CN1265793C - Oral compound levocetirizine pseudoephedrine formulation and its preparation - Google Patents
Oral compound levocetirizine pseudoephedrine formulation and its preparation Download PDFInfo
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- CN1265793C CN1265793C CN 02145454 CN02145454A CN1265793C CN 1265793 C CN1265793 C CN 1265793C CN 02145454 CN02145454 CN 02145454 CN 02145454 A CN02145454 A CN 02145454A CN 1265793 C CN1265793 C CN 1265793C
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- pseudoephedrine
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Abstract
The present invention belongs to the technical field of medicinal preparations. The present invention discloses a levocetirizine pseudoephedrine compound oral-administration preparation. The activity of the preparation of the present invention is equal to that of a cetirizine pseudoephedrine compound preparation. A single optical isomer is adopted, and the dose is reduced by a half. Moreover, the preparation of the present invention achieves the goals of taking effect for a long time and small side effect. The preparation of the present invention is suitable for adults, and can be also suitable for children. The present invention provides a preparation method.
Description
Technical field
The invention belongs to technical field of medicine.Be specifically related to a kind of levocetirizine pseudoephedrine compound oral administration preparation and preparation method.
Background technology
Cetirizine (cetirizine) is a second filial generation histamine H
1Receptor antagonist is a kind of dl-mixture, is made up of the LEVO CITRAZINE (Levocetirizine, R-enantiomer) and the dextrorotation cetirizine (Dextrocetirizine, S-enantiomer) of equivalent.Wherein main active is a LEVO CITRAZINE, and the dextrorotation cetirizine does not then have antihistamine effect.The antihistamine effect of levo form or its pharmaceutically acceptable salt (example hydrochloric acid levocetirizine) is applicable to the anti-allergic agent of treatment of allergic rhinitis symptom.But most rhinitis are with the nasal mucosa hyperemia symptom of promptly having a stuffy nose, and a lot of colds, the flu patients are irritated and the two kinds of symptoms and depositing of having a stuffy nose.We select pseudoephedrine or its pharmaceutically acceptable salt (example hydrochloric acid pseudoephedrine) promptly is in order to address the above problem as another main component of this compound preparation.
Pseudoephedrine or its pharmaceutically acceptable salt (example hydrochloric acid pseudoephedrine) can the mutual receptors of direct exciting kidney gland, also can discharge norepinephrine and indirect exciting adrenoceptor by teleneuron by impelling the adrenal gland, α and beta receptor all there is agonism, has the blood vessel function of contracting, but the stimulating central nervous system system, the expansible bronchus of short application use.According to Allergic Rhinitis often with nasal mucosa hyperemia promptly have a stuffy nose symptom and most cold, the flu patient is irritated and the situation of having a stuffy nose two kinds of symptoms and depositing, therefore two medicines share and make compound preparation highly significant.At present, U.S. FDA has been ratified the compound preparation Zyrtec-D12Hour (every hydrochloric cetirizine 5mg and pseudoephedrine hydrochloride 120mg) of cetirizine and pseudoephedrine, be used for the treatment of multiple anaphylactic disease, comprise seasonality and catarrhus perennialis, allergic asthma, chronic hives etc.It is reported, though the central nervous system of cetirizine is active very light, if but the utmost point has the drowsiness untoward reaction of Denging, studies show that this mainly is that d-isomer and brain inner recipient have due to certain affinity, so with its single optical isomer-LEVO CITRAZINE, just can address this problem well, it does not have central nervous system's side effect such as calm, drowsiness, but anti-histamine activity still is equivalent to cetirizine, and consumption can reduce half, except being applicable to the adult, also applicable to the child.Show also that clinically the antihistamine effect of 5mg LEVO CITRAZINE is identical with the 10mg cetirizine, but side effect and adverse reaction rate are lower.
Because levocetirizine biological half-life (t
1/2) be about 12 hours, pseudoephedrine biological half-life (t
1/2) only be about 5 hours, for making the synchronous coordination effect better of two medicines, pseudoephedrine is made the slow-released part levocetirizine to be made immediate release section to form the compound oral slow releasing preparation jointly then very necessary, what two medicines entered the antihistamine effect of bringing into play levocetirizine in the body simultaneously and pseudoephedrine alleviates the nasal mucosa hyperemization, when the consumption of levocetirizine and pseudoephedrine is 5mg and 90～240mg combination, sustainable 24 hours of drug effect.
