CN108956797A - Chlorphenamine maleate, Determination Paracetamol in Paracetamol method for measuring in a kind of Ankahuangmin Tablets - Google Patents

Chlorphenamine maleate, Determination Paracetamol in Paracetamol method for measuring in a kind of Ankahuangmin Tablets Download PDF

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CN108956797A
CN108956797A CN201810421117.5A CN201810421117A CN108956797A CN 108956797 A CN108956797 A CN 108956797A CN 201810421117 A CN201810421117 A CN 201810421117A CN 108956797 A CN108956797 A CN 108956797A
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paracetamol
solution
ankahuangmin
tablets
chlorphenamine maleate
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陆宽
冯发进
霍昕
李计龙
高玉琼
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GUIZHOU PROVINCE KEHUI PHARMACEUTICAL FACTORY
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GUIZHOU PROVINCE KEHUI PHARMACEUTICAL FACTORY
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/10Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography

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  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
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  • Health & Medical Sciences (AREA)
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  • General Physics & Mathematics (AREA)
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract

The present invention relates to drug detection technique field, chlorphenamine maleate, Determination Paracetamol in Paracetamol method for measuring in specifically a kind of Ankahuangmin Tablets.The present invention use using HPLC method in Ankahuangmin Tablets chlorphenamine maleate and paracetamol detect, be filler with octadecylsilane chemically bonded silica;With potassium dihydrogen phosphate-methanol-triethylamine-phosphoric acid (95:5:0.4:0.2) of 0.01mol/L for mobile phase;Detection wavelength: 215nm, flow velocity: 1mL/min;Column temperature: 30 DEG C.This method is easy, accurate, reproducible, preferable to the separating degree of chlorphenamine maleate and paracetamol, and the quality controllability of Ankahuangmin Tablets can be improved, to improve Drug safety, provides reference frame for the quality control of Ankahuangmin Tablets.

Description

Chlorphenamine maleate, Determination Paracetamol in Paracetamol measurement in a kind of Ankahuangmin Tablets Method
Technical field
The present invention relates to drug detection technique field, chlorphenamine maleate in specifically a kind of Ankahuangmin Tablets, to second Acylamino- phenol content method for measuring.
Background technique
The compound preparation that Ankahuangmin Tablets are made of chlorphenamine maleate, paracetamol etc. is clinical common Coritab.Existing national standards only establish visible/ultraviolet spectrophotometry of measurement Determination Paracetamol in Paracetamol, and right The content of chlorphenamine maleate is not controlled.In order to improve the quality controllability of Ankahuangmin Tablets, to improve Drug safety.It needs to carry out raising research to the quality standard of Ankahuangmin Tablets, drafts internal mass standards, establish ammonia The content assaying method of quick chlorphenamine maleate of coffee Huang, paracetamol.
Therefore, chlorphenamine maleate in Ankahuangmin Tablets, acetparaminosalol can preferably be measured simultaneously by finding one kind The measuring method of phenol content is the task of top priority.
Summary of the invention
In order to solve the above technical problems existing in the prior art, the present invention provides maleic acid in a kind of Ankahuangmin Tablets Chlorphenamine, Determination Paracetamol in Paracetamol method for measuring, comprising the following steps:
Chlorphenamine maleate, Determination Paracetamol in Paracetamol method for measuring in a kind of Ankahuangmin Tablets, for surveying simultaneously The content for determining chlorphenamine maleate in Ankahuangmin Tablets, paracetamol uses HPLC method to be measured, with 18 Alkyl silane bonded silica gel is filler;With potassium dihydrogen phosphate-methanol-triethylamine-phosphoric acid of 0.01mol/L (95:5: It 0.4:0.2) is mobile phase;Detection wavelength: 215nm, flow velocity: 1mL/min;Column temperature: 30 DEG C.
The HPLC method, using Ankahuangmin Tablets solution as test solution.
