CN107536801B - The preparation process of Calcium Chloride and Sodium Bromide Injection - Google Patents
The preparation process of Calcium Chloride and Sodium Bromide Injection Download PDFInfo
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- CN107536801B CN107536801B CN201710713528.7A CN201710713528A CN107536801B CN 107536801 B CN107536801 B CN 107536801B CN 201710713528 A CN201710713528 A CN 201710713528A CN 107536801 B CN107536801 B CN 107536801B
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Abstract
The invention discloses a kind of preparation processes of Calcium Chloride and Sodium Bromide Injection, it has follow steps: 1. being heated to boiling by a small amount of water for injection, and the calcium chloride of recipe quantity is first put under fluidized state, put into the sodium bromide and stirring and dissolving of recipe quantity after stirring and dissolving under fluidized state again；2. first being boiled, being returned with the salt acid for adjusting pH of 0.5N to 2.0~3.0, filter；3. adjusting pH to 7.5~8.5 with the sodium hydroxide of 0.5N again, boil, return, filters；4. add to the full amount of water for injection 70%~85%, medicinal carbon is added, boils, returns, it is cooling, with the salt acid for adjusting pH of 0.1N to 4.6~4.8；5. adding to the full amount of water for injection；6. according to prescription specification encapsulating, 121 DEG C of sterilizing 15min.Method of the invention is able to solve existing Calcium Chloride and Sodium Bromide Injection and the problem of visible foreign matters easily occurs, especially has better stability in high temperature or Frozen-thawed cycled.
Description
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of preparation process of Calcium Chloride and Sodium Bromide Injection.
Background technique
Calcium Chloride and Sodium Bromide Injection is compound preparation, is used for nettle rash, allergic contact dermatitis, insect dermatitis and drug
Property dermatitis, routine prescription specification be every 5mL, chloride containing calcium 0.1g and sodium bromide 0.25g.
With the fast development in China Calcium Chloride and Sodium Bromide Injection market, associated core production technology apply with
Research and development will become the focus of enterprises pay attention in the industry.
Greatest problem existing for the preparation process of existing Calcium Chloride and Sodium Bromide Injection is: being easy to appear apparent visible
Foreign matter, especially in high temperature (60 DEG C or so) or Frozen-thawed cycled (between refrigeration and room temperature).
Summary of the invention
The purpose of the present invention is to solve the above problem, provides a kind of calcium chloride that visible foreign matters qualification rate is relatively high and stable
The preparation process of bromination sodium injection.
Realizing the technical solution of the object of the invention is: a kind of preparation process of Calcium Chloride and Sodium Bromide Injection has following
Step:
1. a small amount of water for injection is heated to boiling, and the calcium chloride of recipe quantity is first put under fluidized state, stir molten
Xie Houzai puts into the sodium bromide and stirring and dissolving of recipe quantity under fluidized state；A small amount of water for injection is water for injection full dose
20%~50%；
2. first being boiled, being returned with the salt acid for adjusting pH of 0.5N to 2.0~3.0, filter；
3. adjusting pH to 7.5~8.5 with the sodium hydroxide of 0.5N again, boil, return, filters；
4. add to the full amount of water for injection 70%~85%, medicinal carbon is added, boils, returns, it is cooling, with the salt of 0.1N
Acid for adjusting pH is to 4.6~4.8；
5. adding to the full amount of water for injection；
6. according to prescription specification encapsulating, 121 DEG C of sterilizing 15min.
Above-mentioned steps 1. described in recipe quantity calcium chloride be 0.1g/5mL；The sodium bromide of the recipe quantity is 0.25g/
5mL。
The good effect that the present invention has: (1) preparation method of the invention must put into calcium chloride under fluidized state, and
Must be after calcium to be chlorinated be completely dissolved, then under fluidized state sodium bromide is put into, which is control calcium chloride bromine
Change one of the key factor of sodium injection visible foreign matters.(2) preparation method of the invention needs repeatedly to adjust in process for preparation
In a certain range, this is another key factor for controlling Calcium Chloride and Sodium Bromide Injection visible foreign matters to pH value.(3) of the invention
Preparation method is able to solve the problem of existing Calcium Chloride and Sodium Bromide Injection is easy to appear visible foreign matters, especially in high temperature or
There is better stability in the case of person's Frozen-thawed cycled.(4) preparation method technique of the invention is unique, controllable, and safety is higher,
It is environmentally friendly, it is suitble to industrialized production.
