CN102106841B - Tamsulosin hydrochloride preparation and preparation method thereof - Google Patents
Tamsulosin hydrochloride preparation and preparation method thereof Download PDFInfo
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- CN102106841B CN102106841B CN 200910155645 CN200910155645A CN102106841B CN 102106841 B CN102106841 B CN 102106841B CN 200910155645 CN200910155645 CN 200910155645 CN 200910155645 A CN200910155645 A CN 200910155645A CN 102106841 B CN102106841 B CN 102106841B
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- tamsulosin hydrochloride
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- ZZIZZTHXZRDOFM-UHFFFAOYSA-N 2-(2-ethoxyphenoxy)ethyl-[1-(4-methoxy-3-sulfamoylphenyl)propan-2-yl]azanium;chloride Chemical compound Cl.CCOC1=CC=CC=C1OCCNC(C)CC1=CC=C(OC)C(S(N)(=O)=O)=C1 ZZIZZTHXZRDOFM-UHFFFAOYSA-N 0.000 title claims abstract description 62
- 229960003198 tamsulosin hydrochloride Drugs 0.000 title claims abstract description 62
- 238000002360 preparation method Methods 0.000 title claims abstract description 61
- 239000002775 capsule Substances 0.000 claims abstract description 45
- 238000013268 sustained release Methods 0.000 claims abstract description 36
- 239000012730 sustained-release form Substances 0.000 claims abstract description 36
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 25
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 claims abstract description 15
- 239000000787 lecithin Substances 0.000 claims abstract description 15
- 235000010445 lecithin Nutrition 0.000 claims abstract description 15
- 229940067606 lecithin Drugs 0.000 claims abstract description 15
- 239000000945 filler Substances 0.000 claims abstract description 9
- 239000011159 matrix material Substances 0.000 claims abstract description 8
- 239000003814 drug Substances 0.000 claims description 17
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 12
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 12
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 12
- 229960003943 hypromellose Drugs 0.000 claims description 12
- 229920001353 Dextrin Polymers 0.000 claims description 8
- 239000004375 Dextrin Substances 0.000 claims description 8
- 229920002472 Starch Polymers 0.000 claims description 8
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 8
- 229930006000 Sucrose Natural products 0.000 claims description 8
- 235000019425 dextrin Nutrition 0.000 claims description 8
- 239000007921 spray Substances 0.000 claims description 8
- 239000008107 starch Substances 0.000 claims description 8
- 235000019698 starch Nutrition 0.000 claims description 8
- 239000005720 sucrose Substances 0.000 claims description 8
- 239000004925 Acrylic resin Substances 0.000 claims description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 5
- 230000001476 alcoholic effect Effects 0.000 claims description 4
- 229920002301 cellulose acetate Polymers 0.000 claims description 4
- 239000011248 coating agent Substances 0.000 claims description 4
- 238000000576 coating method Methods 0.000 claims description 4
- 239000012530 fluid Substances 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 3
- 235000010603 pastilles Nutrition 0.000 claims description 3
- 238000005453 pelletization Methods 0.000 claims description 3
- 239000002202 Polyethylene glycol Substances 0.000 claims description 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 229920000642 polymer Polymers 0.000 claims description 2
- 238000001035 drying Methods 0.000 claims 2
- 238000000034 method Methods 0.000 abstract description 8
- 235000005911 diet Nutrition 0.000 abstract description 6
- 230000037213 diet Effects 0.000 abstract description 6
- 238000010521 absorption reaction Methods 0.000 abstract description 4
- 230000001070 adhesive effect Effects 0.000 abstract description 2
- 239000000853 adhesive Substances 0.000 abstract 1
- DRHKJLXJIQTDTD-OAHLLOKOSA-N Tamsulosine Chemical compound CCOC1=CC=CC=C1OCCN[C@H](C)CC1=CC=C(OC)C(S(N)(=O)=O)=C1 DRHKJLXJIQTDTD-OAHLLOKOSA-N 0.000 description 10
- 229960002613 tamsulosin Drugs 0.000 description 10
