CN103487551A - Method for detecting sodium metabisulfite in vinpocetine injection - Google Patents
Method for detecting sodium metabisulfite in vinpocetine injection Download PDFInfo
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Abstract
The invention relates to a method for detecting sodium metabisulfite in a vinpocetine injection. The method for detecting the sodium metabisulfite in the vinpocetine injection comprises the following steps of using basic compounds or a solution of the basic compounds to adjust the vinpocetine injection until the vinpocetine injection is in basicity, carrying out filtration, removing interference, and detecting the content of the sodium metabisulfite in the vinpocetine injection. The basicity means that the PH of the vinpocetine injection is larger than seven and smaller than or equal to fourteen, and an antioxidant in the vinpocetine injection at least comprises the sodium metabisulfite. The method for detecting the sodium metabisulfite in the vinpocetine injection has the advantages that masking agents, namely the basic compounds, are low in cost and can be easily obtained, cost is low, detection is easy, convenient and easy to implement, accuracy and precision are high, and stability is good.
Description
Technical field
The invention belongs to the detection technique field, be specifically related to a kind of method that detects pyrosulfurous acid sodium content in Vinpocetine injection.
Background technology
Vinpocetine (vinpocetine, VIN, structure is as shown in Equation 1) have another name called Apovincaminic Acid Ethyl Ester, be the derivant of the indoles alkaloid pervone that extracts in the little graceful catharanthus roseus of apocynaceae plant, this medicine by Hungary pharmaceutical companies Cedeon Richter in research and development listing in 1978.Clinical data confirms; vinpocetine can optionally improve the cerebrum blood circulation; promote large brain energy metabolism; regulate the neurotransmitter system function; many-sided protection brain is avoided the infringement of hypoxic-ischemic; be mainly used in treating the illnesss such as brain diseases due to cardiovascular and cerebrovascular disease, ischemic hypertensive encephalopathy, cerebral arteriovenous malformation, cerebral ischaemia, intermittent brain supply of blood flow deficiency, cerebral angiospasm, cerebral thrombus, aging, and evident in efficacy.
At present, clinical main use Vinpocetine injection.But, there is oxidative instability in vinpocetine, need in its parenteral solution, add antioxidant, wherein, described antioxidant is selected from ascorbic acid, sodium pyrosulfite, sodium bisulfite, sodium sulphite etc., and sodium pyrosulfite is comparatively commonly used, and other auxiliary materials such as tartrate, sorbierite, phenmethylol, water for injection.Wherein, the oxidized residual thing of sodium pyrosulfite may cause damage to human body (comprising sulphite etc.).Therefore, should control the addition (its limit the quantity of≤0.2%(mass volume ratio commonly used) of sodium pyrosulfite in parenteral solution), to improve the security of medicine.
If the material of the produced interference coexisted except sodium pyrosulfite in testing sample, generate precipitation or during with the ion of indicator colour developing or compound as reacted with vs, partition methods or masking methods of adopting, disturb with the detection of eliminating due to these interfering materials more.
(the content of sodium pyrosulfite in colorimetric method for determining Amino Acid Compound Injection (18AA-I) such as Wu little Man, " the Chinese drug standards ", 2007, the 8th the 5th phase of volume: the method that 38-40) discloses pyrosulfurous acid sodium content in a kind of colorimetric determination Amino Acid Compound Injection, the method is easily decomposed and is discharged sulphuric dioxide in solution according to sulphite, and the principle that sulphuric dioxide can make the acid fuchsine solution fade, and then test liquid is placed 25 minutes at ambient temperature, adopting colourimetry is that the 549nm place measures absorbance at wavelength again, measure the pyrosulfurous acid sodium content in Amino Acid Compound Injection (18AA-I) with calibration curve method again.Testing result: anhydrous sodium sulfite is in 3～21 μ g/ml scopes, and the logarithm of absorbance and the logarithm of concentration present good linear relationship (r > 0.9995): average average recovery is that 100.8%, RSD is 1.6%.
The gorgeous grade of the beam (content of antioxidant sodium pyrosulfite in the spectrphotometric method for measuring Edaravone Injection, " Henan science ", in November, 2010, the 28th volume o. 11th: 1403-1404) disclose a kind of method that photometry detects pyrosulfurous acid sodium content in Edaravone Injection, the method utilizes sulphite easily to decompose and discharge sulphuric dioxide in solution, and the principle that sulphuric dioxide fades the acid fuchsine solution, and, with reference to the achievement in research of Wu little Man, set up the content assaying method of sodium pyrosulfite in the Edaravone Injection.
