CN101836950A - Moxifloxacin hydrochloride glucose injection and preparation method and use thereof - Google Patents
Moxifloxacin hydrochloride glucose injection and preparation method and use thereof Download PDFInfo
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Abstract
The invention provides moxifloxacin hydrochloride glucose injection and a preparation method and use thereof. The method for preparing the injection comprises the following steps of: adding water for injection accounting for 20 to 98 percent of the batch volume into an ingredient tank, and adding glucose, a metal complexing agent and the moxifloxacin hydrochloride in a ratio; after stirring to fully dissolve the components, regulating the pH value to between 4.0 and 4.5 by using 1mol/L hydrochloric acid solution or 1mol/L sodium hydroxide, adding medicinal carbon accounting for 0.05 percent (W/V) of the total volume, uniformly stirring, maintaining the temperature of between 70 and 80 DEG C for 20 minutes, and performing circular filtering for over 20 minutes; replenishing the water for injection to the batch scale, stirring for 5 to 10 minutes, and detecting the pH value of the prepared solution (controlling to between 4.0 and 4.5); after determining that no residual water is present in an elevated tank and a pipeline, opening a valve of the elevated tank, and sampling liquid medicament at a self-circulation pipeline sampling port after the liquid medicament circulates for 20 minutes through a filter element and the elevated tank; detecting according to the intermediate quality standard, requiring that the content of the moxifloxacin hydrochloride is between 1.52 and 1.68 mg/ml, the glucose content is between 47.5 and 52.5 mg/ml, and the pH value is between 4.0 and 4.5; after the intermediate is detected to be qualified, beginning to fill; and conveying the filled semi-finished products into a sterilizing cabinet for sterilization, wherein the sterilization condition is to sterilize for 8 to 30 minutes at 121 DEG C through thermal pressure steam.
Description
Technical field:
The present invention relates to contain moxifloxacin hydrochloride and be the preparation and its production and use of the injection of main pharmacodynamics composition.
Technical background:
Fluoroquinolones is nearly two to develop very fast a kind of complete synthesis antibacterials during the last ten years, mainly act on the helicase and the topoisomerase of DNA of bacteria, have has a broad antifungal spectrum, antibacterial action is strong, characteristics such as safety height are widely used in treating the various infection such as respiratory tract, urinary tract, skin soft tissue, department of otorhinolaryngology, gynecological and tuberculosis that caused by gram positive bacteria, negative bacterium, anaerobe etc. clinically.Chemical constitution, antibacterial action and physiological disposition according to quinolones can be divided into for one, two, three, four generations, wherein third generation medicine such as ciprofloxacin, levofloxacin magnitude have been ranked among the row of world's situation of selling well medicine owing to have excellent anti-infectious function and safety.But along with the expansion of the quinolones scope of application and the increase of consumption, when resisting various infectious disease, the drug resistance phenomenon is on the rise, it mainly is the drug resistance that causes by staphylococcus aureus, gram positive bacteria and green pus bacterium etc., and share untoward reaction such as bringing out spasm, photosensitive toxicity, joint toxicity with NSAID (non-steroidal anti-inflammatory drug), therefore need the new quinolones of exploitation overcome these problems.
Moxifloxacin hydrochloride is new broad-spectrum high efficacy the 4th generation fluoroquinolone antimicrobial drug of German Bayer company research and development, in June, 1996 at first in Germany's listing, trade name: Avelox, the same year, December obtained the drugs approved by FDA listing.This product tablet went on the market in China in 2002, and the moxifloxacin hydrochloride sodium chloride injection went on the market in China in 2005, trade name: visit multiple pleasure.From chemical constitution, Moxifloxacin 7 bit substituents group is diazabicyclo, can reduce the drug resistance (be the main mechanism of quinolones crossing drug resistant) of microorganism due to initiatively effluxing, guaranteed the low advantage of its drug resistance, introduce the methoxy group at 8, make this product in original antibacterial activity, strengthen antibacterial action to gram negative bacteria to gram positive bacteria, atypia pathogen and anaerobe in the reservation quinolones.Moxifloxacin is weaker than the levofloxacin except that the antibacterial activity to Pseudomonas aeruginosa, to atypia pathogen such as streptococcus pneumoniae, chlamydia, legionella, have brood cell and asporous anaerobe etc. all to be better than levofloxacin.In addition, Moxifloxacin is also effective to the drug-fast antibacterial of beta-lactam, Macrolide, aminoglycoside and tetracycline antibiotics, and does not have cross resistance with these antibacterials.Moxifloxacin is not a liver cell pigment P-450 isozyme inhibitor, therefore and between many other medicines does not have interaction.
