CN106389310A - Sodium ibandronate and glucose injection - Google Patents
Sodium ibandronate and glucose injection Download PDFInfo
- Publication number
- CN106389310A CN106389310A CN201610796989.0A CN201610796989A CN106389310A CN 106389310 A CN106389310 A CN 106389310A CN 201610796989 A CN201610796989 A CN 201610796989A CN 106389310 A CN106389310 A CN 106389310A
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- ibandronate
- glucose
- injection
- water
- add
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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
- A61K31/66—Phosphorus compounds
- A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
- A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
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- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention provides a sodium ibandronate and glucose injection, and relates to the technical field of pharmaceutical preparations. The sodium ibandronate and glucose injection consists of 0.005w/v% of sodium ibandronate, 5-10w/v% of glucose and 4-8w/v% of a stabilizer. The sodium ibandronate injection provided by the invention is simple in prescription, and all adjuvants adopted in the prescription are common adjuvants for injection and are free from sodium acetate; and the injection, in intravenous administration, is free from irritation to human body and is high in safety; and the sodium ibandronate injection is stable in quality, low in cost, simple to prepare and applicable to industrial production.
Description
Technical field
The present invention relates to technical field of medicine is and in particular to a kind of ibandronate Glucose Injection.
Background technology
Venous transfusion is clinical treatment and the main path of first aid using medicine and supply nutrition, and medication infusion phlebitis are
Clinically one of common drug-induced disease.At present it is believed that phlebitis are to form one of venothrombotic risk factor.People
The pH value of body blood is 7.35-7.45, and the pH scope that human body can tolerate transfusion is 4-9.When transfusion pH is less than 4 or is higher than 9, can lead
Cause pain and phlebitic generation, and the phlebitic order of severity is directly related with the pH of transfusion, pH value is lower, and phlebitis are just
More serious.Japanese Otsuka Pharmaceutical Co., Ltd. Kuwahara etc. is tested using rabbit, and result shows that instillation pH value is less than 4.5
Transfusion lead to phlebitic incidence rate to be up to 100%, with transfusion pH value continuous rising, phlebitic incidence rate and inflammation
Degree constantly decline, pH rise to 6.5 and more than, substantially there are not phlebitis.(Chinese medical forward position, 2009,4 (22)：13)
Ibandronate (Sodium Ibandronate) belong to the third generation bisphosphonate compound it is adaptable to or
The hypercalcemia causing without the malignant tumor of Bone tumour, for treating osteodynia that malignant osteolytic Bone tumour causes etc.
Disease.Ibandronate is unstable in aqueous, easily degrades, and main catabolite is free phosphorus hydrochlorate.
Therefore, all there is low, relevant content of material height of adjuvant safety etc. in Ibandronate of the prior art
Problem.How both to adopt the higher pharmaceutic adjuvant of safety, and the relevant material of energy effective control Ibandronate, from
Fundamentally ensure drug safety, remain and need those skilled in the art to put forth effort the technical problem solving.
Content of the invention
For the deficiencies in the prior art, the invention provides a kind of ibandronate Glucose Injection, can be by her class
The relevant content of material of phosphonic acids sodium injection controls to extremely low level, and adjuvant is safe, simple prescription, and low production cost is non-
Often it is suitable for industrialized production.
For realizing object above, the present invention is achieved by the following technical programs：
A kind of ibandronate Glucose Injection, containing ibandronate 0.005w/v% and glucose 5～10w/
V%.
Preferably, the also stabilizer containing 4-8w/v% in described ibandronate Glucose Injection.
Preferably, described stabilizer is from one or more of Sorbitol, Mannitol compositionss.
Preferably, the preparation method of described ibandronate Glucose Injection, comprises the following steps：
(1) weigh glucose to be dissolved in water for injection, add needle-use activated carbon, heated and stirred 15min at 60 DEG C；
(2) filter decarburization；
(3) weigh 5g ibandronate and add 2000ml water, stir and after being completely dissolved to ibandronate, be slowly poured into step
Suddenly in the glucose solution of (2), stirring and evenly mixing, add water to 90000ml；
(4) hydrochloric acid or sodium hydroxide is used to adjust pH value for 4.2～5.2；
(5) mend and inject water to cumulative volume for 100000ml；
(6) with 0.22 μm of microporous filter membrane fine straining；
(7) fill, to 100ml glass infusion bottle, every bottle of 100ml, rolls lid；
(8) 121 DEG C sterilize 8 minutes, and sterilizing is reduced to room temperature in latter 30 minutes.
