CN106667901A - Ribostamycin sulfate injection and preparation method thereof - Google Patents
Ribostamycin sulfate injection and preparation method thereof Download PDFInfo
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- CN106667901A CN106667901A CN201611072872.4A CN201611072872A CN106667901A CN 106667901 A CN106667901 A CN 106667901A CN 201611072872 A CN201611072872 A CN 201611072872A CN 106667901 A CN106667901 A CN 106667901A
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- sodium
- injection
- vistamycin
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- acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/7036—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- Life Sciences & Earth Sciences (AREA)
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- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention provides a ribostamycin sulfate injection and a preparation method thereof, wherein the ribostamycin sulfate injection is prepared from the following components: 100g to 500g of ribostamycin sulfate, 1g of buffering agent, 1g of antioxidant, an appropriate amount of pH (potential of Hydrogen) regulator and 1,000ml of deoxygenated water for injection, wherein the pH of the ribostamycin sulfate injection is 4.5 to 6.5. The ribostamycin sulfate injection and the preparation method thereof, which are disclosed by the invention, have the advantages that the production process is simple and the cost is low; the problems that the ribostamycin sulfate injection cannot meet terminal sterilization and the aseptic guarantee level of a ribostamycin sulfate aseptic powder injection is low are solved; the stability in an expiration date is favorable; the bacterial contamination risk brought about as a currently clinically used powder injection needs to be anew prepared can be avoided.
Description
Technical field
The present invention relates to biological pharmacy technical field, more particularly to a kind of Vistamycin injection and its preparation side
Method.
Background technology
Vistamycin (that is, vistamycin) belongs to aminoglycoside antibioticss, and ribostamycin is to adopt core
A kind of aminoglycoside antibioticss produced by glucosides streptomycete (streptomycesribosidificus), its chemical structural formula
It is as follows.
Ribostamycin feature is that ear, nephrotoxicity are very low, minimum to have now been found that all of D-glucosamine class poisoning by antibiotic
One, therefore, be used to treating the streptococcus sensitive to this product, staphylococcus aureuses, escherichia coli, Proteus,
Respiratory tract infection, urinary tract infection, biliary tract infection caused by streptococcus pneumoniae, pneumobacilluses etc..Because containing in Vistamycin structure
There is glycosidic bond, product is thermo-labile, after high temperature sterilize, product easily becomes the relevant material of normal complexion and raises, therefore is unable to reach pharmacopeia
Requirement.
In existing patent and document, there are no the relevant report with regard to Vistamycin injection, both at home and abroad on
The Vistamycin preparation in city has injection and sterile powder injection, the injection for having listed because ribostamycin cannot high temperature resistant go out
Bacterium, therefore, product cannot meet pharmacopoeial requirements, and the aseptic subpackaged powder pin sterility barrier level for clinically using is low, clinically
Using needing again using using after water for injection preparation, there is the risk for bringing secondary microbiological contamination.Accordingly, it would be desirable to develop one kind
Sterility barrier level is high, and the product of Clinical practice is facilitated again.
The content of the invention
It is an object of the invention to a kind of Vistamycin injection is disclosed, and the Vistamycin injection
Preparation method, to meet Clinical practice demand, it is to avoid clinically using injectable powder prepare injection brought it is operational
Inconvenience, and reduce bacterium infection.
To realize above-mentioned first goal of the invention, the invention provides a kind of Vistamycin injection, including it is following
Component：
Wherein, the pH of Vistamycin injection is in 4.5~6.5.
As a further improvement on the present invention, the buffer agent be acetic acid, sodium acetate, citric acid, sodium citrate, lactic acid,
The mixing of the one or two kinds of any of the above ratio in sodium lactate, disodium hydrogen phosphate, sodium dihydrogen phosphate, carbonic acid or sodium carbonate
Thing.
As a further improvement on the present invention, the antioxidant be sodium sulfite, sodium sulfite, sodium pyrosulfite or
The mixture of the one or two kinds of any of the above ratio in person's sodium thiosulfate.
To realize above-mentioned second goal of the invention, present invention also offers a kind of preparation side of Vistamycin injection
Method, comprises the following steps：
Step (1), Agitation Tank throw in deoxygenate water for injection 800ml, be cooled to room temperature, be passed through shielding gas in Agitation Tank
Body is to saturation；
Step (2), in Agitation Tank buffer agent 1g and antioxidant 1g is thrown in, after fully dissolving, add ribostamycin
100~500g of sulfate and deoxidation water for injection 200ml, and fully dissolve；
Step (3), in Agitation Tank throw in 1.5~3g of medicinal carbon, stirring 30 minutes after, add pH adjusting agent, adjust
The pH to 4.5~6.5 of the solution in section Agitation Tank；
Step (4), filtering with microporous membrane is used, and fill and sealed under the protection of protective gas.
As a further improvement on the present invention, the step (1) is selected from nitrogen, argon with the protective gas in step (4)
Or helium.
