CN101461811A - Loratadine orally disintegrating tablet and technique for preparing the same - Google Patents
Loratadine orally disintegrating tablet and technique for preparing the same Download PDFInfo
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- CN101461811A CN101461811A CN 200710179835 CN200710179835A CN101461811A CN 101461811 A CN101461811 A CN 101461811A CN 200710179835 CN200710179835 CN 200710179835 CN 200710179835 A CN200710179835 A CN 200710179835A CN 101461811 A CN101461811 A CN 101461811A
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Abstract
The invention relates to a loratadine orally disintegrating tablet consisting of a special preparation and a preparation method thereof. The loratadine orally disintegrating tablet contains pharmaceutical excipients such as a disintegrant, a filling agent, an adhesive, a flavoring agent, a sweetening agent, a lubricating agent and so on, and can be used for the treatment of anaphylactic diseases.
Description
Technical field
The present invention relates to proportional loratadine combination of oral medication of a kind of particular group and preparation method thereof, especially oral loratadine disintegrating tablet and preparation method thereof.
Background technology
Loratadine is a kind of after listing in 1988, now go on the market in most countries, it is 2,300,000,000 dollars that 1988 annual sales amounts are sold with nonprescription drugs by 15 countries, estimates will reach 10,000,000,000 dollars in 2007, and the large-scale production loratadine has good society and economic benefit.
Along with the prolongation of human average life and the decline of age growth swallow, the oral tablet administering mode becomes the problem that people pay close attention to.According to estimates, there is 50% people that swallow tablet and capsule are had any problem approximately and influenced the compliance of medicine.In addition, the conventional tablet of loratadine and capsule disintegrate under one's belt could begin to discharge medicine, and onset is slow, and taking needs water delivery service, and be very inconvenient.Though the liquid preparation convenient oral is rapid-action, need when taking certain limit the quantity of and carry vessel, it is very inconvenient to carry.And oral loratadine disintegrating tablet need not water and swallowing act just can disperse disintegrate rapidly in saliva of buccal cavity, after the oral loratadine disintegrating tablet disintegrate, be dispersed into trickle granule, absorption point through oral cavity and the absorption of intraesophageal mucosa is many, when bioavailability improves, also reduced medicine to the gastrointestinal local excitation, and the side effect that first pass metabolism causes can alleviate also.Be particularly useful for the patient of old man, child, dysphagia and the constant person that fetches water takes.
As seen, oral loratadine disintegrating tablet has the advantage that clearly gets than other preparation of loratadine.
Yet in the preparation of oral loratadine disintegrating tablet, the selection of its disintegrating agent, filler, binding agent and consumption proportion all have a significant impact dissolution, content and the mouthfeel etc. of oral cavity disintegration tablet, also are the key points of preparation oral loratadine disintegrating tablet.
So the present invention is intended to prepare a kind of preparation with specific composition and preparation method thereof according to the demand of human body medication.
Summary of the invention
Oral loratadine disintegrating tablet comprises active constituents of medicine loratadine and excipient, it is characterized in that described excipient comprises disintegrating agent, filler, binding agent, correctives, sweeting agent, a kind of and/or several mixture of lubricant.
Oral loratadine disintegrating tablet, the active constituents of medicine loratadine accounts for the 5%-30% of percentage by weight; Excipient accounts for the 70%-95% of percentage by weight.
The kind consumption of disintegrating agent is most important for disintegrate, the result of extraction of oral cavity disintegration tablet, is the overriding concern factor.Disintegrating agent can be selected from, a kind of and/or several mixture in the microcrystalline Cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, sodium carboxymethyl cellulose, carboxymethylcellulose calcium, carboxymethyl starch sodium; Disintegrating agent accounts for the 3%-45% (best proportion 5%-25%) of percentage by weight.
