CN102552314A - Preparation method of compound sodium chloride-potassium chloride infusion solution - Google Patents
Preparation method of compound sodium chloride-potassium chloride infusion solution Download PDFInfo
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- CN102552314A CN102552314A CN2010105788925A CN201010578892A CN102552314A CN 102552314 A CN102552314 A CN 102552314A CN 2010105788925 A CN2010105788925 A CN 2010105788925A CN 201010578892 A CN201010578892 A CN 201010578892A CN 102552314 A CN102552314 A CN 102552314A
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- infusion solution
- potassium
- potassium chloride
- sodium chloride
- chloride
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Abstract
The invention relates to the field of pharmacy and especially relates to a preparation method of a compound sodium chloride-potassium chloride infusion solution. The invention aims at providing a preparation method of an electrolyte supplement and the electrolyte supplement is the compound sodium chloride-potassium chloride infusion solution containing active components of sodium chloride and potassium chloride. Based on a prescribed dose, each 100ml of the compound sodium chloride-potassium chloride infusion solution contains 0.05 to 0.33g of potassium chloride and 0.7 to 1.1g of sodium chloride. The compound sodium chloride-potassium chloride infusion solution is applied by intravenous injection and is suitable for patients having severe hypokalemia or patients unable to take oral medicines. A potassium supplement dose, potassium concentration and a potassium supplement speed of the compound sodium chloride-potassium chloride infusion solution can be set according to clinical conditions, serum potassium concentration and improvement of a potassium deficiency graph of an electrocardiogram.
Description
Technical field
The present invention relates to pharmaceutical field, be specifically related to the method for preparing of compound NaCl potassium chloride infusion solution.
Background technology
Potassium is intracellular main cation, and its concentration is 150-160mmol/L, and extracellular main cation is a sodium ion, and serum potassium concentration is merely 3.5-5.0mmol/L.Body mainly relies on the Na on the cell membrane
+-K
+The ATP enzyme is kept the inside and outside K of cell
+, Na
+Concentration difference.Intravital acid-base balance state is thanked influential to potassio, H during like acidosis
+In the entering cell, in order to keep intracellular potential difference, K
+Be released to the extracellular, cause or increase the weight of hyperpotassemia.And metabolism disorder also can influence acid-base balance; Some function of the inside and outside potassium concentration of normal cell and concentration difference and cell has confidential relation, comprises myocardium irritability and conductivity etc. like carbohydrate metabolism, glycogen storage and protein metabolism, nerve, muscle.Often sodium chloride and potassium chloride are used as electrolyte complementary medical usually clinically.
Existing commercially available potassium chloride injection specification is 10ml: 1.5g and 1.0g, the clinical serious hypokalemia or can not oral person of being used for.Clinical administration method according to describing in " 10ml: 1.5g " specification aqueous injection product description is: generally be 15% potassium chloride injection 7-10ml to be added among the 5% glucose injection 500ml instil (avoid direct intravenous drip and inject).Kalium replenishment dosage, concentration and speed are improved according to the clinical state of an illness and concentration of blood kalium and electrocardiogram potassium deficiency figure and decided: potassium concn is no more than 3.4g/1 (45mmol/L), and kalium replenishment speed is no more than 0.75g/h (10mmol/h), kalium replenishment amount 3-4.5g every day (40-60mmol); Potassium deficiency causes when serious quick chamber property ectopic cardiac rhythm is not normal in vivo; Like torsades de pointes type ventricle property too fast, short battle array aroused in interest, when showing effect life-threatening severe arrhythmia such as multirow property ventricular tachycardia, ventricular flutter repeatedly; That potassium salt concentration is wanted is high (0.5%, even 1%), drip speed and want fast; 1.5g/h (20mmol/h), the kalium replenishment amount reaches the every day of 10g or more than the 10g; As sb.'s sickness becomes critical, kalium replenishment concentration and speed can surpass afore mentioned rules, but need tight blood potassium and the electrocardiogram etc. of dynamic observing, and prevent that hyperpotassemia from taking place.Child dose is pressed body weight 0.22g/kg (3mmol/kg) or is pressed body surface area 3g/m every day
2Calculate.Clinical administration method according to describing in the product description of " 10ml: 1.5g " specification aqueous injection is: before facing usefulness, be diluted to below 0.3% with 5% glucose injection.1-1.5g one consumption per day of intravenous drip is decided according to the state of an illness.
