CN1682739A - Cefadroxil dry suspension and preparing method - Google Patents
Cefadroxil dry suspension and preparing method Download PDFInfo
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- CN1682739A CN1682739A CN 200510012375 CN200510012375A CN1682739A CN 1682739 A CN1682739 A CN 1682739A CN 200510012375 CN200510012375 CN 200510012375 CN 200510012375 A CN200510012375 A CN 200510012375A CN 1682739 A CN1682739 A CN 1682739A
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- cefadroxil
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- soluble filler
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Abstract
The present invention relates to dry cefadroxil suspension and its preparation process, belongs to the field of medicine technology, and is for raising the water solubility and bioavailability of cefadroxil. The dry cefadroxil suspension consists of cefadroxil and supplementary material comprising including agent, water soluble stuffing, distintegrating agent, suspension assistant and adhesive. The dry cefadroxil suspension has the features of high medicine solubility, high medicine bioavailability, high chemical stability, good taste, convenient taking, high patient's compliance, full absorption in gastrointestinal tract, less irritation to gastrointestinal tract of medicine, etc.
Description
Technical field
The present invention relates to a kind of antibiotics oral formulations and preparation method thereof, belong to medical technical field.
Background technology
Cefadroxil is a first generation oral cephalosporin, is broad-spectrum antibiotic.Golden Portugal bacterium and various streptococcus and anaerobic cocci all there are the height antibacterial activity, also very strong to some enterobacteria effect.Its bactericidal action mechanism is to realize by the formation that suppresses bacteria cell wall.This product low toxicity absorbs well, and antibacterial action is lasting, long action time.Be mainly used in treatment respiratory tract infection, urogenital infections, skin soft-tissue infection, digestive tract infection etc., evident in efficacy, untoward reaction is few and light, how to be reflected as the master with gastrointestinal.Cefadroxil is used very extensive at home and abroad, in a plurality of state approval listings.At present cefadroxil preparation has dosage forms such as tablet, dispersible tablet, capsule, granule, and on dosage form, the no disintegrating procedue in the oral back of granule dosage form has bigger specific surface area after decomposing rapidly, so the stripping of medicine, absorbs and prove effective comparatively fast.But because cefadroxil has a kind of special odor beastly, because of the former of abnormal smells from the patient thereby make the patient take certain difficulty, especially child and old man's compliance are poorer when making granule and brewing.The easy moisture absorption of cefadroxil granule simultaneously, less stable, water insoluble, therefore make granule, in passes during brewing, there are loss content, shortcoming that bioavailability is lower.And tablet, capsule formulation need disintegrating procedue after taking, and drug effect is proved effective slowly.In sum, the existing dosage form of cefadroxil can not meet clinical needs, and is badly in need of the more advanced dosage form of exploitation.
Summary of the invention
The objective of the invention is to restrain the problem that the existing preparation of eye exists and provide that a kind of good stability, mouthfeel are good, the cefadroxil dry suspension of water solublity and bioavailability height, taking convenience and preparation method thereof.
The object of the present invention is achieved like this:
A kind of cefadroxil dry suspension, it comprises principal agent cefadroxil and adjuvant, each main materials and auxiliary materials unit is by weight counted:
Cefadroxil 80-120
Inclusion agents 16-60
Water-soluble filler 440-520
Disintegrating agent 55-70
Suspending agent 5-10
Binding agent 30-45
Described inclusion agents is selected from a kind of or its combination in cyclodextrin, beta-schardinger dextrin-, the hydroxypropyl; Described water-soluble filler selects for use sorbitol, sucrose, mannitol or other to be beneficial to one or more combination of the material of moisture penetration in the pharmaceutical preparation; Described disintegrating agent is selected in carboxymethylstach sodium, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone or the crosslinked carboxymethylstach sodium one or more mixture for use; Described suspending agent is selected one or both natural gum combinations in polyvinylpyrrolidone, xanthan gum, the Resina persicae for use; Described binding agent is selected ethanol or polyvinylpyrrolidone alcoholic solution for use.
Above-mentioned cefadroxil dry suspension, described main and auxiliary the medicine optimization formula of unit meter by weight are:
Cefadroxil 90-110
Inclusion agents 20-50
Water-soluble filler 450-500
Disintegrating agent 58-68
Suspending agent 6-9
Binding agent 35-40
Wherein, the compositions of water-soluble filler preferably sucrose, mannitol; The preferred carboxymethylstach sodium of disintegrating agent; The preferred xanthan gum of suspending agent; Preferred 60% ethanol of binding agent.
