CN1218691C - Dual-layer slow releasing tablet of benproperine phosphate - Google Patents
Dual-layer slow releasing tablet of benproperine phosphate Download PDFInfo
- Publication number
- CN1218691C CN1218691C CN 01115128 CN01115128A CN1218691C CN 1218691 C CN1218691 C CN 1218691C CN 01115128 CN01115128 CN 01115128 CN 01115128 A CN01115128 A CN 01115128A CN 1218691 C CN1218691 C CN 1218691C
- Authority
- CN
- China
- Prior art keywords
- milligrams
- layer
- medicine
- slow releasing
- dual
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
- 229960001871 benproperine Drugs 0.000 title claims abstract description 48
- JTUQXGZRVLWBCR-UHFFFAOYSA-N 1-[1-[2-(phenylmethyl)phenoxy]propan-2-yl]piperidine Chemical compound C1CCCCN1C(C)COC1=CC=CC=C1CC1=CC=CC=C1 JTUQXGZRVLWBCR-UHFFFAOYSA-N 0.000 title claims abstract description 40
- 239000002355 dual-layer Substances 0.000 title claims abstract description 14
- 239000010410 layer Substances 0.000 claims abstract description 18
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 24
- -1 benproperine phosphates Chemical class 0.000 claims description 18
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 15
- 229920002472 Starch Polymers 0.000 claims description 15
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 15
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 15
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 15
- 239000008107 starch Substances 0.000 claims description 15
- 235000019698 starch Nutrition 0.000 claims description 15
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 14
- 239000008101 lactose Substances 0.000 claims description 14
- 235000019359 magnesium stearate Nutrition 0.000 claims description 12
- 229910019142 PO4 Inorganic materials 0.000 claims description 8
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 8
- 229920001249 ethyl cellulose Polymers 0.000 claims description 8
- 235000021317 phosphate Nutrition 0.000 claims description 8
- 239000011734 sodium Substances 0.000 claims description 8
- 229910052708 sodium Inorganic materials 0.000 claims description 8
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 7
- 239000002671 adjuvant Substances 0.000 claims 4
- 239000003814 drug Substances 0.000 abstract description 23
- 239000002994 raw material Substances 0.000 abstract description 20
- 238000002360 preparation method Methods 0.000 abstract description 9
- 230000000694 effects Effects 0.000 abstract description 7
- 239000008280 blood Substances 0.000 abstract description 6
- 210000004369 blood Anatomy 0.000 abstract description 6
- 238000001727 in vivo Methods 0.000 abstract description 3
- 239000003826 tablet Substances 0.000 description 14
- 239000011248 coating agent Substances 0.000 description 9
- 238000000576 coating method Methods 0.000 description 9
- 239000008187 granular material Substances 0.000 description 8
- 229940079593 drug Drugs 0.000 description 6
- 239000000203 mixture Substances 0.000 description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 4
- 239000004677 Nylon Substances 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 4
- 238000009826 distribution Methods 0.000 description 4
- 238000001035 drying Methods 0.000 description 4
- 229920001778 nylon Polymers 0.000 description 4
- 230000000954 anitussive effect Effects 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000007921 spray Substances 0.000 description 3
- 206010011224 Cough Diseases 0.000 description 2
- 239000001856 Ethyl cellulose Substances 0.000 description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 2
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000012729 immediate-release (IR) formulation Substances 0.000 description 2
- 230000002045 lasting effect Effects 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- 230000000144 pharmacologic effect Effects 0.000 description 2
- 239000007779 soft material Substances 0.000 description 2
- DKSZLDSPXIWGFO-BLOJGBSASA-N (4r,4ar,7s,7ar,12bs)-9-methoxy-3-methyl-2,4,4a,7,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-7-ol;phosphoric acid;hydrate Chemical compound O.OP(O)(O)=O.OP(O)(O)=O.C([C@H]1[C@H](N(CC[C@@]112)C)C3)=C[C@H](O)[C@@H]1OC1=C2C3=CC=C1OC.C([C@H]1[C@H](N(CC[C@@]112)C)C3)=C[C@H](O)[C@@H]1OC1=C2C3=CC=C1OC DKSZLDSPXIWGFO-BLOJGBSASA-N 0.000 description 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 229940124584 antitussives Drugs 0.000 description 1
- 229960004415 codeine phosphate Drugs 0.000 description 1
- 239000002274 desiccant Substances 0.000 description 1
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000007888 film coating Substances 0.000 description 1
- 238000009501 film coating Methods 0.000 description 1
- 229940084936 gonak Drugs 0.000 description 1
- 229960001375 lactose Drugs 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000003533 narcotic effect Effects 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 235000015424 sodium Nutrition 0.000 description 1
- 229940032147 starch Drugs 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000007939 sustained release tablet Substances 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
The present invention relates to medicine which is a dual-layer slow releasing tablet of benproperine phosphate. The dual-layer slow releasing tablet comprises the raw material of benproperine phosphate slow releasing medicine and the raw material of normal releasing medicine, and is prepared into a dual-layer tablet by double pressing. The proportion of the raw materials of the main medicine of the benproperine phosphate in the raw material of the normal releasing medicine and the raw material of the slow releasing medicine is 13.2 to 34.6 milligrams to 39.6 to 66 milligrams. A layer of normal releasing tablet is added on the basis of releasing tablets of the benproperine phosphate to cause the dual-layer slow releasing tablet simultaneously to have the advantages of fast taking effect in common preparations, and long and stable medicine effect of slow releasing preparations. The dual-layer slow releasing tablet can achieve the quick release of normal releasing part medicine in vivo. After the dual-layer slow releasing tablet quickly reaches the effective blood and medicine concentration, the slow releasing parts are slowly released to continuously maintain the effects, such as stable and effective blood and medicine concentration, etc.