- ZZIZZTHXZRDOFM-XFULWGLBSA-N tamsulosin hydrochloride Chemical compound [H+].[Cl-].CCOC1=CC=CC=C1OCCN[C@H](C)CC1=CC=C(OC)C(S(N)(=O)=O)=C1 ZZIZZTHXZRDOFM-XFULWGLBSA-N 0.000 description 9
- 239000006187 pill Substances 0.000 description 5
- 229940093429 polyethylene glycol 6000 Drugs 0.000 description 5
- 229940079593 drug Drugs 0.000 description 4
- 239000008280 blood Substances 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 206010013990 dysuria Diseases 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 235000012054 meals Nutrition 0.000 description 3
- 210000002460 smooth muscle Anatomy 0.000 description 3
- 206010004446 Benign prostatic hyperplasia Diseases 0.000 description 2
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 2
- 208000004403 Prostatic Hyperplasia Diseases 0.000 description 2
- 210000004907 gland Anatomy 0.000 description 2
- 210000000214 mouth Anatomy 0.000 description 2
- MRBDMNSDAVCSSF-UHFFFAOYSA-N phentolamine Chemical compound C1=CC(C)=CC=C1N(C=1C=C(O)C=CC=1)CC1=NCCN1 MRBDMNSDAVCSSF-UHFFFAOYSA-N 0.000 description 2
- 229960001999 phentolamine Drugs 0.000 description 2
- IENZQIKPVFGBNW-UHFFFAOYSA-N prazosin Chemical compound N=1C(N)=C2C=C(OC)C(OC)=CC2=NC=1N(CC1)CCN1C(=O)C1=CC=CO1 IENZQIKPVFGBNW-UHFFFAOYSA-N 0.000 description 2
- 229960001289 prazosin Drugs 0.000 description 2
- 210000002307 prostate Anatomy 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 210000003708 urethra Anatomy 0.000 description 2
- UCTWMZQNUQWSLP-VIFPVBQESA-N (R)-adrenaline Chemical compound CNC[C@H](O)C1=CC=C(O)C(O)=C1 UCTWMZQNUQWSLP-VIFPVBQESA-N 0.000 description 1
- 229930182837 (R)-adrenaline Natural products 0.000 description 1
- QCQCHGYLTSGIGX-GHXANHINSA-N 4-[[(3ar,5ar,5br,7ar,9s,11ar,11br,13as)-5a,5b,8,8,11a-pentamethyl-3a-[(5-methylpyridine-3-carbonyl)amino]-2-oxo-1-propan-2-yl-4,5,6,7,7a,9,10,11,11b,12,13,13a-dodecahydro-3h-cyclopenta[a]chrysen-9-yl]oxy]-2,2-dimethyl-4-oxobutanoic acid Chemical compound N([C@@]12CC[C@@]3(C)[C@]4(C)CC[C@H]5C(C)(C)[C@@H](OC(=O)CC(C)(C)C(O)=O)CC[C@]5(C)[C@H]4CC[C@@H]3C1=C(C(C2)=O)C(C)C)C(=O)C1=CN=CC(C)=C1 QCQCHGYLTSGIGX-GHXANHINSA-N 0.000 description 1
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- 206010020880 Hypertrophy Diseases 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 206010049816 Muscle tightness Diseases 0.000 description 1
- 241000283973 Oryctolagus cuniculus Species 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 125000003368 amide group Chemical group 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000011978 dissolution method Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229960005139 epinephrine Drugs 0.000 description 1
- 230000009246 food effect Effects 0.000 description 1
- 235000021471 food effect Nutrition 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 229960002897 heparin Drugs 0.000 description 1
- 229920000669 heparin Polymers 0.000 description 1
- 235000009200 high fat diet Nutrition 0.000 description 1
- 206010020718 hyperplasia Diseases 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000036724 intravesical pressure Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000027939 micturition Effects 0.000 description 1
- 230000004220 muscle function Effects 0.000 description 1
- 206010029446 nocturia Diseases 0.000 description 1
- 239000003087 receptor blocking agent Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 210000001635 urinary tract Anatomy 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention relates to a tamsulosin hydrochloride preparation and a preparation method thereof. The preparation comprises the following components in percentage by weight: 0.1 to 2 percent of tamsulosin hydrochloride, 0.5 to 5 percent of lecithin, 55 to 80 percent of filler, 10 to 30 percent of sustained-release matrix agent, and 1 to 10 percent of adhesive matrix agent. The tamsulosin hydrochloride sustained-release capsule preparation prepared by the method can be absorbed in a body more quickly, and acts more quickly, can be used for overcoming the influence of diet on tamsulosin hydrochloride absorption, is more convenient to take, and is suitable for more people.
