CN109507314A - The ion chromatography method of sodium, potassium, magnesium, calcium in Amino Acid Compound Injection - Google Patents
The ion chromatography method of sodium, potassium, magnesium, calcium in Amino Acid Compound Injection Download PDFInfo
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- CN109507314A CN109507314A CN201811267078.4A CN201811267078A CN109507314A CN 109507314 A CN109507314 A CN 109507314A CN 201811267078 A CN201811267078 A CN 201811267078A CN 109507314 A CN109507314 A CN 109507314A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
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Abstract
The present invention provides a kind of ion chromatography method of sodium, potassium, magnesium, calcium in Amino Acid Compound Injection, it uses stationary phase for silica gel or vinyl xylene, ethyl vinyl benzene-divinyl benzene polymers resin, function base is the cation exchange column of carboxylic acid or phosphoric acid, mobile phase is acid compounds aqueous solution and organic solvent mixed solution, to ensure sodium, potassium, magnesium, calcium and other component good separations coexist, and accurately detected using electric conductivity detector.Method is simple and efficient to handle, accurately and reliably, controls and uses safety with important practical value to the quality of Amino Acid Compound Injection.
Description
Technical field
The present invention relates to a kind of ion chromatography methods of sodium, potassium, magnesium, calcium in Amino Acid Compound Injection, belong to inspection
Survey technology field.
Background technique
Amino Acid Compound Injection (Amino Acid Compound Iniection) is by L-type amino acid, sugar (including sugar
Alcohol), vitamin, electrolyte, pH adjusting agent and antioxidant etc. be formulated, be clinically common parenteral nutrition preparation it
One, belong to national essential drugs.The electrolytes being commonly incorporated into includes sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sulfuric acid
Sodium, potassium sulfate, magnesium sulfate, sodium acetate, potassium acetate etc..In addition, pH adjusting agent is often used sodium hydroxide, potassium hydroxide etc., antioxygen
Agent is then often used sodium pyrosulfite, sodium hydrogensulfite etc..The addition of these salt or alkali will necessarily cause sodium in injection
(Sodium), the concentration variation of potassium (Potassium), magnesium (Magnesium) and calcium (Calcium).It is main in human plasma
Cation is sodium, potassium, magnesium and calcium, plays conclusive effect to the distribution and transfer of the osmotic pressure, body fluid for maintaining extracellular fluid,
Keep acid-base balance.When any of which electrolyte quantity changes, it is likely to cause metabolic disturbance of electrolyte and cause
Different degrees of body damage.Therefore, the monitoring and control for carrying out sodium in injection, potassium, magnesium and calcium content, for the injection
Quality control and use safety and have very important significance.
Only there are rule to the analysis method of sodium in 18AA-I type Amino Acid Compound Injection, potassium, magnesium, calcium in Chinese Pharmacopoeia at present
It is fixed, it is detected respectively using atomic absorption method.Ionization buffer need to be added when detecting the potassium and sodium of easily ionizable, and calcium, magnesium then need
Screening agent is added, otherwise will lead to large error, method is at high cost, complex steps and poor repeatability.Plasma emission shines
Method measure sodium, potassium, calcium and magnesium, when, sodium, potassium are the ionization interference that Easily ionizing element is highly prone to matrix, are often proposed with radial (hang down
Directly) observation mode reduces such interference, but sensitivity thus loses.In addition, plasma emission light-emitting appearance price is high
Expensive, detection process need to use a large amount of high-purity argon gas, and testing cost is very high, therefore lower in pharmaceutical factory popularity rate, and method is not easy to push away
Extensively.
The chromatography of ions compare two methods of front, obtained by means of the separating capacity of chromatographic column stronger specificity and
Stability.Many reports existing to the chromatography of ions of sodium, potassium, magnesium, determination of calcium content, but major part uses suppressive conductance method
Detection.If this method to be applied to the detection of Amino Acid Compound Injection, due to the suction-operated of resin in suppressor, amino acid exists
Substantially chromatographic peak will not be detected on electric conductivity detector, without excluding amino acid pair by complicated separation condition
The interference that sodium, potassium, magnesium, calcium detect.But after being used for a long time, the amino acid of absorption will lead to chromatographic column and the service life of suppressor is big
It is big to shorten, greatly increase testing cost.In addition, other Coexisting components also easily Pollution restraint device in sample, and lead to calcium, magnesium color
Spectral peak deformation, detection repeatability and accuracy are deteriorated or even are unsatisfactory for method requirement, and there are the misjudged risks of qualified products.