(UV-VIS spectrophotometry is measured the content analysis of sodium pyrosulfite in Amino Acid Compound Injection to Zhou Qiuyun etc., " clinical rational drug use ", in July, 2012, the 5th volume 7C phase: 108-109) disclose a kind of method that UV-VIS spectrophotometry detects pyrosulfurous acid sodium content in Amino Acid Compound Injection, the method utilizes sodium pyrosulfite and hydrochloric acid effect to generate sulphurous acid, sulphurous acid and basic fuchsin and formaldehyde effect generate the bluish violet compound, and the bluish violet compound is that 400nm-700nm has absorption maximum at wavelength, precision measures test liquid and each 5ml of reference substance solution, it is placed in respectively to the 25mL volumetric flask, add successively 0.05% basic fuchsin test solution 2.0mL and 0.3% formaldehyde test solution 3.0ml, shake up, room temperature is placed 30min, take reagent as blank reference, at wavelength, be that the 556nm place measures absorbance, calculate the content of sodium pyrosulfite in test sample.The recovery of the method is that 101.6%, RSD is 0.6%.
(the pyrosulfurous acid sodium content in the determined by ultraviolet spectrophotometry Vinpocetine injection such as Zheng Wensheng, " medical Leader ", in August, 2012, the 31st the 8th phase of volume: 1802-1803) disclose a kind of method that ultraviolet spectrophotometry detects pyrosulfurous acid sodium content in Vinpocetine injection, react the principle that generates the aubergine complex compound with quinone shape structure under the acid condition that the method exists at EDTA based on the pyrosulfurous acid root with formaldehyde and acid fuchsin, precision measures Vinpocetine injection 1mL, with 500 times of 0.01%EDTA solution dilutions, be made into the Vinpocetine injection need testing solution, precision measures Vinpocetine injection need testing solution 10mL again, adds respectively acid fuchsin solution and each 1mL of 0.2% formalin, mixes, and places 40min, with method, does blank assay for 25 ℃.According to the ultraviolet spectrophotometry of the Pharmacopoeia of the People's Republic of China (version in 2010) record, at 557 nm wavelength places, measure absorbance.Calculate the content of sodium pyrosulfite in Vinpocetine injection according to typical curve, RSD is 0.1%.
In medicine, the method for pyrosulfurous acid sodium content is many detects under acid condition, and the solubleness of vinpocetine presents the pH dependence, the favorable solubility of vinpocetine under acid condition, but vinpocetine can generate yellow mercury oxide with indicator reaction under acid condition, causes detection method can't judge titration end-point; If detect under alkali condition, the easy crystallization of vinpocetine; In addition, other antioxidants (as vitamin C, sodium bisulfite, sodium sulphite etc.) exist and disturb testing result.For this reason, in the detection Vinpocetine injection of needs research simple and effective, the method for pyrosulfurous acid sodium content, to control better product quality, guarantee the security of medicine.
Summary of the invention
The object of the present invention is to provide a kind of method that detects sodium pyrosulfite in Vinpocetine injection, comprise the steps: to regulate Vinpocetine injection to alkalescence with alkaline matter or its solution, filter, after removing interference, detect again pyrosulfurous acid sodium content in Vinpocetine injection, wherein, described alkalescence refers to Vinpocetine injection 7<PH≤14, and the antioxidant in described Vinpocetine injection at least contains sodium pyrosulfite.
In the preferred technical solution of the present invention, described antioxidant is selected from vitamin C, sodium bisulfite, sodium sulphite, dibutyl phenol, sodium thiosulfate, cysteine hydrochloride, gallic acid, any or its combination of glycocoll, fumaric acid, xylitol, sodium ascorbate, malic acid, citric acid, hypophosphorous acid, xylitol, malic acid, sodium formaldehyde sulphoxylate, arabo-ascorbic acid, thioglycerol, sulfo-sorbic acid, thioglycolic acid, methionine.
In the preferred technical solution of the present invention, described alkaline matter is selected from any or its combination of solubility alkalescence material or solubility strong base-weak acid salt.
