CN106880587A - Potassium acetate injection and preparation method thereof - Google Patents
Potassium acetate injection and preparation method thereof Download PDFInfo
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- CN106880587A CN106880587A CN201510936358.XA CN201510936358A CN106880587A CN 106880587 A CN106880587 A CN 106880587A CN 201510936358 A CN201510936358 A CN 201510936358A CN 106880587 A CN106880587 A CN 106880587A
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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
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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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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Abstract
The invention discloses a kind of potassium acetate injection and preparation method thereof, the parenteral solution includes that potassium acetate, acid-base modifier and water for injection pH value are 5.5~8.0, and potassium concentration is 2mEq/mL~4mEq/mL.After described potassium acetate water dissolves, pH value, plus activated carbon are adjusted with acid-base modifier, stirred, de- charcoal, constant volume, using polypropylene ampoule filling, the sterilizing of final sterilization method is obtained.The parenteral solution that the present invention is provided have process is simple, low cost, it is safe and reliable, the features such as be easy to Clinical practice.
Description
Technical field
The invention belongs to pharmaceutical technology field, and in particular to a kind of potassium acetate injection and preparation method thereof.
Background technology
Potassium acetate is a kind of benefit potassium preparation, its molecular formula C2H3KO2.Structural formula is：
Potassium（K）It is the dominant cation of intracellular fluid, necessary by cells survival, internal 98% potassium is present in intracellular, and K is the important component for maintaining intracellular osmotic pressure.Cardiac muscle and neuromuscular are required for the K concentration of relative constancy to maintain normal irritability.Divided by ionic condition in the presence of outer, a part of to be combined with protein, another part is combined potassium with sugar and phosphate in intracellular fluid.Potassium all plays an important role at aspects such as cell metabolism, the maintenances for maintaining intracellular fluid osmotic pressure, keeping intraor extracellular acid-base balance, the transmission of nerve impulse, contraction of muscle, myocardial excitability, self-disciplining and conductibility and normal organ function.
Clinically many reasons can cause hypopotassaemia, such as hypoalimentation, vomiting, severe diarrhea, using row's potassium diuretics, lose potassium ephrosis and prolonged application glucocorticoid and supplement hypertonic glucose after the hypopotassaemia reason that causes.Low potassium can influence the resting potential of myocardial cell membrane, inspire aberrant conduction and reentry phenomenon, form severe arrhythmia, increase the incidence of digitalis poisoning；The neuro-muscular disorders such as myasthenia, paralysis, respiratory insufficiency can be caused simultaneously, rhabdomyolysis, electrocardiographic abnormality and intestinal obstruction is can also result in.Long-term Diagnostic value causes renal damage (Diagnostic value ephrosis).
Abroad, the main manufacturer of potassium acetate injection has HOSPIRA companies of the U.S., and there is no potassium acetate injection to list at home.The potassium acetate of HOSPIRA companies is packed using plastics cillin bottle, and the content of aluminium cannot be greater than 200 μ g/L in clear stipulaties product.
Metallic aluminium had not only been dissolved in acid but also had been dissolved in alkali as a kind of harmful element, and the aluminium ion contained in parenteral solution is directly entered blood, and accumulation can be caused in vivo, caused slow poisoning, caused ovarian atrophy, pulmonary fibrosis, blood sugar and glycogen original content to decline；Meanwhile, aluminium ion has neurotoxicity, bone toxicity and Teratogenesis toxicity.
The parenteral solution of domestic listing is generally glass ampule at present, and its main component contains aluminum oxide, and during with potassium acetate injection Long Term Contact, aluminium ion may dissociate, so as to aluminium content is exceeded in causing parenteral solution.And the plastics cillin bottle that HOSPIRA companies use is not resistant to final sterilization through experiment, Sterility Assurance requirement need to be reached using filtration sterilization method or sterile production technique, it is required that many details such as cleanliness factor and equipment of monitor closely its production environment, will otherwise bring very big potential safety hazard.