Filler is as the maximum composition of consumption in the prescription, and its selection not only produces bigger influence to the disintegrate and the stripping meeting of medicine, and also can produce a very large impact tabletting quality and mouthfeel.Therefore should select that good water solubility, hygroscopicity are poor, the filler of good fluidity for use, can select a kind of and/or several mixture in mannitol, lactose, sorbitol, xylitol, maltose alcohol, erythritol, the pregelatinized Starch through the verification experimental verification filler; Percentage by weight is 10%-85% (best proportion 50%-80%), not only can play good filling effect, and disintegrate, result of extraction are good, good fluidity, and sheet is heavy during tabletting, hardness is stable, oral no grittiness, mouthfeel is good.
Binding agent can be selected from a kind of and/or several mixture in starch slurry, ethyl cellulose, polyvidone, syrup, sodium carboxymethyl cellulose, gelatin, the Polyethylene Glycol; The 1%-10% of binder constitutes percentage by weight (best proportion 2%-8%).
The selection of other adjuvant: correctives can be selected from a kind of and/or several mixture in Herba Menthae, Fructus Citri tangerinae, Fructus Vitis viniferae, Fructus Musae, Fructus Mali pumilae, Rhizoma et radix valerianae, Fructus Citri Limoniae, Fructus Ananadis comosi, Fructus Pruni pseudocerasi, blue berry, the honey peach essence; Correctives accounts for the 0.1%-1.5% of percentage by weight.Sweeting agent can be selected from a kind of and/or several mixture in aspartame, sucrose, saccharin sodium, the stevioside; Sweeting agent accounts for the 1%-20% of percentage by weight.Lubricant can be selected from a kind of and/or several mixture in magnesium stearate, calcium stearate, micropowder silica gel, the Pulvis Talci; Lubricant accounts for the 0.5%-5% of percentage by weight.
Through a large amount of experimental studies, finally determine a kind of loratadine oral disintegrating tablet Ideal Match, comprise loratadine and adjuvant thereof.Adjuvant comprises disintegrating agent, filler, binding agent, correctives, sweeting agent, lubricant.
The more excellent ratio of each component is in the prescription: loratadine 5%-30%; Disintegrating agent 3%-45%; Filler 10%-85%; Binding agent 1%-10%; Correctives 0.1%-15%; Sweeting agent 1%-20%; Lubricant 0.5%-5%.
The ratio of the optimum of each component is in the prescription: loratadine 5%-15%; Disintegrating agent 5%-25%; Filler 50%-80%; Binding agent 2%-8%; Correctives 0.1%-15%; Sweeting agent 1%-20%; Lubricant 0.5%-5%.
Optimum prescription is formed:: loratadine 6.7%; Mannitol 53.5%; Starch 23.3%; Ethyl cellulose 5%; Low-substituted hydroxypropyl cellulose 8%; Aspartame 1%; Mentholum 0.5%; Magnesium stearate 2%.
The preparation technology of oral loratadine disintegrating tablet: the prescription with optimum is that example (1) loratadine was pulverized 100 mesh sieves; (2) mannitol, starch, low-substituted hydroxypropyl cellulose are crossed 80 mesh sieves respectively: (3) Mentholum, ethyl cellulose, aspartame, magnesium stearate are crossed 60 mesh sieves respectively, and be standby; (4) with loratadine, ethyl cellulose, starch, the mannitol of recipe quantity, place quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases; (5) open stirring, add water and granulate; (6) 40 ℃ of-60 ℃ of aeration-dryings, 30 order granulate; (7) will write out a prescription aspartame, Mentholum, the low-substituted hydroxypropyl cellulose of ratio are with high efficient mixed machine and granule mix homogeneously; (8) take by weighing the magnesium stearate of recipe quantity, with high efficient mixed machine and above-mentioned granule mix homogeneously; (9) measure drug content in the granule, determine that its theoretical sheet is heavy; (10) with the stamping of 7mm scrobicula; (11) inspection of semifinished product is packed after qualified.
The sample of above-mentioned prescription is carried out mouthfeel, disintegration, content and dissolution to be measured.The result is as follows:
The disintegrating agent consumption with relation disintegration:
Prepare loratadine oral disintegrating tablet in optimum prescription ratio, only change disintegrating agent consumption in the prescription.