As a further improvement on the present invention, included using one-level micropore using filtering with microporous membrane in the step (4)
Membrane filtration and two grades of filtering with microporous membranes, the maximum filtering of wherein one-level microporous filter membrane is a diameter of 0.3 micron, two grades of micropore filters
0.22 micron of the maximum filtering diameter of film.
As a further improvement on the present invention, the buffer agent be acetic acid, sodium acetate, citric acid, sodium citrate, lactic acid,
The mixing of the one or two kinds of any of the above ratio in sodium lactate, disodium hydrogen phosphate, sodium dihydrogen phosphate, carbonic acid or sodium carbonate
Thing；The antioxidant is the one or two kinds of in sodium sulfite, sodium sulfite, sodium pyrosulfite or sodium thiosulfate
The mixture of any of the above ratio.
Compared with prior art, the invention has the beneficial effects as follows：Disclosed Vistamycin injection and
Its preparation method has the advantages that simple production process, low cost, and solving Vistamycin injection can not meet terminal
Sterilizing and the low problem of Vistamycin aseptic powder injection sterility barrier level, effect duration internal stability is good, can avoid mesh
The front injectable powder for clinically using needs to prepare again the microbiological contamination risk brought.
Specific embodiment
With reference to each embodiment, the present invention is described in detail, but it should explanation, these embodiments are simultaneously
Non- limitation of the present invention, those of ordinary skill in the art are according in these embodiment institute work energy, method or structures
Equivalent transformation or replacement, belong within protection scope of the present invention.
" g " in description in each embodiment is unit of weight " gram "；" h " is unit of time " hour "；" ml " is volume
Unit " milliliter "；" room temperature " is 10~30 DEG C.
Embodiment one：
Present embodiment illustrates a kind of Vistamycin injection, it includes following components：
Wherein, the pH of Vistamycin injection is in 4.5~6.5.
Buffer agent is most preferably sodium citrate, and antioxidant is most preferably sodium sulfite, and pH adjusting agent can be molten for hydrochloric acid
Liquid, sodium hydroxide solution, the oxygen content deoxygenated in water for injection is less than 0.1ppm.
Embodiment two：
Present embodiment discloses a kind of preparation method of Vistamycin injection, comprises the following steps：
Step (1), Agitation Tank throw in deoxygenate water for injection 800ml, be cooled to room temperature, be passed through shielding gas in Agitation Tank
Body is to saturation.
Step (2), in Agitation Tank buffer agent 1g and antioxidant 1g is thrown in, after fully dissolving, add ribostamycin
100~500g of sulfate and deoxidation water for injection 200ml, and fully dissolve.
Step (3), in Agitation Tank throw in 1.5~3g of medicinal carbon, stirring 30 minutes after, add pH adjusting agent, adjust
The pH to 4.5~6.5 of the solution in section Agitation Tank.The pH adjusting agent is sulphuric acid or sodium hydroxide.
Step (4), filtering with microporous membrane is used, and fill and sealed under the protection of protective gas.
Wherein, the protective gas is selected from nitrogen, argon or helium, and most preferably nitrogen.Step adopts micropore in (4)
Membrane filtration includes adopting one-level filtering with microporous membrane and two grades of filtering with microporous membranes, wherein, the most serious offense of one-level microporous filter membrane
A diameter of 0.3 micron is filtered, 0.22 micron of the maximum filtering diameter of two grades of microporous filter membrane.Buffer agent is acetic acid, sodium acetate, citron
One or two kinds of in acid, sodium citrate, lactic acid, sodium lactate, disodium hydrogen phosphate, sodium dihydrogen phosphate, carbonic acid or sodium carbonate
The mixture of any of the above ratio, and most preferably sodium citrate.Antioxidant is sodium sulfite, sodium sulfite, burnt sulfurous
The mixture of the one or two kinds of any of the above ratio in sour sodium or sodium thiosulfate, and most preferably sodium sulfite.
Additionally, the step of the deoxidation water for injection in may also include to being thrown to Agitation Tank in step (1) is heated to 30 DEG C.
The a series of detailed description of those listed above is only for the feasibility embodiment of the present invention specifically
Bright, they simultaneously are not used to limit the scope of the invention, all equivalent implementations made without departing from skill spirit of the present invention
Or change should be included within the scope of the present invention.
It is obvious to a person skilled in the art that the invention is not restricted to the details of above-mentioned one exemplary embodiment, Er Qie
In the case of spirit or essential attributes without departing substantially from the present invention, the present invention can be in other specific forms realized.Therefore, no matter
From the point of view of which point, embodiment all should be regarded as exemplary, and be nonrestrictive, the scope of the present invention is by appended power
Profit is required rather than described above is limited, it is intended that all in the implication and scope of the equivalency of claim by falling
Change is included in the present invention.
Moreover, it will be appreciated that although this specification is been described by according to embodiment, not each embodiment is only wrapped
Containing an independent technical scheme, this narrating mode of description is only that for clarity those skilled in the art should
Using description as an entirety, the technical scheme in each embodiment can also Jing it is appropriately combined, form those skilled in the art
Understandable other embodiment.