Preferably, the consumption of described activated carbon is 30～40g.
Preferably, 1mol/L hydrochloric acid solution or 1mol/L sodium hydroxide solution is used to adjust pH value in step (4).
Beneficial effects of the present invention：
(1) prescription is simple, and adjuvant used in prescription is the conventional adjuvant of injection, safe；
(2) do not contain Sodium Acetate Trihydrate in the present composition, during intravenously administrable, zest will not be produced to human body；
(3) the Ibandronate steady quality of present invention preparation, relevant material and content's index are superior to existing
Technology.
The prescription of Ibandronate of the present invention is extremely simple, safety is high, with low cost, is suitable for industry metaplasia
Produce.
Specific embodiment
Purpose, technical scheme and advantage for making the embodiment of the present invention are clearer, below will be in the embodiment of the present invention
Technical scheme be clearly and completely described it is clear that described embodiment a part of embodiment that is the present invention, rather than
Whole embodiments.Based on the embodiment in the present invention, those of ordinary skill in the art are not making creative work premise
Lower obtained every other embodiment, broadly falls into the scope of protection of the invention.
Embodiment 1：
A kind of ibandronate Glucose Injection, containing ibandronate 0.005w/v% and glucose 5w/v%, 4w/
The Sorbitol of v%.
The preparation method of described ibandronate Glucose Injection, comprises the following steps：
(1) weigh 5Kg glucose to be dissolved in 30L water for injection, add 30g needle-use activated carbon, heated and stirred at 60 DEG C
15min；
(2) filter decarburization；
(3) weigh 5g ibandronate and add 2000ml water, stir and after being completely dissolved to ibandronate, be slowly poured into step
Suddenly, in the glucose solution of (2), add 4Kg Mannitol stirring and evenly mixing, add water to 90000ml；
(4) using 1mol/L sodium hydroxide solution to adjust pH value is 5.2；
(5) mend and inject water to cumulative volume for 100000ml；
(6) with 0.22 μm of microporous filter membrane fine straining；
(7) fill, to 100ml glass infusion bottle, every bottle of 100ml, rolls lid；
(8) 121 DEG C sterilize 8 minutes, and sterilizing is reduced to room temperature in latter 30 minutes.
Embodiment 2：
A kind of ibandronate Glucose Injection, containing ibandronate 0.005w/v% and glucose 10w/v%,
In the Mannitol of 8w/v%.
The preparation method of described ibandronate Glucose Injection, comprises the following steps：
(1) weigh 10Kg glucose to be dissolved in 30L water for injection, add 40g needle-use activated carbon, heated and stirred at 60 DEG C
15min；
(2) filter decarburization；
(3) weigh 5g ibandronate and add 2000ml water, stir and after being completely dissolved to ibandronate, be slowly poured into step
Suddenly, in the glucose solution of (2), add 8Kg Mannitol stirring and evenly mixing, add water to 90000ml；
(4) with adjusting pH value for 4.2 with 1mol/L hydrochloric acid solution；
(5) mend and inject water to cumulative volume for 100000ml；
(6) with 0.22 μm of microporous filter membrane fine straining；
(7) fill, to 100ml glass infusion bottle, every bottle of 100ml, rolls lid；
(8) 121 DEG C sterilize 8 minutes, and sterilizing is reduced to room temperature in latter 30 minutes.
Embodiment 3：
A kind of ibandronate Glucose Injection, containing ibandronate 0.005w/v% and glucose 8w/v%, 6w/
In the Mannitol of v%.
The preparation method of described ibandronate Glucose Injection, comprises the following steps：
(1) weigh 10Kg glucose to be dissolved in 35L water for injection, add 40g needle-use activated carbon, heated and stirred at 60 DEG C
15min；
(2) filter decarburization；
(3) weigh 5g ibandronate and add 2000ml water, stir and after being completely dissolved to ibandronate, be slowly poured into step
Suddenly, in the glucose solution of (2), add 6Kg Mannitol stirring and evenly mixing, add water to 90000ml；
(4) with adjusting pH value for 4.2 with 1mol/L hydrochloric acid solution；
(5) mend and inject water to cumulative volume for 100000ml；
(6) with 0.22 μm of microporous filter membrane fine straining；
(7) fill, to 100ml glass infusion bottle, every bottle of 100ml, rolls lid；
(8) 121 DEG C sterilize 8 minutes, and sterilizing is reduced to room temperature in latter 30 minutes.