Moxifloxacin hydrochloride is applied to treat upper respiratory tract and lower respiratory infection clinically, as acute sinusitis, the anxious hair growth promoting work of chronic bronchitis, community acquired pneumonia, and skin and soft tissue infection etc.Aspect the treatment community acquired pneumonia, according to the monitoring result after to this product listing such as Koch H, 1467 examples are diagnosed as the oral Moxifloxacin 0.4g of community acquired pneumonia patient, and every day 1 time, 90%～99% patient's symptom improves or cures, 54.2% patient takes Moxifloxacin, doing well,improving after 3 days, average cure time are 8.0 ± 2.7, and adverse reaction rate is 0.7%, be mainly gastrointestinal reaction, this product can be used as the choice drug [4] of community acquired pneumonia treatment.
Moxifloxacin is topoisomerase enzyme II and IV as super wide spectrum fluoroquinolone antibacterial agent thing because this product acts on two target position of antibacterial, so this product is not only effective to the antibacterial of sensitivity, and Resistant strain is also had high activity.Clinically multiple infection is demonstrated good therapeutic effect.The maximum characteristics of this product are that the common antibacterial that causes respiratory tract infection is comprised that streptococcus pneumoniae, hemophilus influenza, mucositis Mo Lahan Salmonella and mycoplasma pneumoniae, Chlamydia pneumoniae all have high activity to comprise B one lactam antibiotics, Macrolide and the existing all drug-fast bacterial strain of fluoroquinolone medicine.Simultaneously this product is to the permeate well of respiratory system tissue and body fluid, and toleration and safety are all good.The penetration power of Moxifloxacin is strong, can keep higher concentration in lung tissue, to the special effect of acute episode of chronic bronchitis and chronic obstructive pulmonary disease bacterial infection.In recent years, owing to multiple reasons such as air pollutions, China's respiratory system infection sickness rate straight line was reached the standard grade, and this product has significant advantage in this field.Demand is soaring steadily.From JIUYUE in 1999 Bayer company on the 1st at first since Germany's listing this product, in succession at the U.S., Europe alliance, Latin America and the listing of area, Asia dozens of country, trade name Avelox, Actira, Octegra, Proflox.Existing at least more than the 600 ten thousand routine patients of world wide used this product.This product becomes the important drugs of treatment respiratory tract infection gradually.Chinese patent 00811427.7 has related to a kind of Moxilfloxacin formulation containing common salt.The water formulation that Chinese patent 00811427.7 has been put down in writing moxifloxacin hydrochloride and glucose is owing to the reason of iron ion causes this kind stability of formulation very poor.
Summary of the invention:
The object of the present invention is to provide a kind of new moxifloxacin hydrochloride glucose injection.
The object of the present invention is to provide the Preparation method and use of this kind moxifloxacin hydrochloride glucose injection.
Add the complexing of metal ion agent in the moxifloxacin hydrochloride glucose injection of the present invention and effectively solved the problem of moxifloxacin hydrochloride Fructus Vitis viniferae by the preparation stability difference.
Moxifloxacin hydrochloride glucose injection of the present invention and commercially available moxifloxacin hydrochloride sodium chloride injection relatively have following advantage:
1, moxifloxacin hydrochloride dissolubility in sodium chloride solution is less causes it to precipitate easily under low temperature in the process of depositing; Moxifloxacin hydrochloride glucose injection can not precipitate at low temperatures.
2, moxifloxacin hydrochloride dissolubility in sodium chloride solution is less, and the specification when moxifloxacin hydrochloride is prepared into the sodium chloride preparation is 0.4g/250ml; The moxifloxacin hydrochloride glucose injection specification can be 0.4g/100ml.