The chromatography of ions also has using non-suppressed conductivity detection sample, this method flow path is simple, can mention without using suppressor
The stability of high method, and testing cost is effectively reduced.But in order to obtain relatively low background conductance signal and noise, usually
Select the acidic aqueous solution of low concentration as mobile phase, so separating capacity is very limited, so method only can be suitably used for sample
The simple sample of matrix component type, it is typical such as environmental water sample.Separation not can guarantee then for the sample of constituent species complexity, it is multiple
In square amino acid injection generally split-phase can be organized comprising ten several amino acid, a variety of electrolyte, pH adjusting agent, antioxidant etc.
Work as complexity, also not can guarantee the Accurate Determining of sodium, potassium, magnesium, calcium content according to existing non-inhibited method.
Therefore, it is necessary to establish, a kind of specificity is strong, in reliable and stable and inexpensive measurement Amino Acid Compound Injection
The method of sodium, potassium, magnesium, calcium.
Summary of the invention
The technical problem to be solved by the present invention is to overcome existing analysis and detection technology in Amino Acid Compound Injection liquid
Sodium, potassium, magnesium, the disadvantages of specificity is poor, stability is poor, accuracy is low, testing cost is high existing for determination of calcium content method.We
Method measures sodium, potassium, magnesium, containing for calcium in Amino Acid Compound Injection by developing a set of completely new ion chromatographic method realization
It is fixed, various components especially amino acid quick separating is coexisted into other in sodium, potassium, magnesium, calcium, simple and efficient to handle, method is accurate
Reliably, testing cost is low, has important practical meaning to the quality control of Amino Acid Compound Injection and drug safety.
The present invention is to solve above-mentioned technical problem by the following technical programs:
A kind of ion chromatography method of sodium, potassium, magnesium, calcium in Amino Acid Compound Injection comprising the steps of:
Certain density Amino Acid Compound Injection test sample and reference substance solution is respectively configured in step (1), in which:
A, the preparation of Amino Acid Compound Injection test sample
Precision, which weighs, measures appropriate test sample, sets in 100mL measuring bottle, is dissolved in water and is diluted to assigned scale, shake up to
It surveys;
B, the preparation of mixed reference substance solution
Precision measures appropriate sodium, potassium, magnesium, calcium single element standard solution, sets in 10mL measuring bottle, is diluted with water scale, mixes
It is even to mix intermediate fluid;Precision measures 1.00mL sodium, potassium, magnesium, calcium reference substance and mixes intermediate fluid, sets in 10mL measuring bottle, adds ultrapure
Water is diluted to assigned scale, mixes;
Step (2), using the chromatography of ions to the Amino Acid Compound Injection test sample and the reference substance solution into
Row detection, wherein chromatographic condition are as follows:
Chromatographic column: cation exchange column;
Mobile phase: mobile phase is acid compounds aqueous solution and organic solvent mixed solution, isocratic or gradient elution;
Flow velocity: 0.2mL/min~1.5mL/min;
Detector: electric conductivity detector, signal polarity are "-";
Detection cell temperature: 30 DEG C~40 DEG C;
Column temperature: 25 DEG C~40 DEG C;
Sample volume: 5~100 μ L;
Thus measure the reference substance solution, sodium in the Amino Acid Compound Injection test sample and blank solution, potassium,
The peak area of magnesium, calcium;
Sodium, potassium, magnesium, the concentration of calcium are molten according to the reference substance in step (3), the Amino Acid Compound Injection test sample
Sodium in sodium, potassium, magnesium, the peak area of calcium and reference substance solution in liquid, the Amino Acid Compound Injection test sample and blank solution,
The concentration of potassium, magnesium, calcium substitutes into formula 1, can calculate;
CuThe concentration (mg/L) of sodium, potassium, magnesium, calcium in=test solution
AuThe peak area of sodium, potassium, magnesium, calcium in=test solution
Au0The peak area of sodium, potassium, magnesium, calcium in blank solution used in=preparation test solution
AsThe peak area of sodium, potassium, magnesium, calcium in=reference substance solution
As0The peak area of sodium, potassium, magnesium, calcium in blank solution used in=preparation reference substance solution.