Summary of the invention
Technical problem to be solved by this invention is to overcome above-mentioned weak point, design lasting medicine, the compound oral administration preparation that side effect is little.
The invention discloses a kind of levocetirizine pseudoephedrine compound oral administration preparation, said preparation comprises what levocetirizine and pseudoephedrine were formed as principal agent and pharmaceutic adjuvant.
Another object of the present invention has provided the preparation method of above-mentioned a kind of levocetirizine pseudoephedrine compound oral administration preparation, and this method is:
One. tablet
Slow release label prescription:
| Scope mg/ sheet | Purposes | Substituting agent | |
| 1. 4. ethyl cellulose 5. dolomols of pseudoephedrine hydrochloride 2. lactose 3.HPMC (Hydroxypropyl methylcellulose) | 90-240 15-45 45-120 0-45 0.6-12 | Principal agent diluent framework material blocker lubricant | Microcrystalline Cellulose, the pregelatinized Starch sodium alginate, chitin, carbomer, the polyvinyl alcohol glyceryl monostearate, stearic acid, the Brazil wax calcium stearate, magnesium stearate, sliding |
| Stone powder |
Technology:
By above-mentioned prescription, be wetting agent with the ethanol of 75% (30-90%), will make the wet granular that is fit to size behind the 1.2.3.4 mix homogeneously, after the drying, adding 0.5% magnesium stearate is lubricant, at suitable pressure lower sheeting.Obtain the slow release label.
The release layer preparation:
| Scope (mg/ sheet) | Purposes | Substituting agent | |
| Pseudoephedrine hydrochloride slow release label pseudoephedrine hydrochloride levo-cetirizine hydrochloride Opadry (Opadry) water | 150.6～462 0～60 5 27～75 700～840 | Principal agent principal agent principal agent coating powder solvent | For allocating finite concentration ethanol voluntarily |
Label is carried out coating according to above-mentioned prescription in coating pan, leaving air temp is controlled at 35-40 ℃, has extremely comprised the pseudoephedrine hydrochloride and the 5mg levo-cetirizine hydrochloride of respective amount in every coating tablets layer.
Last coating
Further with 5.0% Opadry coating, leaving air temp is controlled at 35 ℃ with the above sheet that contains 5mg levo-cetirizine hydrochloride and 90～240mg pseudoephedrine hydrochloride.
Two. capsule
1. fast release micropill
Prescription:
| Scope (g) | Purposes | Substituting agent | |
| Levo-cetirizine hydrochloride pseudoephedrine hydrochloride PVP (polyvidone) water-ethanol celphere | 5 0～60 1.96～9.8 39.1～195.5 39.1～195.5 39.1～136.8 | Principal agent principal agent adhesive solvent solvent inert carrier | Icing Sugar sucrose crystal grain, |
| Crystallite crystal grain |
Technology:
According to above-mentioned recipe quantity, celphere is put in the fluid bed, by hot-air celphere is suspended, with levo-cetirizine hydrochloride, pseudoephedrine hydrochloride solution (contain PVP, solvent is 50% ethanol), be sprayed onto drying on the celphere, make required fast release micropill.
2. slow release ball core
Prescription:
| Scope (g) | Purposes | Substituting agent | |
| Pseudoephedrine hydrochloride PVP (polyvidone) water-ethanol celphere | 90～240 5.5～27.5 109.8～549 109.8～549 65.9～329.4 | Principal agent adhesive solvent solvent inert carrier | Icing Sugar sucrose crystal grain, crystallite crystal grain etc. |
Technology:
Celphere is put in the fluid bed, celphere is suspended, pseudoephedrine hydrochloride solution (contain PVP, solvent is 50% ethanol) is sprayed onto drying on the celphere, make required slow release ball ball core by hot-air.After making pseudoephedrine hydrochloride ball core, with ethyl cellulose, phthalic acid diethanol, talcous acetone/isopropanol liquid spray coating, drying, get final product slow-release micro-pill.