Add the complexing of metal ion agent in the moxifloxacin hydrochloride glucose injection of the present invention, described complexing of metal ion agent is meant that the chelating agent of energy complexing metal iron ion is preferably edetic acid, calcium disodium edetate, disodium edetate, sequestrene Na4, tetrasodium pyrophosphate etc.;
The preparation method of moxifloxacin hydrochloride glucose injection of the present invention realizes by following step;
The water for injection that in material-compound tank, adds batch volumes 20%-98%, the glucose, metal chelating agent and the moxifloxacin hydrochloride that add dosage, after stirring makes abundant dissolving, with 1mol/L hydrochloric acid solution or 1mol/L sodium hydroxide adjust pH 4.0～4.5,0.05% (W/V) adding medicinal charcoal by cumulative volume stirs, 70 ℃～be incubated 20 minutes more than 80 ℃, circulating filtration is more than 20 minutes; Add water for injection to the batch scale, stir after 5～10 minutes, detect preparation liquid pH value (being controlled at 4.0～4.5); Confirm to open behind the nothing left water in head tank and the pipeline and lead to the head tank valve, make medicinal liquid behind filter element and head tank circulation 20min in the sampling of self circulation line sample tap, pressing the intermediate quality standard detects, requirement moxifloxacin hydrochloride content (in Moxifloxacin) should be at 1.52～1.68mg/ml, glucose content should be at 47.5～52.5mg/ml, and pH value should be 4.0～4.5; After the intermediate detection is qualified, the beginning fill; The semi-finished product that fill is good are sent into the sterilization of sterilization cabinet, sterilising conditions: 121 ℃ of hot pressing steams were sterilized 8-30 minute.
Moxifloxacin hydrochloride glucose injection of the present invention can be used for adult's (〉=18 years old) upper respiratory tract and lower respiratory infection, as acute sinusitis, acute episode of chronic bronchitis, community acquired pneumonia; And skin and soft tissue infection.
Preparation method prepared preparation of the present invention does not have blood vessel zest, no hemolytic
The specific embodiment:
Embodiment 1: the preparation of moxifloxacin hydrochloride glucose injection (0.4g/250ml)
Prescription: moxifloxacin hydrochloride 400g (in Moxifloxacin)
Glucose 12.5kg
Calcium disodium edetate 25g
Water for injection adds to 250L
1000 bottles
1) gets qualified moxifloxacin hydrochloride raw material, glucose and calcium disodium edetate by batching nuclear material list;
2) water for injection of adding batch volumes 95% in material-compound tank, the glucose, calcium disodium edetate and the moxifloxacin hydrochloride that add dosage, after stirring makes abundant dissolving, with 1mol/L hydrochloric acid solution or 1mol/L sodium hydroxide adjust pH 4.0～4.5,0.05% (W/V) adding medicinal charcoal by cumulative volume stirs, 70 ℃～be incubated 20 minutes more than 80 ℃, circulating filtration is more than 20 minutes;
3) add water for injection to the batch scale, stir after 5～10 minutes, detect preparation liquid pH value (being controlled at 4.0～4.5);
4) confirm to open behind the nothing left water in head tank and the pipeline and lead to the head tank valve, make medicinal liquid behind filter element and head tank circulation 20min in the sampling of self circulation line sample tap, pressing the intermediate quality standard detects, requirement moxifloxacin hydrochloride content (in Moxifloxacin) should be at 1.52～1.68mg/ml, glucose content should be at 47.5～52.5mg/ml, and pH value should be 4.0～4.5;
5) intermediate detect qualified after, notice fill workshop section begins fill;
6) fill is good semi-finished product are sent into the sterilization of sterilization cabinet, sterilising conditions: 121 ℃ of hot pressing steams were sterilized 12 minutes, and condition in accordance with regulations offers for sale, and sampling detects by the intermediate quality standard;
7) semi-finished product of will sterilizing carry out the visible foreign matters inspection, reject defective work;
8) with packaged finished product packing, warehouse-in.