Further, the Ankahuangmin Tablets solution is to be dissolved in Ankahuangmin Tablets in mobile phase solution obtaining.
Further, the Ankahuangmin Tablets solution is that configuration obtains by the following method: taking finely ground Ankahuangmin Tablets Powder 5g is placed in 100mL stuffed conical flask, and mobile phase solution 50mL, weighing is added in precision, and ultrasonic 15min is mixed with flowing Liquid supplies weight, and filtration, filtrate is Ankahuangmin Tablets solution.This Ankahuangmin Tablets solution is more suitable for chlorphenamine maleate The detection of content.
Further, the Ankahuangmin Tablets solution is that configuration obtains by the following method: taking finely ground Ankahuangmin Tablets powder Last 1g is placed in 100mL stuffed conical flask, and precision pipettes mobile phase solution 50mL, weighing, ultrasonic 15min, with mobile phase solution The weight for supplying less loss, shakes up, filtration, and precision draws filtrate 5mL in 100mL volumetric flask, and mobile phase solution is settled to scale Test solution as paracetamol.This Ankahuangmin Tablets solution is more suitable for the detection of Determination Paracetamol in Paracetamol.
The HPLC method, chlorphenamine maleate reference substance solution are prepared via a method which: with 100,000 / mono- balance accurate weighing chlorphenamine maleate reference substance 50.05mg, is placed in 50mL volumetric flask, adds mobile phase solution molten The solution for solving and being settled to scale to get 1.001mg/mL, precision measures above-mentioned solution 1mL and is placed in 100mL volumetric flask, then uses Mobile phase solution constant volume is configured to the chlorphenamine maleate reference substance solution of 10.01 μ g/mL to graduation mark.
The HPLC method, paracetamol reference substance solution are prepared via a method which: very much with ten One of balance accurate weighing paracetamol reference substance 125.43mg, be placed in 50mL volumetric flask, add mobile phase solution dissolve And scale is settled to get the solution of 2.5086mg/mL, precision measures above-mentioned solution 1mL and is placed in 100mL volumetric flask, then uses Mobile phase solution constant volume is configured to the paracetamol reference substance solution of 25.086 μ g/mL to graduation mark.
The HPLC method, chlorphenamine maleate, acetparaminosalol in Ankahuangmin Tablets according to claim 1 Phenol content method for measuring, which is characterized in that the HPLC method, sample volume are 10 μ L.
Under conditions of mobile phase solution is as solvent, to chlorphenamine maleate and paracetamol contrast solution, Test solution, negative control solution and containing chlorphenamine maleate and paracetamol mixing contrast solution progress The spectral scan of 200nm-700nm, obtains: chlorphenamine maleate reference substance has larger absorption peak at 261nm and 226nm; Paracetamol contrast solution has larger absorption peak at 242nm;And negative control solution nothing in respective absorbing wavelength Absorption peak;Mixing has absorption peak to impinging upon at 242.5nm and 223nm.Although paracetamol and chlorphenamine maleate The wavelength of maximum absorption band is different, but their maximum absorption wavelength is closer, but due in metho kahuangmin tablet recipe to second Acylamino- phenol content is larger, and the content of chlorphenamine maleate is smaller, therefore measuring wavelength should select chlorphenamine maleate maximum Absorbing wavelength 223nm or so.By test of many times, finally selecting the common Detection wavelength of two kinds of compounds is 215nm.
It is of the invention specific steps are as follows:
(1) preparation reference substance solution and test solution, negative control solution:
The preparation of reference substance solution:
1. the preparation of chlorphenamine maleate reference substance solution: with ten a ten thousandth balance accurate weighing chlorphenamine maleates Quick reference substance 50.05mg, is placed in 50mL volumetric flask, adds mobile phase solution to dissolve and is settled to scale to get 1.001mg/mL Solution, precision measures above-mentioned solution 1mL and is placed in 100mL volumetric flask, then with mobile phase solution constant volume to graduation mark, is configured to The chlorphenamine maleate reference substance solution of 10.01 μ g/mL.
