CN105982915A - Preparation method of potassium chloride injection - Google Patents
Preparation method of potassium chloride injection Download PDFInfo
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- CN105982915A CN105982915A CN201510100373.0A CN201510100373A CN105982915A CN 105982915 A CN105982915 A CN 105982915A CN 201510100373 A CN201510100373 A CN 201510100373A CN 105982915 A CN105982915 A CN 105982915A
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- preparation
- potassium chloride
- solution
- injection
- chloride injection
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Abstract
The invention discloses a preparation method of potassium chloride injection, and 1,000 g of potassium chloride is contained per 10,000 ml of the potassium chloride injection. The preparation method includes the following steps that water for injection accounting for 80% the total preparation amount is added into a preparation container; the potassium chloride with formula dosage is added into the preparation container, and stirring is conducted to dissolve the potassium chloride; the pH value of a solution is maintained at 5.5-6.8; the water for injection is added till the total solution amount is the total preparation amount, and the solution is stirred to be uniform; the solution is filtered to be clear through a 0.45-micron-folded filter element or a 0.22-micon-folded filter element; the solution is subjected to encapsulation, and N2 is introduced into an ampoule in the encapsulation process; a solution of an obtained product is sterilized, and the sterilization condition is that sterilization is conducted for 30 minutes at the temperature of 100 DEG C, or sterilization is conducted for 12 minutes at the temperature of 121 DEG C. In the preparation method, a terminal sterilization method can be adopted for the prepared potassium chloride injection, and an excessive sterilization method can be adopted so that the obtained potassium chloride injection can meet requirements of 'Notice'.
Description
Technical field
The present invention relates to pharmaceutical field, especially relate to chemicals injection.
Background technology
State Food and Drug Administration evaluates center and has issued state's food medicine prison [2008] No. 7 literary compositions of note in 2008---" closes
In the notice issuing chemicals injection and multicomponent Biochemical Drugs injection main technique requirements ", its literary composition regulation: low capacity is noted
Penetrate agent and should take terminal sterilization technique, it is proposed that first-selected overkill method (F0>=12) it, is not resistant to the bar of overkill such as product
Part, it is contemplated that use probability of surviving method (8≤F0＜ 12), but all should ensure that the SAL (sterilization assurance after product sterilizing
Sterility assurance level) it is not more than 10-6.Use other F0Value is less than the technique of the terminal sterilization condition of 8, in principle
Not accreditation.If any sufficient according to proving to use terminal sterilization technique, and for clinical must the kind of drug administration by injection,
It is contemplated that use sterile production technique, but should ensure that SAL is not more than 10-3.Circulation be have employed simultaneously for filtration sterilization technique
The kind of steam assisted sterilization, it is proposed that be revised as terminal sterilization technique, to the kind that really cannot use terminal sterilization technique,
Sterile production technique should be revised as.
Potassium chloride injection is indispensable sterilization preparation in clinical treatment, can treat the hypopotassaemia that a variety of causes causes, as
Hypoalimentation, vomiting, severe diarrhea, application row's potassium diuretics, low potassium familial periodic paralysis, prolonged application sugar cortex
The hypopotassaemia etc. causing after hormone and supplementary hypertonic glucose.Hypopotassaemia can be prevented, when patient exists mistake potassium situation, especially
(as used the patient of digitaloid drugs) when being if it occur that patient is endangered bigger by hypopotassaemia, need preventative supplementary sylvite,
Such as little, serious or chronic diarrhea, long-term taking cortex hormone of aadrenaline, mistake potassium ephrosis, the Bartter syndrome etc. of taking food.
Also digitalis poisoning frequent, polyphyly premature beat or tachy-arrhythmia can be caused.
Serious hypopotassaemia caused by each section reason is electrolyte disturbance more typically, and the serious conditions of clinic can be caused to even result in
Dead.Need rationally to process rapidly accurately in time, but orally kalium supplement is helpless to correct rapidly Diagnostic value state, and heavy dose of mouth
Taking potassium preparation can increase intestinal complications.To emergency patients, the treatment method of usual employing is that potassium is mended in drip-feed.Therefore potassium chloride
The clinical demand amount of parenteral solution is very big.
It would therefore be desirable to the preparation method of a kind of new potassium chloride injection, the quality of the potassium chloride injection of acquisition is made to meet
The requirement of above-mentioned " notice ".
Content of the invention
It is an object of the invention to provide the preparation method of a kind of potassium chloride injection, the potassium chloride injection that the method prepares is permissible
Use terminal sterilization method, and overkill method can be used, make the potassium chloride injection of acquisition meet the requirement of " notice ".
In order to solve the problems referred to above, the present invention provides the preparation method of a kind of potassium chloride injection, wherein,
The described potassium chloride injection of every 10000ml contains potassium chloride 1000g；
Described preparation method has steps of:
(1) in preparation container, add the water for injection of amount of preparation 80%；
(2) adding the potassium chloride of recipe quantity in preparation container, stirring is to being completely dissolved；
(3) pH value of solution is controlled between 5.5～6.8；
(4) water for injection is added until solution total amount is preparation total amount, by solution stirring until uniformly；
(5) by solution through 0.45 μm, 0.22 μm of collapsible filtration core filters to clear and bright；
(6) solution that step (5) obtains is carried out embedding, during embedding, in ampoule, lead to N2。
(7) product that step (6) obtains is sterilized.