Further, the stationary phase of the cation-exchange chromatography column is silica gel or vinyl xylene, ethyl vinyl benzene-divinylbenzene
Fluoropolymer resin, function base are carboxylic acid or phosphoric acid.
Further, the acid compounds include hydrochloric acid, nitric acid, sulfuric acid, methane sulfonic acid, pyridinedicarboxylic acid, tartaric acid,
One of malic acid or oxalic acid are a variety of;The organic solvent includes one of acetonitrile, acetone or a variety of;The mixing is molten
Organic solvent ratio is 15~50% in liquid, can be separated according to sample and need to be adjusted.
It further, include glucose, sorb in the Amino Acid Compound Injection test sample component in addition to amino acid
Alcohol, xylitol, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium sulphate, potassium sulfate, magnesium sulfate, sodium acetate, potassium acetate, hydrogen-oxygen
Change one or more of sodium, potassium hydroxide, sodium pyrosulfite and sodium hydrogensulfite.
Further, reference substance solution sodium, potassium, magnesium, calcium peak theoretical cam curve are not less than 3000;Test solution is if any it
Its component or impurity chromatographic peak are not less than 2 with sodium, potassium, magnesium, calcium chromatographic peak separating degree.
Further, the value of reference substance solution concentration and the equation of linear regression of corresponding peak area value, related coefficient are calculated
Not less than 0.99.
Further, the blank solution and diluent are one of ultrapure water, deionized water or distilled water.
Further, the acid compounds are 4.3mmol/L methane sulfonic acid and 0.8mmol/L pyridinedicarboxylic acid;It is described
Organic solvent is acetonitrile, and the volume ratio of methane sulfonic acid and acetonitrile is 75/25, isocratic elution.
The positive effect of the present invention is that: this method without using used in common ion chromatographic process by inhibiting
Device and using non-inhibited type conductance method directly detect thus improvement method stability and accuracy.Utilize special mobile phase group
The retention behavior difference of pairs of complex sample component make sodium, potassium, magnesium, calcium and other Coexisting components especially amino acid sun from
Sub- exchange chromatography column good separation without interference measurement as a result, improving the specificity and accuracy of the chromatography of ions, analyze by shortening
Time improves the service life of chromatographic column.Method operation is more simple and efficient, and accurately and reliably, testing cost is low, to amino acid
The quality control of injection and drug safety have important practical meaning.
Detailed description of the invention
In order to more clearly explain the embodiment of the invention or the technical proposal in the existing technology, to embodiment or will show below
There is attached drawing needed in technical description to be briefly described, it should be apparent that, the accompanying drawings in the following description is this hair
Bright some embodiments for those of ordinary skill in the art without creative efforts, can be with root
Other attached drawings are obtained according to these attached drawings.
Fig. 1 is the ion chromatography survey of sodium in a kind of Amino Acid Compound Injection provided in an embodiment of the present invention, potassium, magnesium, calcium
Determine the chromatography of ions figure of the reference substance of method;
Fig. 2 is the ion chromatography survey of sodium in a kind of Amino Acid Compound Injection provided in an embodiment of the present invention, potassium, magnesium, calcium
Determine the chromatography of ions figure of the test sample of method.
Specific embodiment
In order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below in conjunction with the embodiment of the present invention
In attached drawing, technical scheme in the embodiment of the invention is clearly and completely described, it is clear that described embodiment is
A part of the embodiment of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, those of ordinary skill in the art
Every other embodiment obtained without making creative work, shall fall within the protection scope of the present invention.
