CN105147690A - Pharmaceutical sildenafil citrate composition tablets for treating diseases of urinary surgery - Google Patents
Pharmaceutical sildenafil citrate composition tablets for treating diseases of urinary surgery Download PDFInfo
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- CN105147690A CN105147690A CN201510622768.7A CN201510622768A CN105147690A CN 105147690 A CN105147690 A CN 105147690A CN 201510622768 A CN201510622768 A CN 201510622768A CN 105147690 A CN105147690 A CN 105147690A
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- sildenafil citrate
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Abstract
The invention relates to pharmaceutical sildenafil citrate composition tablets for treating diseases of urinary surgery and belongs to the technical field of medicines. The pharmaceutical citric acid sildenafil composition tablets are prepared from sildenafil citrate, microcrystalline cellulose, calcium sulphate, casein, hydroxypropyl cellulose, starch, purified water and superfine silica powder. The sildenafil citrate is a novel crystal-form compound and is different from sildenafil citrate disclosed in the prior art, as shown in Figure 1 of an X-ray powder diffraction diagram obtained through Cu-KAlpha ray measurement. A test shows that the novel crystal-form compound improves moisture absorption, the tablets prepared by utilizing the sildenafil citrate crystal-form compound are high in dissolution rate, good in stability and low in moisture and impurity content compared with the prior art, and the safety of clinic application is improved.
Description
Technical field
The invention belongs to medical art, relate to a kind of medicine sildenafil citrate composition tablet for the treatment of Urology Surgery class disease.
Background technology
Sldenafil is the medicine of the Erectile Dysfunction disease that the objective and subjective reason of a kind of effective treatment causes, in March, 1997 goes on the market in the U.S. as prescription drugs through FDA approval, sldenafil is high selectivity PDE5 (PDE5) inhibitor, PDE5 expresses at cavernous body of penis camber, and in other tissue, (comprising platelet, blood vessel and visceral smooth muscle, skeletal muscle), expression is low.Sldenafil, by Selective depression PDE5, strengthens nitric oxide (NO)-cGMP approach, raises cGMP level and causes corpus cavernosum smooth muscle to relax, making patients with erectile dysfunction produce natural erectile response to sexual stimulus.Erectile response generally with sldenafil dosage and plasma concentration increase and strengthen.
Sildenafil citrate hygroscopicity is strong, easy moisture absorption under normality and going bad, and therefore the height of water content to the stability influence of medicine comparatively greatly, needs strictly to control product quality, bring larger difficulty to the preparation of preparation.Therefore, the sildenafil citrate compound that a kind of performance improvement is provided is necessary.
The present inventor starts with from the research of sildenafil citrate solid chemical material existence, a kind of sildenafil citrate crystalline compounds has been prepared through a large amount of tests, find through overtesting, the compound of this novel crystal forms structure has the hygroscopicity improved, compared with prior art dissolution is high for the tablet prepared of this sildenafil citrate crystal compound, good stability, moisture and impurity content low, improve the safety of clinical practice.
Summary of the invention
Goal of the invention of the present invention is to provide a kind of medicine sildenafil citrate composition tablet for the treatment of Urology Surgery class disease.
In order to complete object of the present invention, the technical scheme of employing is:
A kind of medicine sildenafil citrate composition tablet for the treatment of Urology Surgery class disease of the present invention, it is characterized in that, described composition tablet is made up of sildenafil citrate, microcrystalline Cellulose, calcium sulfate, casein, hyprolose, starch, purified water, micropowder silica gel; Described sildenafil citrate is crystal, and the X-ray powder diffraction pattern that the measurement of use Cu-K alpha ray obtains as shown in Figure 1.
As preferably, with parts by weight, described composition tablet is made up of the sildenafil citrate of 10 weight portions, the microcrystalline Cellulose of 4-6 weight portion, the calcium sulfate of 3-5 weight portion, the casein of 0.8-1.2 weight portion, the hyprolose of 4-4.8 weight portion, the starch of 0.4-0.6 weight portion, the purified water of 4-6 weight portion, the micropowder silica gel of 0.8-1.2 weight portion.
As preferably, with parts by weight, described composition tablet is made up of the sildenafil citrate of 10 weight portions, the microcrystalline Cellulose of 5 weight portions, the calcium sulfate of 4 weight portions, the casein of 1 weight portion, the hyprolose of 4.4 amount parts, the starch of 0.5 weight portion, the purified water of 5 weight portions, the micropowder silica gel of 1 weight portion.