Description
Technical field
The present invention relates to medicine, is a kind of dual-layer slow releasing tablet of benproperine phosphate.
Background technology
Benproperine phosphate is a kind of powerful antitussive medicine, belongs to non-narcotic and obeys no addicted maincenter cough suppressing medicine for a long time.The benproperine phosphate slow releasing tablet has oral easy absorption, and antitussive effect is obvious, the length of holding time, few side effects, advantage such as easy to use is found in actual clinical, though its antitussive effect is remarkable, for acute, sudden emergency case, because the drug release rate of its slow releasing tablet is slow, it is slow to play a role, and it is slow to prove effective, be unfavorable for removing rapidly slight illness, its range of application is restricted.
Summary of the invention
The objective of the invention is, a kind of dual-layer slow releasing tablet of benproperine phosphate is provided, on the basis of benproperine phosphate slow releasing tablet, increase one deck and often release sheet, make that it has simultaneously that ordinary preparation proves effective soon, slow releasing preparation lasting medicine, stable advantage, it can reach the often release part medicine and discharge rapidly in vivo, reach effective blood drug concentration fast after, slow-released part slowly discharges again, and continues to keep the effect etc. of effective blood drug concentration stably.
The present invention is in order to solve the existing in prior technology problem, adopt following scheme to solve, dual-layer slow releasing tablet of benproperine phosphate, it comprises benproperine phosphate slow releasing pharmaceutical raw material and normal release raw material, slow release layer and often to release layer be the double-layer tablet that forms through twice compacting, the ratio of benproperine phosphate principal agent feed distribution in often releasing gentle release raw material is: 13.2-39.6 milligram and 52.8 milligrams.Benproperine phosphate principal agent feed distribution further ratio in often releasing gentle release raw material is: 26.4 milligrams and 52.8 milligrams.Benproperine phosphate slow releasing pharmaceutical material component and content are:
52.8 milligrams of benproperine phosphates
40 milligrams of starch
51.2 milligrams of lactose
40 milligrams of hydroxypropyl emthylcelluloses
5 milligrams of ethyl celluloses
5 milligrams of microcrystalline Cellulose
40 milligrams of 1.5% Gonaks
5 milligrams of Pulvis Talci
1 milligram of magnesium stearate.
Benproperine phosphate normal release raw material component and content are:
Benproperine phosphate 13.2-39.6 milligram
28 milligrams of starch
30 milligrams of lactose
15 milligrams of microcrystalline Cellulose
20 milligrams of 8% polyvinylpyrrolidonesolution solution
5 milligrams of Sodium Hydroxymethyl Stalcses
1 milligram of magnesium stearate.
The component of benproperine phosphate slow releasing pharmaceutical raw material and content is preferably:
52.8 milligrams of benproperine phosphates
40 milligrams of starch
51.2 milligrams of lactose
40 milligrams of hydroxypropyl emthylcelluloses
5 milligrams of ethyl celluloses
5 milligrams of microcrystalline Cellulose
40 milligrams of 1.5% Gonaks
5 milligrams of Pulvis Talci
1 milligram of magnesium stearate.
Benproperine phosphate normal release raw material component and content is preferably:
26.4 milligrams of benproperine phosphates
28 milligrams of starch
30 milligrams of lactose
15 milligrams of microcrystalline Cellulose
20 milligrams of 8% polyvinylpyrrolidonesolution solution
5 milligrams of Sodium Hydroxymethyl Stalcses
1 milligram of magnesium stearate.
Medicine of the present invention proves through pharmacological testing, it has that ordinary preparation proves effective soon, slow releasing preparation lasting medicine, stable advantage, can reach the often release part medicine fully discharges rapidly in vivo, after reaching effective blood drug concentration fast, slow-released part slowly discharges again, and continue to keep the pharmacological effect of equilibrated effective blood drug concentration, and have further reduction side effect, safety good, keep long, advantage such as oral absorption is rapid of treatment time.