Above-mentioned cefadroxil dry suspension, the correctives of adding 5-5.3 unit of weight in the described accessory drugs, described correctives is selected the compositions of one or more flavorants or edible glucin for use.
Above-mentioned cefadroxil dry suspension, the coloring agent of adding 0.2-0.3 unit of weight in the described accessory drugs, coloring agent is selected the compositions of one or more its food colorings for use.
The preparation method of above-mentioned cefadroxil dry suspension, it carries out as follows:
A. prepare clathrate: cefadroxil, inclusion agents in the above-mentioned prescription are added water grind, vacuum drying is crossed 120 mesh sieves;
B. major-minor medicine mixes: water-soluble filler, disintegrating agent, suspending agent in the above-mentioned prescription are crossed 100 mesh sieves respectively, clathrate, water-soluble filler, disintegrating agent, the suspending agent of preparation are pressed recipe quantity mix, stir;
C. add correctives, coloring agent: get the recipe quantity correctives, coloring agent is put in the ethanol and dissolved, stir and add in the above-mentioned main ingredient that mixes, make soft material;
D. granulate, pack: 20 mesh sieves are granulated, 55-60 ℃ of oven dry, 18 mesh sieve granulate, dress compound membrane bag or bottle.
The cefadroxil dry suspension that utilizes the present invention to make, because of in adjuvant, adding inclusion agents, make itself and principal agent form clathrate, utilize the distinctive advantage of clathrate, improve dissolubility, bioavailability and the chemical stability of medicine effectively, under the synergism of suspending agent and correctives, can also cover up the bad smell of cefadroxil simultaneously well.The present invention and plain particles preparation compare, and it is good to have mouthfeel, taking convenience, and patient's compliance is strong, especially is more suitable for characteristics such as child and old man take.In addition, the present invention makes the dry suspension type, can be in gastrointestinal tract extensively distributes, and absorption point increases, and absorbs more fully, but also has reduced medicine to the gastrointestinal local excitation.
The present invention has good stable, and its test result is as follows:
(1) influence factor's test:
| Condition | Time (my god) | Character | The settling volume ratio | Related substance | Content (%) |
| Illumination | ????0 ????5 ????10 | The faint yellow granule of the faint yellow granule of faint yellow granule | ????0.99 ????0.98 ????0.99 | Qualified qualified | ????100.02 ????99.76 ????99.47 |
| 60 ℃ of high temperature | ????5 ????10 | The faint yellow granule of faint yellow granule | ????0.99 ????0.99 | Qualified | ????99.58 ????99.38 |
(2) under the high humidity situation with the comparison of granule stability
| Dosage form | Condition | Time (my god) | Character | The settling volume ratio | Related substance | Content (%) |
| Dried suspendible | High humidity RH75% | 5 10 | The faint yellow granule of faint yellow granule | ?0.99 ?0.99 | Qualified | 99.69 99.57 |
| Granule | High humidity RH92.5 % | 5 10 | Faint yellow granule, adhesion is arranged, be lumps, one touches the yellow particle of promptly leading an idle life, adhesion is arranged, be lumps, one touches promptly and to loose | ?0.98 ?0.99 | Qualified | 99.63 99.52 |
More than two result of experiment show that this product was high temperature 5 days, 10 days, following 5 days of illumination condition and 10 days outward appearances obviously do not change, high humidity 5 days, 10 days, the tester granule has adhesion, is lumps, one touches promptly and looses, and illustrates that granule more easily absorbs water less stable.
The specific embodiment
The inclusion agents that the present invention adds in adjuvant is called as molecular capsule, and it can contain various active component and give its new physicochemical property on molecular level.Cefadroxil is made and is had poorly water-soluble, bioavailability is low, gastrointestinal irritation is big, bad smell is big defective behind the dried suspendible, and after adopting inclusion agents of the present invention, just the problems referred to above have been solved, thereby can increase water solublity, increase bioavailability, improve stability, abirritate, and can cover up the bad smell in the composition better.
According to the formulation characteristic of dry suspension, the selection of suspending agent is most important, if select improperly, can produce lamination in passes during brewing, so we screens to suspending agent.