Slow-release micro-pill and fast release micropill mixed getting final product requiredly the ball mixture, No. 0 capsule of its cover is got final product.
Main hydrochloric LEVO CITRAZINE 5mg of compound oral administration preparation of the present invention and pseudoephedrine hydrochloride 240mg.In order to verify its curative effect, we compare with the mixture (5mg:120mg) (twice on the one) of compound hydrochloric acid levocetirizine and cetirizine hydrochloride and the pseudoephedrine hydrochloride anti-allergic effects to Cavia porcellus allergic rhinitis and allergic asthma animal model.
Select the healthy adult Cavia porcellus, use 2 respectively, and 4-dimethyl TI (2,4-toluenediisocyanate, TDI) setting up Cavia porcellus allergic rhinitis model for sensitizer, is that sensitizer and immunological adjuvant are set up Cavia porcellus allergic bronchial asthma model with ovalbumin and pertussis vaccine.Every kind of animal model is established 5 groups, and medication is respectively: 1. compound hydrochloric acid levocetirizine high dose group (levocetirizine 1.5mg/kg+ pseudoephedrine hydrochloride 15mg/kg); 2. compound hydrochloric acid levocetirizine low dose group (levocetirizine 0.5mg/kg+ pseudoephedrine hydrochloride 5mg/kg); 3. Zyrtec-D 12 Hour high dose group (cetirizine hydrochloride 3mg/kg+ hydrochloric acid pseudo-ephedrine 15mg/kg); 4. Zyrtec-D 12 Hour low dose group (cetirizine hydrochloride 1mg/kg+ hydrochloric acid pseudo-ephedrine 5mg/kg); 5. matched group (give with volume 0.5% carboxymethyl cellulose).Each group is gastric infusion, and every day 2 times, successive administration is 3 days before exciting.
The observation of curative effect of Cavia porcellus allergic rhinitis model is mainly according to sniffle and signs such as rhinocnesmus, sneeze, watery nasal discharges, and integration stack scoring is measured the histamine in nasal mucosa and the blood plasma, the comparable group differences simultaneously.The observation of curative effect of Cavia porcellus allergic asthma model mainly according to uneasy, perpendicular hair, tremble, scratch nose, sneeze, cough, rapid breathing, urinate, discharge feces, shed tears, dyspnea, snore sound, cyanosis, instability of gait, jump, pant, spasm, lie on one's side, 20 symptoms of allergic such as Cheyne-Stokes respiration, death and sign, carry out the sxemiquantitative classification, measure the level of IgE in the blood simultaneously, the comparable group differences.No matter the result is at Cavia porcellus allergic rhinitis model or in Cavia porcellus allergic bronchial asthma model, the anti-allergic effects of compound hydrochloric acid levocetirizine is all suitable with Zyrtec-D 12 Hour with dosage, illustrates that the compound hydrochloric acid levocetirizine is identical with Zyrtec-D 12 Hour for the bronchial curative effect of allergic rhinitis and anaphylaxis.
The specific embodiment
Embodiment 1
The slow release label:
Weight (mg/ sheet)
1. pseudoephedrine hydrochloride 180
2. lactose 18.5
(3.HPMC hypromellose) 80
4. ethyl cellulose 20
5. magnesium stearate 1.5
Technology:
By above-mentioned prescription, the ethanol with 75% is wetting agent, will make the wet granular that is fit to size behind the 1.2.3.4 mix homogeneously, and after the drying, the magnesium stearate of adding 0.5% is a lubricant, at suitable pressure lower sheeting.Obtain the slow release label.
The release layer preparation:
Weight (mg/ sheet)
Pseudoephedrine hydrochloride slow release label 300
Pseudoephedrine hydrochloride 60
Levo-cetirizine hydrochloride 5
Opadry (Opadry) 55.5
Water 802.3
Label is carried out coating according to above-mentioned prescription in coating pan, leaving air temp is controlled at 35-40 ℃, has comprised 60mg pseudoephedrine hydrochloride and 5mg levo-cetirizine hydrochloride to every coating tablets layer.