The content of the invention
The technical problems to be solved by the invention are：Because existing parenteral solution is packed using cillin bottle, it is impossible to tolerate final sterilization, easily bring potential safety hazard；And the country there is no plastics cillin bottle and the equipment that forms a complete production network；Glass ampule may wash out inorganic ion, and wherein chlorion separates out toxic.It is this invention provides a kind of process is simple, low cost, safe and reliable, the potassium acetate injection of being easy to Clinical practice and preparation method thereof.
The present invention is achieved by the following technical solutions：
A kind of potassium acetate injection, is made up of potassium acetate, acid-base modifier, water for injection, and packing container is polypropylene ampoule, using final sterilization method.
Potassium concentration is 2mEq/mL~4mEq/mL, more preferably 2mEq/mL or 4mEq/mL in potassium acetate injection.
Acid-base modifier selection hydrochloric acid, sulfuric acid, acetic acid, citric acid, NaOH, potassium hydroxide, sodium carbonate, potassium carbonate etc., more preferably acetic acid or potassium hydroxide.
The preparation method of the potassium acetate injection, comprises the following steps：
（1）The water for injection of recipe quantity 70% is taken, the potassium acetate of recipe quantity is added, is stirred to dissolve.
（2）Above-mentioned resulting solution pH value is determined, solution ph to 5.5~8.0 is adjusted with acetic acid or potassium hydroxide.
（3）0.1% needle-use activated carbon is added in above-mentioned solution, 30min, filtering decarbonization is stirred.
（4）Water for injection is added to be settled to full dose above-mentioned solution.
（5）By above-mentioned solution with 0.22 μm of filtering with microporous membrane.
（6）With the above-mentioned resulting solution of polypropylene ampoule filling.
（7）By above-mentioned gained parenteral solution pressure sterilizing, 121 DEG C of temperature, time 30min.
The beneficial effect of potassium acetate injection of the present invention and preparation method thereof is：Process is simple, low cost, it is safe and reliable, be easy to Clinical practice, compared with existing potassium acetate injection, the present invention uses final sterilization, is effectively guaranteed the aseptic level of product, and country's polypropylene ampoule filling technology is highly developed at present, beneficial to the industrialization production of product.
Specific embodiment
Embodiment 1
| Potassium acetate | 3.92kg |
| Acetic acid | 0.41kg |
| Water for injection | Add to 20000ml |
| It is made 1000 |
The preparation method of the potassium acetate injection, comprises the following steps：
（1）The water for injection of recipe quantity 70% is taken, the potassium acetate of recipe quantity is added, is stirred to dissolve.
（2）Above-mentioned resulting solution pH value is determined, solution ph to 6.2 is adjusted with acetic acid or potassium hydroxide.
（3）0.1% needle-use activated carbon is added in above-mentioned solution, 30min, filtering decarbonization is stirred.
（4）Water for injection is added to be settled to full dose above-mentioned solution.
（5）By above-mentioned solution with 0.22 μm of filtering with microporous membrane.
（6）With the above-mentioned resulting solution of polypropylene ampoule filling.
（7）By above-mentioned gained parenteral solution pressure sterilizing, 121 DEG C of temperature, time 30min.
Testing result：
| Inspection project | Standard specifies | Assay |
| Proterties | Colourless or almost colourless clear liquid | Colourless clear liquid |
| Differentiate | The identification of aobvious sylvite and acetate | The identification of aobvious sylvite and acetate |
| Content | The 95.0% ~ 105.0% of labelled amount. | 98.2% |
| Acid-base value | PH value should be 5.5 ~ 8.0 | 6.17 |
| Bacterial endotoxin | Meet regulation | Meet regulation |
| It is aseptic | Meet regulation | Meet regulation |
Embodiment 2
| Potassium acetate | 3.92kg |
| Acetic acid | 0.32kg |
| Water for injection | Add to 20000ml |
| It is made 1000 |
The preparation method of the potassium acetate injection, comprises the following steps：
（1）The water for injection of recipe quantity 70% is taken, the potassium acetate of recipe quantity is added, is stirred to dissolve.