In an embodiment of the present invention, the sterilising conditions of described step (7) is: 100 DEG C of sterilizings sterilizing 12 in 30 minutes or 121 DEG C
Minute.Preferably, described sterilising conditions is 121 DEG C of sterilizings 12 minutes.
In the step (3) of above-mentioned preparation method, can reach to regulate pH value of solution by the reagent of any of regulation pH value
The purpose of value, this reagent is such as, but not limited to the sodium hydroxide solution of 0.5% or the hydrochloric acid solution of 0.5%.
In the preparation process in accordance with the present invention, the potassium chloride injection preparing can use terminal sterilization method, and can use and excessively kill
Go out method, make the potassium chloride injection of acquisition meet the requirement of " notice ".
Detailed description of the invention
Being described in detail the present invention below in conjunction with embodiment, embodiment is intended to explain and non-limiting technical scheme.
Embodiment 1
The present embodiment provides the preparation method of a kind of potassium chloride, wherein, contains chlorine in the described potassium chloride injection of every 10000ml
Change potassium 1000g；Described preparation method comprises the steps of
(1) in preparation container, add the water for injection of amount of preparation 80%；
(2) add the potassium chloride of recipe quantity in preparation container, and stirring makes potassium chloride dissolve；
(3) keep the pH value of solution 5.5～6.8, if pH value is in this interval, be then directly entered next step；If pH
Value is not in this interval, and available 0.5% sodium hydroxide solution or 0.5% hydrochloric acid solution are regulated；
(4) water for injection is added until solution total amount is preparation total amount, by solution stirring until uniformly；
(5) by solution through 0.45 μm, 0.22 μm of collapsible filtration core filters to clear and bright；
(6) solution that step (5) obtains is carried out embedding, during embedding, in ampoule, lead to N2。
(7) sterilizing the product that step (6) obtains, sterilising conditions is 100 DEG C of sterilizings sterilizings 12 in 30 minutes or 121 DEG C
Minute.
In order to determine potassium chloride to above-mentioned two kinds of preparation under 100 DEG C of 30 minutes and 121 DEG C of sterilising conditions of 12 minutes respectively
The pH value detection of sample, results contrast is as shown in table 1.
The pH value contrast of 1. two kinds of sterilising conditions of table
| Detection | 100 DEG C sterilize 30 minutes | 121 DEG C sterilize 12 minutes |
| PH value | Qualified | Qualified |
According to Chinese Pharmacopoeia two quality criteria requirements about potassium chloride injection of version in 2010,121 DEG C are gone out for 12 minutes
Under the conditions of bacterium, the sample of preparation carries out study on the stability and detection, and results contrast is as follows:
| Detection | 121 DEG C sterilize 12 minutes |
| KCE content | Qualified |
| There is related substance | Qualified |
| Visible foreign matters | Qualified |
In view of this product is to thermally-stabilised, noting [2008] No. 7 civilian pertinent regulations according to state's food medicine prison, we finally select 121 DEG C to go out
The bacterium sterilising conditions of 12 minutes.
In the preparation process in accordance with the present invention, the potassium chloride injection preparing can use terminal sterilization method, and can use and excessively kill
Go out method, make the potassium chloride injection of acquisition meet the requirement of " notice ".
The above is only the preferred embodiment of the present invention, it is noted that for those skilled in the art,
Without departing from the principles of the invention, can also make some improvements and modifications, these improvements and modifications also should be regarded as the present invention
Protection domain.
Claims (2)
1. the preparation method of a potassium chloride injection, it is characterised in that
The described potassium chloride injection of every 10000ml contains potassium chloride 1000g；
Described preparation method has steps of:
(1) in preparation container, add the water for injection of amount of preparation 80%；
(2) adding the potassium chloride of recipe quantity in preparation container, stirring is to being completely dissolved；
(3) pH value of solution is controlled between 5.5～6.8；
(4) water for injection is added until solution total amount is preparation total amount, by solution stirring until uniformly；
(5) by solution through 0.45 μm, 0.22 μm of collapsible filtration core filters to clear and bright；
(6) solution that step (5) obtains is carried out embedding, during embedding, in ampoule, lead to N2。
(7) product that step (6) obtains is sterilized.
2. preparation method as claimed in claim 1, it is characterised in that the sterilising conditions of described step (7) is: 100 DEG C of sterilizings 30
Minute or 121 DEG C sterilize 12 minutes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510100373.0A CN105982915A (en) | 2015-03-06 | 2015-03-06 | Preparation method of potassium chloride injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510100373.0A CN105982915A (en) | 2015-03-06 | 2015-03-06 | Preparation method of potassium chloride injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105982915A true CN105982915A (en) | 2016-10-05 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510100373.0A Pending CN105982915A (en) | 2015-03-06 | 2015-03-06 | Preparation method of potassium chloride injection |
Country Status (1)
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| CN (1) | CN105982915A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111904930A (en) * | 2020-08-19 | 2020-11-10 | 扬州中宝药业股份有限公司 | Potassium chloride injection and preparation method thereof |
-
2015
- 2015-03-06 CN CN201510100373.0A patent/CN105982915A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111904930A (en) * | 2020-08-19 | 2020-11-10 | 扬州中宝药业股份有限公司 | Potassium chloride injection and preparation method thereof |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| WD01 | Invention patent application deemed withdrawn after publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20161005 |