2. the preparation of paracetamol reference substance solution: with ten a ten thousandth balance accurate weighing paracetamol pair It according to product 125.43mg, is placed in 50mL volumetric flask, mobile phase solution is added to dissolve and is settled to scale to get 2.5086mg/mL's Solution, precision measure above-mentioned solution 1mL and are placed in 100mL volumetric flask, then with mobile phase solution constant volume to graduation mark, are configured to The paracetamol reference substance solution of 25.086 μ g/mL.
The preparation of test solution:
1. taking finely ground Ankahuangmin Tablets powder 5g, it is placed in 100mL stuffed conical flask, mobile phase solution is added in precision 50mL, weighing, ultrasonic 15min supply weight with mobile phase solution, filter, filtrate is Ankahuangmin Tablets solution.
2. taking finely ground Ankahuangmin Tablets powder 1g, it is placed in 100mL stuffed conical flask, precision pipettes mobile phase solution 50mL, weighing, ultrasonic 15min supplies the weight of less loss with mobile phase solution, shakes up, and filters, precision draw filtrate 5mL in In 100mL volumetric flask, mobile phase solution be settled to scale to get.
The preparation of negative control solution:
1. removing chlorphenamine maleate and paracetamol in prescription ratio, is prepared by technique and lack chlorphenamine maleate Double-negative contrast solution is made with the test sample 1. identical method of solution is prepared in quick and paracetamol double-negative sample ①。
2. removing chlorphenamine maleate and paracetamol in prescription ratio, is prepared by technique and lack chlorphenamine maleate Double-negative contrast solution is made with the test sample 2. identical method of solution is prepared in quick and paracetamol double-negative sample ②。
(2) continuous mode:
Set chromatographic condition are as follows: with octadecylsilane chemically bonded silica be filler;With the potassium dihydrogen phosphate of 0.01mol/L Solution-methyl alcohol-triethylamine-phosphoric acid (95:5:0.4:0.2) is mobile phase;Detection wavelength: 215nm, flow velocity: 1mL/min;Column temperature: 30 DEG C, each 10 μ L of sample volume.
1. chlorphenamine maleate reference substance solution, chlorphenamine maleate and the double-negative control of paracetamol is molten 1. 1. liquid injects liquid chromatograph with test solution, record chromatogram.
2. by paracetamol reference substance solution, chlorphenamine maleate and the double-negative contrast solution of paracetamol 2. 2. injecting liquid chromatograph with test solution, chromatogram is recorded.
Compared with prior art, the technical effect of the invention is embodied in:
The present invention use using HPLC method in Ankahuangmin Tablets chlorphenamine maleate and paracetamol into Row detection, is filler with octadecylsilane chemically bonded silica;With-three second of potassium dihydrogen phosphate-methanol of 0.01mol/L Amine-phosphoric acid (95:5:0.4:0.2) is mobile phase;Detection wavelength: 215nm, flow velocity: 1mL/min;Column temperature: 30 DEG C.This method letter Just, accurately, reproducible, it is preferable to the separating degree of chlorphenamine maleate and paracetamol, Ankahuangmin Tablets can be improved Quality controllability provide reference frame for the quality control of Ankahuangmin Tablets to improve Drug safety.
Detailed description of the invention
Fig. 1 is chlorphenamine maleate reference substance map.
Fig. 2 is chlorphenamine maleate and the double-negative contrast solution of paracetamol 1. map.
Fig. 3 is test sample 1. map.
Fig. 4 is chlorphenamine maleate canonical plotting.
Fig. 5 is paracetamol reference substance map.
Fig. 6 is chlorphenamine maleate and the double-negative contrast solution of paracetamol 2. map.
Fig. 7 is test sample 2. map.