（2）Above-mentioned resulting solution pH value is determined, solution ph to 7.1 is adjusted with acetic acid or potassium hydroxide.
（3）0.1% needle-use activated carbon is added in above-mentioned solution, 30min, filtering decarbonization is stirred.
（4）Water for injection is added to be settled to full dose above-mentioned solution.
（5）By above-mentioned solution with 0.22 μm of filtering with microporous membrane.
（6）With the above-mentioned resulting solution of polypropylene ampoule filling.
（7）By above-mentioned gained parenteral solution pressure sterilizing, 121 DEG C of temperature, time 30min.
Testing result：
| Inspection project | Standard specifies | Assay |
| Proterties | Colourless or almost colourless clear liquid | Colourless clear liquid |
| Differentiate | The identification of aobvious sylvite and acetate | The identification of aobvious sylvite and acetate |
| Content | The 95.0% ~ 105.0% of labelled amount. | 98.7% |
| Acid-base value | PH value should be 5.5 ~ 8.0 | 7.12 |
| Bacterial endotoxin | Meet regulation | Meet regulation |
| It is aseptic | Meet regulation | Meet regulation |
Embodiment 3
| Potassium acetate | 7.85kg |
| Acetic acid | 0.78kg |
| Water for injection | Add to 20000ml |
| It is made 1000 |
The preparation method of the potassium acetate injection, comprises the following steps：
（1）The water for injection of recipe quantity 70% is taken, the potassium acetate of recipe quantity is added, is stirred to dissolve.
（2）Above-mentioned resulting solution pH value is determined, solution ph to 6.5 is adjusted with acetic acid or potassium hydroxide.
（3）0.1% needle-use activated carbon is added in above-mentioned solution, 30min, filtering decarbonization is stirred.
（4）Water for injection is added to be settled to full dose above-mentioned solution.
（5）By above-mentioned solution with 0.22 μm of filtering with microporous membrane.
（6）With the above-mentioned resulting solution of polypropylene ampoule filling.
（7）By above-mentioned gained parenteral solution pressure sterilizing, 121 DEG C of temperature, time 30min.
Testing result：
| Inspection project | Standard specifies | Assay |
| Proterties | Colourless or almost colourless clear liquid | Colourless clear liquid |
| Differentiate | The identification of aobvious sylvite and acetate | The identification of aobvious sylvite and acetate |
| Content | The 95.0% ~ 105.0% of labelled amount. | 99.1% |
| Acid-base value | PH value should be 5.5 ~ 8.0 | 6.47 |
| Bacterial endotoxin | Meet regulation | Meet regulation |
| It is aseptic | Meet regulation | Meet regulation |
Embodiment 4
| Potassium acetate | 7.85kg |
| Acetic acid | 0.86kg |
| Water for injection | Add to 20000ml |
| It is made 1000 |
The preparation method of the potassium acetate injection, comprises the following steps：
（1）The water for injection of recipe quantity 70% is taken, the potassium acetate of recipe quantity is added, is stirred to dissolve.
（2）Above-mentioned resulting solution pH value is determined, solution ph to 5.9 is adjusted with acetic acid or potassium hydroxide.
（3）0.1% needle-use activated carbon is added in above-mentioned solution, 30min, filtering decarbonization is stirred.
（4）Water for injection is added to be settled to full dose above-mentioned solution.
（5）By above-mentioned solution with 0.22 μm of filtering with microporous membrane.
（6）With the above-mentioned resulting solution of polypropylene ampoule filling.
（7）By above-mentioned gained parenteral solution pressure sterilizing, 121 DEG C of temperature, time 30min.
