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Quality control method of potassium chloride and sodium chloride injection

A technology of potassium chloride, sodium chloride, and quality control methods, which is applied to the active ingredients of alkali/alkaline earth metal chlorides, pharmaceutical formulas, and measuring devices, and can solve the problems of inconspicuous titration end-point jumps, time-consuming, and complicated operating procedures, etc. question

Active Publication Date: 2014-02-12
SICHUAN QILI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The assay method operation procedure of above-mentioned potassium chloride content is numerous and diverse and time-consuming, and in the assay method actual operation of total chlorine, often cause error because titration end-point abrupt phenomenon is not obvious, the content of sodium chloride is based on total chlorine amount and potassium chloride The content of the two salts is calculated, resulting in the inability to effectively control the true content of the two salts

Method used

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  • Quality control method of potassium chloride and sodium chloride injection
  • Quality control method of potassium chloride and sodium chloride injection
  • Quality control method of potassium chloride and sodium chloride injection

Examples

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preparation example Construction

[0021] 1) Preparation of blank test solution:

[0022] Dissolve 0.9g of sodium chloride with water and dilute to 100mL, shake well, accurately measure 5.0mL of the resulting solution, put it in a 50mL measuring bottle, add water to dilute to the mark, shake well, and obtain a blank test solution;

[0023] 2) Preparation of reference substance solution:

[0024] Accurately measure 5.0mL of potassium standard solution with a concentration of 1000μg / mL, place it in a 50mL measuring bottle, dilute with water to the mark, and shake well to obtain a solution with a concentration of 100μg / mL. Accurately measure 1.0mL of a 100μg / mL solution 2.0mL, 3.0mL, 4.0mL and 5.0mL were placed in 100mL measuring bottles respectively, and then 5.0mL of the blank test solution was precisely added, diluted to the mark with water, and shaken well to obtain the reference substance solution;

[0025] 3) Preparation of the test solution:

[0026] Precisely measure the sample to be tested, dilute with ...

Embodiment 1

[0065] The mensuration of embodiment 1 potassium chloride content

[0066] 1) Preparation of blank test solution:

[0067] Dissolve 0.9g of sodium chloride with water and dilute to 100mL, shake well, accurately measure 5.0mL of the resulting solution, put it in a 50mL measuring bottle, add water to dilute to the mark, shake well, and obtain a blank test solution;

[0068] 2) Preparation of reference substance solution:

[0069] Precisely measure 5.0 mL of potassium standard solution ([National Standard Solution GBS G 62020-90 (2601)] National Iron and Steel Materials Testing Center, General Iron and Steel Research Institute) with a concentration of 1000 μg / mL and a medium of 10% HCl, and place it in a 50 mL volume In the bottle, dilute to the mark with water, shake well to obtain a solution with a concentration of 100μg / mL, accurately measure 1.0mL, 2.0mL, 3.0mL, 4.0mL and 5.0mL of the 100μg / mL solution, and place them in 100mL measuring bottles , and then precisely add 5.0m...

Embodiment 2

[0111] The mensuration of embodiment 2 sodium chloride content

[0112] 1) Preparation of blank test solution:

[0113] Dissolve 0.3g of potassium chloride with water and dilute to 100mL, shake well, accurately measure 5.0mL of the resulting solution, place it in a 100mL measuring bottle, add water to dilute to the mark, shake well, and obtain a blank test solution;

[0114] 2) Preparation of reference substance solution:

[0115] Precisely measure 5.0 mL of sodium standard solution ([National Standard Solution GBSG 62020-90 (2601)] National Iron and Steel Materials Testing Center, General Iron and Steel Research Institute) with a concentration of 1000 μg / mL and a medium of 10% HCl, and place it in a 100 mL measuring bottle , dilute to the mark with water, and shake well to obtain a solution with a concentration of 50 μg / mL. Accurately measure 1.0 mL, 2.0 mL, 3.0 mL, 4.0 mL and 5.0 mL of the 50 μg / mL solution, and place them in 100 mL measuring bottles respectively. Then pre...

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Abstract

The invention relates to a quality control method of a potassium chloride and sodium chloride injection. The quality control method comprises the following steps: determining the content, detecting properties, identifying and detecting. The content determination step comprises the determination of the total chlorinity, the potassium chloride content and the sodium chloride content; the detecting step comprises the detection of pH values, heavy metals, arsenic salts, insoluble particles, osmotic pressure ratios, bacterial endotoxin and sterility. The quality control method provides detection indexes, detection means, technical methods and the like for related production and detection mechanisms so as to control the quality of products, ensure the safety of medicines, better guide production and enable the production process control to be strict and reasonable.

Description

technical field [0001] The invention relates to a quality control method for potassium chloride and sodium chloride injection, including a sterility inspection method and the like. Background technique [0002] Potassium chloride (KCl) is one of the most basic clinical medicines. It is a product in the national basic medical drug catalog and a national social insurance catalogue. It is mainly used to treat various hypokalemia and has been widely used in various hospitals for a long time. According to the Merck Manual, Seventeenth Edition, p. 157: For KCl supplementation, glucose solution is not an ideal choice, because the subsequent increase in the patient's plasma insulin level can lead to aggravation of transient hypokalemia and exacerbation of symptoms, especially digitalis patient. Finally, when hypokalemia is accompanied by low magnesium, it is usually necessary to correct the magnesium deficiency, prevent excessive potassium loss, and promote potassium replenishment....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/15G01N21/31G01N13/04A61K33/14A61K9/08A61P3/12
Inventor 张康宁廖立东邓艳阙灵
Owner SICHUAN QILI PHARM CO LTD
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