Grope to making disintegration and tabletting quality reach good unification through a large amount of tests, determine that finally the disintegrating agent consumption is 3%-45% (best proportion 5%-25%).
Binder dosage and dissolution and friability relation:
Prepare loratadine oral disintegrating tablet in optimum prescription ratio, only change binder dosage in the prescription.
When the binder constitutes percentage by weight is 1%-10%, dissolution be more than 90.0% and friability good; When the binder constitutes percentage by weight is 2%-8%, dissolution be more than 95.0% and friability good.So binder dosage is 1%-10% (best proportion 2%-8%).
The specific embodiment:
Below in conjunction with embodiment the present invention is further described, but the present invention is not limited by embodiment.
Embodiment 1:
Comparative example 1 (binder dosage transfinites):
Comparative example 2 (the disintegrating agent consumption transfinites):
Preparation technology
(1) loratadine was pulverized 100 mesh sieves;
(2) mannitol, starch, low-substituted hydroxypropyl cellulose are crossed 80 mesh sieves respectively:
(3) Mentholum, ethyl cellulose, aspartame, magnesium stearate are crossed 60 mesh sieves respectively, and be standby;
(4) with loratadine, ethyl cellulose, starch, the mannitol of recipe quantity, place quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases;
(5) open stirring, add water and granulate;
(6) 40 ℃ of-60 ℃ of aeration-dryings, 30 order granulate;
(7) will write out a prescription aspartame, Mentholum, the low-substituted hydroxypropyl cellulose of ratio are with high efficient mixed machine and granule mix homogeneously;
(8) take by weighing the magnesium stearate of recipe quantity, with high efficient mixed machine and above-mentioned granule mix homogeneously;
(9) measure drug content in the granule, determine that its theoretical sheet is heavy;
(10) with the stamping of 7mm scrobicula;
(11) inspection of semifinished product is packed after qualified.
Analyzing and testing
Embodiment 1, comparative example 1, comparative example's 2 sample is carried out drowsiness property, mouthfeel, disintegration, content, dissolution measure, the result is as follows:
Embodiment 2:
Preparation technology
(1) loratadine was pulverized 100 mesh sieves;
(2) xylitol, starch, cross-linking sodium carboxymethyl cellulose are crossed 80 mesh sieves respectively:
(3) flavoring orange essence, ethyl cellulose, sucrose, magnesium stearate are crossed 60 mesh sieves respectively, and be standby;
(4) with loratadine, ethyl cellulose, starch, the xylitol of recipe quantity, place quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases;
(5) open stirring, add water and granulate;
(6) 40 ℃ of-60 ℃ of aeration-dryings, 30 order granulate;
(7) will write out a prescription sucrose, flavoring orange essence, the cross-linking sodium carboxymethyl cellulose of ratio are with high efficient mixed machine and granule mix homogeneously;
(8) take by weighing the magnesium stearate of recipe quantity, with high efficient mixed machine and above-mentioned granule mix homogeneously;
(9) measure drug content in the granule, determine that its theoretical sheet is heavy;
(10) with the stamping of 7mm scrobicula;
(11) inspection of semifinished product is packed after qualified.
Analyzing and testing
The sample of above-mentioned prescription is carried out drowsiness property, mouthfeel, disintegration, content, dissolution measure, the result is as follows:
Embodiment 3:
Preparation technology
(1) loratadine was pulverized 100 mesh sieves;
(2) sorbitol, starch, polyvinylpolypyrrolidone are crossed 80 mesh sieves respectively:
(3) 60 mesh sieves are crossed in grape essence, ethyl cellulose, stevioside, micropowder silica gel respectively, and are standby;
(4) with loratadine, ethyl cellulose, starch, the sorbitol of recipe quantity, place quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases;
(5) open stirring, add water and granulate;
(6) 40 ℃ of-60 ℃ of aeration-dryings, 30 order granulate;
(7) will write out a prescription stevioside, grape essence, the polyvinylpolypyrrolidone of ratio are with high efficient mixed machine and granule mix homogeneously;
(8) take by weighing the micropowder silica gel of recipe quantity, with high efficient mixed machine and above-mentioned granule mix homogeneously;
(9) measure drug content in the granule, determine that its theoretical sheet is heavy;
(10) with the stamping of 7mm scrobicula;
(11) inspection of semifinished product is packed after qualified.