Embodiment 2: the preparation of moxifloxacin hydrochloride glucose injection (0.4g/100ml)
Prescription: moxifloxacin hydrochloride 400g (in Moxifloxacin)
Glucose 5kg
Disodium edetate 25g
Water for injection adds to 100L
1000 bottles
1) gets qualified moxifloxacin hydrochloride raw material, glucose and disodium edetate by batching nuclear material list;
2) water for injection of adding batch volumes 90% in material-compound tank, the glucose, calcium disodium edetate and the moxifloxacin hydrochloride that add dosage, after stirring makes abundant dissolving, with 1mol/L hydrochloric acid solution or 1mol/L sodium hydroxide adjust pH 4.0～4.5,0.05% (W/V) adding medicinal charcoal by cumulative volume stirs, 70 ℃～be incubated 20 minutes more than 80 ℃, circulating filtration is more than 20 minutes;
3) add water for injection to the batch scale, stir after 5～10 minutes, detect preparation liquid pH value (being controlled at 4.0～4.5);
4) confirm to open behind the nothing left water in head tank and the pipeline and lead to the head tank valve, make medicinal liquid behind filter element and head tank circulation 20min in the sampling of self circulation line sample tap, pressing the intermediate quality standard detects, requirement moxifloxacin hydrochloride content (in Moxifloxacin) should be at 1.52～1.68mg/ml, glucose content should be at 47.5～52.5mg/ml, and pH value should be 4.0～4.5;
5) intermediate detect qualified after, notice fill workshop section begins fill;
6) fill is good semi-finished product are sent into the sterilization of sterilization cabinet, sterilising conditions: 121 ℃ of hot pressing steams were sterilized 12 minutes, and condition in accordance with regulations offers for sale, and sampling detects by the intermediate quality standard;
7) semi-finished product of will sterilizing carry out the visible foreign matters inspection, reject defective work;
8) with packaged finished product packing, warehouse-in.
Embodiment 3: the preparation of moxifloxacin hydrochloride glucose injection (0.4g/250ml)
Prescription: moxifloxacin hydrochloride 400g (in Moxifloxacin)
Glucose 12.5kg
Edetic acid 20g
Water for injection adds 250L
1000 bottles
1) gets qualified moxifloxacin hydrochloride raw material, glucose and calcium disodium edetate by batching nuclear material list;
2) water for injection of adding batch volumes 70% in material-compound tank, the glucose, edetic acid and the moxifloxacin hydrochloride that add dosage, after stirring makes abundant dissolving, with 1mol/L sodium hydroxide adjust pH 4.0～4.5,0.05% (W/V) adding medicinal charcoal by cumulative volume stirs, 70 ℃～be incubated 20 minutes more than 80 ℃, circulating filtration is more than 20 minutes;
3) add water for injection to the batch scale, stir after 5～10 minutes, detect preparation liquid pH value (being controlled at 4.0～4.5);
4) confirm to open behind the nothing left water in head tank and the pipeline and lead to the head tank valve, make medicinal liquid behind filter element and head tank circulation 20min in the sampling of self circulation line sample tap, pressing the intermediate quality standard detects, requirement moxifloxacin hydrochloride content (in Moxifloxacin) should be at 1.52～1.68mg/ml, glucose content should be at 47.5～52.5mg/ml, and pH value should be 4.0～4.5;
5) intermediate detect qualified after, notice fill workshop section begins fill;
6) fill is good semi-finished product are sent into the sterilization of sterilization cabinet, sterilising conditions: 121 ℃ of hot pressing steams were sterilized 8 minutes, and condition in accordance with regulations offers for sale, and sampling detects by the intermediate quality standard;
7) semi-finished product of will sterilizing carry out the visible foreign matters inspection, reject defective work;
8) with packaged finished product packing, warehouse-in.
Embodiment 4: the preparation of moxifloxacin hydrochloride glucose injection (0.4g/250ml)
Prescription: moxifloxacin hydrochloride 400g (in Moxifloxacin)
Glucose 12.5kg
Tetrasodium pyrophosphate 25g
Water for injection adds to 250L
1000 bottles
1) gets qualified moxifloxacin hydrochloride raw material, glucose and calcium disodium edetate by batching nuclear material list;
2) water for injection of adding batch volumes 70% in material-compound tank, the glucose, tetrasodium pyrophosphate and the moxifloxacin hydrochloride that add dosage, after stirring makes abundant dissolving, with 1mol/L sodium hydroxide adjust pH 4.3,0.05% (W/V) adding medicinal charcoal by cumulative volume stirs, 70 ℃～be incubated 20 minutes more than 80 ℃, circulating filtration is more than 20 minutes;
3) add water for injection to the batch scale, stir after 5～10 minutes, detect preparation liquid pH value and (be controlled at 4.0～4.5;
4) confirm to open behind the nothing left water in head tank and the pipeline and lead to the head tank valve, make medicinal liquid behind filter element and head tank circulation 20min in the sampling of self circulation line sample tap, pressing the intermediate quality standard detects, requirement moxifloxacin hydrochloride content (in Moxifloxacin) should be at 1.52～1.68mg/ml, glucose content should be at 47.5～52.5mg/ml, and pH value should be 4.0～4.5;
5) intermediate detect qualified after, notice fill workshop section begins fill;
6) fill is good semi-finished product are sent into the sterilization of sterilization cabinet, sterilising conditions: 121 ℃ of hot pressing steams were sterilized 30 minutes, and condition in accordance with regulations offers for sale, and sampling detects by the intermediate quality standard;
7) semi-finished product of will sterilizing carry out the visible foreign matters inspection, reject defective work;
8) with packaged finished product packing, warehouse-in.