As preferably, the preparation method of described composition tablet comprises the following steps:
(1) supplementary material process: sildenafil citrate was pulverized 100 mesh sieves, calcium sulfate crosses 80 mesh sieves;
(2) weigh: weigh according to technology preparation;
(3) preparation of binding agent: with milk cooking process, the starch of recipe quantity and purified water are mixed with starch slurry, are cooled to room temperature stand-by;
(4) mixing granulation: be added in wet mixing pelletizer by sildenafil citrate, microcrystalline Cellulose, calcium sulfate, casein, hyprolose, opens stirring motor and is dry mixed 10 minutes; Add the binding agent wet mixing cutting got ready, with 18 mesh sieve soft materials;
(5) dry: the wet granular of granulation gained to be joined in fluid bed dryer, set temperature 60-70 DEG C, dry 2 hours, by material 18 order granulate after drying;
(6) mix: granule after granulate and micropowder silica gel are dropped into three-dimensional motion mixer, premixing speed 15 revs/min, incorporation time 25 minutes are set;
(7) tabletting: carry out tabletting according to after the heavy scope of the theoretical sheet of total mixed gained material cubage;
(8) pack.
As preferably, the preparation method of the crystal of described sildenafil citrate comprises the following steps:
(1) ground by sildenafil citrate crude product, cross 80 mesh sieves, then joining volume is in the deionized water of 6 times of sildenafil citrate weight, and 130 revs/min are stirred 10 minutes;
Add the methanol that volume is 5 times of sildenafil citrate weight under (2) 90 revs/min of stirrings, be warming up to 35 DEG C simultaneously;
(3) after solution adds, leave standstill 3 hours, the volume dripping 0 DEG C under 180 revs/min of conditions stirred is 8 times of propyl ether of sildenafil citrate weight, the mixed solution of hexane, and the volume ratio of propyl ether, hexane is 1:4, at the uniform velocity dropwises in 2 hours;
(4) be cooled to-5 DEG C after being added dropwise to complete, continue stirring 2 hours under the stir speed (S.S.) of 110 revs/min, leave standstill 1 hour crystallize out, filter, washing, vacuum drying obtains sildenafil citrate crystal.
Below technical scheme of the present invention is made further explanation:
The present invention is by the precise controlling to crystallization condition, and prepared a kind of sildenafil citrate novel crystal forms unlike the prior art, the X-ray powder diffraction pattern of this sildenafil citrate crystal unlike the prior art.Simultaneously due to the ins and outs of this crystal formation, find through test, the compound of this novel crystal forms structure has the hygroscopicity significantly improved, the tablet prepared of this sildenafil citrate crystal compound comparatively prior art to compare dissolution high, good stability, moisture and impurity content low, improve the safety of clinical practice.
Accompanying drawing explanation
Fig. 1 is the X-ray powder diffraction that the sildenafil citrate crystal of the embodiment of the present invention 1 preparation uses the measurement of Cu-K alpha ray to obtain.
Detailed description of the invention
Below by specific embodiment, summary of the invention of the present invention is described in further detail, but does not therefore limit content of the present invention.
embodiment 1:the preparation of sildenafil citrate crystal
(1) ground by sildenafil citrate crude product, cross 80 mesh sieves, then joining volume is in the deionized water of 6 times of sildenafil citrate weight, and 130 revs/min are stirred 10 minutes;
Add the methanol that volume is 5 times of sildenafil citrate weight under (2) 90 revs/min of stirrings, be warming up to 35 DEG C simultaneously;
(3) after solution adds, leave standstill 3 hours, the volume dripping 0 DEG C under 180 revs/min of conditions stirred is 8 times of propyl ether of sildenafil citrate weight, the mixed solution of hexane, and the volume ratio of propyl ether, hexane is 1:4, at the uniform velocity dropwises in 2 hours;
(4) be cooled to-5 DEG C after being added dropwise to complete, continue stirring 2 hours under the stir speed (S.S.) of 110 revs/min, leave standstill 1 hour crystallize out, filter, washing, vacuum drying obtains sildenafil citrate crystal.