Analyzing and testing
The sample of above-mentioned prescription is carried out drowsiness property, mouthfeel, disintegration, content, dissolution measure, the result is as follows:
Embodiment 4:
Preparation technology
(1) loratadine was pulverized 100 mesh sieves;
(2) maltose alcohol, lactose, microcrystalline Cellulose are crossed 80 mesh sieves respectively:
(3) apple essence, polyvidone, saccharin sodium, calcium stearate are crossed 60 mesh sieves respectively, and be standby;
(4) with loratadine, polyvidone, lactose, the maltose alcohol of recipe quantity, place quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases;
(5) open stirring, add water and granulate;
(6) 40 ℃ of-60 ℃ of aeration-dryings, 30 order granulate;
(7) will write out a prescription saccharin sodium, apple essence, the microcrystalline Cellulose of ratio are with high efficient mixed machine and granule mix homogeneously;
(8) take by weighing the calcium stearate of recipe quantity, with high efficient mixed machine and above-mentioned granule mix homogeneously;
(9) measure drug content in the granule, determine that its theoretical sheet is heavy;
(10) with the stamping of 7mm scrobicula;
(11) inspection of semifinished product is packed after qualified.
Analyzing and testing
The sample of above-mentioned prescription is carried out drowsiness property, mouthfeel, disintegration, content, dissolution measure, the result is as follows:
Claims (10)
1, a kind of oral cavity disintegration tablet that contains loratadine, its composition comprises active constituents of medicine loratadine and excipient, described excipient is selected from one or more mixture of disintegrating agent, filler, binding agent, correctives, sweeting agent, lubricant.
2, the described oral loratadine disintegrating tablet of claim 1 is characterized in that loratadine accounts for percentage by weight for being 5%-15%.
3, the described oral loratadine disintegrating tablet of claim 1 is characterized in that disintegrating agent is selected from one or more the mixture in low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, sodium carboxymethyl cellulose, carboxymethylcellulose calcium, the carboxymethyl starch sodium; It is 5%-25% that disintegrating agent accounts for percentage by weight.
4, the described oral loratadine disintegrating tablet of claim 1 is characterized in that filler is selected from one or more the mixture in lactose, pregelatinized Starch, mannitol, sorbitol, xylitol, maltose alcohol, the erythritol; It is 50%-80% that filler accounts for percentage by weight.
5, the described oral loratadine disintegrating tablet of claim 1 is characterized in that binding agent is selected from one or more the mixture in starch slurry, ethyl cellulose, syrup, sodium carboxymethyl cellulose, polyvidone, gelatin, the Polyethylene Glycol; The binder constitutes percentage by weight is 2%-8%.
6, the described oral loratadine disintegrating tablet of claim 1 is characterized in that correctives is selected from one or more the mixture in Herba Menthae, Fructus Citri tangerinae, Fructus Vitis viniferae, Fructus Musae, Fructus Mali pumilae, Rhizoma et radix valerianae, Fructus Citri Limoniae, Fructus Ananadis comosi, Fructus Pruni pseudocerasi, blue berry, the honey peach essence; Correctives accounts for the 0.1%-1.5% of percentage by weight.
7, the described oral loratadine disintegrating tablet of claim 1 is characterized in that sweeting agent is selected from one or more the mixture in aspartame, sucrose, saccharin sodium, the stevioside; Sweeting agent accounts for the 1%-20% of percentage by weight.
8, the described oral loratadine disintegrating tablet of claim 1 is characterized in that lubricant is selected from one or more the mixture in micropowder silica gel, Pulvis Talci, the magnesium stearate; Lubricant accounts for the 0.5%-5% of percentage by weight.