Further with 5.0% Opadry coating, leaving air temp is controlled at 35 ℃ with the above sheet that contains 5mg levo-cetirizine hydrochloride and 240mg pseudoephedrine hydrochloride.
Embodiment 2
The slow release label:
Weight (mg/ sheet)
1. pseudoephedrine hydrochloride 200
2. lactose 25
(3.HPMC hypromellose) 65
4. magnesium stearate 0.6
Technology:
By above-mentioned prescription, the ethanol with 30% is wetting agent, will make the wet granular that is fit to size behind the 1.2.3 mix homogeneously, and after the drying, the magnesium stearate of adding 0.5% is a lubricant, at suitable pressure lower sheeting.Obtain the slow release label.
The release layer preparation:
Weight (mg/ sheet)
Pseudoephedrine hydrochloride slow release label 290.6
Pseudoephedrine hydrochloride 40
Levo-cetirizine hydrochloride 5
Opadry (Opadry) 27
Water 700
Label is carried out coating according to above-mentioned prescription in coating pan, leaving air temp is controlled at 35-40 ℃, has comprised 40mg pseudoephedrine hydrochloride and 5mg levo-cetirizine hydrochloride to every coating tablets layer.
Further with 5.0% Opadry coating, leaving air temp is controlled at 35 ℃ with the above sheet that contains 5mg levo-cetirizine hydrochloride and 240mg pseudoephedrine hydrochloride.
Embodiment 3
The slow release label:
Weight (mg/ sheet)
1. pseudoephedrine hydrochloride 240
2. lactose 45
(3.HPMC hypromellose) 120
4. ethyl cellulose 45
5. magnesium stearate 12
Technology:
By above-mentioned prescription, the ethanol with 90% is wetting agent, will make the wet granular that is fit to size behind the 1.2.3.4 mix homogeneously, and after the drying, the magnesium stearate of adding 0.5% is a lubricant, at suitable pressure lower sheeting.Obtain the slow release label.
The preparation of release layer:
Weight (mg/ sheet)
Pseudoephedrine hydrochloride slow release label 462
Levo-cetirizine hydrochloride 5
Opadry (Opadry) 75
Water 840
Label is carried out coating according to above-mentioned prescription in coating pan, leaving air temp is controlled at 35-40 ℃, has comprised the 5mg levo-cetirizine hydrochloride to every coating tablets layer.
Further with 5.0% Opadry coating, leaving air temp is controlled at 35 ℃ with the above slice, thin piece that contains 5mg levo-cetirizine hydrochloride and 240mg pseudoephedrine hydrochloride.
Embodiment 4 (children's uses preparation)
The slow release label:
Weight (mg/ sheet)
1. pseudoephedrine hydrochloride 90
2. lactose 17
(3.HPMC hypromellose) 80
4. ethyl cellulose 20
5. magnesium stearate 1.5
Technology:
By above-mentioned prescription, the ethanol with 75% is wetting agent, will make the wet granular that is fit to size behind the 1.2.3.4 mix homogeneously, and after the drying, the magnesium stearate of adding 0.5% is a lubricant, at suitable pressure lower sheeting.Obtain the slow release label.
The preparation of release layer:
Weight (mg/ sheet)
Pseudoephedrine hydrochloride slow release label 208.5
Levo-cetirizine hydrochloride 5
Opadry (Opadry) 75
Water 840
Label is carried out coating according to above-mentioned prescription in coating pan, leaving air temp is controlled at 35-40 ℃, has comprised the 5mg levo-cetirizine hydrochloride to every coating tablets layer.
Further with 5.0% Opadry coating, leaving air temp is controlled at 35 ℃, gets final product to such an extent that children's uses preparation with the above sheet that contains 5mg levo-cetirizine hydrochloride and 90mg pseudoephedrine hydrochloride.