Specific embodiment
(embodiment 1)
The preparation process of the Calcium Chloride and Sodium Bromide Injection of the present embodiment is as follows:
1. the water for injection of 300,000 mL is heated to boiling, and calcium chloride 16kg is first put under fluidized state, keep boiling
State, stirring and dissolving are risen, medical fluid clarification until boiling after being completely dissolved, and puts into sodium bromide 40kg again under fluidized state, stirs
Dissolution is mixed, medical fluid is muddy, and 20min is boiled, is returned, refined filtration.
2. first being boiled 10min with the salt acid for adjusting pH of 0.5N to 2.55, being returned, filter.
3. adjusting pH to 8.11 with the sodium hydroxide of 0.5N again, 20min is boiled, is returned, filtered.
4. inject water to the 80% of 640,000 mL[full doses], medicinal carbon 160g is added, boils 30min, decarburization is returned
10min, after cooling clarification, with 0.1N salt acid for adjusting pH to 4.65.
5. adding to the full amount of water for injection.
6. according to prescription specification [every 5mL] encapsulating, 121 DEG C of sterilizing 15min.
(2~embodiment of embodiment 4)
The preparation process of each embodiment is substantially the same manner as Example 1, and difference is shown in Table 1.
Table 1
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | |
| The salt acid for adjusting pH of 0.5N | 2.55 | 2.10 | 2.58 | 2.23 |
| The sodium hydroxide of 0.5N adjusts pH | 7.61 | 8.11 | 8.42 | 7.85 |
| The salt acid for adjusting pH of 0.1N | 4.65 | 4.62 | 4.71 | 4.68 |
(comparative example 1)
The preparation process of the Calcium Chloride and Sodium Bromide Injection of this comparative example is substantially the same manner as Example 1, the difference is that
Step is 1.: putting into calcium chloride 16kg, stirring and dissolving, medical fluid clarification into the water for injection [70 DEG C or so] of 300,000 mL, then puts into
Sodium bromide 40kg, stirring and dissolving, medical fluid is muddy, boils 20min, returns, refined filtration.
(comparative example 2)
The preparation process of the Calcium Chloride and Sodium Bromide Injection of this comparative example is substantially the same manner as Example 1, the difference is that
Step is 1.: the water for injection of 300,000 mL being heated to boiling, and puts into calcium chloride 16kg and sodium bromide simultaneously under fluidized state
40kg keeps fluidized state, and stirring and dissolving, medical fluid is muddy, boils 20min, returns, refined filtration.
(comparative example 3)
The preparation process of the Calcium Chloride and Sodium Bromide Injection of this comparative example is substantially the same manner as Example 1, the difference is that
Step is 1.: the water for injection of 300,000 mL being heated to boiling, and first puts into sodium bromide 40kg under fluidized state, keeps boiling-like
State, stirring and dissolving, medical fluid clarification until boiling after being completely dissolved, and put into calcium chloride 16kg again under fluidized state, stir molten
Solution, medical fluid is muddy, boils 20min, returns, refined filtration.
(4~comparative example of comparative example 8)
The preparation process of each comparative example is substantially the same manner as Example 1, the difference is that the adjusting of each step pH value, specifically
It is shown in Table 2.
Table 2
| Embodiment 1 | Comparative example 4 | Comparative example 5 | Comparative example 6 | Comparative example 7 | Comparative example 8 | |
| 0.5N salt acid for adjusting pH | 2.55 | / | / | 2.55 | 2.55 | 3.89 |
| 0.5N sodium hydroxide adjusts pH | 7.61 | / | 7.61 | / | 8.96 | 7.61 |
| 0.1N salt acid for adjusting pH | 4.65 | 4.65 | 4.65 | 4.65 | 4.65 | 4.65 |
Note: "/" shows not carry out the step in table 2.
(test case)
PH value, medicament contg and visible are carried out to Calcium Chloride and Sodium Bromide Injection made from each embodiment and comparative example 1~3
Foreign bodies detection the results are shown in Table 3.
PH value and visible foreign matters detection are carried out to Calcium Chloride and Sodium Bromide Injection made from comparative example 4~8, the results are shown in Table 4.
Table 3
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Comparative example 1 | Comparative example 2 | Comparative example 3 | |
| PH value | 5.11 | 5.26 | 5.33 | 5.29 | 5.77 | 5.71 | 5.61 |
| Calcium chloride content | 101.97% | 100.87% | 101.77% | 101.77% | 95.60% | 97.05% | 98.97% |
| Bromination sodium content | 100.41% | 100.36% | 99.54% | 100.54% | 96.01% | 96.17% | 98.41% |
| Visible foreign matters qualification rate (0 day) | 99.59% | 98.76% | 98.49% | 98.96% | 59.88% | 77.61% | 86.59% |
As seen from Table 3: each embodiment detected value difference is smaller, and pH value is respectively less than 5.4, and medicament contg is stablized on 100% left side
It is right, it is seen that foreign bodies detection qualification rate is greater than 98%.
