CN101822669A - Liposome injection of amoxicillin sodium sulbactam sodium medicinal composition - Google Patents
Liposome injection of amoxicillin sodium sulbactam sodium medicinal composition Download PDFInfo
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- CN101822669A CN101822669A CN 201010153804 CN201010153804A CN101822669A CN 101822669 A CN101822669 A CN 101822669A CN 201010153804 CN201010153804 CN 201010153804 CN 201010153804 A CN201010153804 A CN 201010153804A CN 101822669 A CN101822669 A CN 101822669A
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Abstract
The invention provides liposome injection of an amoxicillin sodium sulbactam sodium medicinal composition. The liposome injection consists of amoxicillin sodium, sulbactam sodium, liposome carriers, freeze-drying supporting agents and optional antioxidant, wherein the liposome carriers are dipalmitoyl phosphatidyl choline and deoxysodium cholate. The liposome injection has high stability; in the freeze-drying process, a phenomenon of breaking liposome caused by dehydration, fusion, ice crystal generation and the like does not occur; and the liposome can remain good encapsulation ratio after being hydrated and redissolved.
Description
Technical field
The present invention relates to a kind of antibiotic Liposomal formulation, relate in particular to a kind of liposome injection of amoxicillin sodium sulbactam sodium medicinal composition and method for making thereof, belong to medical technical field.
Background technology
Amoxicillin Sodium is the bactericidal properties broad ectrum antibiotic, and sulbactam sodium is irreversible wide spectrum beta-lactamase inhibitor, can suppress the beta-lactamase that fastbacteria produces effectively.Many clinically Grain-positives and gram-negative bacteria produce beta-lactamase, and this enzyme can make the amoxicillin lose antibacterial activity.Because the existence of sulbactam sodium can make the amoxicillin exempt from the destruction of p-lactamase, thereby make the amoxicillin drug resistance and produce the antibacterial of beta-lactamase, still to the amoxicillin sensitivity.This product is a bactericidal antibiotic, can kill multiple Grain-positive and gram-negative bacteria clinically, and is particularly effective in cure to the fastbacteria that produces beta-lactamase.
The clinical consumption of amoxicillin sodium and sulbactam sodium compound preparation is big, determined curative effect, and market prospect is good, and is the same with most of cephalosporinses, all is to be made by Amoxicillin Sodium and the aseptic raw material packing of sulbactam sodium or lyophilizing.There is a common defective in it is exactly that preparation stabilization is poor, the prescription that can not satisfy the prescriptive period.Patent documentation CN101322701A discloses the preparation method of a kind of amoxicillin sodium for injection sulbactam sodium and lyophilized injectable powder thereof, and the isolation and purification method of the Amoxicillin Sodium of injection and sulbactam sodium, adopt high speed adverse current chromatogram, constitute the dicyandiamide solution of immobile phase, mobile phase with chloroform, ethyl acetate, the preparation of first alcohol and water, Amoxicillin Sodium and sulbactam sodium are carried out separation and purification, obtain the Amoxicillin Sodium and the sulbactam sodium of injection, lyophilization, aseptic subpackaged, make the amoxicillin sodium for injection sulbactam sodium.This patent has improved the purity of preparation to a certain extent, but just with simple aseptic subpackaged the making of two kinds of compositions, active component Amoxicillin Sodium and sulbactam sodium is not carried out corresponding protection, causes product stability poor, has had a strong impact on clinical efficacy.
Summary of the invention
This injection that common process is prepared, physics and poor chemical stability, long-term storage drug quality can descend but also can generate some impurity, bring toxic and side effects, have stayed hidden danger for clinical use.If can screen some specific adjuvant and preparation technologies, increase the stability of this product, bring very big safety will for clinical use.In line with this meaning, the inventor has finally finished the present invention by consulting a large amount of documents and materials and carrying out arduous experiment sieving demonstration.
