CN103142526B - Dropping pills containing colloidal bismuth pectin - Google Patents
Dropping pills containing colloidal bismuth pectin Download PDFInfo
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- CN103142526B CN103142526B CN201310092650.9A CN201310092650A CN103142526B CN 103142526 B CN103142526 B CN 103142526B CN 201310092650 A CN201310092650 A CN 201310092650A CN 103142526 B CN103142526 B CN 103142526B
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- CN
- China
- Prior art keywords
- drop pill
- colloidal bismmth
- bismmth pectin
- clathrate
- pectin
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- 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.)
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- 229920001277 pectin Polymers 0.000 title claims abstract description 41
- 235000010987 pectin Nutrition 0.000 title claims abstract description 41
- 239000001814 pectin Substances 0.000 title claims abstract description 41
- 239000006187 pill Substances 0.000 title claims abstract description 34
- 229910052797 bismuth Inorganic materials 0.000 title abstract description 5
- JCXGWMGPZLAOME-UHFFFAOYSA-N bismuth atom Chemical compound [Bi] JCXGWMGPZLAOME-UHFFFAOYSA-N 0.000 title abstract description 5
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 claims description 14
- 150000001875 compounds Chemical class 0.000 abstract 1
- 238000002360 preparation method Methods 0.000 description 13
- ZPWVASYFFYYZEW-UHFFFAOYSA-L dipotassium hydrogen phosphate Chemical compound [K+].[K+].OP([O-])([O-])=O ZPWVASYFFYYZEW-UHFFFAOYSA-L 0.000 description 9
- 239000012530 fluid Substances 0.000 description 9
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 9
- 235000019796 monopotassium phosphate Nutrition 0.000 description 9
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 description 9
- 229940057995 liquid paraffin Drugs 0.000 description 8
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 7
- 229940093429 polyethylene glycol 6000 Drugs 0.000 description 7
- 235000021355 Stearic acid Nutrition 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- 239000000203 mixture Substances 0.000 description 6
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 6
- 239000008117 stearic acid Substances 0.000 description 6
- 239000000758 substrate Substances 0.000 description 5
- 229920001450 Alpha-Cyclodextrin Polymers 0.000 description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 4
- HFHDHCJBZVLPGP-RWMJIURBSA-N alpha-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO HFHDHCJBZVLPGP-RWMJIURBSA-N 0.000 description 4
- 229940043377 alpha-cyclodextrin Drugs 0.000 description 4
- 238000006243 chemical reaction Methods 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 229920001983 poloxamer Polymers 0.000 description 3
- 208000007882 Gastritis Diseases 0.000 description 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- 208000032843 Hemorrhage Diseases 0.000 description 2
- 238000005352 clarification Methods 0.000 description 2
- 239000000084 colloidal system Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 238000010316 high energy milling Methods 0.000 description 2
- 239000012982 microporous membrane Substances 0.000 description 2
- TZBAVQKIEKDGFH-UHFFFAOYSA-N n-[2-(diethylamino)ethyl]-1-benzothiophene-2-carboxamide;hydrochloride Chemical compound [Cl-].C1=CC=C2SC(C(=O)NCC[NH+](CC)CC)=CC2=C1 TZBAVQKIEKDGFH-UHFFFAOYSA-N 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000007962 solid dispersion Substances 0.000 description 2
- 239000003381 stabilizer Substances 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 239000001828 Gelatine Substances 0.000 description 1
- 229920002230 Pectic acid Polymers 0.000 description 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 1
- 208000007107 Stomach Ulcer Diseases 0.000 description 1
- 208000025865 Ulcer Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000003139 buffering effect Effects 0.000 description 1
- 208000016644 chronic atrophic gastritis Diseases 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 208000023652 chronic gastritis Diseases 0.000 description 1
- 229940008099 dimethicone Drugs 0.000 description 1
- 239000004205 dimethyl polysiloxane Substances 0.000 description 1
- 235000013870 dimethyl polysiloxane Nutrition 0.000 description 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 1
- 229910000397 disodium phosphate Inorganic materials 0.000 description 1
- 235000019800 disodium phosphate Nutrition 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 208000000718 duodenal ulcer Diseases 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011187 glycerol Nutrition 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
- 235000019799 monosodium phosphate Nutrition 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- LCLHHZYHLXDRQG-ZNKJPWOQSA-N pectic acid Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)O[C@H](C(O)=O)[C@@H]1OC1[C@H](O)[C@@H](O)[C@@H](OC2[C@@H]([C@@H](O)[C@@H](O)[C@H](O2)C(O)=O)O)[C@@H](C(O)=O)O1 LCLHHZYHLXDRQG-ZNKJPWOQSA-N 0.000 description 1
- 229960000502 poloxamer Drugs 0.000 description 1
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 description 1
- 239000010318 polygalacturonic acid Substances 0.000 description 1
- -1 polyoxyethylene monostearate Polymers 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
- 235000015112 vegetable and seed oil Nutrition 0.000 description 1
- 239000008158 vegetable oil Substances 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The application relates to dropping pills, and in particular relates to dropping pills containing colloidal bismuth pectin clathrate compounds.