The pH of comparative example 1~3 is all larger than 5.6, and medicament contg is 97% or so, it is seen that foreign matter qualification rate is then significant lower.
The result shows that: the feeding mode of calcium chloride and sodium bromide has an important influence the control of visible foreign matters.
Table 4
| Embodiment 1 | Comparative example 4 | Comparative example 5 | Comparative example 6 | Comparative example 7 | Comparative example 8 | |
| PH value | 5.11 | 5.44 | 5.74 | 5.91 | 5.28 | 5.49 |
| Visible foreign matters qualification rate (0 day) | 99.59% | 30.21% | 59.88% | 41.02% | 89.44% | 62.55% |
As can be seen from Table 4: the control of pH value is for visible foreign matters in the preparation process of Calcium Chloride and Sodium Bromide Injection
Be affected, the appropriate pH value that adjusts can be effectively improved medical fluid visible foreign matters situation, phenomena such as foreign matter precipitating otherwise will occur.
(experimental example)
Correlative Influence Factors experiment is carried out to the Calcium Chloride and Sodium Bromide Injection of embodiment 1, comparative example 1 and comparative example 8,
It the results are shown in Table 5.
Table 5
As seen from Table 5: the pH value of embodiment 1, comparative example 1 and comparative example 8 changes less, but comparative example 1 and right
The visible foreign matters qualification rate of ratio 8 is declined in Frozen-thawed cycled, and is in the case of a high temperature even more to decline obviously, is stablized
Property is poor.And the visible foreign matters qualification rate of embodiment 1 is equally higher in high temperature and Frozen-thawed cycled, 97% or more.
Claims (2)
1. a kind of preparation process of Calcium Chloride and Sodium Bromide Injection, it is characterised in that have follow steps:
1. a small amount of water for injection is heated to boiling, and the calcium chloride of recipe quantity is first put under fluidized state, after stirring and dissolving
The sodium bromide and stirring and dissolving of recipe quantity are put under fluidized state again；A small amount of water for injection is water for injection full dose
20%~50%；
2. first being boiled, being returned with the salt acid for adjusting pH of 0.5N to 2.0~3.0, filter；
3. adjusting pH to 7.5~8.5 with the sodium hydroxide of 0.5N again, boil, return, filters；
4. add to the full amount of water for injection 70%~85%, medicinal carbon is added, boils, returns, it is cooling, with the hydrochloric acid tune of 0.1N
Save pH to 4.6~4.8；
5. adding to the full amount of water for injection；
6. according to prescription specification encapsulating, 121 DEG C of sterilizing 15min.
2. the preparation process of Calcium Chloride and Sodium Bromide Injection according to claim 1, it is characterised in that: above-mentioned steps 1. in
The calcium chloride of the recipe quantity is 0.1g/5mL；The sodium bromide of the recipe quantity is 0.25g/5mL.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1957917A (en) * | 2006-10-09 | 2007-05-09 | 中国人民解放军第四军医大学 | Method for preparing high oxygen large transfusion fluid |
| WO2014003199A1 (en) * | 2012-06-27 | 2014-01-03 | Takeda Pharmaceutical Company Limited | Liquid preparations of amines and organic acids stabilized by salts |
| CN104189001A (en) * | 2014-09-22 | 2014-12-10 | 昆明南疆制药有限公司 | Method for preparing compound sodium chloride injection prepared solution |
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- 2017-08-18 CN CN201710713528.7A patent/CN107536801B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1957917A (en) * | 2006-10-09 | 2007-05-09 | 中国人民解放军第四军医大学 | Method for preparing high oxygen large transfusion fluid |
| WO2014003199A1 (en) * | 2012-06-27 | 2014-01-03 | Takeda Pharmaceutical Company Limited | Liquid preparations of amines and organic acids stabilized by salts |
| CN104582687A (en) * | 2012-06-27 | 2015-04-29 | 武田药品工业株式会社 | Liquid preparations of amines and organic acids stabilized by salts |
| CN104189001A (en) * | 2014-09-22 | 2014-12-10 | 昆明南疆制药有限公司 | Method for preparing compound sodium chloride injection prepared solution |
Non-Patent Citations (2)
| Title |
|---|
| 改进门诊荨麻疹过敏患者静脉注射氯化钙溴化钠的护理体会;汪春花等;《中国现代药物应用》;20120425;第6卷(第8期);第118-119页 |
| 痒苦乐民治疗荨麻疹的观察与护理;闫琳;《中国实用医药》;20060210;第1卷(第4期);第81-82页 |
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