According to the Chinese Pharmacopoeia relevant requirements, be main detection index with the settling volume ratio, (get test sample 50ml according to the detection method that state-promulgated pharmacopoeia provides with the plug graduated cylinder, firmly jolting is 1 minute, write down the beginning height H 0 of suspended matter, left standstill 3 hours, write down the final height H of suspended matter, by formula " settling volume ratio=H/H0 " calculates) suspending agent is screened, the result is as follows:
Suspending agent kind and consumption option table
| Prescription | 1 | ?2 | ?3 | ?4 |
| Cefadroxil | 1.25g | ?1.25g | 1.25g | ?1.25g |
| Xanthan gum | ------- | ------- | 120mg | 100mg |
| Sodium carboxymethyl cellulose | 600mg | ------- | ------- | ------- |
| Polyvinylpyrrolidone | ------- | 5g | ------- | ------- |
| Amount of water | 50ml | 50ml | 50ml | 50ml |
| Outward appearance and mouthfeel | Be gelatin during cooling, outward appearance is relatively poor, except that main, there is not other poor taste | Mouthfeel is relatively poor, and disagreeable taste is arranged | Tasteless than thickness | Viscosity is better, except that principal agent, does not have other poor taste |
| The settling volume ratio | 0.91 | 0.80 | 1.00 | 0.99 |
Xanthan gum is best suspending agent as can be seen from the above table, and dosage selects for use the content of prescription 4 to be advisable.
Several embodiment below are provided.
Embodiment 1:
Composition weight
Principal agent cefadroxil 100g
Inclusion agents cyclodextrin 48g
Water-soluble filler sucrose 240g
Mannitol 240g
Disintegrator carboxymethylstarch sodium 64g
Suspending agent xanthan gum 8g
Correctives saccharin sodium 0.32g
Flavoring pineapple essence 4.8g
Coloring agent Gardenia Yellow 0.24g
Binding agent 60% ethanol 40ml
With the efficient grinding fast of cefadroxil, beta-schardinger dextrin-and water 1 hour, 40 ℃ of dryings of vacuum were pulverized, and cross 120 mesh sieves; Water-soluble filler, disintegrating agent, suspending agent are crossed 100 mesh sieves respectively, and be standby.By recipe quantity take by weighing cefadroxil, sucrose and mannitol, carboxymethylstach sodium, xanthan gum mixes, and stirs more than 30 minutes mix homogeneously.Saccharin sodium, flavoring pineapple essence and the Gardenia Yellow of recipe quantity put in 60% ethanol dissolve, be binding agent, the system soft material.20 mesh sieves are granulated, 55-60 ℃ of oven dry; 18 mesh sieve granulate.Dress compound membrane bag or bottle.
Embodiment 2:
Composition weight
Principal agent cefadroxil 90g
Inclusion agents hydroxypropyl 35g
Water-soluble filler sucrose 220g
Xylitol 220g
Disintegrator carboxymethylstarch sodium 57g
Suspending agent polyvinylpyrrolidone 7.6g
Binding agent 60% ethanol 35ml
With the efficient grinding fast of cefadroxil, beta-schardinger dextrin-and water 1 hour, 40 ℃ of dryings of vacuum were pulverized, and cross 120 mesh sieves; Water-soluble filler, disintegrating agent, suspending agent are crossed 100 mesh sieves respectively, and be standby.By recipe quantity take by weighing cefadroxil, sucrose and xylitol, carboxymethylstach sodium, polyvinylpyrrolidone mixes, and stirs more than 30 minutes mix homogeneously.60% ethanol stirs and adds in the above-mentioned main ingredient that mixes, and makes soft material; 20 mesh sieves are granulated, 55-60 ℃ of oven dry; 18 mesh sieve granulate.Dress compound membrane bag or bottle.
Embodiment 3:
Composition weight
Principal agent cefadroxil 80g
Inclusion agents hydroxypropyl 27g
Water-soluble filler xylitol 250g
Mannitol 250g
Disintegrator carboxymethylstarch sodium 58g
Suspending agent Resina persicae 6.6g
Binding agent 10% polyvinylpyrrolidone alcoholic solution 32ml
Supplementary material is sieved respectively, and cefadroxil is crossed 120 mesh sieves; Mannitol and xylitol, carboxymethylstach sodium, Resina persicae are crossed 100 mesh sieves respectively, and be standby.By recipe quantity take by weighing cefadroxil, mannitol and xylitol, carboxymethylstach sodium, Resina persicae mixes, and stirs more than 30 minutes mix homogeneously.10% polyvinylpyrrolidone alcoholic solution stirs and adds in the above-mentioned main ingredient that mixes, and makes soft material.20 mesh sieves are granulated, 55-60 ℃ of oven dry; 18 mesh sieve granulate.Dress compound membrane bag or bottle.