Present inventor under study for action, uses the chromatography of ions to obtain good specificity, gives up current ion color
Spectrometry detects sodium, potassium, magnesium, the common suppressor of calcium, and the stability of detection method is improved while reducing testing cost.It utilizes
The rule found in experimentation, i.e., when using organic solvent in mobile phase, variety classes amino acid, sodium, potassium, magnesium and calcium exist
Retention behavior difference in chromatographic column significantly increases, and is optimized by the composition ratio of water phase and organic phase by most of amino acid
It excludes outside sodium, potassium, magnesium and calcium appearance range, improves the specificity of the chromatography of ions.Pass through acid compounds concentration again
So that sodium, potassium, magnesium and calcium can also be efficiently separated each other, gained peak sequence and conventional method are entirely different for optimization, from
And it ensures other components in Amino Acid Compound Injection and does not interfere the Accurate Determining of sodium, potassium, magnesium and calcium.The use of organic solvent
The strong reservation amino acid for containing Amino Acid Compound Injection also can shorten single analysis time by fast and effective elution, have
Help further increase the repeatability, accuracy and using life of chromatographic column of method, reduces sample detection cost.If being deposited in sample
In the component of stronger reservation, can after completing component elution to be measured, be changed to the higher mobile phase of organic Phase Proportion rinse with
The reliability of ensuring method.
Embodiment 1
Instrument and reagent
940Professional IC Vario ion chromatograph (Metrohm company, Switzerland);
Ultrapure water (Milli-Q, Millipore company, the U.S.);
Sodium single element standard solution (1000mg/L, manufacturer: China National Measuring Science Research Inst., GBW (E) 080127, batch
Number: 17113);
Potassium single element standard solution (1000mg/L, manufacturer: China National Measuring Science Research Inst., GBW (E) 080125, batch
Number: 17084);
Calcium single element standard solution (1000mg/L, manufacturer: China National Measuring Science Research Inst., GBW (E) 080118, batch
Number: 17104);
Magnesium single element standard solution (1000mg/L, manufacturer: China National Measuring Science Research Inst., GBW (E) 080126, batch
Number: 17101).
Sodium, potassium, magnesium, calcium catalyst
1, chromatographic condition
Chromatographic column: Metrosep C6 (4mm × 250mm) cation exchange column;
Mobile phase: (4.3mmol/L methane sulfonic acid/0.8mmol/L pyridinedicarboxylic acid)/acetonitrile=75/25, isocratic elution;
Flow velocity: 0.8mL/min;
Detector: electric conductivity detector, signal polarity be-;
Detection cell temperature: 35 DEG C;
Column temperature: 30 DEG C;
Sample volume: 20 μ L.
2, the preparation of test solution
Precision weigh measure test sample 1.000mL, set in 100mL measuring bottle, be dissolved in water and be diluted to scale, shake up to
It surveys.
3, the preparation of reference substance intermediate fluid
Precision measures 2.50mL sodium single element standard solution, 0.30mL magnesium single element standard solution, 0.30mL calcium single element
Standard solution, 3.50mL potassium single element standard solution, set in 10mL measuring bottle, ultrapure water are added to be diluted to scale, mix.
4, the preparation of reference substance solution
Precision measures 1.00mL sodium, potassium, magnesium, calcium intermediate fluid, sets in 10mL measuring bottle, ultrapure water is added to be diluted to scale, mixes.
Experimental result:
1, method detection limit, quantitative limit, linear and range
According to the measuring method sample introduction measurement of chromatographic condition 1 in example, chromatogram is recorded, referring to Fig. 1 and Fig. 2.With sodium,
Potassium, magnesium, calcium peak area carry out linear regression to its concentration, and sodium, potassium, magnesium, calcium is in the concentration range shown in table 1, peak area with
Linear relationship is presented in concentration, and related coefficient is 0.9998~1.0000.Sodium, potassium, magnesium, calcium quantitative limit (LOQ) test solution color
For signal-to-noise ratio in spectrogram 10~30, the concentration of quantitative limit solution is 0.018mgl/L~0.129mgl/L.Detection limit (LOD) is surveyed
Trying signal-to-noise ratio in solution chromatogram is 3~5, and detection limit solution concentration is 0.006mgl/L~0.039mgl/L.Specific data can
Reference table 1.