Embodiment 5
Fast release micropill
Weight (g)
Levo-cetirizine hydrochloride 5
Pseudoephedrine hydrochloride 60
PVP (polyvidone) 6
Water 120
Ethanol 120
Celphere 80
Slow release ball core
Weight (g)
Pseudoephedrine hydrochloride 180
PVP 18
Water 360
Ethanol 360
Celphere 180
Embodiment 6
Fast release micropill weight (g)
Levo-cetirizine hydrochloride 5
Pseudoephedrine hydrochloride 40
PVP (polyvidone) 1.96
Water 39.1
Ethanol 50.0
Celphere 39.1
Slow release ball core
Weight (g)
Pseudoephedrine hydrochloride 200
PVP 5.5
Water 109.8
Ethanol 150
Celphere 66.0
Embodiment 7
Fast release micropill
Weight (g)
Levo-cetirizine hydrochloride 5
PVP (polyvidone) 9.8
Water 100
Ethanol 100
Celphere 135
Slow release ball core
Weight (g)
Pseudoephedrine hydrochloride 240
PVP 27.5
Water 549
Ethanol 300
Celphere 329
Embodiment 8 (children's uses preparation)
Fast release micropill
Weight (g)
Levo-cetirizine hydrochloride 5
PVP (polyvidone) 8.8
Water 110
Ethanol 100
Celphere 135
Slow release ball core
Weight (g)
Pseudoephedrine hydrochloride 90
PVP 22.5
Water 400
Ethanol 300
Celphere 229
According to above-mentioned compound oral administration preparation of giving an example, the compound recipe LEVO CITRAZINE that my company developed.
Claims (2)
1. the preparation method of a levocetirizine pseudoephedrine compound oral tablet is characterized in that this method is:
(1) slow release label preparation
Prescription scope mg/ sheet
Pseudoephedrine hydrochloride 90～240
Lactose 15～45
Hypromellose 45～120
Ethyl cellulose 0～45
Magnesium stearate 0.6～12 wherein, pseudoephedrine hydrochloride is a principal agent, lactose is a diluent, hydroxypropyl emthylcellulose is a framework material, ethyl cellulose is a blocker, magnesium stearate is a lubricant;
In addition, diluent also can be replaced by microcrystalline Cellulose or pregelatinized Starch, framework material also can be by sodium alginate or chitin or carbomer or polyvinyl alcohol replacement, blocker also can be by glyceryl monostearate or stearic acid or Brazil wax replacement, and lubricant also can be replaced by calcium stearate or Pulvis Talci;
Technology:
By above-mentioned prescription, be wetting agent with the ethanol of 30-90%, will make the wet granular that is fit to size behind principal agent, diluent, framework material and the blocker mix homogeneously, after the drying, add lubricant, tabletting obtains the slow release label;
(2) release layer preparation
Prescription scope mg/ sheet
Pseudoephedrine hydrochloride slow release label 150.6～462
Pseudoephedrine hydrochloride 0～60
Levo-cetirizine hydrochloride 5
Opadry 27～75
Water or ethanol 700～840 wherein, pseudoephedrine hydrochloride slow release label and pseudoephedrine hydrochloride and levo-cetirizine hydrochloride are principal agent, Opadry is a coating powder, water or ethanol are solvent;
Technology:
Label is carried out coating according to above-mentioned prescription in coating pan, leaving air temp is controlled at 35-40 ℃, has comprised the pseudoephedrine hydrochloride and the 5mg levo-cetirizine hydrochloride of respective amount in every coating tablets layer;
(3) last coating
Further with 5.0% Opadry coating, leaving air temp is controlled at 35 ℃ with the above sheet that contains 5mg levo-cetirizine hydrochloride and 90～240mg pseudoephedrine hydrochloride.
