CN102716147A - Sodium bicarbonate injection and preparation method thereof - Google Patents
Sodium bicarbonate injection and preparation method thereof Download PDFInfo
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- CN102716147A CN102716147A CN2012102091627A CN201210209162A CN102716147A CN 102716147 A CN102716147 A CN 102716147A CN 2012102091627 A CN2012102091627 A CN 2012102091627A CN 201210209162 A CN201210209162 A CN 201210209162A CN 102716147 A CN102716147 A CN 102716147A
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Abstract
The invention discloses sodium bicarbonate injection and a preparation method thereof. The sodium bicarbonate injection is characterized by comprising 46.0 to 53.5 grams of sodium bicarbonate, 0.98 to 0.11 gram of calcium disodium edentate and 1,000 milliliters of water for injection. By the sodium bicarbonate injection and the preparation method thereof, the problem that the related patent protection of the sodium bicarbonate injection is not provided at present is solved.
Description
Technical field
The present invention relates to the medicament preparation field, be specifically related to a kind of sodium bicarbonate injection and method for preparing.
Background technology
Sodium bicarbonate injection can be treated metabolic acidosis, can make that carbonate concentration raises in the blood plasma, in and hydrion; Thereby the correction acidosis, sodium bicarbonate injection ability alkalized urine is because carbonate concentration increases back pH value rising in the urine; Make uric acid, sulfa drugs and hemoglobin etc. be difficult in urine, forming crystallization or gathering; Sodium bicarbonate injection can antacid, orally can neutralize rapidly or cushion gastric acid, and directly not influence gastric acid secretion.Thereby gastric pH raises rapidly and alleviates the symptom that high gastric acid causes, sodium bicarbonate injection records in Chinese Pharmacopoeia version in 2005, is categorized as 6 types of registrations according to existing " medicine registration management way " chemical medicine registration, i.e. the preparation of existing national standard.These article are imitated kinds, through patent retrieval, do not see relevant patent protection.
Summary of the invention
To the problem that does not have spendable sodium bicarbonate injection clinically in the prior art and propose the present invention, for this reason, main purpose of the present invention is to provide a kind of sodium bicarbonate injection and method for preparing, to address the above problem.
According to an aspect of the present invention, a kind of sodium bicarbonate injection is provided, has comprised: sodium bicarbonate 46.0～53.5g, calcium disodium edetate 0.98～0.11g and water for injection add to 1000ml.
According to a further aspect in the invention, a kind of method for preparing of above-mentioned sodium bicarbonate injection is provided also, has comprised: 25%～35% the water for injection of getting total amount of preparation 1000ml is in dense preparing tank; Water for injection is cooled to 30 ℃～40 ℃, drops into the sodium bicarbonate of 46.0～53.5g, the calcium disodium edetate of 0.98～0.11g, process concentrated solution; Stirring makes dissolving, adds moistening 0.02% (g/v) active carbon in advance, opens blender; Stir 10～20min, coarse filtration beats medicinal liquid to dilute preparing tank.In dilute preparing tank, mend and add to the full amount of water for injection, open blender and reflux pump, stirring and refluxing 10～20min ceaselessly feeds carbon dioxide toward medicinal liquid in, and sampling detects, and makes pH value to 7.9-8.1, filters, and lid is rolled in embedding, the sterilization lamp inspection, and packing is put in storage.
Preferably, the preparation of said sodium bicarbonate injection is earlier dense joins rare joining of back.
Need add a certain proportion of calcium disodium edetate when preferably, preparing sodium bicarbonate solution.
Preferably, said sampling is detected on rare turn on pump detection level, pH value of taking a sample behind 10～20min that reflux of joining.
Preferably, after pH value meets the requirements, extremely clear and bright with 0.22 micron filtering with microporous membrane.
Preferably, said vial is 250ml, and the specification of sodium bicarbonate injection is 250ml:12.5g.
Through the present invention, solved the problem that does not have spendable sodium bicarbonate injection at present clinically.。
Description of drawings
Below in conjunction with accompanying drawing and embodiment the present invention is further specified.
Fig. 1 is preparation technology's flow chart of a kind of sodium bicarbonate injection of the present invention and method for preparing.
The specific embodiment
Below in conjunction with accompanying drawing and specific embodiment a kind of sodium bicarbonate injection of the present invention and method for preparing are done further to describe.
