药工业研究院 | Composition of danazol semisolid skeleton preparation |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1449760A (en) * | 2003-04-10 | 2003-10-22 | 上海医药工业研究院 | Composition of danazol semisolid skeleton preparation |
Non-Patent Citations (1)
| Title |
|---|
| 丁劲松等: ""生物粘附性达那唑缓释栓剂的处方筛选与体外释放度考察"", 《中国药房》 * |
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Application publication date: 20120104 |