Fig. 8 paracetamol canonical plotting.
Specific embodiment
It is limited below with reference to specific embodiment technical solution of the present invention is further, but claimed Range is not only limited to made description.
Embodiment:
(1) preparation reference substance solution and test solution, negative control solution:
The preparation of reference substance solution:
1. the preparation of chlorphenamine maleate reference substance solution: with ten a ten thousandth balance accurate weighing chlorphenamine maleates Quick reference substance 50.05mg, is placed in 50mL volumetric flask, adds mobile phase solution to dissolve and is settled to scale to get 1.001mg/mL Solution, precision measures above-mentioned solution 1mL and is placed in 100mL volumetric flask, then with mobile phase solution constant volume to graduation mark, is configured to The chlorphenamine maleate reference substance solution of 10.01 μ g/mL.
2. the preparation of paracetamol reference substance solution: with ten a ten thousandth balance accurate weighing paracetamol pair It according to product 125.43mg, is placed in 50mL volumetric flask, mobile phase solution is added to dissolve and is settled to scale to get 2.5086mg/mL's Solution, precision measure above-mentioned solution 1mL and are placed in 100mL volumetric flask, then with mobile phase solution constant volume to graduation mark, are configured to The paracetamol reference substance solution of 25.086 μ g/mL.
The preparation of test solution:
1. taking finely ground Ankahuangmin Tablets powder 5g, it is placed in 100mL stuffed conical flask, mobile phase solution is added in precision 50mL, weighing, ultrasonic 15min supply weight with mobile phase solution, filter, filtrate is Ankahuangmin Tablets solution.
2. taking finely ground Ankahuangmin Tablets powder 1g, it is placed in 100mL stuffed conical flask, precision pipettes mobile phase solution 50mL, weighing, ultrasonic 15min supplies the weight of less loss with mobile phase solution, shakes up, and filters, precision draw filtrate 5mL in In 100mL volumetric flask, mobile phase solution be settled to scale to get.
The preparation of negative control solution:
1. removing chlorphenamine maleate and paracetamol in prescription ratio, is prepared by technique and lack chlorphenamine maleate Double-negative contrast solution is made with the test sample 1. identical method of solution is prepared in quick and paracetamol double-negative sample ①。
2. removing chlorphenamine maleate and paracetamol in prescription ratio, is prepared by technique and lack chlorphenamine maleate Double-negative contrast solution is made with the test sample 2. identical method of solution is prepared in quick and paracetamol double-negative sample ②。
(2) continuous mode:
Set chromatographic condition are as follows: with octadecylsilane chemically bonded silica be filler;With the potassium dihydrogen phosphate of 0.01mol/L Solution-methyl alcohol-triethylamine-phosphoric acid (95:5:0.4:0.2) is mobile phase;Detection wavelength: 215nm, flow velocity: 1mL/min;Column temperature: 30 DEG C, each 10 μ L of sample volume.
1. chlorphenamine maleate reference substance solution, chlorphenamine maleate and the double-negative control of paracetamol is molten 1. 1. liquid injects liquid chromatograph with test solution, record chromatogram.
2. by paracetamol reference substance solution, chlorphenamine maleate and the double-negative contrast solution of paracetamol 2. 2. injecting liquid chromatograph with test solution, chromatogram is recorded.
Embodiment 1: the assay of chlorphenamine maleate in Ankahuangmin Tablets
In the present embodiment, reference substance solution is chlorphenamine maleate reference substance solution;Chlorphenamine maleate and right The double-negative contrast solution of Paracetamol be chlorphenamine maleate and the double-negative contrast solution of paracetamol 1.;For examination Product solution be test solution 1..