Embodiment 4:
Composition weight
Principal agent cefadroxil 120g
Inclusion agents beta-schardinger dextrin-60g
Water-soluble filler sucrose 300g
Mannitol 220g
The low interior basic cellulose 55g of hydroxyl that replaces of disintegrating agent
Suspending agent tragacanth 8.5g
Correctives saccharin sodium 0.34g
Flavoring pineapple essence 5g
Coloring agent Gardenia Yellow 0.26g
Binding agent 60% ethanol 45ml
With the efficient grinding fast of cefadroxil, beta-schardinger dextrin-and water 1 hour, 40 ℃ of dryings of vacuum were pulverized, and cross 120 mesh sieves; Water-soluble filler, disintegrating agent, suspending agent are crossed 100 mesh sieves respectively, and be standby.By recipe quantity take by weighing cefadroxil, sucrose and mannitol, low-substituted hydroxypropyl cellulose, tragacanth mixes, and stirs more than 30 minutes mix homogeneously.Saccharin sodium, flavoring pineapple essence and the Gardenia Yellow of recipe quantity put in 60% ethanol dissolve, be binding agent, the system soft material.20 mesh sieves are granulated, 55-60 ℃ of oven dry; 18 mesh sieve granulate.Dress compound membrane bag or bottle.
Embodiment 5:
Composition weight
Principal agent cefadroxil 80g
Inclusion agents cyclodextrin 16g
Water-soluble filler sucrose 220g
Mannitol 220g
Disintegrator carboxymethylstarch sodium 70g
Suspending agent xanthan gum 10g
Binding agent 60% ethanol 40ml
With the efficient grinding fast of cefadroxil, beta-schardinger dextrin-and water 1 hour, 40 ℃ of dryings of vacuum were pulverized, and cross 120 mesh sieves; Water-soluble filler, disintegrating agent, suspending agent are crossed 100 mesh sieves respectively, and be standby.By recipe quantity take by weighing cefadroxil, sucrose and mannitol, carboxymethylstach sodium, xanthan gum mixes, and stirs more than 30 minutes mix homogeneously.60% ethanol stirs and adds in the above-mentioned main ingredient that mixes, the system soft material.20 mesh sieves are granulated, 55-60 ℃ of oven dry; 18 mesh sieve granulate.Dress compound membrane bag or bottle.
Embodiment 6:
Composition weight
Principal agent cefadroxil 110g
Inclusion agents cyclodextrin 50g
Water-soluble filler sucrose 225g
Mannitol 225g
Disintegrator carboxymethylstarch sodium 58g
Suspending agent xanthan gum 8g
Binding agent 60% ethanol 40ml
With the efficient grinding fast of cefadroxil, beta-schardinger dextrin-and water 1 hour, 40 ℃ of dryings of vacuum were pulverized, and cross 120 mesh sieves; Water-soluble filler, disintegrating agent, suspending agent are crossed 100 mesh sieves respectively, and be standby.By recipe quantity take by weighing cefadroxil, sucrose and mannitol, carboxymethylstach sodium, xanthan gum mixes, and stirs more than 30 minutes mix homogeneously.60% ethanol stirs and adds in the above-mentioned main ingredient that mixes, the system soft material.20 mesh sieves are granulated, 55-60 ℃ of oven dry; 18 mesh sieve granulate.Dress compound membrane bag or bottle.
Product of the present invention can adopt packed or bottled, can directly take after the bath, and this product is stable in acid, and the influence of unable to take food thing is recommended to take after the meal.Child's recommended dose was generally 30mg/kg/ days, took once in per 12 hours, and adult's common dose is 1-2g every day, takes once or twice.
Claims (5)
1. cefadroxil dry suspension, it comprises principal agent cefadroxil and pharmaceutically acceptable auxiliaries, it is characterized in that: described each main materials and auxiliary materials unit is by weight counted:
Cefadroxil 80-120
Inclusion agents 16-60
Water-soluble filler 440-520
Disintegrating agent 55-70
Suspending agent 5-10
Binding agent 30-45
Described inclusion agents is selected from a kind of or its combination in cyclodextrin, beta-schardinger dextrin-, the hydroxypropyl; Described water-soluble filler selects for use sorbitol, sucrose, mannitol or other to be beneficial to one or more combination of moisture penetration material in the pharmaceutical preparation; Described disintegrating agent is selected in carboxymethylstach sodium, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone or the crosslinked carboxymethylstach sodium one or more mixture for use; Described suspending agent is selected one or both natural gum combinations in polyvinylpyrrolidone, xanthan gum, the Resina persicae for use; Described binding agent is selected ethanol or polyvinylpyrrolidone alcoholic solution for use.