Table 1, regression equation, quantitative limit (LOQ) and detection limit (LOD) result
2, repeatability, Intermediate precision and stability test
2.1 repeated
6 parts of same batch of Amino Acid Compound Injection test sample is taken, according to said determination method, is measured.It is tied by test
Fruit as it can be seen that with batch of 6 bottles of test solutions sodium, potassium, magnesium, calcium content, RSD be 0.34%~0.66%.
2.2 Intermediate precision
Replacement operation person, and same batch 6 parts of Amino Acid Compound Injection test sample are used in not same date, according to measurement side
Method is measured.By test result as it can be seen that with batch of 6 bottles of test solutions sodium, potassium, magnesium, calcium content content, RSD is
0.10%~0.42%.The Intermediate precision RSD of two bit manipulation persons is 0.24%~0.55%.
2.3 stability
Reference substance solution, test solution are being placed at room temperature for, respectively place 1 hour, 2 hours, 4 hours, 8 hours,
12 hours, 24 hours stable solutions.As a result as it can be seen that relative standard deviation of the test sample content results within 24 hours is
0.68%~1.06%, show that method can stable detection in 24 hours.
3, sample recovery rate is tested
Sodium, potassium, magnesium, calcium the rate of recovery investigated in three concentration, work is added into blank auxiliary solution respectively
50%, 100% and the 150% of concentration (25mg/L sodium, 3mg/L magnesium, 3mg/L calcium, 35mg/L potassium).Sodium, potassium, magnesium, calcium are each
The rate of recovery under horizontal is 99.22%~103.80%.
4, product to be tested measures
Four different batches are measured according to test method, the results are shown in Table 2, sodium content 2176mg/L~
2431mg/L;Content of magnesium is in 265mg/L~322mg/L;Calcium content is in 269mg/L~450mg/L;Potassium content 3139mg/L~
3710mg/L。
2, four batches of sample measurement results of table
Finally, it should be noted that the above embodiments are merely illustrative of the technical solutions of the present invention, rather than its limitations;Although
Present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that: it still may be used
To modify the technical solutions described in the foregoing embodiments or equivalent replacement of some of the technical features;
And these are modified or replaceed, technical solution of various embodiments of the present invention that it does not separate the essence of the corresponding technical solution spirit and
Range.
Claims (10)
1. a kind of ion chromatography method of sodium, potassium, magnesium, calcium in Amino Acid Compound Injection, which is characterized in that comprising following
Step:
Certain density Amino Acid Compound Injection test sample and reference substance solution is respectively configured in step (1), in which:
A, the preparation of Amino Acid Compound Injection test sample
Precision, which weighs, measures appropriate test sample, is placed in measuring bottle, is dissolved in water and is diluted to assigned scale, shake up to be measured;
B, the preparation of mixed reference substance solution
Precision measures appropriate sodium, potassium, magnesium, calcium single element standard solution, is placed in mL measuring bottle, is diluted with water scale, mixes
Mix intermediate fluid;Precision measures appropriate sodium, potassium, magnesium, calcium reference substance and mixes intermediate fluid, is placed in measuring bottle, ultrapure water is added to be diluted to
Assigned scale mixes;
Step (2) examines the Amino Acid Compound Injection test sample and the reference substance solution using the chromatography of ions
It surveys, wherein chromatographic condition are as follows:
Chromatographic column: cation exchange column;
Mobile phase: mobile phase is acid compounds aqueous solution and organic solvent mixed solution, isocratic or gradient elution;
Flow velocity: 0.2mL/min~1.5mL/min;
Detector: electric conductivity detector, signal polarity are "-";
Detection cell temperature: 30 DEG C~40 DEG C;
Column temperature: 25 DEG C~40 DEG C;
Sample volume: 5~100 μ L;
Thus the reference substance solution is measured, sodium, potassium, magnesium, calcium in the Amino Acid Compound Injection test sample and blank solution
Peak area;
Sodium in step (3), the Amino Acid Compound Injection test sample, potassium, magnesium, calcium concentration according to the reference substance solution,
Sodium in sodium, potassium, magnesium, the peak area of calcium and reference substance solution in the Amino Acid Compound Injection test sample and blank solution, potassium,
The concentration of magnesium, calcium substitutes into formula 1, can calculate;
CuThe concentration (mg/L) of sodium, potassium, magnesium, calcium in=test solution
AuThe peak area of sodium, potassium, magnesium, calcium in=test solution
Au0The peak area of sodium, potassium, magnesium, calcium in blank solution used in=preparation test solution
AsThe peak area of sodium, potassium, magnesium, calcium in=reference substance solution
As0The peak area of sodium, potassium, magnesium, calcium in blank solution used in=preparation reference substance solution.