Preparation lipidosome injection membrane material commonly used is phospholipid and additives, wherein phospholipid can be selected natural phospholipid and synthetic phospholipid for use usually, and described natural phospholipid is one or more in Ovum Gallus domesticus Flavus lecithin, hydrogenation egg yolk lecithin, EPG, egg yolk lecithin acyl serine, egg yolk lecithin acyl inositol, soybean lecithin, hydrogenated soya phosphatide, soybean phospholipid acyl glycerol, soy phosphatidylserine, the soybean phospholipid acyl inositol; Described synthetic phospholipid is one or more in dioleoyl phospholipid phatidylcholine, distearyl acid phosphatidylcholine, dipalmitoyl phosphatidyl choline, dimyristoyl phosphatidyl choline, two Laurel phosphatidyl cholines, DOPG, distearyl acid phosphatidyl glycerol, two palmityl phosphatidyl glycerols, GLYCEROL,DIMYRISTOYL PHOSPHATIDYL, the two lauroyl phosphatidyl glycerols.The membrane material of additives commonly used has cholesterol, 18-amine., phosphatidic acid, sodium deoxycholate and poloxamer 188.The membrane material that is used to prepare lipidosome injection also has PHOSPHATIDYL ETHANOLAMINE, cholesterol second fat, paddy to carry alcohol, natrii tauroglycocholas, phosphatidyl silk amino acid, stearmide, single stearoyl phosphatidic acid, single stearoyl PHOSPHATIDYL ETHANOLAMINE, two cetyl phosphate (DCP), two palmityl PHOSPHATIDYL ETHANOLAMINE, single palmityl PHOSPHATIDYL ETHANOLAMINE, two myristoyl PHOSPHATIDYL ETHANOLAMINE.Additives generally are used for regulating membrane structure, change charged character, as cholesterol liposome bimolecular tunic are solidified, thereby reduce the generation of free radical, have reduced oxidation level, and liposome stability is significantly strengthened.
Bound by theory not, the inventor has found dipalmitoyl phosphatidyl choline, two kinds of materials of sodium deoxycholate are made up unexpectedly, has beyond thought effect, thereby obtained the liposome of excellent in stability, it has good preparation stability, liposome can not break because of dehydration, fusion, ice crystal generation etc. in the freeze-drying process, and after aquation was redissolved, liposome kept good envelop rate equally.
Technical solution of the present invention is as follows:
A kind of liposome injection of amoxicillin sodium sulbactam sodium medicinal composition, be made up of Amoxicillin Sodium, sulbactam sodium, liposome vectors, frozen-dried supporting agent and the optional antioxidant that exists, wherein said liposome vectors is dipalmitoyl phosphatidyl choline and sodium deoxycholate.
Liposome injection of amoxicillin sodium sulbactam sodium medicinal composition of the present invention, wherein Amoxicillin Sodium and sulbactam sodium are 2: 1 aseptic mixtures of weight ratio.
Liposome injection of amoxicillin sodium sulbactam sodium medicinal composition of the present invention, each composition weight umber is:
2 parts of Amoxicillin Sodiums
1 part of sulbactam sodium
Dipalmitoyl phosphatidyl choline 1.5-11 part
Sodium deoxycholate 0.8-5 part
Frozen-dried supporting agent 3-18 part
Antioxidant 0-2 part.
As the present invention's one preferred embodiment, each composition weight umber is:
2 parts of Amoxicillin Sodiums
1 part of sulbactam sodium
Dipalmitoyl phosphatidyl choline 3-7 part
Sodium deoxycholate 1-4 part
Frozen-dried supporting agent 4-12 part
Antioxidant 0.05-0.5 part.
Above-mentioned described liposome injection of amoxicillin sodium sulbactam sodium medicinal composition, wherein said frozen-dried supporting agent is selected from one or more in sodium chloride, mannitol, glucose, lactose, polyvinylpyrrolidone, sucrose, glycine, sorbitol, trehalose, the dextran, is preferably 3: 1 the mixture of weight ratio of mannitol and lactose.
Above-mentioned described liposome injection of amoxicillin sodium sulbactam sodium medicinal composition, wherein said antioxidant is selected from one or more in sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, ascorbic acid, vitamin E, propyl gallate, ascorbyl palmitate, the butylated hydroxyarisol, preferred ascorbyl palmitate.