Said according to the 17 edition the 157th page in Merck diagnosis and treatment handbook: in order to replenish KCL, Glucose Liquid is not desirable the selection, can cause the property a crossed hypokalemia to increase the weight of symptom aggravation, particularly Folium Digitalis Purpureae patient because increase patient's plasma insulin level subsequently.At last, when hypokalemia with low magnesium, usually need to correct magnesium deficiency and stop and contain potassium loss and to impel potassium full." domesticly also have bibliographical information " to make K when the synthetic glycogen because of the input of glucose has
+Get into cell, fall hypokalemic phenomenon, 10% glucose also has the osmotic diuresis effect, so do the dilution of potassium chloride injection with 10% glucose improper part is arranged.
The sodium chloride Chang Zuowei infusion solution of domestic present listing uses.Potassium chloride is injection, or instils with 5% glucose injection dilution posterior vein, does not see the report of directly processing infusion solution.
Summary of the invention
The technical problem that the present invention solved provides a kind of method for preparing of electrolyte complementary medical, is the infusion solution that active component is processed with sodium chloride and potassium chloride promptly, and recipe quantity is: contain 0.05-0.33g potassium chloride and 0.7-1.1 sodium chloride in every 100ml infusion solution.
The method for preparing of infusion solution of the present invention is made up of following steps:
A, take by weighing potassium chloride and sodium chloride by recipe quantity;
B, add an amount of water for injection and make abundant dissolving, and add and add to the full amount of water for injection;
C, add the needle-use activated carbon of 0.1% (g/ml), stir, filter decarburization;
D, through intermediate detect qualified after, coarse filtration, fine straining (preferred 0.22 μ m filter membrane), sterilization is sealed in fill.
In this method for preparing the control product quality being had a committed step promptly is to detect intermediate, and concrete grammar is that intermediate control pH value scope is 4.0-6.5.Detect intermediate and be in the control production process to the influential key link of product quality (as densely join, rare joining), guarantee that production process is controlled, meet the principle of total quality control, make end product quality reliable and stable.It is for guaranteeing these article stability of drug that pH is controlled at this scope, and makes that it is close with blood pH)
The invention provides the specification of three infusion solutions for convenient clinical use:
1, contains 0.11g potassium chloride and 0.9 sodium chloride in every 100ml infusion solution;
2, contain 0.22g potassium chloride and 0.9 sodium chloride in every 100ml infusion solution;
3, contain 0.30g potassium chloride and 0.9 sodium chloride in every 100ml infusion solution.
Above-mentioned three specifications are applicable to hypokalemia in various degree respectively.In clinical use, need to decide according to the clinical state of an illness and concentration of blood kalium and electrocardiogram potassium deficiency figure because of kalium replenishment dosage, concentration and speed; Cause serious fast when property ectopic cardiac rhythm in chamber is not normal etc. during emergency situation like potassium deficiency in the body; Need to use the kalium replenishment preparation of variable concentrations, provide this moment the different preparation of recipe quantity can greatly facilitate the doctor and use according to the state of an illness.)
Compound NaCl potassium chloride infusion solution through the inventive method preparation can be used for:
1, the hypokalemia that causes of treatment a variety of causes is like the hypokalemia that causes after hypoalimentation, vomiting, serious diarrhoea, the row's of application potassium property diuretic, low potassium property familial periodic paralysis, prolonged application glucocorticoid and the additional hypertonic glucose etc.
2, prevention hypokalemia; When there is the potassium situation of losing in the patient; If hypokalemia especially takes place to patient's harm when big the patient of digitaloid drugs (if with); Need preventative additional potassium salt, as feed seldom, serious or chronic diarrhea, for a long time take adrenocortical hormone, lose potassium property nephropathy, Bartter syndrome etc.
3, digitalism causes taking place frequently property, polyphyly premature beat or tachy-arrhythmia.
This infusion solution adopts the mode administration of intravenous drip, is used for serious hypokalemia or can not oral person.Kalium replenishment dosage, concentration and speed are improved according to the clinical state of an illness and concentration of blood kalium and electrocardiogram potassium deficiency figure and are decided.
The specific embodiment
The invention provides a kind of method for preparing of electrolyte complementary medical, is to be the infusion solution that active component is processed with sodium chloride and potassium chloride, contains 0.05-0.33g potassium chloride and 0.7-1.1 sodium chloride in every 100ml infusion solution.
For adapting to clinical practice the specification of three infusion solutions is provided:
1, contains 0.11g potassium chloride and 0.9 sodium chloride in every 100ml infusion solution;
2, contain 0.22g potassium chloride and 0.9 sodium chloride in every 100ml infusion solution;
3, contain 0.30g potassium chloride and 0.9 sodium chloride in every 100ml infusion solution.