Description
(1) technical field: the present invention relates to a kind of oral chemicals slow releasing preparation, be specifically related to a kind of tamsulosin hydrochloride sustained-release capsule and preparation method thereof.
(2) background technology: tamsulosin hydrochloride chemical name: (R) (-) 5-{2-[[2-(2-ethoxyphenyl) ether base] amido]-the 2-methyl }-ethyl-2-methoxybenzenesulphoismide hydrochlorate, molecular formula: C
20H
28N
2O
5SHCl.
Tamsulosin hydrochloride is novel a1 receptor blocking agent, optionally blocks the smooth muscle a1 receptor of neck of bladder, prostate body of gland and tunicle, reduces smooth muscle tension force, reduces the lower urinary tract resistance, thereby improves the dysuria that causes because of prostate hyperplasia.Zoopery proves that tamsulosin is optionally blocked the epinephrine a1 receptor of rat, rabbit.Its effect is than the strong 12-22 of prazosin times, than the strong 45-140 of phentolamine doubly.To people and animal urethra, bladder and the effect of prostatic a1 receptor blocking, than the strong 2.2-98 of prazosin doubly, than the strong 40-320 of phentolamine doubly.Anesthetized dog studies show that tamsulosin hydrochloride can obviously reduce the pressure of prostatic, but anesthetized rat rhythmicity bladder contraction and intravesical pressure are had no significant effect.
Tamsulosin hydrochloride can be used for treating the symptom of unusually urinating due to the prostatic hyperplasia, as frequent micturition, nocturia increase, dysuria etc.Because this product is to reach therapeutic purposes by improving urethra, neck of bladder and prostatic smooth muscle function, be not to dwindle the hypertrophy body of gland, so be applicable to light, moderate patient and do not cause serious dysuria person.
By the exploitation of Japanese Yamanouchi drugmaker, commodity are called Harnal to the tamsulosin hydrochloride sustained-release capsule oral formulations the earliest, and extensive use at home and abroad entered Chinese market in 1996.Domestic this peroral dosage form specification is the 0.2mg/ grain, is used for the treatment of the symptom of BPH, oral meal, adult once a day, one time one.When being grown up once oral 0.2mg, blood drug level reaches the peak after 6.8 hours, and the half-life is 10.0 hours.
Because it is slower that the tamsulosin hydrochloride slow releasing preparation absorbs, peak reaching time of blood concentration is longer, and the simultaneously oral impact that also is subjected to easily diet, particularly high fat diet of tamsulosin can affect the attraction of tamsulosin.Be to accelerate the attraction of tamsulosin, all developed at present the oral cavity disintegration preparation of tamsulosin hydrochloride both at home and abroad, but oral cavity disintegration preparation needs oral 3 times on the 1st, and the treatment prostatic hyperplasia needs long-term prescription, makes troubles so also for patient's medication.
(3) summary of the invention: task of the present invention is to overcome existing tamsulosin hydrochloride slow releasing agent defective, a kind of new tamsulosin hydrochloride sustained-release capsule preparation is provided, in vivo quicker absorption has also overcome the impact that diet absorbs tamsulosin hydrochloride simultaneously.
The technical solution used in the present invention is: add lecithin in existing tamsulosin hydrochloride slow releasing agent, the component of described preparation and percentage by weight are:
Tamsulosin hydrochloride 0.08-2%
Lecithin 0.5-5%
Filler 55-80%
Sustained-release matrix agent 10-30%
Bind skeleton agent 1-10%
Said filler is dextrin, starch, sucrose;
Said sustained-release matrix agent is high molecular insoluble polymer, is selected from one or more of hypromellose, polyacrylic resin, cellulose acetate;
One or both in hypromellose, the Polyethylene Glycol are selected in the agent of said bonding skeleton.