Description
Technical field
The application relates to a kind of drop pill, particularly, is the drop pill that comprises colloidal bismmth pectin clathrate.
Background technology
Drop pill has the following feature: 1, equipment simple, easy to operate, be beneficial to labor protection, process cycle is short, productivity ratio is high; 2, process conditions are easy to control, steady quality, and dosage is accurate, and heated time is short, and the volatile medicine of oxidizable and tool is dissolved in after substrate, can increase its stability; 3, to hold liquid drug amount large for substrate, therefore can make liquid drug solidify; 4, the drop pill of preparing with solid dispersion technology has the feature rapid, bioavailability is high that absorbs.
Clathrate has the following advantages: cover bad stink, reduce zest; Increase drug dissolution and bioavailability; Improve medicine stability.
Colloidal bismmth pectin is a kind of novel macromolecule bismuth, and molecular weight is large, colloid-stabilised, be difficult to be absorbed by the body, and the untoward reaction easily causing without similar drugs and side effect.Be mainly used in treating chronic gastritis.Colloidal bismmth pectin with biomacromolecule pectic acid replaced in traditional bismuth preparation in, micromolecule acid group, improved colloid property, mucosa is stronger; Stomach Microscopic observation, colloidal bismmth pectin gel more trends towards being deposited on ulcer and hemorrhage mucomembranous surface, has fabulous selection adhesiveness.Colloidal bismmth pectin is mainly used in gastric and duodenal ulcers, also can be used for the treatment of chronic superficial gastritis, chronic atrophic gastritis and digestive tract hemorrhage.
Summary of the invention
The present invention, in order to solve existing colloid pectin bismuth preparation poor stability, shortcoming that bioavailability is low, has invented colloidal bismmth pectin clathrate drop pill.
The application is first prepared into clathrate by colloidal bismmth pectin, and then is prepared into drop pill, enclose and drop pill technology are united two into one, and the advantage of performance two aspects.
Colloidal bismmth pectin clathrate comprises active component and enclose material, and active component is colloidal bismmth pectin, and enclose material is alpha-cyclodextrin, beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, one or more of hydroxypropylβ-cyclodextrin.The part by weight of active component and enclose material is 3:2-2:3.
The preparation method of colloidal bismmth pectin clathrate comprises:
(1) in water or aquiferous ethanol medium, by a certain percentage, by colloidal bismmth pectin and alpha-cyclodextrin, beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, one or more reactions of hydroxypropylβ-cyclodextrin, gained solution, through extremely clarification of filtering with microporous membrane, is isolated to clathrate from mixture; Or
(2) with solid form, by colloidal bismmth pectin and alpha-cyclodextrin, beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, one or more reactions of hydroxypropylβ-cyclodextrin; Or
(3) colloidal bismmth pectin and alpha-cyclodextrin, beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, high energy milling is carried out in one or more reactions of hydroxypropylβ-cyclodextrin.
The above-mentioned colloidal bismmth pectin clathrate preparing is crossed to 100-200 mesh sieve, be mixed into solid dispersion system with substrate and stabilizing agent, at 70 ± 5 ℃, splash into the condensed fluid of 0-20 ℃, adsorption condensing liquid, drop pill drying, obtains.