The sodium bicarbonate injection that provides in the present embodiment is write out a prescription as follows:
Sodium bicarbonate 46.0～53.5g
Calcium disodium edetate 0.98～0.11g
Water for injection adds to 1000ml
In the present embodiment, preferred sodium bicarbonate injection specification is: 250ml:12.5g.
Sodium bicarbonate is prone to dissolving in water.And the prescription in the present embodiment through the test, sodium bicarbonate: 46.0～53.5g, calcium disodium edetate: 0.98～0.11g, water for injection add to 1000ml.Dissolving in order.Through sterilization back with deposit more than half a year, achromatism and clarity still.
The consumption of adjuvant
Owing to contain a small amount of Ca2+, Mg2+ and other metal ion in the sodium bicarbonate raw material; Medicinal liquid is put for a long time and is prone to produce deposition; Therefore when preparating liquid, need add a certain proportion of calcium disodium edetate complexation Ca2+, Mg2+ and other metal ion, we confirm that following three prescriptions screen:
Table 1 prescription component table
| Prescription 1 | Prescription 2 | Prescription 3 | |
| The sodium bicarbonate raw material | 50.0～53.5g | 46.0～53.5g | 48.0～53.5g |
| Calcium disodium edetate | / | 0.98～0.11g | 0.19～0.22g |
| Water for injection | Add to 1000ml | Add to 1000ml | Add to 1000ml |
Prepare sample respectively by above prescription, through 110～120 ℃ of (flowing steam sterilization in 25～35 minutes, variations of items such as the visible foreign matters of investigation sample, pH value, content.Test data sees the following form.
Table 2 three prescription sterilization back test data tables
Result of the test: after prescription 1 sterilization, its visible foreign matters is against regulation, pH value, content do not have significant change; After prescription 2, prescription 3 sterilizations, its visible foreign matters is all up to specification, pH value, content have no significant change.In line with the principle that adds adjuvant less as far as possible, we confirm the prescription 2 final prescriptions as this preparation under the prerequisite of ensuring the quality of products.
The mensuration of osmotic pressure
Take by weighing sodium bicarbonate 46.0～53.5g; Add the injection water to 1000ml, pH value transfers to 7.9-8.1, after stirring makes and dissolves; Therefrom getting about 1ml puts in the special-purpose test tube of osmometry; On the SMC freezing-point osmometer, go up the rule of operation of defined then to specifications and measure its osmotic pressure, measuring the result is 1002m0smol, suitable with the osmotic pressure of the sample that goes on the market.We select concentration is 4.5%～5.5% the sodium bicarbonate solution optium concentration as these article.
The consumption of medicinal charcoal
The consumption of injection medicinal charcoal is generally 0.01%-0.5% (the 4th edition Bi Dianzhou chief editor 259 of pharmaceutics), and the consumption result of the test of relevant medicinal charcoal is seen table 3:
| Medicinal charcoal consumption (g/v) | Visible foreign matters | Content (%) |
| 0 | Against regulation | 99.37 |
| 0.02％ | Up to specification | 99.16 |
| 0.05％ | Up to specification | 98.91 |
To sum up show saidly, amount of activated is little to content influence, but influential to visible foreign matters, and in line with the principle that under the prerequisite of ensuring the quality of products, adds adjuvant less as far as possible, the consumption that we select medicinal charcoal is 0.01%～0.05%.The research of sterilising temp and time
Press the sodium bicarbonate injection sample of recipe quantity preparation some, embedding.We are divided into halves with the medicinal liquid that makes, and a copy of it was sterilized in water-bath type sterilization cabinet through 110～120 ℃, 25～35 minutes, and another part warp was sterilized in water-bath type sterilization cabinet in 115～125 ℃, 10～20 minutes.Detect visible foreign matters, pH value, the content of sterilization front and back respectively, the result sees the following form 4:
Table 4 sample sterilization before and after test result
Conclusion: these article were through 110～120 ℃, 25～35 minutes and sterilization in 115～125 ℃, 10～20 minutes, and character, pH value, content do not have to change basically, and is up to specification.But excessively the sterilization bottle explosion is too many, and possibly meeting high temperature with medicinal liquid, to produce excess air relevant.Therefore, it is feasible that these article adopt 110～120 ℃, 25～35 minutes sterilization schemes.
The supplementary material source and the quality standard thereof of present embodiment: the sodium bicarbonate quality standard meets Chinese Pharmacopoeia 2005 editions, and the calcium disodium edetate quality standard meets YBH09652009.