The present invention also provides a kind of method for preparing liposome injection of amoxicillin sodium sulbactam sodium medicinal composition, and concrete steps comprise:
(1) dipalmitoyl phosphatidyl choline and sodium deoxycholate are dissolved in the organic solvent, placing reduces pressure on the rotating thin film evaporimeter eliminates organic solvent, has obtained immobilized artificial membrane, adds the buffer salt solution stirring and dissolving, obtains blank liposome solution;
(2) Amoxicillin Sodium and sulbactam sodium are dissolved in the water for injection,, are incubated under the 50-70 ℃ of state supersound process 40-60 minute, add again after frozen-dried supporting agent, antioxidant fully dissolves, filter with prepared blank liposome solution mix homogeneously;
(3) above-mentioned steps (2) gained solution is carried out spray drying, carry out packing under the aseptic condition, make liposome injection of amoxicillin sodium sulbactam sodium medicinal composition.
In the above-mentioned described preparation method, organic solvent is selected from one or more in ethanol, isopropyl alcohol, methanol, butanone, acetone, ethyl acetate, chloroform, dichloromethane or the Ethyl formate, and being preferably volume ratio is 1: 1 the ethanol and the mixed solvent of chloroform.
In the above-mentioned described preparation method, what buffer salt solution can be in phosphate buffer, citrate buffer, carbonate buffer solution, the borate buffer solution is a kind of, is preferably pH value and is phosphoric acid-dipotassium hydrogen phosphate buffer of 6.0.
Liposome injection of amoxicillin sodium sulbactam sodium medicinal composition advantage provided by the invention is as follows:
(1) stability is high: active component Amoxicillin Sodium and sulbactam sodium are wrapped in the liposome, and the long-term every detection index in back of placing does not all have significant change, has greatly improved stability;
(2) envelop rate height: the envelop rate of Liposomal formulation of the present invention is generally 85%-90%, can reach 93%, is higher than other Liposomal formulations according to the conventional method preparation significantly, and long-term placement the seepage phenomenon can not take place, and has guaranteed product quality;
(3) side effect is little: liposome vectors vivo degradation, avirulence and non-immunogenicity, and can improve the Drug therapy index, reduce drug toxicity and reduce drug side effect;
(4) preparation is simple: the present invention selects mixed organic solvents for use, compares with using single organic solvent, and solubility property is better, dissolves sooner, and easier reduction vaporization is removed.
The specific embodiment
Following examples all are for further explaining that the superiority to preparation technology of the present invention and prepared sample carries out, and are unintelligible for the present invention has been done further claim limitation.
The preparation of embodiment 1 liposome injection of amoxicillin sodium sulbactam sodium medicinal composition
Prescription (specification 1.5g)
Amoxicillin Sodium 100g
Sulbactam sodium 50g
Dipalmitoyl phosphatidyl choline 150g
Sodium deoxycholate 50g
Mannitol 150g
Lactose 50g
Ascorbyl palmitate 2.5g
Preparation process
(1) 150g dipalmitoyl phosphatidyl choline and 50g sodium deoxycholate are dissolved in the mixed solvent that the 800ml volume ratio is 1: 1 ethanol and chloroform, placing reduces pressure on the rotating thin film evaporimeter eliminates organic solvent, obtained immobilized artificial membrane, add pH value 6.0 phosphoric acid-dipotassium hydrogen phosphate buffer solution 500ml stirring and dissolving, obtain blank liposome solution;
(2) 100g Amoxicillin Sodium and 50g sulbactam sodium are dissolved in the 400ml water for injection, with prepared blank liposome solution mix homogeneously, be incubated under 50 ℃ of states supersound process 40 minutes, add again after 150g mannitol and 50g lactose, 2.5g ascorbyl palmitate fully dissolve, with 0.45 μ m filtering with microporous membrane;
(3) above-mentioned steps (2) gained solution is carried out spray drying, be distributed into 100 bottles under the aseptic condition, make liposome injection of amoxicillin sodium sulbactam sodium medicinal composition.