The substrate of indication of the present invention is selected from the two or more mixture such as polyethylene glycol 6000, Macrogol 4000, polyoxyethylene monostearate, sodium stearate, glycerin gelatine, poloxamer, stearic acid.
Applicant is surprised to find that, when substrate is selected polyethylene glycol 6000 and stearic compositions, and the part by weight of the two is while being 60:40, and the drop pill making becomes ball, roundness best.
The stabilizing agent of indication of the present invention comprises that phosphatic PH buffering is right, as sodium hydrogen phosphate and sodium dihydrogen phosphate; Dipotassium hydrogen phosphate and potassium dihydrogen phosphate.
The condensed fluid of indication of the present invention comprises condensed fluid dimethicone, liquid paraffin, Oleum Camelliae, vegetable oil etc.
Metering of the present invention is weight.
Embodiment 1
The prescription of drop pill is (by weight):
Preparation method:
1. prepare by the following method colloidal bismmth pectin clathrate:
(1) in water or aquiferous ethanol medium, in proportion, colloidal bismmth pectin is reacted with hydroxypropylβ-cyclodextrin, gained solution, through extremely clarification of filtering with microporous membrane, is isolated to clathrate from mixture; Or
(2), with solid form, colloidal bismmth pectin is reacted with hydroxypropylβ-cyclodextrin; Or
(3) colloidal bismmth pectin reacts with hydroxypropylβ-cyclodextrin and carries out high energy milling.
2. colloidal bismmth pectin clathrate was pulverized to 100-200 mesh sieve; Polyethylene glycol 6000, stearic acid, dipotassium hydrogen phosphate and potassium dihydrogen phosphate ground and mixed is even, heating and melting on water-soluble, and mix; Colloidal bismmth pectin clathrate is added in the fused mass of polyethylene glycol 6000, stearic acid, dipotassium hydrogen phosphate and potassium dihydrogen phosphate, mix, in impouring material fluid bath, keep 65-75 ℃ of temperature 10 minutes, above-mentioned medicinal liquid is splashed in the liquid paraffin of 0-20 ℃ and form drop pill, absorb condensed fluid, dry drop pill, packing.
Embodiment 2
The prescription of drop pill is (by weight):
Colloidal bismmth pectin clathrate (colloidal bismmth pectin: hydroxypropylβ-cyclodextrin is 2:3) 4g
Polyethylene glycol 6000 5g
Stearic acid 5g
Dipotassium hydrogen phosphate and potassium dihydrogen phosphate 0.2g
Liquid paraffin is appropriate.
Preparation method is with embodiment 1.
Embodiment 3
The prescription of drop pill is (by weight):
Preparation method is with embodiment 1.
Embodiment 4
The prescription of drop pill is (by weight):
Preparation method is with embodiment 1.
Embodiment 5
The prescription of drop pill is (by weight):
Colloidal bismmth pectin clathrate (colloidal bismmth pectin: hydroxypropylβ-cyclodextrin is 2:3) 4g
PLURONICS F87 6g
Stearic acid 4g
Dipotassium hydrogen phosphate and potassium dihydrogen phosphate 0.2g
Liquid paraffin is appropriate.
Preparation method is with embodiment 1.
Embodiment 6
The prescription of drop pill is (by weight):
Preparation method is with embodiment 1.
Matched group 1
The prescription of drop pill is (by weight):
Colloidal bismmth pectin clathrate (colloidal bismmth pectin: hydroxypropylβ-cyclodextrin is 2:3) 4g
Polyethylene glycol 6000 10g
Dipotassium hydrogen phosphate and potassium dihydrogen phosphate 0.2g
Condensed fluid is liquid paraffin.
Preparation method is with embodiment 1.
Matched group 2
The prescription of drop pill is (by weight):
Colloidal bismmth pectin clathrate (colloidal bismmth pectin: hydroxypropylβ-cyclodextrin is 2:3) 4g
Macrogol 4000 10g
Dipotassium hydrogen phosphate and potassium dihydrogen phosphate 0.2g
Condensed fluid is liquid paraffin.
Preparation method is with embodiment 1.
Matched group 3
The prescription of drop pill is (by weight):
Colloidal bismmth pectin clathrate (colloidal bismmth pectin: hydroxypropylβ-cyclodextrin is 2:3) 4g
Stearic acid 10g
Dipotassium hydrogen phosphate and potassium dihydrogen phosphate 0.2g
Condensed fluid is liquid paraffin.