Pharmacokinetic parameter also is provided in the present embodiment: sodium bicarbonate injection directly gets into blood circulation after intravenous drip.Sodium bicarbonate gets into urine and discharges through glomerular filtration in the blood.Hydrogen ions generates carbonic acid in part bicarbonate ion and the urine, resolves into carbon dioxide and water again.But the former gets into renal tubular cell at disperse, combines with water in the born of the same parents, generates carbonic acid, and the bicarbonate ion after dissociating is heavily absorbed gets into blood circulation.Hydrogen ions generation carbonic acid in bicarbonate ion and the blood in the blood, and then resolve into carbon dioxide and water, the former breathes out through lung.
Above-described embodiment, the present invention specific embodiment a kind of more preferably just, common variation that those skilled in the art carries out in technical scheme scope of the present invention and replacement all should be included in protection scope of the present invention.
Claims (6)
1. sodium bicarbonate injection and method for preparing, comprising: sodium bicarbonate 46.0～53.5g, calcium disodium edetate 0.98～0.11g and water for injection add to 1000ml, it is characterized in that: comprising: 25%～35% the water for injection of getting total amount of preparation 1000ml is in dense preparing tank; Water for injection is cooled to 30 ℃～40 ℃, drops into the sodium bicarbonate of 46.0～53.5g, the calcium disodium edetate of 0.98～0.11g, process concentrated solution; Stirring makes dissolving; Add moistening 0.01%-0.5% (g/v) active carbon in advance, open blender, stir 10～20min; Coarse filtration beats medicinal liquid to dilute preparing tank.In dilute preparing tank, mend and add to the full amount of water for injection, open blender and reflux pump, stirring and refluxing 10～20min ceaselessly feeds carbon dioxide toward medicinal liquid in, and sampling detects, and makes pH value to 7.9-8.1, filters, and lid is rolled in embedding, sterilization, and lamp inspection, packing is put in storage.
2. a kind of sodium bicarbonate injection according to claim 1 and method for preparing is characterized in that, the preparation of said sodium bicarbonate injection is earlier dense joins rare joining of back.
3. a kind of sodium bicarbonate injection according to claim 1 and method for preparing is characterized in that, need add a certain proportion of calcium disodium edetate during the preparation sodium bicarbonate solution.
4. a kind of sodium bicarbonate injection according to claim 1 and method for preparing is characterized in that, said sampling is detected on rare turn on pump detection level, pH value of taking a sample behind 10～20min that reflux of joining.
5. a kind of sodium bicarbonate injection according to claim 1 and method for preparing is characterized in that, and be after pH value meets the requirements, extremely clear and bright with 0.22 micron filtering with microporous membrane.
6. a kind of sodium bicarbonate injection according to claim 1 and method for preparing is characterized in that, said vial is 250ml, and the specification of sodium bicarbonate injection is 250ml:12.5g.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103754403A (en) * | 2014-01-08 | 2014-04-30 | 中国大冢制药有限公司 | Method for packaging sodium bicarbonate injection |
| CN103800285A (en) * | 2012-11-06 | 2014-05-21 | 四川科伦药业股份有限公司 | Sodium bicarbonate injection liquid and preparation method thereof |
| US11925703B1 (en) | 2022-07-29 | 2024-03-12 | Xellia Pharmaceuticals Aps | Liquid composition comprising glucose |
-
2012
- 2012-06-25 CN CN2012102091627A patent/CN102716147A/en active Pending
Non-Patent Citations (1)
| Title |
|---|
| 曹瑞敏等: "碳酸氢钠注射液配制方法的研究", 《中国兽药杂志》 * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103800285A (en) * | 2012-11-06 | 2014-05-21 | 四川科伦药业股份有限公司 | Sodium bicarbonate injection liquid and preparation method thereof |
| CN103800285B (en) * | 2012-11-06 | 2016-06-22 | 四川科伦药业股份有限公司 | A kind of sodium bicarbonate injection and preparation method thereof |
| CN103754403A (en) * | 2014-01-08 | 2014-04-30 | 中国大冢制药有限公司 | Method for packaging sodium bicarbonate injection |
| CN103754403B (en) * | 2014-01-08 | 2016-06-01 | 中国大冢制药有限公司 | The Packaging Method of sodium bicarbonate injection |
| US11925703B1 (en) | 2022-07-29 | 2024-03-12 | Xellia Pharmaceuticals Aps | Liquid composition comprising glucose |
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Application publication date: 20121010 |