CN106619500A - Method for preparing calcium gluconate injection - Google Patents
Method for preparing calcium gluconate injection Download PDFInfo
- Publication number
- CN106619500A CN106619500A CN201611266008.8A CN201611266008A CN106619500A CN 106619500 A CN106619500 A CN 106619500A CN 201611266008 A CN201611266008 A CN 201611266008A CN 106619500 A CN106619500 A CN 106619500A
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- CN
- China
- Prior art keywords
- calcium
- injection
- acetate
- acetic acid
- glacial acetic
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- 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
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic 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
- A61K47/08—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
-
- 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
Abstract
The invention belongs to the technical field of medicament preparation, and particularly relates to a method for preparing a calcium gluconate injection. Every liter of the injection contains 90 to 110g of calcium gluconate, 3 to 40g of calcium acetate, 0.5 to 2g of sodium acetate, 0.5 to 6ml of glacial acetic acid, 1 to 10g of sodium hydroxide and the balance of water for injection. Compared with the prior art, the method has the advantages that the sodium acetate and the calcium acetate are added in a prescription process of the calcium gluconate injection, so that the dissolution-promoting effect of the calcium gluconate is enhanced; the sodium acetate and the calcium acetate are taken as a co-solvent and a stabilizer of the calcium gluconate, so that the stability of the calcium gluconate injection is enhanced. As proved by long-time review of stability, crystals are basically not produced in a storage period, particularly under a low-temperature condition, and stable quality is achieved.
Description
Technical field
The invention belongs to field of medicine preparing technology, it particularly relates to a kind of calcium gluconate injection for preparing
Method.
Background technology
In the prior art, calcium gluconate injection is small-volume injection product, and calcium gluconae is molten in water
Xie Du is 3.33%, and the specification of product is 10% concentration, is supersaturated solution.Therefore, easily occurs crystallization during storing.
In traditional prescription, lactic acid and calcium hydroxide generate calcium lactate, though certain hydrotropy effect can be played to calcium gluconae,
Calcium gluconae can only be made to occur without crystallization at short notice, with the prolongation of period of storage, especially under cryogenic, grape
The solubility of Calciofon is gradually lowered, and the calcium gluconae for making saturation gradually separates out crystallization.
The content of the invention
In order to solve above-mentioned technical problem, the invention provides a kind of calcium gluconate injection and preparation method thereof, its
Stability is strong, will not produce crystallization, steady quality in storage period substantially under cryogenic.
A kind of calcium gluconate injection of the present invention, per liter of the parenteral solution containing calcium gluconae 90-110g,
Calcium acetate 3-40g, sodium acetate 0.5-2g, glacial acetic acid 0.5-6ml, NaOH 1-10g, remaining is water for injection.
The preparation method of calcium gluconate injection of the present invention, the preparation method is concretely comprised the following steps：According to prescription
Amount, weighs calcium gluconae, calcium acetate, sodium acetate, glacial acetic acid and NaOH；Water for injection is measured, the vinegar of recipe quantity is added
Sour sodium, glacial acetic acid and calcium acetate, after being stirred to dissolve, are heated to 70 DEG C-boiling, add the calcium gluconae of recipe quantity, stirring
Dissolving, pH value is adjusted to 4.1-7.3 with NaOH and glacial acetic acid, adds activated carbon, adsorbs 5-30 minutes, filters carbon removal, is used
0.1-0.45 μm of filter is filtered to qualified, and in embedding to middle borosilicate glass ampoule, moist heat sterilization is obtained final product.
The preparation method of calcium gluconate injection of the present invention, the preparation method is concretely comprised the following steps：Take 90L injections
With water, sodium acetate 200g, glacial acetic acid 500ml, calcium acetate 3560g are added, after being stirred to dissolve, be heated to boiling, add grape
Calciofon 10kg, stirring and dissolving；PH value is adjusted to 5.0-7.0, add 200g activated carbons, benefit to inject water to NaOH
100L, agitation cycle is adsorbed 20 minutes；Carbon removal is filtered, is sequentially filtered to qualified with 0.45 μm, 0.22 μm, 0.22 μm of filter；
Into middle borosilicate glass ampoule, moist heat sterilization, lamp inspection is packed for embedding.
The preparation method of calcium gluconate injection of the present invention, the preparation method is concretely comprised the following steps：Take 90L injections
With water, sodium acetate 200g, Folium Sauropi acid 10g, glacial acetic acid 500ml, calcium acetate 3560g are added, after being stirred to dissolve, be heated to boiling
Rise, add calcium gluconae 10kg, stirring and dissolving；PH value is adjusted to 5.97, add 200g activated carbons, add note with NaOH
Penetrate with water to 100L, agitation cycle absorption 20 minutes；Carbon removal is filtered, is sequentially filtered with 0.45 μm, 0.22 μm, 0.22 μm of filter
It is extremely qualified；Into middle borosilicate glass ampoule, moist heat sterilization, lamp inspection is packed for embedding.