Preparation method is with embodiment 1.
Matched group 4
The prescription of drop pill is (by weight):
Colloidal bismmth pectin clathrate (colloidal bismmth pectin: hydroxypropylβ-cyclodextrin is 2:3) 4g
PLURONICS F87 10g
Dipotassium hydrogen phosphate and potassium dihydrogen phosphate 0.2g
Condensed fluid is liquid paraffin.
Preparation method is with embodiment 1.
Colloidal bismmth pectin clathrate drop pill experimental result
The method of pressing Chinese Pharmacopoeia (2000 editions) detects smooth rounding rate and the dissolve scattered time limit of drop pill, the results are shown in Table 1.
Table 1
| Group | Smooth rounding rate (%) | Dissolve scattered time limit (min) |
| Embodiment 1 | 98.64 | 2.1 |
| Embodiment 2 | 90.41 | 2.9 |
| Embodiment 3 | 91.32 | 2.6 |
| Embodiment 4 | 85.46 | 2.8 |
| Embodiment 5 | 83.92 | 2.2 |
| Embodiment 6 | 86.14 | 2.5 |
| Matched group 1 | 80.37 | 5.6 |
| Matched group 2 | 77.83 | 6.0 |
| Matched group 3 | 74.38 | 5.8 |
| Matched group 4 | 76.98 | 5.7 |
Result shows, colloidal bismmth pectin clathrate drop pill provided by the invention meets Chinese Pharmacopoeia (2000 editions) about the regulation of drop pill.And according to polyethylene glycol 6000: to be the clathrate drop pill prepared of 60:40 have more excellent effect with respect to drop pill and the non-clathrate drop pill of non-this special ratios to stearic acid part by weight.
Claims (1)
1. a colloidal bismmth pectin drop pill, is characterized in that: the prescription of drop pill is by weight:
Colloidal bismmth pectin in colloidal bismmth pectin clathrate wherein: hydroxypropylβ-cyclodextrin weight ratio is 2:3.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310092650.9A CN103142526B (en) | 2013-03-21 | 2013-03-21 | Dropping pills containing colloidal bismuth pectin |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310092650.9A CN103142526B (en) | 2013-03-21 | 2013-03-21 | Dropping pills containing colloidal bismuth pectin |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103142526A CN103142526A (en) | 2013-06-12 |
| CN103142526B true CN103142526B (en) | 2014-04-30 |
Family
ID=48541042
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310092650.9A Active CN103142526B (en) | 2013-03-21 | 2013-03-21 | Dropping pills containing colloidal bismuth pectin |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103142526B (en) |
-
2013
- 2013-03-21 CN CN201310092650.9A patent/CN103142526B/en active Active
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| Publication number | Publication date |
|---|---|
| CN103142526A (en) | 2013-06-12 |
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Address after: 266103 Qingdao economic and Technological Development Zone, unity Road, No. 3601, Shandong Applicant after: Qingdao Zhengda Haier Pharmaceutical Co.,Ltd. Address before: 266103 Haier Road, Shandong, Qingdao, No. 1 Applicant before: Qingdao Zhengda Haier Pharmaceutical Co.,Ltd. |
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| CP01 | Change in the name or title of a patent holder |
Address after: 266103 3601 Tuen Jie Road, Qingdao economic and Technological Development Zone, Shandong Patentee after: CP PHARMACEUTICAL (QINGDAO) Co.,Ltd. Address before: 266103 3601 Tuen Jie Road, Qingdao economic and Technological Development Zone, Shandong Patentee before: Qingdao Zhengda Haier Pharmaceutical Co.,Ltd. |
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Address after: No.3601 Tuanjie Road, Qingdao Economic and Technological Development Zone, Shandong Province 266426 Patentee after: Qingdao Guoxin Pharmaceutical Co.,Ltd. Country or region after: China Address before: No. 3601 Tuanjie Road, Qingdao Economic and Technological Development Zone, Shandong Province Patentee before: CP PHARMACEUTICAL (QINGDAO) Co.,Ltd. Country or region before: China |