System suitability:
By chlorphenamine maleate reference substance solution, chlorphenamine maleate and the double-negative contrast solution of paracetamol Liquid chromatograph is injected with test solution, records chromatogram, blank control liquid noiseless peak at reference substance position, above-mentioned Under the conditions of chlorphenamine maleate sample solution theoretical cam curve be 13915, separating degree 2.9, tailing factor 1.18.Its Reference value meets 2010 editions States Pharmacopoeia specifications.Specific as shown in Figure 1, Figure 2, Fig. 3.
Linear relationship:
With ten a ten thousandth balance accurate weighing chlorphenamine maleate reference substance 50.13mg, it is placed in 10mL volumetric flask, Add mobile phase solution to dissolve and be settled to scale, shakes up to get 5.013mg/mL solution, precision draws 1mL to 100mL volumetric flask In, mobile phase constant volume to graduation mark shakes up to get 50.13 μ g/mL, respectively it is accurate measure reference substance solution 1mL, 3mL, 5mL, 7mL, 9mL add mobile phase to be diluted to scale in the volumetric flask of 25mL, shake up, and each 10 μ L of sample introduction is surveyed under the wavelength of 215nm It is fixed.Using concentration as abscissa, using peak area as ordinate, linear regression processing is carried out.As a result such as Fig. 4.
Linear relationship investigates result table
Equation of linear regression: Y=12990X+2203.9, chlorphenamine maleate correlation coefficient r=0.9998.According to reality It tests as a result, chlorphenamine maleate is within the scope of 2.01~18.09 μ g/mL, in good linear relationship.
Precision test:
Chlorphenamine maleate test sample is taken, with the solution after filtering with microporous membrane, the peak of six this samples of METHOD FOR CONTINUOUS DETERMINATION Area, and the concentration of chlorphenamine maleate is calculated, as a result such as following table, the RSD value of chlorphenamine maleate is 0.61% (standard value RSD value is less than 2%), shows that instrument precision is good.
Precision test result table
Stability test:
Chlorphenamine maleate test sample is taken, primary, measurement 8 times in total are measured at interval of 1h, chlorphenamine maleate RSD value is 0.31%, the results showed that test sample is stablized in 7h.As a result as follows.
Stability test result table
Repetitive test: taking the Ankahuangmin Tablets sample of same lot number finely ground, accurately weighs 6 parts, and every part of 5g is placed in In 100mL stuffed conical flask, processing method obtains test solution by the same way, with filtering with microporous membrane, is in wavelength Peak area is measured at 215nm, the average content that chlorphenamine maleate is calculated is that 100.147 μ g/g, RSD values are 1.40%, it is as a result as follows.
Repetitive test result table
It is loaded recovery test:
Precision weighs finely ground 9 parts of Ankahuangmin Tablets sample of 2.5g, is placed in 100mL stuffed conical flask, precision addition 4, 5, the chlorphenamine maleate contrast solution 50mL of 6 μ g/mL takes 10 μ L sample introduction of filtrate, in 215nm wavelength according to test sample processing Lower its peak area of measurement calculates the rate of recovery and RSD value, as a result such as following table.
It is loaded recovery test result table
Test result shows that being loaded average recovery rate be 99.60%, RSD value is 1.37%, reaches standard requirements, method It is feasible.
Embodiment 2: the assay of paracetamol in Ankahuangmin Tablets
In the present embodiment, reference substance solution is paracetamol reference substance solution;Chlorphenamine maleate and to second The double-negative contrast solution of acylamino- phenol be chlorphenamine maleate and the double-negative contrast solution of paracetamol 2.;Test sample Solution be test solution 2..
System suitability:
Paracetamol reference substance solution, double-negative contrast solution and test solution are injected into liquid chromatograph, note Record chromatogram, blank control liquid noiseless peak at reference substance position, paracetamol sample solution under the above conditions Theoretical cam curve is 14547, separating degree 37.6, tailing factor 1.16.Its reference value meets 2010 editions States Pharmacopoeia specifications.Tool Body such as Fig. 5, Fig. 6, Fig. 7.