Hypromellose plays slow release and adhesive effect simultaneously in the preparation of the present invention.
The tamsulosin hydrochloride sustained-release capsule preparation that the present invention relates to, its preparation method comprises the following steps:
(1) prepare blank piller: filler starch, dextrin, sucrose are adopted the standby blank piller of centrifugal coating pelletizing legal system, and size is between the 18-26 order;
(2) slow-release pill of the hydrochloric tamsulosin medicine of preparation:
A. active medicine tamsulosin hydrochloride and lecithin are dissolved in 50% the alcoholic solution, the rear adding sustained-release matrix agent that fully is mixed, mixing obtains medicament slow release skeleton solution;
B. get the agent of bonding skeleton and all dissolve with suitable quantity of water, make and bind the skeleton agent solution;
C. the blank piller with step (1) preparation places fluid bed, spray one deck medicament slow release skeleton solution, and logical hot-air dry, spray one deck binds the skeleton agent solution, logical hot-air dry; Repeat aforesaid operations, until medicine-feeding fully;
(3) preparation slow releasing capsule: the pastille slow-release piller of step (2) preparation is incapsulated, namely make the tamsulosin hydrochloride sustained-release capsule preparation.
The present invention adds lecithin in existing tamsulosin hydrochloride slow releasing agent, lecithin is with after tamsulosin hydrochloride mixes, can with the tamsulosin hydrochloride enclose, form clathrate, and because lecithin has water solublity and oil-soluble concurrently, can accelerate to have discharged the absorption of tamsulosin hydrochloride, simultaneously it has fat-solublely also reduced the impact that diet attracts tamsulosin hydrochloride, so that tamsulosin hydrochloride is taken absorption after diet substantially unaffected.
Show according to drug release determination method (two appendix XD of Chinese Pharmacopoeia version in 2005 first method) and human bioavailability test, the tamsulosin hydrochloride sustained-release capsule preparation of the present invention's preparation, early stage, rate of release was fast, quick acting more, overcome the impact that diet absorbs tamsulosin hydrochloride, and taking more conveniently, suitable crowd is more extensive.
(4) specific embodiment: the following examples are used for further specifying and describe the present invention, but and do not mean that the present invention only limits to this.
Embodiment 1: the preparation of tamsulosin hydrochloride sustained-release capsule preparation
Prescription:
Tamsulosin hydrochloride 0.2g
Lecithin 2g
Sucrose 62.5g
Starch 43.75g
Dextrin 18.75g
Hypromellose 60g
Polyacrylic resin 20g
Polyethylene glycol 6000 0.7g
Preparation method:
The preparation of I, blank piller
Get recipe quantity sucrose, starch, dextrin, mix, enter in the centrifugal coating granulator, with centrifugal coating pelletizing method, prior art and technological parameter prepare blank piller, and size is between the 18-26 order;
The preparation of II, slow-release pill
A. recipe quantity tamsulosin hydrochloride and lecithin are dissolved in 50% the alcoholic solution, the rear adding recipe quantity polyacrylic resin that fully is mixed, an amount of hypromellose get medicament slow release skeleton solution, and be for subsequent use.
B. recipe quantity polyethylene glycol 6000 and remaining hypromellose is soluble in water, make and bind the skeleton agent solution, for subsequent use.
C. the blank piller that then step I is prepared places fluid bed, spray one deck medicament slow release skeleton solution, and logical hot-air dry, and then spray one deck bonding skeleton agent solution lead to hot-air dry again; Repeat aforesaid operations, until medicine-feeding fully.
III, slow releasing capsule preparation
The slow-release pill of Step II preparation is incapsulated, use the micropill automatic capsule filler, namely get tamsulosin hydrochloride sustained-release capsule, every hydrochloric tamsulosin 0.2mg of slow releasing capsule.
Embodiment 2: the preparation of tamsulosin hydrochloride sustained-release capsule preparation
Prescription:
Tamsulosin hydrochloride 0.4g
Lecithin 5g
Sucrose 72.5g
Starch 51.75g
Dextrin 21.75g
Hypromellose 50g
Cellulose acetate 24g
Polyacrylic resin 24g
Polyethylene glycol 6000 1g
Preparation method:
The preparation of I, blank piller
Preparation method by embodiment 1 empty piller is prepared
The preparation of II, slow-release pill
A. recipe quantity tamsulosin hydrochloride and lecithin are dissolved in 50% an amount of alcoholic solution, the cellulose acetate of the rear adding recipe quantity that fully is mixed, polyacrylic resin and an amount of hypromellose get medicament slow release skeleton solution, and be for subsequent use.