Embodiment 5: the research of moxifloxacin hydrochloride glucose injection stability test
Declare the stability test listed investigation project of clinical research with injection in quality standard and Chinese Pharmacopoeia two appendix of version in 2005 " medicine stability test guideline " according to moxifloxacin hydrochloride glucose injection, we have carried out study on the stability to this product.
The accelerated test test method is sample thief respectively, by the listing packing, under the condition of 40 ℃ of temperature, placed 6 months, in 1st month, the 2nd month, the 3rd month and sampling detection respectively in 6th month, and this product is carried out bacterial endotoxin and aseptic the detection in 6th month, the detection data of testing result and 0 day compare, and the results are shown in Table 1 and table 2.
Table 1 moxifloxacin hydrochloride glucose injection accelerated test result (one) (40 ℃)
Table 2 moxifloxacin hydrochloride glucose injection accelerated test result (two) (40 ℃)
The result shows: this product was placed 6 months under 40 ℃ of conditions of temperature under simulation listing terms of packing, every detection index and having no significant change in 0 day, and this position 3 months is up to specification with 6th month bacterial endotoxin and sterility test.Show that this product has stability preferably.
Test for a long time keeps sample
Delivery is intended the sample of listing packing, places 6 months down in the environment of 25 ℃ of temperature, detects respectively at sampling in the 3rd, 6 month, and testing result compares with 0 day detection data, the results are shown in Table 3, table 4.
Table 3 moxifloxacin hydrochloride glucose injection long-term test results (one)
Table 4 moxifloxacin hydrochloride glucose injection accelerated test result (two)
The result shows: this product was placed 6 months under 25 ℃ of conditions of temperature, and the testing result of every detection index and 0 month does not all have obvious variation.
This product was placed 6 months under 40 ℃ of conditions, and every index has no significant change, and illustrated that this product is more stable under the listing packing; Placed 6 months at 25 ℃, every index has no significant change, and this product steady quality under the listing terms of packing be described, is 24 months so this product effect duration fixes tentatively.
Claims (4)
1. as the water formulation of medicine, it contains the metal chelating agent of moxifloxacin hydrochloride 0.04%-0.4% weight/volume, 0.001%-0.5% weight/volume and the glucose of 2%-15% weight/volume.
2. according to the water formulation of claim 1, wherein said metal chelating agent is calcium disodium edetate, edetic acid, disodium edetate, sequestrene Na4, sodium hexameta phosphate.
3. the method for preparing the moxifloxacin hydrochloride water formulation of claim 1, the water for injection that in material-compound tank, adds batch volumes 95%, the glucose, metal chelating agent and the moxifloxacin hydrochloride that add dosage, after stirring makes abundant dissolving, with 1mol/L hydrochloric acid solution or 1mol/L sodium hydroxide adjust pH 4.0～4.5,0.05% (W/V) adding medicinal charcoal by cumulative volume stirs, and 70 ℃～be incubated 20 minutes more than 80 ℃, circulating filtration is more than 20 minutes; Add water for injection to the batch scale, stir after 5～10 minutes, detect preparation liquid pH value (being controlled at 4.0～4.5); Confirm to open behind the nothing left water in head tank and the pipeline and lead to the head tank valve, make medicinal liquid behind filter element and head tank circulation 20min in the sampling of self circulation line sample tap, pressing the intermediate quality standard detects, requirement moxifloxacin hydrochloride content (in Moxifloxacin) should be at 1.52～1.68mg/ml, glucose content should be at 47.5～52.5mg/ml, and pH value should be 4.0～4.5; After the intermediate detection is qualified, the beginning fill; The semi-finished product that fill is good are sent into the sterilization of sterilization cabinet, sterilising conditions: 121 ℃ of hot pressing steams were sterilized 8-30 minute.