Claims (7)
1. a kind of Vistamycin injection, it is characterised in that including following components：
Wherein, the pH of Vistamycin injection is in 4.5~6.5.
2. Vistamycin injection according to claim 1, it is characterised in that the buffer agent is acetic acid, acetic acid
One kind in sodium, citric acid, sodium citrate, lactic acid, sodium lactate, disodium hydrogen phosphate, sodium dihydrogen phosphate, carbonic acid or sodium carbonate or
The mixture of the two or more arbitrary proportions of person.
3. Vistamycin injection according to claim 1, it is characterised in that the antioxidant is sulfurous acid
The mixture of the one or two kinds of any of the above ratio in sodium, sodium sulfite, sodium pyrosulfite or sodium thiosulfate.
4. a kind of preparation method of Vistamycin injection, it is characterised in that comprise the following steps：
Step (1), Agitation Tank throw in deoxygenate water for injection 800ml, be cooled to room temperature, protective gas is passed through in Agitation Tank extremely
Saturation；
Step (2), in Agitation Tank buffer agent 1g and antioxidant 1g is thrown in, after fully dissolving, add ribostamycin sulphuric acid
100~500g of salt and deoxidation water for injection 200ml, and fully dissolve；
Step (3), 1.5~3g of medicinal carbon is thrown in in Agitation Tank, after stirring 30 minutes, add pH adjusting agent, regulation matches somebody with somebody
The pH of the solution in flow container to 4.5~6.5；
Step (4), filtering with microporous membrane is used, and fill and sealed under the protection of protective gas.
5. preparation method according to claim 4, it is characterised in that the protective gas in the step (1) and step (4)
Selected from nitrogen, argon or helium.
6. preparation method according to claim 4, it is characterised in that filtering with microporous membrane bag is adopted in the step (4)
Include using one-level filtering with microporous membrane and two grades of filtering with microporous membranes, the maximum filtering a diameter of 0.3 of wherein one-level microporous filter membrane
Micron, 0.22 micron of the maximum filtering diameter of two grades of microporous filter membrane.
7. preparation method according to claim 4, it is characterised in that the buffer agent be acetic acid, sodium acetate, citric acid,
It is more than the one or two kinds of in sodium citrate, lactic acid, sodium lactate, disodium hydrogen phosphate, sodium dihydrogen phosphate, carbonic acid or sodium carbonate
The mixture of arbitrary proportion；The antioxidant is in sodium sulfite, sodium sulfite, sodium pyrosulfite or sodium thiosulfate
One or two kinds of any of the above ratio mixture.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611072872.4A CN106667901A (en) | 2016-11-29 | 2016-11-29 | Ribostamycin sulfate injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611072872.4A CN106667901A (en) | 2016-11-29 | 2016-11-29 | Ribostamycin sulfate injection and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106667901A true CN106667901A (en) | 2017-05-17 |
Family
ID=58866831
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201611072872.4A Pending CN106667901A (en) | 2016-11-29 | 2016-11-29 | Ribostamycin sulfate injection and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107670043A (en) * | 2017-10-31 | 2018-02-09 | 无锡福祈制药有限公司 | A kind of pharmaceutical composition for treating helicobacter pylori |
| CN109900817A (en) * | 2017-12-11 | 2019-06-18 | 江苏省食品药品监督检验研究院 | A kind of analysis injection ribostamin content and the high performance liquid chromatography charged aerosol detectors method in relation to substance |
| CN109900836A (en) * | 2017-12-11 | 2019-06-18 | 江苏省食品药品监督检验研究院 | A kind of analysis injection ribostamin content and high performance liquid chromatography-pulsed amperometry method in relation to substance |
| CN109900816A (en) * | 2017-12-11 | 2019-06-18 | 江苏省食品药品监督检验研究院 | A kind of analysis injection ribostamin content and the high performance liquid chromatography evaporative light-scattering detector method in relation to substance |
-
2016
- 2016-11-29 CN CN201611072872.4A patent/CN106667901A/en active Pending
Non-Patent Citations (2)
| Title |
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| 李平、王万武: "硫酸核糖霉素注射液的制备", 《药学通报》 * |
| 杜克礼等编写: "《简明药剂学》", 28 February 1994, 人民卫生出版社 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107670043A (en) * | 2017-10-31 | 2018-02-09 | 无锡福祈制药有限公司 | A kind of pharmaceutical composition for treating helicobacter pylori |
| CN109900817A (en) * | 2017-12-11 | 2019-06-18 | 江苏省食品药品监督检验研究院 | A kind of analysis injection ribostamin content and the high performance liquid chromatography charged aerosol detectors method in relation to substance |
| CN109900836A (en) * | 2017-12-11 | 2019-06-18 | 江苏省食品药品监督检验研究院 | A kind of analysis injection ribostamin content and high performance liquid chromatography-pulsed amperometry method in relation to substance |
| CN109900816A (en) * | 2017-12-11 | 2019-06-18 | 江苏省食品药品监督检验研究院 | A kind of analysis injection ribostamin content and the high performance liquid chromatography evaporative light-scattering detector method in relation to substance |
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