Compared with prior art, calcium gluconate injection of the present invention adds sodium acetate and vinegar in formulation and technology
Sour calcium, increased the solubilization-aid effect of calcium gluconae, because of cosolvent and stabilizer that sodium acetate and calcium acetate are calcium gluconae,
Enhance the stability of this product.Through prolonged study on the stability, storage period especially substantially will not under cryogenic
Produce crystallization, steady quality.
Specific embodiment
Further is made to calcium gluconate injection of the present invention and preparation method thereof with reference to specific embodiment
Illustrate, but protection scope of the present invention is not limited to this.
Embodiment 1
1. 90L waters for injection are taken, sodium acetate 200g, glacial acetic acid 500ml, calcium acetate 3560g is added, after being stirred to dissolve,
Boiling is heated to, calcium gluconae 11kg, stirring and dissolving is added；2. pH value is adjusted to 6.01, add 200g to live with NaOH
Property charcoal, benefit injects water to 100L, and agitation cycle is adsorbed 20 minutes；3. filter carbon removal, sequentially with 0.45 μm, 0.22 μm,
0.22 μm of filter is filtered to qualified；4. into middle borosilicate glass ampoule, moist heat sterilization, lamp inspection is packed for embedding.
Embodiment 2
1. 90L waters for injection are taken, sodium acetate 100g, glacial acetic acid 300ml, calcium acetate 1560g is added, after being stirred to dissolve,
Boiling is heated to, calcium gluconae 9kg, stirring and dissolving is added；2. pH value is adjusted to 5.93, add 200g active with NaOH
Charcoal, benefit injects water to 100L, and agitation cycle is adsorbed 20 minutes；3. carbon removal is filtered, sequentially with 0.45 μm, 0.22 μm, 0.22 μ
The filter of m is filtered to qualified；4. into middle borosilicate glass ampoule, moist heat sterilization, lamp inspection is packed for embedding.
Embodiment 3
1. 90L waters for injection are taken, sodium acetate 150g, glacial acetic acid 300ml, calcium acetate 3560g is added, after being stirred to dissolve,
Boiling is heated to, calcium gluconae 10kg, stirring and dissolving is added；2. pH value is adjusted to 5.97, add 200g to live with NaOH
Property charcoal, benefit injects water to 100L, and agitation cycle is adsorbed 20 minutes；3. filter carbon removal, sequentially with 0.45 μm, 0.22 μm,
0.22 μm of filter is filtered to qualified；4. into middle borosilicate glass ampoule, moist heat sterilization, lamp inspection is packed for embedding.
Embodiment 4
1. 90L waters for injection are taken, sodium acetate 200g, Folium Sauropi acid 10g, glacial acetic acid 500ml, calcium acetate 3560g is added, is stirred
Mixing makes after dissolving, is heated to boiling, adds calcium gluconae 10kg, stirring and dissolving；2. with NaOH pH value is adjusted to 5.97,
200g activated carbons, benefit is added to inject water to 100L, agitation cycle is adsorbed 20 minutes；3. filter carbon removal, sequentially with 0.45 μm,
0.22 μm, 0.22 μm of filter filtered to qualified；4. into middle borosilicate glass ampoule, moist heat sterilization, lamp inspection is packed for embedding.
Control group 1
1. 90L waters for injection are taken, sodium acetate 200g, glacial acetic acid 500ml is added, after being stirred to dissolve, boiling is heated to, plus
Enter calcium gluconae 10kg, stirring and dissolving；2. pH value is adjusted to 5.97, add 200g activated carbons, add injection with NaOH
With water to 100L, agitation cycle absorption 20 minutes；3. carbon removal is filtered, is sequentially filtered with 0.45 μm, 0.22 μm, 0.22 μm of filter
It is extremely qualified；4. into middle borosilicate glass ampoule, moist heat sterilization, lamp inspection is packed for embedding.
Control group 2
1. 90L waters for injection are taken, Folium Sauropi acid 10g, glacial acetic acid 500ml, calcium acetate 3560g is added, after being stirred to dissolve,
Boiling is heated to, calcium gluconae 10kg, stirring and dissolving is added；2. pH value is adjusted to 5.97, add 200g to live with NaOH
Property charcoal, benefit injects water to 100L, and agitation cycle is adsorbed 20 minutes；3. filter carbon removal, sequentially with 0.45 μm, 0.22 μm,
0.22 μm of filter is filtered to qualified；4. into middle borosilicate glass ampoule, moist heat sterilization, lamp inspection is packed for embedding.