2. cefadroxil dry suspension according to claim 1 is characterized in that: the described main and auxiliary medicine optimization formula of unit meter by weight is:
Cefadroxil 90-110,
Inclusion agents 20-40
Water-soluble filler 450-500,
Disintegrating agent 58-68,
Suspending agent 6-9,
Binding agent 35-40;
Wherein, the compositions of water-soluble filler preferably sucrose, mannitol; The preferred carboxymethylstach sodium of disintegrating agent; The preferred xanthan gum of suspending agent; Preferred 60% ethanol of binding agent.
3. cefadroxil dry suspension according to claim 2 is characterized in that: add the correctives of 5-5.3 unit of weight in the described accessory drugs, described correctives is selected the compositions of one or more flavorants or edible glucin for use.
4. cefadroxil dry suspension according to claim 3 is characterized in that: add the coloring agent of 0.2-0.3 unit of weight in the described accessory drugs, coloring agent is selected the compositions of one or more its food colorings for use.
5. according to the preparation method of claim 1 or 2 or 3 or 4 described cefadroxil dry suspensions, it is characterized in that: it carries out as follows:
A. prepare clathrate: cefadroxil, inclusion agents in the above-mentioned prescription are added water grind, vacuum drying is crossed 120 mesh sieves;
B. major-minor medicine mixes: water-soluble filler, disintegrating agent, suspending agent in the above-mentioned prescription are crossed 100 mesh sieves respectively, clathrate, water-soluble filler, disintegrating agent, the suspending agent of preparation are pressed recipe quantity mix, stir;
C. add correctives, coloring agent: get the recipe quantity correctives, coloring agent is put in the ethanol and dissolved, stir and add in the above-mentioned main ingredient that mixes, make soft material;
D. granulate, pack: 20 mesh sieves are granulated, 55-66 ℃ of oven dry, 18 mesh sieve granulate, dress compound membrane bag or bottle.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510012375 CN1282458C (en) | 2005-03-09 | 2005-03-09 | Cefadroxil dry suspension and preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510012375 CN1282458C (en) | 2005-03-09 | 2005-03-09 | Cefadroxil dry suspension and preparing method |
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| CN1282458C CN1282458C (en) | 2006-11-01 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101002782B (en) * | 2007-01-10 | 2010-05-19 | 南京师范大学 | Medicine composition containing ceftin cyclodextrin clathrate, and its preparing method |
| CN101816635A (en) * | 2010-05-17 | 2010-09-01 | 广东恒健制药有限公司 | Cephalosporin suspension granule and preparation method thereof |
| CN116712568A (en) * | 2023-08-04 | 2023-09-08 | 山东第一医科大学附属省立医院(山东省立医院) | Risedronate sodium inclusion compound, preparation and application |
| CN117582403A (en) * | 2023-12-01 | 2024-02-23 | 上海金城素智药业有限公司 | Cefadroxil dry suspension and preparation method and application thereof |
-
2005
- 2005-03-09 CN CN 200510012375 patent/CN1282458C/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101002782B (en) * | 2007-01-10 | 2010-05-19 | 南京师范大学 | Medicine composition containing ceftin cyclodextrin clathrate, and its preparing method |
| CN101816635A (en) * | 2010-05-17 | 2010-09-01 | 广东恒健制药有限公司 | Cephalosporin suspension granule and preparation method thereof |
| CN116712568A (en) * | 2023-08-04 | 2023-09-08 | 山东第一医科大学附属省立医院(山东省立医院) | Risedronate sodium inclusion compound, preparation and application |
| CN116712568B (en) * | 2023-08-04 | 2023-10-03 | 山东第一医科大学附属省立医院(山东省立医院) | Risedronate sodium inclusion compound, preparation and application |
| CN117582403A (en) * | 2023-12-01 | 2024-02-23 | 上海金城素智药业有限公司 | Cefadroxil dry suspension and preparation method and application thereof |
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| Publication number | Publication date |
|---|---|
| CN1282458C (en) | 2006-11-01 |
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