Testing result：
| Inspection project | Standard specifies | Assay |
| Proterties | Colourless or almost colourless clear liquid | Colourless clear liquid |
| Differentiate | The identification of aobvious sylvite and acetate | The identification of aobvious sylvite and acetate |
| Content | The 95.0% ~ 105.0% of labelled amount. | 99.4% |
| Acid-base value | PH value should be 5.5 ~ 8.0 | 5.88 |
| Bacterial endotoxin | Meet regulation | Meet regulation |
| It is aseptic | Meet regulation | Meet regulation |
Stability test：
Accelerated test is carried out to 1~embodiment of embodiment 4, method is：Temperature under conditions of relative humidity 25% ± 5%, is investigated at 40 DEG C ± 2 DEG C to 1~embodiment of embodiment 4, time is 6 months, respectively at 0,1,2,3, June sampling, Testing index is proterties, content, acid-base value, aluminium, and the detection bacterium endotoxin and aseptic when 6 months.
As a result：Potassium acetate injection declines by content after study on the stability and is no more than 2.0%, and aluminium is no more than 200 μ g/L, while proterties, acid-base value bacterial endotoxin and aseptic meeting regulation.
Claims (6)
1. a kind of potassium acetate injection, is made up of potassium acetate, acid-base modifier, water for injection, it is characterised in that the parenteral solution potassium concentration is 2mEq/mL~4mEq/mL, and pH value is 5.5~8.0, and packing container is polypropylene ampoule, using final sterilization method.
2. potassium acetate injection according to claim 1, it is characterised in that potassium concentration is 2mEq/mL or 4mEq/mL.
3. potassium acetate injection according to claim 1, it is characterised in that acid-base modifier selection hydrochloric acid, sulfuric acid, acetic acid, citric acid, NaOH, potassium hydroxide, sodium carbonate, potassium carbonate etc..
4. acid-base modifier according to claim 3 is acetic acid or potassium hydroxide.
5. potassium acetate injection according to claim 1, it is characterised in that the pH value is 6.0~7.0.
6. a kind of method of the potassium acetate injection prepared described in claim 1, comprises the following steps：
1）The water for injection of recipe quantity 70% is taken, the potassium acetate of recipe quantity is added, is stirred to dissolve；
2）Above-mentioned resulting solution pH value is determined, solution ph to 5.5~8.0 is adjusted with acetic acid or potassium hydroxide；
3）0.1% needle-use activated carbon is added in above-mentioned solution, 30min, filtering decarbonization is stirred；
4）Water for injection is added to be settled to full dose above-mentioned solution；
5）By above-mentioned solution with 0.22 μm of filtering with microporous membrane；
6）With the above-mentioned resulting solution of polypropylene ampoule filling；
7）By above-mentioned gained parenteral solution pressure sterilizing, 121 DEG C of temperature, time 30min.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510936358.XA CN106880587A (en) | 2015-12-16 | 2015-12-16 | Potassium acetate injection and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510936358.XA CN106880587A (en) | 2015-12-16 | 2015-12-16 | Potassium acetate injection and preparation method thereof |
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| CN106880587A true CN106880587A (en) | 2017-06-23 |
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| CN201510936358.XA Pending CN106880587A (en) | 2015-12-16 | 2015-12-16 | Potassium acetate injection and preparation method thereof |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN204250525U (en) * | 2014-11-28 | 2015-04-08 | 河北天成药业股份有限公司 | A kind of convenient and safe polypropylene ampoule bottle |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN204250525U (en) * | 2014-11-28 | 2015-04-08 | 河北天成药业股份有限公司 | A kind of convenient and safe polypropylene ampoule bottle |
Non-Patent Citations (3)
| Title |
|---|
| OMEGA LABORATORIES LTD.: ""POTASSIUM ACETATE INJECTION USP (Potassium Acetate 39.2% w/v)"", 《PRESCRIBING INFORMATION》 * |
| 刘绪贵 等: "塑料安瓿用于小容量注射剂包装的现状及发展趋势", 《药学研究》 * |
| 张闻天 等: "小容量注射剂于新版GMP实施后的发展方向", 《化工管理》 * |
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Application publication date: 20170623 |
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