Effect detection
For in detection sample separate out calcium gluconae crystal amount, to the parenteral solution obtained by embodiment 1-4 and control group 1-2
Insoluble matter under different preservation temperatures and time is filtered, drying, is weighed, and is calculated insoluble matter and is accounted for former calcium gluconae total amount
Percentage composition.As a result see the table below 1：
Calcium gluconae crystal amount is separated out under embodiment 1-4 of table 1 and control group 1-2 parenteral solution different conditions
As it can be seen from table 1 adding after sodium acetate and calcium acetate in calcium gluconate injection, calcium gluconae is low
The situation of precipitation of catching a cold under the conditions of temperature is obviously improved, i.e., its solubility has and substantially increased.Complicated organic acid is in ordinary circumstance
Under, the precipitation of calcium ion, such as Folium Sauropi acid can be promoted, though after alkalization, can still promote the precipitation of calcium gluconae, but in this reality
In applying example 4, it may be possible to because with sodium acetate compatibility, solubilization-aid effect is very good.
Claims (3)
1. a kind of calcium gluconate injection, it is characterised in that per liter of the parenteral solution contains calcium gluconae 90-110g, vinegar
Sour calcium 3-40g, sodium acetate 0.5-2g, glacial acetic acid 0.5-6ml, NaOH 1-10g, remaining is water for injection.
2. the preparation method of calcium gluconate injection according to claim 1, it is characterised in that the preparation method is concrete
Step is：According to recipe quantity, calcium gluconae, calcium acetate, sodium acetate, glacial acetic acid and NaOH are weighed；Measure water for injection,
Sodium acetate, glacial acetic acid and the calcium acetate of recipe quantity are added, after being stirred to dissolve, 70 DEG C-boiling is heated to, the Portugal of recipe quantity is added
Grape Calciofon, stirring and dissolving adjusts pH value to 4.1-7.3 with NaOH and glacial acetic acid, adds activated carbon, 5-30 point of absorption
Clock, filters carbon removal, is filtered to qualified with 0.1-0.45 μm of filter, in embedding to middle borosilicate glass ampoule, moist heat sterilization, i.e.,
.
3. the preparation method of calcium gluconate injection according to claim 1, it is characterised in that the preparation method is concrete
Step is：90L waters for injection are taken, sodium acetate 200g, glacial acetic acid 500ml, calcium acetate 3560g is added, after being stirred to dissolve, heating
To seething with excitement, calcium gluconae 10kg, stirring and dissolving are added；PH value is adjusted to 5.0-7.0, add 200g active with NaOH
Charcoal, benefit injects water to 100L, and agitation cycle is adsorbed 20 minutes；Carbon removal is filtered, sequentially with 0.45 μm, 0.22 μm, 0.22 μm
Filter filter to qualified；Into middle borosilicate glass ampoule, moist heat sterilization, lamp inspection is packed for embedding.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611266008.8A CN106619500A (en) | 2016-12-31 | 2016-12-31 | Method for preparing calcium gluconate injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611266008.8A CN106619500A (en) | 2016-12-31 | 2016-12-31 | Method for preparing calcium gluconate injection |
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|---|---|
| CN106619500A true CN106619500A (en) | 2017-05-10 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201611266008.8A Pending CN106619500A (en) | 2016-12-31 | 2016-12-31 | Method for preparing calcium gluconate injection |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107397756A (en) * | 2017-09-15 | 2017-11-28 | 南通荣成医药化工有限公司 | A kind of glucose injection |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101518512A (en) * | 2009-03-24 | 2009-09-02 | 河北天成药业有限公司 | Calcium gluconate injection and preparation method thereof |
| CN103393715A (en) * | 2013-07-22 | 2013-11-20 | 珠海经济特区生物化学制药厂 | Sodium potassium magnesium calcium and glucose injection and preparation method thereof |
-
2016
- 2016-12-31 CN CN201611266008.8A patent/CN106619500A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101518512A (en) * | 2009-03-24 | 2009-09-02 | 河北天成药业有限公司 | Calcium gluconate injection and preparation method thereof |
| CN103393715A (en) * | 2013-07-22 | 2013-11-20 | 珠海经济特区生物化学制药厂 | Sodium potassium magnesium calcium and glucose injection and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107397756A (en) * | 2017-09-15 | 2017-11-28 | 南通荣成医药化工有限公司 | A kind of glucose injection |
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Application publication date: 20170510 |