In the preferred technical solution of the present invention, described alkaline matter is selected from NaOH, potassium hydroxide, baryta hydrate, sodium carbonate, sal tartari, sodium bicarbonate, saleratus, sodium sulphite, potassium sulfite, sodium bisulfite, potassium bisulfite, sodium sulphide, potassium sulfide, NaHS, potassium bisulfide, sodium silicate, potassium silicate, sodium metaaluminate, potassium metaaluminate, sodium acetate, potassium acetate, sodium hypochlorite, postassium hypochlorite, sodium phosphate, potassium phosphate, triethanolamine, one hydration ammonia, diethylamine, triethylamine, caustic alcohol, sodium methoxide, any in sodium tert-butoxide or its combination.
In the preferred technical solution of the present invention, the aqueous solution that the solution of described alkaline matter is alkaline matter.
In the preferred technical solution of the present invention, in testing process, adopt the negative solution of sodium pyrosulfite to carry out blank correction.
The negative solution of sodium pyrosulfite of the present invention refers to composition and the preparation method according to described Vinpocetine injection, prepares it and forms the Vinpocetine injection that does not only contain sodium pyrosulfite, is the negative solution of its corresponding sodium pyrosulfite.
Removal of the present invention is disturbed and is referred to, if the material of the produced interference coexisted except sodium pyrosulfite in testing sample, generate precipitation or during with the ion of indicator colour developing or compound as reacted with vs, adopt partition methods or masking methods more, disturb with the detection of eliminating due to these interfering materials, remove the detection that other materials treat due to detection material and disturb.
Except as otherwise noted, while the present invention relates to the number percent between liquid and liquid, described number percent is volume/volume number percent; While the present invention relates to the number percent between liquid and solid, described number percent is volume/weight number percent; While the present invention relates to the number percent between solid and liquid, described number percent is weight/volume percent; All the other are weight/percentage by weight.
Compared with prior art, the present invention has following useful technique effect:
1, the present invention detects the method for sodium pyrosulfite in Vinpocetine injection and utilizes extremely alkalescence of alkali compounds or its solution adjusting Vinpocetine injection, wherein, described alkalescence is 7<pH≤14, the one, eliminate in Vinpocetine injection the detection interference due to instable other antioxidants of alkali (as Vc) that has except sodium pyrosulfite, and make vinpocetine crystallization under alkali condition, and then eliminate the interference caused because producing chemical reaction between vinpocetine and indicator, the 2nd, adopt the negative solution of sodium pyrosulfite to carry out blank correction, to get rid of vinpocetine, the interference of other components beyond the instable antioxidant of alkali etc., measure the purpose of pyrosulfurous acid sodium content in Vinpocetine injection to reach efficiently and accurately, guarantee the controllability of Vinpocetine injection quality and the security of patient's medication, wherein, the negative solution of described sodium pyrosulfite refers to composition and the preparation method according to described Vinpocetine injection, prepare it and form the Vinpocetine injection that does not only contain sodium pyrosulfite, for the negative solution of its corresponding sodium pyrosulfite.
2, the present invention detects in Vinpocetine injection the method for sodium pyrosulfite to have a screening agent (alkaline matter) cheap and easy to get, and cost is low, detect simple and easy to do, and have that accuracy is high, the advantage such as precision and good stability.
Embodiment
Illustrate the present invention below with reference to embodiment, embodiments of the invention are only for technical scheme of the present invention is described, and non-limiting essence of the present invention.
embodiment 1-9the assay method of pyrosulfurous acid sodium content in Vinpocetine injection
Embodiment 1-9 detects the composition of Vinpocetine injection used in Table 1, and wherein, the content of sodium pyrosulfite is 2mg/mL.
Table 1
Embodiment 1-9 detects the preparation method of Vinpocetine injection Vinpocetine injection used, comprises the steps:
1) add the water for injection that accounts for cumulative volume 80% in preparing tank, add tartrate, stir, after dissolving, add again vinpocetine, stir, dissolve, add again sorbierite, vitamin C and sodium pyrosulfite, stir, dissolve, the sodium hydroxide solution with 2% is regulated pH value to 3.3～3.6, benefit adds to the full amount of water for injection, and makes preparating liquid;
2) will configure liquid first by 0.45 μ m and 0.22 μ m filter element filtering degerming;
3) detect pH value, vinpocetine content and bacterial endotoxin, the visible foreign matters of filtrate, to be detected qualified after, packing, obtain.