The present invention proves through animal experiment: can suppress the cough that various stimulations cause fully, effect improves 2-4 doubly etc. than codeine phosphate.
The specific embodiment
Dual-layer slow releasing tablet of benproperine phosphate, it comprises benproperine phosphate slow releasing pharmaceutical raw material and normal release raw material, be suppressed into double-layer tablet through twice, the ratio of benproperine phosphate principal agent feed distribution in often releasing gentle release raw material is: 13.2-34.6 milligram and 39.6-66 milligram.The ratio of benproperine phosphate principal agent feed distribution in often releasing gentle release raw material is: 26.4 milligrams and 52.8 milligrams.Benproperine phosphate slow releasing pharmaceutical material component and content are:
Benproperine phosphate 39.6-66 milligram
40 milligrams of starch
51.2 milligrams of lactose
40 milligrams of hydroxypropyl emthylcelluloses
5 milligrams of ethyl celluloses
5 milligrams of microcrystalline Cellulose
40 milligrams of 1.5% Gonaks
5 milligrams of Pulvis Talci
1 milligram of magnesium stearate.
Benproperine phosphate normal release raw material component and content are:
Benproperine phosphate 13.2-39.6 milligram
28 milligrams of starch
30 milligrams of lactose
15 milligrams of microcrystalline Cellulose
20 milligrams of 8% polyvinylpyrrolidonesolution solution
5 milligrams of Sodium Hydroxymethyl Stalcses
1 milligram of magnesium stearate.
Benproperine phosphate slow releasing pharmaceutical material component and content can be:
52.8 milligrams of benproperine phosphates
40 milligrams of starch
51.2 milligrams of lactose
40 milligrams of hydroxypropyl emthylcelluloses
5 milligrams of ethyl celluloses
5 milligrams of microcrystalline Cellulose
40 milligrams of 1.5% Gonaks
5 milligrams of Pulvis Talci
1 milligram of magnesium stearate.
Benproperine phosphate normal release raw material component and content can be:
26.4 milligrams of benproperine phosphates
28 milligrams of starch
30 milligrams of lactose
15 milligrams of microcrystalline Cellulose
20 milligrams of 8% polyvinylpyrrolidonesolution solution
5 milligrams of Sodium Hydroxymethyl Stalcses
1 milligram of magnesium stearate.
The film-coat component and the content of double-layer sustained release tablets of the present invention are:
3 milligrams of hydroxypropyl emthylcelluloses
8 milligrams of PEG400s
0.6 milligram of titanium dioxide
1.2 milligrams of Pulvis Talci
95% ethanol, 80 microlitres
Water 20 microlitres.
The preparation technology of double-layer tablet of the present invention is as follows:
Respectively benproperine phosphate, starch, hydroxypropyl emthylcellulose, ethyl cellulose, microcrystalline Cellulose, Sodium Hydroxymethyl Stalcs are pressed component of the present invention and content drying, pulverize, cross 100 mesh sieves respectively, standby.
Normal release raw material preparation technology:
Respectively benproperine phosphate, starch, lactose, microcrystalline Cellulose are crossed 80 mesh sieve mix homogeneously by content of the present invention.Add 8% polyvinylpyrrolidonesolution solution and make soft material in right amount, with the promptly diffusing degree of holding of being of agglomerating, light pressure; Crossing 18 order nylon mesh granulates; Drying is 2 hours under 70 ℃ of conditions; With 16 order nylon mesh granulate, add Sodium Hydroxymethyl Stalcs and lubricant, mix homogeneously is immediate-release granules.
Slow releasing pharmaceutical feedstock production technology:
By component of the present invention and content benproperine phosphate, starch 80 mesh sieves are mixed.Lactose, ethyl cellulose, microcrystalline Cellulose and hydroxypropyl emthylcellulose are crossed 80 mesh sieve mix homogeneously by content of the present invention.Again two kinds of mixture are crossed 80 mesh sieve mix homogeneously, add 1.5% Gonak and make soft material in right amount, with the promptly diffusing degree of holding of being of agglomerating, light pressure; Crossing 18 order nylon mesh granulates; Drying is 2 hours under 70 ℃ of conditions; With 16 order nylon mesh granulate, add lubricant, mix homogeneously is slow-releasing granules.
Immediate-release granules and slow-releasing granules are placed the administration funnel respectively, use the bi-layer tablet press tabletting.