The X-ray powder diffraction pattern that the sildenafil citrate crystal prepared uses the measurement of Cu-K alpha ray to obtain as shown in Figure 1.
embodiment 2:the preparation of Sildenafil citrate tablets
Prescription: with parts by weight
Preparation method:
(1) supplementary material process: sildenafil citrate was pulverized 100 mesh sieves, calcium sulfate crosses 80 mesh sieves;
(2) weigh: weigh according to technology preparation;
(3) preparation of binding agent: with milk cooking process, the starch of recipe quantity and purified water are mixed with starch slurry, are cooled to room temperature stand-by;
(4) mixing granulation: be added in wet mixing pelletizer by sildenafil citrate, microcrystalline Cellulose, calcium sulfate, casein, hyprolose, opens stirring motor and is dry mixed 10 minutes; Add the binding agent wet mixing cutting got ready, with 18 mesh sieve soft materials;
(5) dry: the wet granular of granulation gained to be joined in fluid bed dryer, set temperature 60-70 DEG C, dry 2 hours, by material 18 order granulate after drying;
(6) mix: granule after granulate and micropowder silica gel are dropped into three-dimensional motion mixer, premixing speed 15 revs/min, incorporation time 25 minutes are set;
(7) tabletting: carry out tabletting according to after the heavy scope of the theoretical sheet of total mixed gained material cubage;
(8) pack.
embodiment 3:the preparation of Sildenafil citrate tablets
Prescription: with parts by weight
Preparation method:
(1) supplementary material process: sildenafil citrate was pulverized 100 mesh sieves, calcium sulfate crosses 80 mesh sieves;
(2) weigh: weigh according to technology preparation;
(3) preparation of binding agent: with milk cooking process, the starch of recipe quantity and purified water are mixed with starch slurry, are cooled to room temperature stand-by;
(4) mixing granulation: be added in wet mixing pelletizer by sildenafil citrate, microcrystalline Cellulose, calcium sulfate, casein, hyprolose, opens stirring motor and is dry mixed 10 minutes; Add the binding agent wet mixing cutting got ready, with 18 mesh sieve soft materials;
(5) dry: the wet granular of granulation gained to be joined in fluid bed dryer, set temperature 60-70 DEG C, dry 2 hours, by material 18 order granulate after drying;
(6) mix: granule after granulate and micropowder silica gel are dropped into three-dimensional motion mixer, premixing speed 15 revs/min, incorporation time 25 minutes are set;
(7) tabletting: carry out tabletting according to after the heavy scope of the theoretical sheet of total mixed gained material cubage;
(8) pack.
embodiment 4:the preparation of Sildenafil citrate tablets
Prescription: with parts by weight
Preparation method:
(1) supplementary material process: sildenafil citrate was pulverized 100 mesh sieves, calcium sulfate crosses 80 mesh sieves;
(2) weigh: weigh according to technology preparation;
(3) preparation of binding agent: with milk cooking process, the starch of recipe quantity and purified water are mixed with starch slurry, are cooled to room temperature stand-by;
(4) mixing granulation: be added in wet mixing pelletizer by sildenafil citrate, microcrystalline Cellulose, calcium sulfate, casein, hyprolose, opens stirring motor and is dry mixed 10 minutes; Add the binding agent wet mixing cutting got ready, with 18 mesh sieve soft materials;
(5) dry: the wet granular of granulation gained to be joined in fluid bed dryer, set temperature 60-70 DEG C, dry 2 hours, by material 18 order granulate after drying;
(6) mix: granule after granulate and micropowder silica gel are dropped into three-dimensional motion mixer, premixing speed 15 revs/min, incorporation time 25 minutes are set;
(7) tabletting: carry out tabletting according to after the heavy scope of the theoretical sheet of total mixed gained material cubage;
(8) pack.
test example 1:wettability test
This test example compares the hygroscopicity of the sildenafil citrate of sildenafil citrate compound of the present invention and prior art.
Test method: respectively under the condition of humidity 60% and 90%, room temperature, each sample thief 1g is placed on electronic balance, and time recording weight, to detect moisture absorption degree, the results are shown in Table 1.
Table 1, sample hygroscopicity measurement result
Wherein:
Sample 1: the obtained sildenafil citrate of the embodiment of the present invention 1 first;
Sample 2: the sildenafil citrate second batch that the embodiment of the present invention 1 is obtained;
Sample 3: according to " sildenafil citrate improvement in synthesis " [Xiang Honglin, Hu Gaoyun, etc. sildenafil citrate improvement in synthesis, Hunan Medical college journal, 2000,2(1): 47-48] the obtained sildenafil citrate compound of method;
Sample 4: sildenafil citrate crude drug imported product (PfizerIrelandPharmaceuticals).
As can be seen from above-mentioned result of the test, compared with the sildenafil citrate of prior art, sildenafil citrate provided by the present invention has the hygroscopicity significantly improved.
test example 2: Dissolution Rate Testing
Comparative example 1: viagra (Pfizer factory).