9, the described oral loratadine disintegrating tablet of claim 1 is characterized in that being made up of loratadine 6.7%, mannitol 53.5%, starch 23.3%, ethyl cellulose 5%, low-substituted hydroxypropyl cellulose 8%, aspartame 1%, Mentholum 0.5% and magnesium stearate 2%.
10, the preparation method of the described oral loratadine disintegrating tablet of claim 9, it is characterized in that with loratadine pulverized 100 mesh sieves, mannitol is crossed 80 mesh sieves: Mentholum, ethyl cellulose, aspartame, magnesium stearate are crossed 60 mesh sieves respectively, and be standby; Loratadine, ethyl cellulose, starch, mannitol with recipe quantity place quick mixer granulator, by the equivalent principle mix homogeneously that progressively increases; Open and stir, add water and granulate; 40 ℃ of-60 ℃ of aeration-dryings, 30 order granulate; With aspartame, Mentholum, the low-substituted hydroxypropyl cellulose of prescription ratio, with high efficient mixed machine and granule mix homogeneously; Take by weighing the magnesium stearate of recipe quantity, with high efficient mixed machine and above-mentioned granule mix homogeneously; Measure drug content in the granule, determine that its theoretical sheet is heavy; With the stamping of 7mm scrobicula; Pack after the inspection of semifinished product is qualified.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200710179835 CN101461811A (en) | 2007-12-19 | 2007-12-19 | Loratadine orally disintegrating tablet and technique for preparing the same |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200710179835 CN101461811A (en) | 2007-12-19 | 2007-12-19 | Loratadine orally disintegrating tablet and technique for preparing the same |
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| CN101461811A true CN101461811A (en) | 2009-06-24 |
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| CN 200710179835 Pending CN101461811A (en) | 2007-12-19 | 2007-12-19 | Loratadine orally disintegrating tablet and technique for preparing the same |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102614178A (en) * | 2012-03-09 | 2012-08-01 | 重庆康刻尔制药有限公司 | Loratadine combination drug orally disintegrating tablet and application thereof |
| CN104825411A (en) * | 2015-06-08 | 2015-08-12 | 孙莉新 | Levofloxacin mesylate orally disintegrating tablet and preparation method thereof |
| CN107648191A (en) * | 2017-09-27 | 2018-02-02 | 扬子江药业集团上海海尼药业有限公司 | A kind of loratadine tablet and its preparation technology |
| CN108926542A (en) * | 2017-05-26 | 2018-12-04 | 万特制药(海南)有限公司 | Loratadine tablet of Fast Stripping and preparation method thereof |
| CN112043676A (en) * | 2020-10-21 | 2020-12-08 | 广东食品药品职业学院 | 3D printing loratadine orally disintegrating tablet and raw material composition and preparation method thereof |
-
2007
- 2007-12-19 CN CN 200710179835 patent/CN101461811A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102614178A (en) * | 2012-03-09 | 2012-08-01 | 重庆康刻尔制药有限公司 | Loratadine combination drug orally disintegrating tablet and application thereof |
| CN104825411A (en) * | 2015-06-08 | 2015-08-12 | 孙莉新 | Levofloxacin mesylate orally disintegrating tablet and preparation method thereof |
| CN108926542A (en) * | 2017-05-26 | 2018-12-04 | 万特制药(海南)有限公司 | Loratadine tablet of Fast Stripping and preparation method thereof |
| CN107648191A (en) * | 2017-09-27 | 2018-02-02 | 扬子江药业集团上海海尼药业有限公司 | A kind of loratadine tablet and its preparation technology |
| CN107648191B (en) * | 2017-09-27 | 2018-08-17 | 扬子江药业集团上海海尼药业有限公司 | A kind of loratadine tablet and its preparation process |
| CN112043676A (en) * | 2020-10-21 | 2020-12-08 | 广东食品药品职业学院 | 3D printing loratadine orally disintegrating tablet and raw material composition and preparation method thereof |
| CN112043676B (en) * | 2020-10-21 | 2022-07-12 | 广东食品药品职业学院 | 3D printing loratadine orally disintegrating tablet and raw material composition and preparation method thereof |
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