Composition and preparation method according to the described Vinpocetine injection of embodiment 1-9, prepare the negative solution of its corresponding sodium pyrosulfite, wherein, the negative solution of described sodium pyrosulfite refers to composition and the preparation method according to described Vinpocetine injection, preparing in its composition and only do not contain the Vinpocetine injection of sodium pyrosulfite, is the negative solution of its corresponding sodium pyrosulfite.
Adopt direct iodimetric titration to detect the content of sodium pyrosulfite in embodiment 1-9 Vinpocetine injection, described iodimetric titration is based on I
2oxidisability and I
-the redox analytic approach set up of reductibility, use I
2the standard solution direct titration is than the method for strong reductant.The basic half-reaction of the method: I
2+ 2e=2I
-; Titration condition: weak acid (HAc, pH=5) or weak base (Na
2cO
3, pH=8) in property solution, carry out, wherein, S
2-, S
2o
3 2-, SO
3 2-, As
2o
3, equal available standards solution direct titration such as Vc.
In embodiment 1-9 Vinpocetine injection, the detection method of pyrosulfurous acid sodium content, comprise the steps:
Precision measures Vinpocetine injection 20ml, and it is put in the 25ml measuring bottle, adds 20% sodium hydroxide solution 1ml, make its pH12-13, produce precipitation, after solution is placed to 20 minutes, add water and be settled to scale, filter, precision measures filtrate 10ml to iodine flask, add spirit of vinegar 5ml, starch indicator solution 1ml, with iodine titration solution (0.025mol/L) titration, also continued for 30 seconds to the aobvious blueness of solution and do not take off, and titration results is proofreaied and correct with blank test, record consumes the volume of iodine titration solution.Wherein, every 1ml iodine titration solution (0.025mol/L) is equivalent to the 2.376mg sodium pyrosulfite.
Wherein, described blank test is proofreaied and correct to be referred to the negative solution of sodium pyrosulfite and carries out titration, with the interference of other component to measurement result in the deduction parenteral solution.
In testing sample
Wherein, V
1volume (ml) for need testing solution consumption iodine titration solution;
V
0the volume that consumes iodine titration solution for blank solution is 0.02ml;
V
samplefor sample volume, 20ml;
T is titer, 2.376mg/ml
F is that the vs concentration correction factor is 1.012 (the actual iodine titration solution concentration of f=/theoretical value iodine titration solution concentration=0.0253 mol/L/0.025mol/L=1.012).
Sodium pyrosulfite location parameter and the results are shown in Table 2 in embodiment 1-9, wherein, in each embodiment, the content detection of sodium pyrosulfite is carried out 2 parallel experiments.
Table 2
From table 2, in embodiment 1-9, the assay result of sodium pyrosulfite and its actual value 2mg/ml approach (because Vinpocetine injection can consume the part sodium pyrosulfite in production, storage process).
embodiment 10the accuracy studies of detection method of the present invention
Composition and preparation method according to embodiment 1 described Vinpocetine injection, prepare the negative solution of its sodium pyrosulfite, wherein, the negative solution of described sodium pyrosulfite refers to composition and the preparation method according to described Vinpocetine injection, preparing in its composition and only do not contain the Vinpocetine injection of sodium pyrosulfite, is the negative solution of its corresponding sodium pyrosulfite.
Precision takes sodium pyrosulfite 40mg, is placed in the 25ml measuring bottle, adds the negative solution 20ml of sodium pyrosulfite and dissolves, and adds water and is settled to scale, is made into the recovery solution containing sodium pyrosulfite 100% concentration;
Precision takes sodium pyrosulfite 32mg and 48mg, adds the negative solution 20ml of sodium pyrosulfite and dissolves, and adds water and is settled to scale, is made into containing the recovery solution of sodium pyrosulfite 80% concentration with containing the recovery solution of sodium pyrosulfite 120% concentration.
Detect respectively the above-mentioned content containing sodium pyrosulfite in the recovery solution of sodium pyrosulfite 80% concentration, 100% concentration, 120% concentration according to the described detection method of embodiment 1, each concentration is carried out three parallel experiments.The results are shown in Table 3.