According to the dissolubility of this product raw material, and with reference to Sildenafil citrate tablets national drug registered standard WS
1method in-(X-010)-2010Z quality standard under dissolution test item, measures the dissolution of this product with ultraviolet visible spectrophotometry.
Get this product, according to dissolution method (Chinese Pharmacopoeia version in 2010 two annex XC, first method), with the hydrochloric acid solution 900ml of 0.01mol/L for solvent, rotating speed is 100 turns per minute, operates in accordance with the law.Through 15 minutes time, get solution and filter, get subsequent filtrate as need testing solution (specification: 25mg); Or it is appropriate to get subsequent filtrate, make every 1ml about containing sldenafil 27 μ g(specification: 50mg with the dilution of 0.01mol/L hydrochloric acid solution) or 22 μ g(specification: 100mg) solution, as need testing solution; Separately get sildenafil citrate reference substance appropriate, accurately weighed, be diluted to every 1ml about containing sldenafil 27 μ g(specification with 0.01mol/L dissolve with hydrochloric acid solution: 25mg, 50mg) or 22 μ g(specification: 100mg) solution product solution in contrast.Get above-mentioned need testing solution and reference substance solution, according to ultraviolet visible spectrophotometry (Chinese Pharmacopoeia version in 2010 two annex IVA), measure absorbance respectively at 290nm place, calculate the stripping quantity of every sheet, the results are shown in Table 2.
Table 2 dissolution determination result
As seen from the experiment, the dissolution of tablet of the present invention is significantly higher than imported product.
test example 3: stability test
1, accelerated test
The Sildenafil citrate tablets that Example 3 is obtained and viagra (Pfizer factory), under high temperature 40 DEG C, relative humidity 75% ± 5% condition 6 months, carry out accelerated test investigation, result was as table 3.
Table 3 accelerated test investigates result
From accelerated test result, viagra all has significant change through 6 months accelerated test moisture, content, related substances, and product of the present invention has no significant change through 6 months accelerated test character, moisture, content, related substances, and moisture and its related substances are all well below imported product viagra, as can be seen here, the Sildenafil citrate tablets good stability of gained of the present invention, moisture, impurity content are low.
2, long term test
Sample thief, by commercially available back, place 24 months under long term test (temperature 30 DEG C ± 2 DEG C, relative humidity 65% ± 5%) condition, every quality index inspection has no significant change, and moisture all controls below 1.0%, and its related substances is all below 0.15%, well below imported product viagra, as can be seen here, the Sildenafil citrate tablets good stability of gained of the present invention, moisture, impurity content are low.
Identical verification experimental verification is carried out to other embodiments, has obtained similar result of the test.
Claims (5)
1. treat a medicine sildenafil citrate composition tablet for Urology Surgery class disease, it is characterized in that: described composition tablet is made up of sildenafil citrate, microcrystalline Cellulose, calcium sulfate, casein, hyprolose, starch, purified water, micropowder silica gel; Described sildenafil citrate is crystal, and the X-ray powder diffraction pattern that the measurement of use Cu-K alpha ray obtains as shown in Figure 1.
2. the medicine sildenafil citrate composition tablet for the treatment of Urology Surgery class disease according to claim 1, it is characterized in that: with parts by weight, described composition tablet is made up of the sildenafil citrate of 10 weight portions, the microcrystalline Cellulose of 4-6 weight portion, the calcium sulfate of 3-5 weight portion, the casein of 0.8-1.2 weight portion, the hyprolose of 4-4.8 weight portion, the starch of 0.4-0.6 weight portion, the purified water of 4-6 weight portion, the micropowder silica gel of 0.8-1.2 weight portion.
3. the medicine sildenafil citrate composition tablet for the treatment of Urology Surgery class disease according to claim 2, it is characterized in that: with parts by weight, described composition tablet is made up of the sildenafil citrate of 10 weight portions, the microcrystalline Cellulose of 5 weight portions, the calcium sulfate of 4 weight portions, the casein of 1 weight portion, the hyprolose of 4.4 amount parts, the starch of 0.5 weight portion, the purified water of 5 weight portions, the micropowder silica gel of 1 weight portion.