Film coating procedure:
The preparation of coating solution: by component of the present invention and content hydroxypropyl emthylcellulose is added in 95% ethanol, under constantly stirring, add entry, it is fully dissolved, add other raw materials of recipe quantity again, stirred 40 minutes, promptly get coating solution.Art for coating: plain sheet is removed fine powder add in the coating pan, be preheated to 45 ℃, regulate compressed air, making its pressure is 0.4Mpa, and regulating the coating pan rotating speed is 3-10 rev/min, regulates the spray speed of spray gun, makes the label in the coating pan must not bonding die.Operating period, should keep a close eye on the unilateral situation of label in the coating pan, adjust spray speed at any time, heavily increased to 1% o'clock to sheet, stop coating.Coated tablet is taken out in coating pan, put into the drying cupboard of desiccant, after at least 5 hours, take out check, packing promptly gets this product.
The content of various components of the present invention is the content of making 1 double-layer tablet of the present invention.
Claims (2)
1, dual-layer slow releasing tablet of benproperine phosphate, it comprises slow release layer and often releases layer, slow release layer and often to release layer be the double-layer tablet that compacting forms through secondary, it is characterized in that: the component of benproperine phosphate and adjuvant and content are in the slow release layer: (every consumption)
52.8 milligrams of benproperine phosphates
40 milligrams of starch
51.2 milligrams of lactose
40 milligrams of hydroxypropyl emthylcelluloses
5 milligrams of ethyl celluloses
5 milligrams of microcrystalline Cellulose
40 milligrams of 1.5% Gonaks
5 milligrams of Pulvis Talci
1 milligram of magnesium stearate;
Often release that the component and the content of benproperine phosphate and adjuvant is in the layer: (every consumption)
Benproperine phosphate 13.2-39.6 milligram
28 milligrams of starch
30 milligrams of lactose
15 milligrams of microcrystalline Cellulose
20 milligrams of 8% polyvinylpyrrolidonesolution solution
5 milligrams of Sodium Hydroxymethyl Stalcses
1 milligram of magnesium stearate.
2, dual-layer slow releasing tablet of benproperine phosphate according to claim 1 is characterized in that: the component of benproperine phosphate and adjuvant and content are in the slow release layer: (every consumption)
52.8 milligrams of benproperine phosphates
40 milligrams of starch
51.2 milligrams of lactose
40 milligrams of hydroxypropyl emthylcelluloses
5 milligrams of ethyl celluloses
5 milligrams of microcrystalline Cellulose
40 milligrams of 1.5% Gonaks
5 milligrams of Pulvis Talci
1 milligram of magnesium stearate;
Often release that the component and the content of benproperine phosphate and adjuvant is in the layer: (every consumption)
26.4 milligrams of benproperine phosphates
28 milligrams of starch
30 milligrams of lactose
15 milligrams of microcrystalline Cellulose
20 milligrams of 8% polyvinylpyrrolidonesolution solution
5 milligrams of Sodium Hydroxymethyl Stalcses
1 milligram of magnesium stearate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01115128 CN1218691C (en) | 2001-07-11 | 2001-07-11 | Dual-layer slow releasing tablet of benproperine phosphate |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01115128 CN1218691C (en) | 2001-07-11 | 2001-07-11 | Dual-layer slow releasing tablet of benproperine phosphate |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1329890A CN1329890A (en) | 2002-01-09 |
| CN1218691C true CN1218691C (en) | 2005-09-14 |
Family
ID=4661711
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 01115128 Expired - Lifetime CN1218691C (en) | 2001-07-11 | 2001-07-11 | Dual-layer slow releasing tablet of benproperine phosphate |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1218691C (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1301716C (en) * | 2002-10-09 | 2007-02-28 | 重庆太极医药研究院 | Slow-releasing Benproperine phosphate dripping pill and its prepn process |
| CN101543481B (en) * | 2008-03-28 | 2011-03-23 | 北京四环科宝制药有限公司 | Double-layer breviscapine sustained-release tablet and preparation method thereof |
-
2001
- 2001-07-11 CN CN 01115128 patent/CN1218691C/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| CN1329890A (en) | 2002-01-09 |
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Owner name: XI'AN DONGSHENG GROUP CO.,LTD. Free format text: FORMER OWNER: HUANG ZHENHUA Effective date: 20040806 |
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Effective date of registration: 20040806 Address after: 710075 Shaanxi city of Xi'an Province Tang Yan Road No. 23 Dongsheng Building Applicant after: Dongsheng Group Co., Ltd., Xi-an Address before: 250013 No. 161, Jiefang Road, Shandong, Ji'nan Applicant before: Huang Zhenhua |
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Effective date of registration: 20160203 Address after: 721400, Xiguan County, Fengxiang County, Shaanxi, Baoji Patentee after: Shaanxi Heng Cheng Pharmaceutical Co., Ltd. Address before: 710075 Shaanxi city of Xi'an Province Tang Yan Road No. 23 Dongsheng Building Patentee before: Dongsheng Group Co., Ltd., Xi-an |
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