Table 3 recovery experimental result
From table 3, the average recovery rate of detection method of the present invention is 98.7%, and the RSD of the recovery is 0.21%, has the advantages such as accuracy is high, good stability.
embodiment 11the precision research of detection method of the present invention
The precision research of detection method of the present invention comprises replica test and middle precision test.Test method and result are as follows.
1, replica test
Precision measures Vinpocetine injection (the pyrosulfurous acid na concn the is 2mg/ml) 20ml of embodiment 1 preparation, detect pyrosulfurous acid sodium content in Vinpocetine injection by same experimenter according to the described detection method of embodiment 1, and carry out 3 parallel experiments, the results are shown in Table 4.
Table 4 replica test result
2, middle precision
Precision measures the Vinpocetine injection 20ml of embodiment 1 preparation, is detected pyrosulfurous acid sodium content in Vinpocetine injection by different experiments person according to the described detection method of embodiment 1, and carries out 3 parallel experiments, the results are shown in Table 5.
Precision test result in the middle of table 5
From table 4-table 5 result, the advantage such as detection method of the present invention has simple to operate, and repeated and middle precision is good.
Claims (6)
1. a method that detects sodium pyrosulfite in Vinpocetine injection, comprise the steps: to regulate Vinpocetine injection to alkalescence with alkaline matter or its solution, filter, after removing interference, detect pyrosulfurous acid sodium content in Vinpocetine injection, wherein, described alkalescence refers to Vinpocetine injection 7<PH≤14, and the antioxidant in described Vinpocetine injection at least contains sodium pyrosulfite.
2. method according to claim 1, described antioxidant is selected from vitamin C, sodium bisulfite, sodium sulphite, dibutyl phenol, sodium thiosulfate, cysteine hydrochloride, gallic acid, any or its combination of glycocoll, fumaric acid, xylitol, sodium ascorbate, malic acid, citric acid, hypophosphorous acid, xylitol, malic acid, sodium formaldehyde sulphoxylate, arabo-ascorbic acid, thioglycerol, sulfo-sorbic acid, thioglycolic acid, methionine.
3. method according to claim 1 and 2, described alkaline matter is selected from any or its combination of solubility alkalescence material or solubility strong base-weak acid salt.
4. method according to claim 3, described alkaline matter is selected from NaOH, potassium hydroxide, baryta hydrate, sodium carbonate, sal tartari, sodium bicarbonate, saleratus, sodium sulphite, potassium sulfite, sodium bisulfite, potassium bisulfite, sodium sulphide, potassium sulfide, NaHS, potassium bisulfide, sodium silicate, potassium silicate, sodium metaaluminate, potassium metaaluminate, sodium acetate, potassium acetate, sodium hypochlorite, postassium hypochlorite, sodium phosphate, potassium phosphate, triethanolamine, one hydration ammonia, diethylamine, triethylamine, caustic alcohol, sodium methoxide, any in sodium tert-butoxide or its combination.
5. according to the described method of claim 1-4 any one, the aqueous solution that the solution of described alkaline matter is alkaline matter.
6. according to the described method of claim 1-5 any one, in testing process, adopt the negative solution of sodium pyrosulfite to carry out blank correction.
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| CN105954463A (en) * | 2016-06-22 | 2016-09-21 | 山东钢铁股份有限公司 | Detection method for sulfur content in sulfur cream |
| CN107478734A (en) * | 2017-06-29 | 2017-12-15 | 河北工业大学 | The chromatography of ions detection method of sulfate radical and inferior sulfate radical is determined in a kind of desulfurization seawater simultaneously |
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| CN109342649A (en) * | 2018-12-07 | 2019-02-15 | 昌邑市检验检测中心 | The measuring method of pyrosulfurous acid sodium content in ginger |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103893115A (en) * | 2014-04-15 | 2014-07-02 | 天津药业集团新郑股份有限公司 | Vinpocetine injection |
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| CN105954463A (en) * | 2016-06-22 | 2016-09-21 | 山东钢铁股份有限公司 | Detection method for sulfur content in sulfur cream |
| CN107478734A (en) * | 2017-06-29 | 2017-12-15 | 河北工业大学 | The chromatography of ions detection method of sulfate radical and inferior sulfate radical is determined in a kind of desulfurization seawater simultaneously |
| CN107478734B (en) * | 2017-06-29 | 2020-03-27 | 河北工业大学 | Ion chromatography detection method for simultaneously measuring sulfate radicals and sulfite radicals in desulfurized seawater |
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