Linear relationship:
With ten a ten thousandth balance accurate weighing paracetamol reference substance 125.60mg, it is placed in 10mL volumetric flask, Add mobile phase solution to dissolve and be settled to scale, shakes up to get 12.56mg/mL solution, precision draws 1mL to 100mL volumetric flask In, be settled to scale with mobile phase, shake up to get 0.1256mg/mL solution, precision measure reference substance solution 1mL, 3mL, 5mL, In the volumetric flask of 7mL, 9mL to 5 25mL, adds mobile phase to be diluted to scale, shake up, each 10 μ L of sample introduction, under the wavelength of 215nm Measurement.Using concentration as abscissa, using peak area as ordinate, linear regression processing is carried out.As a result such as Fig. 8.
Linear relationship investigates result table
Concentration (μ g/mL) Peak area
5.024 121377
15.072 369364
25.120 600320
35.168 829910
45.216 1054247
Equation of linear regression: Y=23263X+13472, paracetamol correlation coefficient r=0.9997.It is tied according to experiment Fruit, paracetamol are in a linear relationship within the scope of 5.024~45.216 μ g/mL.
Precision test:
A paracetamol test sample is taken, with the solution after filtering with microporous membrane, six this samples of METHOD FOR CONTINUOUS DETERMINATION Peak area, and the concentration of paracetamol is calculated, RSD value is 0.04% (standard value RSD value is less than 2%), shows instrument Precision is good, as a result as follows.
Precision test result table
Stability test:
Same test sample is taken, measures once at interval of 1h, measures 8 times in total, the RSD value of paracetamol is 0.42%, the results showed that test sample is stablized in 7h, as a result as follows.
Paracetamol stability test result
Repetitive test:
It takes the Ankahuangmin Tablets sample of same lot number finely ground, accurately weighs 6 parts, every part weighs 1g, is respectively placed in 100mL tool It fills in conical flask, processing method obtains test solution by the same way, is at 215nm in wavelength with filtering with microporous membrane Peak area is measured, the average content that paracetamol is calculated is 25.92mg/g, and RSD value is 1.05%, as a result as follows.
Repetitive test result
It is loaded recovery test:
Precision weighs finely ground 9 parts of Ankahuangmin Tablets sample of 0.5g, is placed in 100mL stuffed conical flask, and precision is added 0.2,0.25,0.3mg/mL reference substance solution 50mL, according to the processing of test sample method, filtering with microporous membrane is surveyed under 215nm wavelength Its fixed peak area calculates the rate of recovery and RSD value, as a result as follows.
It is loaded recovery test result table
Test result shows that being loaded average recovery rate is 100.55%, RSD 1.43%, reaches standard requirements, method can Row.
From the foregoing, it will be observed that method of the invention can separating degree to chlorphenamine maleate and paracetamol it is preferable, can The quality controllability of Ankahuangmin Tablets is improved, to improve Drug safety, provides ginseng for the quality control of Ankahuangmin Tablets Examine foundation.
Finally it is pointed out that above embodiments are only the more representational examples of the present invention.Obviously, technology of the invention Scheme is not limited to above-described embodiment, and acceptable there are many deformations.Those skilled in the art can be from disclosed by the invention All deformations that content is directly exported or associated, are considered as protection scope of the present invention.

Claims (8)

1. chlorphenamine maleate, Determination Paracetamol in Paracetamol method for measuring in a kind of Ankahuangmin Tablets, for measuring simultaneously The content of chlorphenamine maleate, paracetamol in Ankahuangmin Tablets, which is characterized in that surveyed using HPLC method It is fixed, it is filler with octadecylsilane chemically bonded silica;With potassium dihydrogen phosphate-methanol-triethylamine-phosphorus of 0.01mol/L Acid
(95:5:0.4:0.2) is mobile phase;Detection wavelength: 215nm, flow velocity: 1mL/min;Column temperature: 30 DEG C.