The method for preparing of above-mentioned infusion solution is:
A, take by weighing potassium chloride and sodium chloride by recipe quantity;
B, add an amount of water for injection (be about water for injection cumulative volume 1/10) and make abundant dissolving, and add and add to the full amount of water for injection;
C, add the needle-use activated carbon of 0.1% (g/ml), stir, filter decarburization;
D, through intermediate detect qualified after, coarse filtration, fine straining (preferred 0.22 μ m filter membrane), sterilization is sealed in fill.
Through the pilot sample (030101#) of three kinds of specifications being carried out influence factor's test of 60 ℃/10 days, illumination 4500LUX/10 days, the result, investigation indexs such as outward appearance, pH value and assay have no significant change with the initial phase ratio.Show that these article all have stability preferably to heat, light.
Pilot sample (030101#, 030201#, 030203#) to three kinds of specifications carries out 40 ℃ of study on the stability that quickened 6 months and kept sample for a long time 6 months; Each is investigated index and has no significant change with the initial phase ratio; Show these article stability better; The sealing of these article of prediction room temperature is preserved, and stability can reach more than 2 years at least.
Claims (6)
1. the method for preparing of compound NaCl potassium chloride infusion solution, it is characterized in that: it is made up of following steps:
A, by containing 0.05-0.33g potassium chloride in every 100ml infusion solution and 0.7-1.1 sodium chloride takes by weighing potassium chloride and sodium chloride;
B, add an amount of water for injection and make abundant dissolving, and add and add to the full amount of water for injection;
C, add the needle-use activated carbon of 0.1% (g/ml), stir, filter decarburization;
D, through intermediate detect qualified after, coarse filtration, fine straining, sterilization is sealed in fill.
2. the method for preparing of compound NaCl potassium chloride infusion solution according to claim 1 is characterized in that: contain 0.11g potassium chloride and 0.9 sodium chloride in every 100ml infusion solution.
3. the method for preparing of compound NaCl potassium chloride infusion solution according to claim 1 is characterized in that: contain 0.22g potassium chloride and 0.9 sodium chloride in every 100ml infusion solution.
4. the method for preparing of compound NaCl potassium chloride infusion solution according to claim 1 is characterized in that: contain 0.30g potassium chloride and 0.9 sodium chloride in every 100ml infusion solution.
5. the method for preparing of compound NaCl potassium chloride infusion solution according to claim 1 is characterized in that: step D intermediate control pH value scope is 4.0-6.5.
6. the method for preparing of compound NaCl potassium chloride infusion solution according to claim 1 is characterized in that: the said fine straining of step D adopts 0.22 μ m filter membrane.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010105788925A CN102552314A (en) | 2010-12-08 | 2010-12-08 | Preparation method of compound sodium chloride-potassium chloride infusion solution |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010105788925A CN102552314A (en) | 2010-12-08 | 2010-12-08 | Preparation method of compound sodium chloride-potassium chloride infusion solution |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103575866A (en) * | 2012-08-08 | 2014-02-12 | 四川奇力制药有限公司 | Quality control method of potassium chloride and sodium chloride injection |
| CN103575867A (en) * | 2012-08-08 | 2014-02-12 | 四川奇力制药有限公司 | Potassium chloride and sodium chloride injection and determination method of osmotic pressure molar concentration ratio thereof |
| CN105560272A (en) * | 2014-10-15 | 2016-05-11 | 辽宁药联制药有限公司 | Potassium-supplement injection for reducing vascular irritation |
-
2010
- 2010-12-08 CN CN2010105788925A patent/CN102552314A/en active Pending
Non-Patent Citations (2)
| Title |
|---|
| 国家食品药品监督管理局: "氯化钾氯化钠注射液", 《HTTP://APP1.SFDA.GOV.CN/DATASEARCH/FACE3/BASE.JSP?TABLEID=25&TABLENAME=TABLE25&TITLE=国产药品&BCID=124356560303886909015737447882》 * |
| 注册司: "2004年12月批准的新药——化学药品（一）", 《全国医药信息》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103575866A (en) * | 2012-08-08 | 2014-02-12 | 四川奇力制药有限公司 | Quality control method of potassium chloride and sodium chloride injection |
| CN103575867A (en) * | 2012-08-08 | 2014-02-12 | 四川奇力制药有限公司 | Potassium chloride and sodium chloride injection and determination method of osmotic pressure molar concentration ratio thereof |
| CN103575866B (en) * | 2012-08-08 | 2016-03-02 | 四川奇力制药有限公司 | The method of quality control of potassium chloride in sodium chloride inj |
| CN105560272A (en) * | 2014-10-15 | 2016-05-11 | 辽宁药联制药有限公司 | Potassium-supplement injection for reducing vascular irritation |
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Application publication date: 20120711 |