B. recipe quantity polyethylene glycol 6000, remaining hypromellose are dissolved in the suitable quantity of water, make and bind the skeleton agent solution, for subsequent use.
C. the blank piller that then step I is prepared places fluid bed, spray one deck medicament slow release skeleton solution, and then logical hot-air dry sprays one deck and binds the skeleton agent solution, more logical hot-air dry; Repeat aforesaid operations, until medicine-feeding fully.
III, slow releasing capsule preparation
The slow-release pill of Step II preparation is incapsulated, use the micropill automatic capsule filler, namely get tamsulosin hydrochloride sustained-release capsule, every hydrochloric tamsulosin 0.4mg of slow releasing capsule.
Embodiment 3: the preparation of tamsulosin hydrochloride sustained-release capsule preparation
Prescription:
Tamsulosin hydrochloride 1g
Lecithin 4g
Sucrose 80g
Starch 48g
Dextrin 25g
Hypromellose 70g
Polyacrylic resin 25g
Polyethylene glycol 6000 2g
Preparation method: be prepared into tamsulosin hydrochloride sustained-release capsule by embodiment 1 method, every hydrochloric tamsulosin 1mg of slow releasing capsule.
Embodiment 4
Get the tamsulosin hydrochloride sustained-release capsule of embodiment 1 preparation, according to drug release determination method (two appendix XD of Chinese Pharmacopoeia version in 2005 first method), with dissolution method the 3rd subtraction unit, with hydrochloride buffer 250ml as solvent, rotating speed is that per minute 100 turns, in accordance with the law operation.Calculate every in the release of different time.And the tamsulosin hydrochloride sustained-release capsule Harnal of producing with Japanese Yamanouchi Pharmaceutical Co., Ltd
Lot number KO25NO1 (lot number of the repackaged products 010507A) compares test, the results are shown in Table 1.
Table 1 tamsulosin hydrochloride sustained-release capsule and Harnal capsule release profiles are relatively
By as seen from Table 1, embodiment 1 prepared tamsulosin hydrochloride sustained-release capsule is compared with the Harnal capsule, discharges obviously faster than Harnal capsule (KO25NO1) before 5 hours, and is basically identical after 8 hours.
Embodiment 5
Embodiment 1 prepared tamsulosin hydrochloride sustained-release capsule is carried out the uniformity test of release, and result of the test sees Table 2.
The uniformity test of table 2 tamsulosin hydrochloride sustained-release capsule
Illustrate by the prepared acid hydrochloride salt tamsulosin sustained release capsule release of the inventive method even.
Embodiment 6
The human bioavailability test of the tamsulosin hydrochloride sustained-release capsule of embodiment 1 preparation and Harnal capsule (lot number KO25NO1).
Three experimenters in morning 7:00 take tamsulosin hydrochloride sustained-release capsule and the Harnal capsule (lot number KO25NO1) of embodiment 1 preparation, wherein two experimenters distinguish tamsulosin hydrochloride sustained-release capsule and the Harnal capsules (lot number KO25NO1) that (medicine) being taken before meal prepares with embodiment 1, another experimenter takes the tamsulosin hydrochloride sustained-release capsule of embodiment 1 preparation after the meal, after taking medicine 1,2,3,4,6,8,10h respectively takes a blood sample 6mL in the heparin test tube, measure the wherein concentration of tamsulosin after the separated plasma, result such as following table 3:
Table 3 tamsulosin hydrochloride sustained-release capsule of the present invention and Harnal capsule (lot number KO25NO1) human bioavailability relatively
From human bioavailability, the tamsulosin hydrochloride sustained-release capsule of the present invention's preparation absorbs obvious tamsulosin hydrochloride sustained-release capsule faster than routine, and substantially is not subjected to food effect.Conclusion: the tamsulosin hydrochloride sustained-release capsule of the present invention preparation is quick acting more, and takes more conveniently, and suitable crowd is more extensive.