To sum up, the embodiment of the present invention has the advantages that：The prescription of Ibandronate of the present invention is extremely simple
Single, safety is high, with low cost, suitable industrialized production.
It should be noted that herein, such as first and second or the like relational terms are used merely to a reality
Body or operation are made a distinction with another entity or operation, and not necessarily require or imply these entities or deposit between operating
In any this actual relation or order.And, term " inclusion ", "comprising" or its any other variant are intended to
Comprising of nonexcludability, wants so that including a series of process of key elements, method, article or equipment and not only including those
Element, but also include other key elements being not expressly set out, or also include for this process, method, article or equipment
Intrinsic key element.In the absence of more restrictions, the key element that limited by sentence "including a ..." it is not excluded that
Also there is other identical element including in the process of described key element, method, article or equipment.
Above example only in order to technical scheme to be described, is not intended to limit；Although with reference to the foregoing embodiments
The present invention has been described in detail, it will be understood by those within the art that：It still can be to aforementioned each enforcement
Technical scheme described in example is modified, or carries out equivalent to wherein some technical characteristics；And these modification or
Replace, do not make the essence of appropriate technical solution depart from the spirit and scope of various embodiments of the present invention technical scheme.
Claims (6)
1. a kind of ibandronate Glucose Injection is it is characterised in that contain ibandronate 0.005w/v% and glucose 5
～10w/v%.
2. ibandronate Glucose Injection as claimed in claim 1 is it is characterised in that described ibandronate glucose
The also stabilizer containing 4-8w/v% in injection.
3. ibandronate Glucose Injection as claimed in claim 2 is it is characterised in that described stabilizer is from Pyrusussuriensiss
One or more of alcohol, Mannitol compositionss.
4. ibandronate Glucose Injection as claimed in claim 3 is it is characterised in that described ibandronate glucose
The preparation method of injection, comprises the following steps：
(1) weigh glucose to be dissolved in water for injection, add needle-use activated carbon, heated and stirred 15min at 60 DEG C；
(2) filter decarburization；
(3) weigh 5g ibandronate and add 2000ml water, stir and after being completely dissolved to ibandronate, be slowly poured into step (2)
Glucose solution in, stirring and evenly mixing, add water to 90000ml；
(4) hydrochloric acid or sodium hydroxide is used to adjust pH value for 4.2～5.2；
(5) mend and inject water to cumulative volume for 100000ml；
(6) with 0.22 μm of microporous filter membrane fine straining；
(7) fill, to 100ml glass infusion bottle, every bottle of 100ml, rolls lid；
(8) 121 DEG C sterilize 8 minutes, and sterilizing is reduced to room temperature in latter 30 minutes.
5. ibandronate Glucose Injection as claimed in claim 4 is it is characterised in that the consumption of described activated carbon is 30
～40g.
6. ibandronate Glucose Injection as claimed in claim 5 is it is characterised in that use 1mol/L in step (4)
Hydrochloric acid solution or 1mol/L sodium hydroxide solution adjust pH value.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610796989.0A CN106389310A (en) | 2016-08-31 | 2016-08-31 | Sodium ibandronate and glucose injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610796989.0A CN106389310A (en) | 2016-08-31 | 2016-08-31 | Sodium ibandronate and glucose injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106389310A true CN106389310A (en) | 2017-02-15 |
Family
ID=58001276
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610796989.0A Pending CN106389310A (en) | 2016-08-31 | 2016-08-31 | Sodium ibandronate and glucose injection |
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| Country | Link |
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| CN (1) | CN106389310A (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103070824A (en) * | 2013-01-24 | 2013-05-01 | 天津红日药业股份有限公司 | Ibandronate sodium containing injection |
| CN104922060A (en) * | 2015-05-23 | 2015-09-23 | 河北仁合益康药业有限公司 | Sodium ibandronate injection composition |
-
2016
- 2016-08-31 CN CN201610796989.0A patent/CN106389310A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103070824A (en) * | 2013-01-24 | 2013-05-01 | 天津红日药业股份有限公司 | Ibandronate sodium containing injection |
| CN104922060A (en) * | 2015-05-23 | 2015-09-23 | 河北仁合益康药业有限公司 | Sodium ibandronate injection composition |
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| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20170215 |
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