The preparation of embodiment 2 liposome injection of amoxicillin sodium sulbactam sodium medicinal composition
Prescription (specification 0.75g)
Amoxicillin Sodium 50g
Sulbactam sodium 25g
Dipalmitoyl phosphatidyl choline 175g
Sodium deoxycholate 100g
Mannitol 225g
Lactose 75g
Ascorbyl palmitate 1.25g
Preparation process
(1) 175g dipalmitoyl phosphatidyl choline and 100g sodium deoxycholate are dissolved in the mixed solvent that the 1200ml volume ratio is 1: 1 ethanol and chloroform, placing reduces pressure on the rotating thin film evaporimeter eliminates organic solvent, obtained immobilized artificial membrane, add pH value 6.0 phosphoric acid-dipotassium hydrogen phosphate buffer solution 600ml stirring and dissolving, obtain blank liposome solution;
(2) 50g Amoxicillin Sodium and 25g sulbactam sodium are dissolved in the 300ml water for injection, with prepared blank liposome solution mix homogeneously, be incubated under 70 ℃ of states supersound process 60 minutes, add again after 225g mannitol and 75g lactose, 1.25g ascorbyl palmitate fully dissolve, with 0.45 μ m filtering with microporous membrane;
(3) above-mentioned steps (2) gained solution is carried out spray drying, be distributed into 100 bottles under the aseptic condition, make liposome injection of amoxicillin sodium sulbactam sodium medicinal composition.
The preparation of embodiment 3 liposome injection of amoxicillin sodium sulbactam sodium medicinal composition
Prescription (specification 0.375g)
Amoxicillin Sodium 25g
Sulbactam sodium 12.5g
Dipalmitoyl phosphatidyl choline 62.5g
Sodium deoxycholate 25g
Mannitol 75g
Lactose 25g
Ascorbyl palmitate 0.25g
Preparation process makes liposome injection of amoxicillin sodium sulbactam sodium medicinal composition with embodiment 2.Comparative example 1-3 respectively write out a prescription component and parts by weight such as table 1.
Table 1 Comparative Examples prescription is formed
| Component | Comparative Examples 1 | Comparative Examples 2 | Comparative Examples 3 |
| Amoxicillin Sodium | ??100g | ??50g | ??25g |
| Sulbactam sodium | ??50g | ??25g | ??12.5g |
| Dipalmitoyl phosphatidyl choline | ??/ | ??175g | ??62.5g |
| Component | Comparative Examples 1 | Comparative Examples 2 | Comparative Examples 3 |
| Soybean lecithin | ??150g | ??/ | ??/ |
| Sodium deoxycholate | ??50g | ??/ | ??25g |
| 18-amine. | ??/ | ??100g | ??/ |
| Mannitol | ??150g | ??225g | ??/ |
| Lactose | ??50g | ??75g | ??/ |
| Trehalose | ??/ | ??/ | ??100g |
| Ascorbyl palmitate | ??2.5g | ??1.25g | ??/ |
| Vitamin E | ??/ | ??/ | ??0.25g |
Prepare liposome injection of amoxicillin sodium sulbactam sodium medicinal composition by above prescription component, preparation method is with embodiment 1.
The investigation of test example 1 liposome
Sample prepared among embodiment 1-3 and the Comparative Examples 1-3 is carried out quality investigation, mainly carry out liposome morphologic observation, particle size determination and liposome encapsulation and measure.
Wherein liposome form and particle size determination adopt optical microscopy and the computing of statistica 5.0 statistical softwares to observe about 2000 to average.Entrapment efficiency determination adopts column chromatography for separation in conjunction with spectrophotometry, this method operating procedure is: use column chromatography the liposome in the drug solution is separated, utilize surfactant to destroy the liposome bilayer, calculate envelop rate with ultraviolet spectrophotometry and standard control again after medicine is discharged.
Every result adds up as following table 2:
The investigation of table 2 liposome
| The liposome form | Mean diameter (nm) | Envelop rate (%) | |
| Embodiment 1 | Spherical or oval entity | ??260 | ??89.6 |
| Embodiment 2 | Spherical or oval entity | ??210 | ??90.1 |
| Embodiment 3 | Spherical or oval entity | ??220 | ??87.7 |
| Comparative Examples 1 | Irregular shape | ??1300 | ??15.0 |
| The liposome form | Mean diameter (nm) | Envelop rate (%) | |
| Comparative Examples 2 | Irregular shape | ??1020 | ??23.3 |
| Comparative Examples 3 | Spherical or oval entity | ??610 | ??55.9 |
Above result has proved absolutely that the liposome effect of embodiment of the invention 1-3 preparation is fine, the form rule, and size is suitable for injection, and envelop rate is higher, has proved practical feasibility of the present invention.