2. the side that chlorphenamine maleate, Determination Paracetamol in Paracetamol measure in Ankahuangmin Tablets according to claim 1 Method, which is characterized in that the HPLC method, using Ankahuangmin Tablets solution as test solution.
3. the side that chlorphenamine maleate, Determination Paracetamol in Paracetamol measure in Ankahuangmin Tablets according to claim 2 Method, which is characterized in that the Ankahuangmin Tablets solution is to be dissolved in Ankahuangmin Tablets in mobile phase solution obtaining.
4. the side that chlorphenamine maleate, Determination Paracetamol in Paracetamol measure in Ankahuangmin Tablets according to claim 3 Method, which is characterized in that the Ankahuangmin Tablets solution is that configuration obtains by the following method: taking finely ground Ankahuangmin Tablets powder Last 5g is placed in 100mL stuffed conical flask, and mobile phase solution 50mL, weighing, ultrasonic 15min, with mobile phase solution is added in precision Weight is supplied, is filtered, filtrate is Ankahuangmin Tablets solution.
5. the side that chlorphenamine maleate, Determination Paracetamol in Paracetamol measure in Ankahuangmin Tablets according to claim 3 Method, which is characterized in that the Ankahuangmin Tablets solution is that configuration obtains by the following method: taking finely ground Ankahuangmin Tablets powder 1g is placed in 100mL stuffed conical flask, and precision pipettes mobile phase solution 50mL, weighing, and ultrasonic 15min is mended with mobile phase solution The weight of sufficient less loss, shakes up, filtration, and precision draws filtrate 5mL in 100mL volumetric flask, and mobile phase solution is settled to scale, i.e., ?.
6. the side that chlorphenamine maleate, Determination Paracetamol in Paracetamol measure in Ankahuangmin Tablets according to claim 1 Method, which is characterized in that the HPLC method, chlorphenamine maleate reference substance solution are prepared via a method which: With ten a ten thousandth balance accurate weighing chlorphenamine maleate reference substance 50.05mg, it is placed in 50mL volumetric flask, adds mobile phase The solution that solution dissolves and is settled to scale to get 1.001mg/mL, precision measure above-mentioned solution 1mL and are placed in 100mL volumetric flask In, then with mobile phase solution constant volume to graduation mark, it is configured to the chlorphenamine maleate reference substance solution of 10.01 μ g/mL.
7. the side that chlorphenamine maleate, Determination Paracetamol in Paracetamol measure in Ankahuangmin Tablets according to claim 1 Method, which is characterized in that the HPLC method, paracetamol reference substance solution are prepared via a method which: it uses Ten a ten thousandth balance accurate weighing paracetamol reference substance 125.43mg, are placed in 50mL volumetric flask, flowing are added to mix The solution that liquid dissolves and is settled to scale to get 2.5086mg/mL, precision measure above-mentioned solution 1mL and are placed in 100mL volumetric flask In, then with mobile phase solution constant volume to graduation mark, it is configured to the paracetamol reference substance solution of 25.086 μ g/mL.
8. the side that chlorphenamine maleate, Determination Paracetamol in Paracetamol measure in Ankahuangmin Tablets according to claim 1 Method, which is characterized in that the HPLC method, chlorphenamine maleate in Ankahuangmin Tablets according to claim 1, to second Acylamino- phenol content method for measuring, which is characterized in that the HPLC method, sample volume are 10 μ L.
CN201810421117.5A 2018-05-04 2018-05-04 Chlorphenamine maleate, Determination Paracetamol in Paracetamol method for measuring in a kind of Ankahuangmin Tablets Pending CN108956797A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110018254A (en) * 2019-04-22 2019-07-16 江西和盈药业有限公司 A kind of quality determining method of metho kahuangmin oral administration solution

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110018254A (en) * 2019-04-22 2019-07-16 江西和盈药业有限公司 A kind of quality determining method of metho kahuangmin oral administration solution

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