2. the preparation method of levocetirizine pseudoephedrine compound oral capsule agent is characterized in that this method is:
(1) fast release micropill preparation
Prescription:
Scope g
Levo-cetirizine hydrochloride 5
Pseudoephedrine hydrochloride 0～60
Polyvidone 1.96～9.8
Water 39.1～195.5
Ethanol 39.1～195.5
Celphere 39.1～136.8 wherein, levo-cetirizine hydrochloride and pseudoephedrine hydrochloride are principal agent, polyvidone is a binding agent, water and ethanol are solvent, celphere is an inert carrier;
In addition, binding agent also can be replaced by Icing Sugar;
Technology:
Recipe quantity is put celphere in the fluid bed, by hot-air celphere is suspended, and principal agent and binding agent are dissolved in 50% alcohol solvent, is sprayed onto drying on the celphere, makes required fast release micropill;
(2) slow release ball core
Prescription:
g
Pseudoephedrine hydrochloride 90～240
Polyvidone 5.5～27.5
Water 109.8～549
Ethanol 109.8～549
Celphere 65.9～329.4
Wherein, pseudoephedrine hydrochloride is a principal agent, and polyvidone is a binding agent, and water and ethanol are solvent, and celphere is an inert carrier;
In addition, binding agent also can be replaced by Icing Sugar;
Technology:
Celphere is put in the fluid bed, by hot-air celphere is suspended, pseudoephedrine hydrochloride and binding agent are dissolved in 50% alcohol solvent, be sprayed onto on the celphere dry, make required slow release ball ball core, make pseudoephedrine hydrochloride ball core after, with ethyl cellulose and phthalic acid diethanol and talcous acetone/isopropanol liquid spray coating, drying, get final product slow-release micro-pill;
(3) cover glue capsule
Fast release micropill that above-mentioned steps (1), (2) are made and slow release ball core are filled to Capsules and make capsule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02145454 CN1265793C (en) | 2002-11-18 | 2002-11-18 | Oral compound levocetirizine pseudoephedrine formulation and its preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02145454 CN1265793C (en) | 2002-11-18 | 2002-11-18 | Oral compound levocetirizine pseudoephedrine formulation and its preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1500487A CN1500487A (en) | 2004-06-02 |
| CN1265793C true CN1265793C (en) | 2006-07-26 |
Family
ID=34232452
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 02145454 Expired - Lifetime CN1265793C (en) | 2002-11-18 | 2002-11-18 | Oral compound levocetirizine pseudoephedrine formulation and its preparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1265793C (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1706385B (en) * | 2004-06-04 | 2011-10-19 | 杭州民生药业有限公司 | New composition for treating seasonal and perennial allergic rhinitis |
| CN101073563B (en) * | 2007-02-07 | 2010-10-06 | 西安利君制药有限责任公司 | Chiral composition containing dextrothyroxine buprofenli and levomethadyl cysteliqin and its double slow-releasing tablet |
| KR101193495B1 (en) * | 2010-02-01 | 2012-10-23 | 한미사이언스 주식회사 | Oral complex composition comprising pseudoephedrine and levocetirizine |
| CN102319224B (en) * | 2011-07-27 | 2013-03-20 | 赛乐医药科技(上海)有限公司 | Compound methoxyphenamine rapid-release slow-release osmotic pump preparation |
| JO3479B1 (en) * | 2012-09-06 | 2020-07-05 | Bayer Healthcare Llc | Coated Pharmaceutical Composition containing Regorafenib |
| CN104161807A (en) * | 2013-05-20 | 2014-11-26 | 陕西雪龙海姆普德药业股份有限公司 | Preparation method for medicine used for treating acute and chronic nasosinusitis and rhinitis |
| CN104490880A (en) * | 2014-11-21 | 2015-04-08 | 哈尔滨圣吉药业股份有限公司 | Cetirizine hydrochloride pseudo ephedrine sustained-release pellet and preparation method thereof |
-
2002
- 2002-11-18 CN CN 02145454 patent/CN1265793C/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| CN1500487A (en) | 2004-06-02 |
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Owner name: BEIJING SHUGUANG PHARMACEUTICAL LLC Free format text: FORMER OWNER: HANGZHOU RONGLI MEDICINE SCIENCE +. TECHNOLOGY CO., LTD. Effective date: 20150812 |
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Effective date of registration: 20150812 Address after: 100062 Beijing city Dongcheng District Xiyuan sub Lane No. 7 Building 1 Patentee after: Beijing Shuguang Pharmaceutical Co.,Ltd. Address before: 310012 hi tech building, No. 212, Wen two road, Zhejiang, Hangzhou Patentee before: Hangzhou Rongli Pharmaceutical Technology Co.,Ltd. |
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Granted publication date: 20060726 |