Test example 2 study on the stability
The amoxicillin sodium for injection sulbactam sodium that the sample and the HARBIN PHARMACEUTICAL GROUP CO., LTD. General Pharm. Factory of embodiment of the invention 1-3, Comparative Examples 1-3 preparation are produced was respectively at accelerated test under 40 ℃ of high temperature, relative humidity 75% condition 6 months, respectively the 0th, 1,2,3,6 sampling at the end of month, detect the variation of every index, the every detection index of sample of embodiment of the invention 1-3 preparation as a result has no significant change, related substance obviously increases after 6 months and Comparative Examples 1-3 and listing preparation quicken, content obviously reduces, and the back clarity of redissolving is against regulation.The superiority of the present invention aspect the increase product stability has been described.
Foregoing description of the present invention is intended to explaining, rather than restriction.Concerning the art technology people, can carry out multiple variation or modification in the embodiment described herein.Do not depart from the scope of the present invention or spirit in can obtain these variations.Each list of references that the application quoted is incorporated herein by reference in full at this.
Claims (9)
1. liposome injection of amoxicillin sodium sulbactam sodium medicinal composition, be made up of Amoxicillin Sodium, sulbactam sodium, liposome vectors, frozen-dried supporting agent and the optional antioxidant that exists, wherein said liposome vectors is dipalmitoyl phosphatidyl choline and sodium deoxycholate.
2. liposome injection of amoxicillin sodium sulbactam sodium medicinal composition according to claim 1 is characterized in that Amoxicillin Sodium and sulbactam sodium are 2: 1 aseptic mixtures of weight ratio.
3. according to the arbitrary described liposome injection of amoxicillin sodium sulbactam sodium medicinal composition of claim 1-2, it is characterized in that each composition weight umber is:
2 parts of Amoxicillin Sodiums
1 part of sulbactam sodium
Dipalmitoyl phosphatidyl choline 1.5-11 part
Sodium deoxycholate 0.8-5 part
Frozen-dried supporting agent 3-18 part
Antioxidant 0-2 part.
4. liposome injection of amoxicillin sodium sulbactam sodium medicinal composition according to claim 3 is characterized in that each composition weight umber is:
2 parts of Amoxicillin Sodiums
1 part of sulbactam sodium
Dipalmitoyl phosphatidyl choline 3-7 part
Sodium deoxycholate 1-4 part
Frozen-dried supporting agent 4-12 part
Antioxidant 0.05-0.5 part.
5. according to the arbitrary described liposome injection of amoxicillin sodium sulbactam sodium medicinal composition of claim 1-4, wherein said frozen-dried supporting agent is selected from one or more in sodium chloride, mannitol, glucose, lactose, polyvinylpyrrolidone, sucrose, glycine, sorbitol, trehalose, the dextran, is preferably 3: 1 the mixture of weight ratio of mannitol and lactose.
6. according to the arbitrary described liposome injection of amoxicillin sodium sulbactam sodium medicinal composition of claim 1-5, wherein said antioxidant is selected from one or more in sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, ascorbic acid, vitamin E, propyl gallate, ascorbyl palmitate, the butylated hydroxyarisol, preferred ascorbyl palmitate.
7. method for preparing the arbitrary described liposome injection of amoxicillin sodium sulbactam sodium medicinal composition of claim 1-6, concrete steps comprise:
(1) dipalmitoyl phosphatidyl choline and sodium deoxycholate are dissolved in the organic solvent, placing reduces pressure on the rotating thin film evaporimeter eliminates organic solvent, has obtained immobilized artificial membrane, adds the buffer salt solution stirring and dissolving, obtains blank liposome solution;
(2) Amoxicillin Sodium and sulbactam sodium are dissolved in the water for injection,, are incubated under the 50-70 ℃ of state supersound process 40-60 minute, add again after frozen-dried supporting agent, antioxidant fully dissolves, filter with prepared blank liposome solution mix homogeneously;
(3) above-mentioned steps (2) gained solution is carried out spray drying, carry out packing under the aseptic condition, make liposome injection of amoxicillin sodium sulbactam sodium medicinal composition.
8. the preparation method of liposome injection of amoxicillin sodium sulbactam sodium medicinal composition according to claim 7, it is characterized in that described organic solvent is selected from one or more in ethanol, isopropyl alcohol, methanol, butanone, acetone, ethyl acetate, chloroform, dichloromethane or the Ethyl formate, being preferably volume ratio is 1: 1 the ethanol and the mixed solvent of chloroform.