Claims (2)
1. a tamsulosin hydrochloride preparation is characterized in that described preparation contains tamsulosin hydrochloride and lecithin, and the component of described preparation and percentage by weight are:
Tamsulosin hydrochloride 0.08-2%
Lecithin 0.5-5%
Filler 55-80%
Sustained-release matrix agent 10-30%
Bind skeleton agent 1-10%
Said filler is the mixture of dextrin, starch and sucrose;
Said sustained-release matrix agent is high molecular insoluble polymer, is selected from one or more of hypromellose, polyacrylic resin, cellulose acetate;
One or both in hypromellose, the Polyethylene Glycol are selected in the agent of said bonding skeleton.
2. the preparation method of tamsulosin hydrochloride preparation according to claim 1 is characterized in that, the following step of preparation tamsulosin hydrochloride preparation process:
(1) prepares blank piller: filler starch, dextrin, sucrose are adopted the standby blank piller of centrifugal coating pelletizing legal system;
(2) preparation pastille slow-release piller:
A. active medicine tamsulosin hydrochloride and lecithin are dissolved in 50% the alcoholic solution, the rear adding sustained-release matrix agent that fully is mixed obtains medicament slow release skeleton solution;
B. get the agent of bonding skeleton and be dissolved in the suitable quantity of water, make and bind the skeleton agent solution;
C. the blank piller with step (1) preparation places fluid bed, and spray one deck medicament slow release skeleton solution leads to hot-air a few minutes drying, and spray one deck binds the skeleton agent solution, logical hot-air a few minutes drying; Repeat aforesaid operations, until medicine-feeding fully;
(3) preparation slow releasing capsule: the pastille slow-release piller of step (2) preparation is incapsulated, namely make the tamsulosin hydrochloride sustained-release capsule preparation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200910155645 CN102106841B (en) | 2009-12-24 | 2009-12-24 | Tamsulosin hydrochloride preparation and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200910155645 CN102106841B (en) | 2009-12-24 | 2009-12-24 | Tamsulosin hydrochloride preparation and preparation method thereof |
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| Publication Number | Publication Date |
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| CN102106841A CN102106841A (en) | 2011-06-29 |
| CN102106841B true CN102106841B (en) | 2013-01-09 |
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| CN110755396B (en) * | 2019-12-06 | 2022-04-08 | 北京悦康科创医药科技股份有限公司 | Ibuprofen sustained-release pellet and preparation method thereof |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1358088A (en) * | 1999-06-28 | 2002-07-10 | 圣诺菲-合成实验室公司 | Pharmaceuticla dosage forms for controlled telease producing at least timed pulse |
| CN1691965A (en) * | 2003-03-06 | 2005-11-02 | 山之内制药株式会社 | Pharmaceutical composition for controlled release and manufacturing method thereof |
| CN101125134A (en) * | 2006-08-16 | 2008-02-20 | 常州市第四制药厂有限公司 | Hydrochloric tamsulosin sustained-release capsule and its preparation method |
| CN101204387A (en) * | 2006-12-19 | 2008-06-25 | 北京德众万全药物技术开发有限公司 | Novel tamsulosin hydrochloride sustained release capsules |
-
2009
- 2009-12-24 CN CN 200910155645 patent/CN102106841B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1358088A (en) * | 1999-06-28 | 2002-07-10 | 圣诺菲-合成实验室公司 | Pharmaceuticla dosage forms for controlled telease producing at least timed pulse |
| CN1691965A (en) * | 2003-03-06 | 2005-11-02 | 山之内制药株式会社 | Pharmaceutical composition for controlled release and manufacturing method thereof |
| CN101125134A (en) * | 2006-08-16 | 2008-02-20 | 常州市第四制药厂有限公司 | Hydrochloric tamsulosin sustained-release capsule and its preparation method |
| CN101204387A (en) * | 2006-12-19 | 2008-06-25 | 北京德众万全药物技术开发有限公司 | Novel tamsulosin hydrochloride sustained release capsules |
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| CN102106841A (en) | 2011-06-29 |
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