4., according to the medicine sildenafil citrate composition tablet of the arbitrary described treatment Urology Surgery class disease of claim 1-3, it is characterized in that, the preparation method of described composition tablet comprises the following steps:
(1) supplementary material process: sildenafil citrate was pulverized 100 mesh sieves, calcium sulfate crosses 80 mesh sieves;
(2) weigh: weigh according to technology preparation;
(3) preparation of binding agent: with milk cooking process, the starch of recipe quantity and purified water are mixed with starch slurry, are cooled to room temperature stand-by;
(4) mixing granulation: be added in wet mixing pelletizer by sildenafil citrate, microcrystalline Cellulose, calcium sulfate, casein, hyprolose, opens stirring motor and is dry mixed 10 minutes; Add the binding agent wet mixing cutting got ready, with 18 mesh sieve soft materials;
(5) dry: the wet granular of granulation gained to be joined in fluid bed dryer, set temperature 60-70 DEG C, dry 2 hours, by material 18 order granulate after drying;
(6) mix: granule after granulate and micropowder silica gel are dropped into three-dimensional motion mixer, premixing speed 15 revs/min, incorporation time 25 minutes are set;
(7) tabletting: carry out tabletting according to after the heavy scope of the theoretical sheet of total mixed gained material cubage;
(8) pack.
5. the medicine sildenafil citrate composition tablet for the treatment of Urology Surgery class disease according to claim 1, it is characterized in that, the preparation method of the crystal of described sildenafil citrate comprises the following steps:
(1) ground by sildenafil citrate crude product, cross 80 mesh sieves, then joining volume is in the deionized water of 6 times of sildenafil citrate weight, and 130 revs/min are stirred 10 minutes;
Add the methanol that volume is 5 times of sildenafil citrate weight under (2) 90 revs/min of stirrings, be warming up to 35 DEG C simultaneously;
(3) after solution adds, leave standstill 3 hours, the volume dripping 0 DEG C under 180 revs/min of conditions stirred is 8 times of propyl ether of sildenafil citrate weight, the mixed solution of hexane, and the volume ratio of propyl ether, hexane is 1:4, at the uniform velocity dropwises in 2 hours;
(4) be cooled to-5 DEG C after being added dropwise to complete, continue stirring 2 hours under the stir speed (S.S.) of 110 revs/min, leave standstill 1 hour crystallize out, filter, washing, vacuum drying obtains sildenafil citrate crystal.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510622768.7A CN105147690A (en) | 2015-09-28 | 2015-09-28 | Pharmaceutical sildenafil citrate composition tablets for treating diseases of urinary surgery |
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| CN201510622768.7A CN105147690A (en) | 2015-09-28 | 2015-09-28 | Pharmaceutical sildenafil citrate composition tablets for treating diseases of urinary surgery |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111388433A (en) * | 2020-03-27 | 2020-07-10 | 广州白云山医药集团股份有限公司白云山制药总厂 | Sildenafil citrate oral preparation and preparation method thereof |
| CN113694035A (en) * | 2021-10-09 | 2021-11-26 | 药大制药有限公司 | Preparation method of sildenafil tablets |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004072079A1 (en) * | 2003-02-11 | 2004-08-26 | Pfizer Limited | Hydrated and anhydrous sildenafil hemi-citrate compound |
| WO2007110559A1 (en) * | 2006-03-29 | 2007-10-04 | Pliva Hrvatska D.O.O. | Pharmaceutically acceptable salts and polymorphic forms of sildenafil |
| CN104829622A (en) * | 2015-05-12 | 2015-08-12 | 山东罗欣药业集团股份有限公司 | Sildenafil citrate compound and pharmaceutical composition thereof |
-
2015
- 2015-09-28 CN CN201510622768.7A patent/CN105147690A/en not_active Withdrawn
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004072079A1 (en) * | 2003-02-11 | 2004-08-26 | Pfizer Limited | Hydrated and anhydrous sildenafil hemi-citrate compound |
| WO2007110559A1 (en) * | 2006-03-29 | 2007-10-04 | Pliva Hrvatska D.O.O. | Pharmaceutically acceptable salts and polymorphic forms of sildenafil |
| CN104829622A (en) * | 2015-05-12 | 2015-08-12 | 山东罗欣药业集团股份有限公司 | Sildenafil citrate compound and pharmaceutical composition thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111388433A (en) * | 2020-03-27 | 2020-07-10 | 广州白云山医药集团股份有限公司白云山制药总厂 | Sildenafil citrate oral preparation and preparation method thereof |
| CN111388433B (en) * | 2020-03-27 | 2021-11-23 | 广州白云山医药集团股份有限公司白云山制药总厂 | Sildenafil citrate oral preparation and preparation method thereof |
| CN113694035A (en) * | 2021-10-09 | 2021-11-26 | 药大制药有限公司 | Preparation method of sildenafil tablets |
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