9. the preparation method of liposome injection of amoxicillin sodium sulbactam sodium medicinal composition according to claim 7, what it is characterized in that wherein said buffer salt solution can be in phosphate buffer, citrate buffer, carbonate buffer solution, the borate buffer solution is a kind of, is preferably pH value and is phosphoric acid-dipotassium hydrogen phosphate buffer of 6.0.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103012429A (en) * | 2012-12-28 | 2013-04-03 | 吴秋萍 | Novel amoxicillin sodium compound and composition of amoxicillin sodium compound and sulbactam sodium compound |
| CN103720657A (en) * | 2013-11-19 | 2014-04-16 | 广东丸美生物技术股份有限公司 | Preparation method of deformable liposome and deformable liposome prepared with method |
| CN104586843A (en) * | 2014-12-25 | 2015-05-06 | 重庆福安药业(集团)股份有限公司 | Amoxicillin sodium sulbactam sodium compound pharmaceutical composition for injector and preparation process thereof |
| CN104887679A (en) * | 2015-04-27 | 2015-09-09 | 海南通用康力制药有限公司 | Piperacillin sodium and sulbactam sodium sterile powder-injection and preparation method thereof |
| US20170202774A1 (en) * | 2014-04-30 | 2017-07-20 | Fujifilm Corporation | Liposome composition and method for producing same |
| WO2018120920A1 (en) * | 2016-12-26 | 2018-07-05 | 上药东英（江苏）药业有限公司 | Cisatracurium besilate lyophilized powder-injection preparation |
| US11684575B2 (en) | 2014-04-30 | 2023-06-27 | Fujifilm Corporation | Liposome composition and method for producing same |
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| CN101623259A (en) * | 2009-07-23 | 2010-01-13 | 海南美大制药有限公司 | Amoxicillin lipidosome solid preparation and new application thereof |
| CN101632660A (en) * | 2009-08-18 | 2010-01-27 | 海南永田药物研究院有限公司 | Suspensoid powder injection of amoxicillin sodium sulbactam sodium medicine composition and novel application thereof |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103012429A (en) * | 2012-12-28 | 2013-04-03 | 吴秋萍 | Novel amoxicillin sodium compound and composition of amoxicillin sodium compound and sulbactam sodium compound |
| CN103012429B (en) * | 2012-12-28 | 2014-12-31 | 吴秋萍 | Novel amoxicillin sodium compound and composition of amoxicillin sodium compound and sulbactam sodium compound |
| CN103720657A (en) * | 2013-11-19 | 2014-04-16 | 广东丸美生物技术股份有限公司 | Preparation method of deformable liposome and deformable liposome prepared with method |
| CN103720657B (en) * | 2013-11-19 | 2017-01-04 | 广东丸美生物技术股份有限公司 | The preparation method of a kind of deformable liposome, and the transmutability liposome of preparation |
| US20170202774A1 (en) * | 2014-04-30 | 2017-07-20 | Fujifilm Corporation | Liposome composition and method for producing same |
| US10772834B2 (en) * | 2014-04-30 | 2020-09-15 | Fujifilm Corporation | Liposome composition and method for producing same |
| US11684575B2 (en) | 2014-04-30 | 2023-06-27 | Fujifilm Corporation | Liposome composition and method for producing same |
| CN104586843A (en) * | 2014-12-25 | 2015-05-06 | 重庆福安药业(集团)股份有限公司 | Amoxicillin sodium sulbactam sodium compound pharmaceutical composition for injector and preparation process thereof |
| CN104887679A (en) * | 2015-04-27 | 2015-09-09 | 海南通用康力制药有限公司 | Piperacillin sodium and sulbactam sodium sterile powder-injection and preparation method thereof |
| CN104887679B (en) * | 2015-04-27 | 2018-07-17 | 海南通用康力制药有限公司 | A kind of piperacillin-sulbactam sodium sterile powder injection and preparation method thereof |
| WO2018120920A1 (en) * | 2016-12-26 | 2018-07-05 | 上药东英（江苏）药业有限公司 | Cisatracurium besilate lyophilized powder-injection preparation |
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| CN101822669B (en) | 2012-06-13 |
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