2. measuring method as described in claim 1, which is characterized in that the stationary phase of the cation-exchange chromatography column is silica gel
Or vinyl xylene, ethyl vinyl benzene-divinyl benzene polymers resin, function base are carboxylic acid or phosphoric acid.
3. measuring method as claimed in claim 1 or 2, which is characterized in that the acid compounds be hydrochloric acid, nitric acid, sulfuric acid,
One of methane sulfonic acid, pyridinedicarboxylic acid, tartaric acid, malic acid or oxalic acid are a variety of;The organic solvent is acetonitrile, acetone
One of or it is a variety of;Organic solvent volume accounting example is 15~50% in the mixed solution, can separate needs according to sample
It is adjusted.
4. measuring method as claimed in claim 1 or 2, which is characterized in that the Amino Acid Compound Injection test sample component
In in addition to amino acid, include glucose, sorbierite, xylitol, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium sulphate, sulfuric acid
One of potassium, magnesium sulfate, sodium acetate, potassium acetate, sodium hydroxide, potassium hydroxide, sodium pyrosulfite and sodium hydrogensulfite or
It is a variety of.
5. measuring method as claimed in claim 1 or 2, which is characterized in that reference substance solution sodium, potassium, magnesium, calcium peak theoretical tray
Number is not less than 3000;Test solution is not small with sodium, potassium, magnesium, calcium chromatographic peak separating degree if any other components or impurity chromatographic peak
In 2.
6. measuring method as claimed in claim 1 or 2, which is characterized in that calculate the value and respective peaks of reference substance solution concentration
The equation of linear regression of area value, related coefficient are not less than 0.99.
7. measuring method as claimed in claim 1 or 2, which is characterized in that the blank solution and diluent be ultrapure water,
One of deionized water or distilled water.
8. measuring method as claimed in claim 1 or 3, which is characterized in that the acid compounds are 4.3mmol/L methyl sulphur
Acid and 0.8mmol/L pyridinedicarboxylic acid;The organic solvent is acetonitrile, and the volume ratio of methane sulfonic acid and acetonitrile is 75/25, isocratic
Elution.
9. measuring method as claimed in claim 1 or 3, which is characterized in that in step (1), Amino Acid Compound Injection is for examination
When the preparation of product, precision, which weighs, measures appropriate test sample, sets in 100mL measuring bottle.
10. measuring method as claimed in claim 1 or 3, which is characterized in that in step (1), the preparation of mixed reference substance solution
When, precision measures appropriate sodium, potassium, magnesium, calcium single element 10mL standard solution, sets in measuring bottle, is diluted with water scale, mixes mixed
Close intermediate fluid;Precision measures 1.0mL sodium, potassium, magnesium, calcium reference substance and mixes intermediate fluid, sets in 10mL measuring bottle, ultrapure water is added to be diluted to
Assigned scale mixes.
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CN110618188A (en) * | 2019-09-20 | 2019-12-27 | 成都第一制药有限公司 | Method for detecting content of cations in motherwort injection |
CN113325118A (en) * | 2021-07-21 | 2021-08-31 | 海南通用三洋药业有限公司 | Method for measuring sodium content in parecoxib sodium |
CN113325118B (en) * | 2021-07-21 | 2022-12-09 | 海南通用三洋药业有限公司 | Method for measuring sodium content in parecoxib sodium |
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