4. preparation according to claim 1 is used for preventing or treats the application of medicine of people's bacterial infection in production.
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Cited By (8)
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| CN102100666A (en) * | 2011-01-17 | 2011-06-22 | 南京新港医药有限公司 | New moxifloxacin hydrochloride injection |
| CN102784108A (en) * | 2011-05-18 | 2012-11-21 | 兆科药业（合肥）有限公司 | Ulifloxacin water-soluble salt injection |
| CN102908323A (en) * | 2012-10-30 | 2013-02-06 | 天津红日药业股份有限公司 | Moxifloxacin-containing pharmaceutical composition |
| CN103520093A (en) * | 2013-10-14 | 2014-01-22 | 南京正大天晴制药有限公司 | Moxifloxacin hydrochloride injection and preparation method thereof |
| CN103830164A (en) * | 2012-11-20 | 2014-06-04 | 北大方正集团有限公司 | Moxifloxacin hydrochloride injection liquid and preparation method thereof |
| CN106176617A (en) * | 2016-08-31 | 2016-12-07 | 中牧南京动物药业有限公司 | Amoxicillin soluble powder and preparation method thereof |
| CN106821972A (en) * | 2017-03-15 | 2017-06-13 | 成都天台山制药有限公司 | Moxifloxacin hydrochloride injection pharmaceutical composition and its preparation and quality control method |
| CN109260180A (en) * | 2017-07-17 | 2019-01-25 | 北京盈科瑞创新药物研究有限公司 | A kind of moxifloxacin hydrochloride Neulized inhalation pharmaceutical solutions and preparation method thereof |
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Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102100666A (en) * | 2011-01-17 | 2011-06-22 | 南京新港医药有限公司 | New moxifloxacin hydrochloride injection |
| CN102100666B (en) * | 2011-01-17 | 2012-07-18 | 南京新港医药有限公司 | New moxifloxacin hydrochloride injection |
| CN102784108A (en) * | 2011-05-18 | 2012-11-21 | 兆科药业（合肥）有限公司 | Ulifloxacin water-soluble salt injection |
| CN102908323B (en) * | 2012-10-30 | 2015-03-04 | 天津红日药业股份有限公司 | Moxifloxacin-containing pharmaceutical composition |
| CN102908323A (en) * | 2012-10-30 | 2013-02-06 | 天津红日药业股份有限公司 | Moxifloxacin-containing pharmaceutical composition |
| CN103830164A (en) * | 2012-11-20 | 2014-06-04 | 北大方正集团有限公司 | Moxifloxacin hydrochloride injection liquid and preparation method thereof |
| CN103520093A (en) * | 2013-10-14 | 2014-01-22 | 南京正大天晴制药有限公司 | Moxifloxacin hydrochloride injection and preparation method thereof |
| CN103520093B (en) * | 2013-10-14 | 2015-05-20 | 南京正大天晴制药有限公司 | Moxifloxacin hydrochloride injection and preparation method thereof |
| CN106176617A (en) * | 2016-08-31 | 2016-12-07 | 中牧南京动物药业有限公司 | Amoxicillin soluble powder and preparation method thereof |
| CN106176617B (en) * | 2016-08-31 | 2018-02-13 | 中牧南京动物药业有限公司 | Amoxicillin soluble powder and preparation method thereof |
| CN106821972A (en) * | 2017-03-15 | 2017-06-13 | 成都天台山制药有限公司 | Moxifloxacin hydrochloride injection pharmaceutical composition and its preparation and quality control method |
| CN106821972B (en) * | 2017-03-15 | 2018-03-23 | 成都天台山制药有限公司 | Moxifloxacin hydrochloride injection pharmaceutical composition and its preparation and quality control method |
| CN109260180A (en) * | 2017-07-17 | 2019-01-25 | 北京盈科瑞创新药物研究有限公司 | A kind of moxifloxacin hydrochloride Neulized inhalation pharmaceutical solutions and preparation method thereof |
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Application publication date: 20100922 |