CN103048319A - Method for detecting residual disinfecting Cetyltrimethylammonium Chloride used in production process of sodium hyaluronate - Google Patents
Method for detecting residual disinfecting Cetyltrimethylammonium Chloride used in production process of sodium hyaluronate Download PDFInfo
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- CN103048319A CN103048319A CN2012105635350A CN201210563535A CN103048319A CN 103048319 A CN103048319 A CN 103048319A CN 2012105635350 A CN2012105635350 A CN 2012105635350A CN 201210563535 A CN201210563535 A CN 201210563535A CN 103048319 A CN103048319 A CN 103048319A
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- WOWHHFRSBJGXCM-UHFFFAOYSA-M cetyltrimethylammonium chloride Chemical compound [Cl-].CCCCCCCCCCCCCCCC[N+](C)(C)C WOWHHFRSBJGXCM-UHFFFAOYSA-M 0.000 title claims abstract description 68
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 10
- 229920002385 Sodium hyaluronate Polymers 0.000 title claims abstract description 9
- 229940010747 sodium hyaluronate Drugs 0.000 title claims abstract description 9
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 title claims abstract description 9
- 238000000034 method Methods 0.000 title abstract description 11
- 230000000249 desinfective effect Effects 0.000 title abstract description 3
- 238000001514 detection method Methods 0.000 claims abstract description 20
- 239000012085 test solution Substances 0.000 claims abstract description 19
- ONBIUAZBGHXJDM-UHFFFAOYSA-J bismuth;potassium;tetraiodide Chemical compound [K+].[I-].[I-].[I-].[I-].[Bi+3] ONBIUAZBGHXJDM-UHFFFAOYSA-J 0.000 claims abstract description 14
- 238000012417 linear regression Methods 0.000 claims abstract description 9
- 239000012488 sample solution Substances 0.000 claims abstract description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 32
- 239000000243 solution Substances 0.000 claims description 23
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 19
- 230000001954 sterilising effect Effects 0.000 claims description 14
- 238000004659 sterilization and disinfection Methods 0.000 claims description 14
- 239000000523 sample Substances 0.000 claims description 10
- 238000005303 weighing Methods 0.000 claims description 8
- 238000002360 preparation method Methods 0.000 claims description 7
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 6
- 238000002835 absorbance Methods 0.000 claims description 6
- 238000004140 cleaning Methods 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 6
- 239000007788 liquid Substances 0.000 claims description 5
- 239000008213 purified water Substances 0.000 claims description 5
- 238000012360 testing method Methods 0.000 claims description 5
- 229960000583 acetic acid Drugs 0.000 claims description 3
- 238000010790 dilution Methods 0.000 claims description 3
- 239000012895 dilution Substances 0.000 claims description 3
- 239000012467 final product Substances 0.000 claims description 3
- 239000012362 glacial acetic acid Substances 0.000 claims description 3
- XMBWDFGMSWQBCA-UHFFFAOYSA-N hydrogen iodide Chemical compound I XMBWDFGMSWQBCA-UHFFFAOYSA-N 0.000 claims description 3
- QGWDKKHSDXWPET-UHFFFAOYSA-E pentabismuth;oxygen(2-);nonahydroxide;tetranitrate Chemical compound [OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[O-2].[Bi+3].[Bi+3].[Bi+3].[Bi+3].[Bi+3].[O-][N+]([O-])=O.[O-][N+]([O-])=O.[O-][N+]([O-])=O.[O-][N+]([O-])=O QGWDKKHSDXWPET-UHFFFAOYSA-E 0.000 claims description 3
- 239000013558 reference substance Substances 0.000 claims description 3
- 238000006243 chemical reaction Methods 0.000 abstract description 2
- 239000012086 standard solution Substances 0.000 abstract 2
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 239000000645 desinfectant Substances 0.000 abstract 1
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 3
- 238000007689 inspection Methods 0.000 description 3
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 238000005189 flocculation Methods 0.000 description 2
- 230000016615 flocculation Effects 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- MPNXSZJPSVBLHP-UHFFFAOYSA-N 2-chloro-n-phenylpyridine-3-carboxamide Chemical compound ClC1=NC=CC=C1C(=O)NC1=CC=CC=C1 MPNXSZJPSVBLHP-UHFFFAOYSA-N 0.000 description 1
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 1
- HFERDKMSOGYJNM-UHFFFAOYSA-N C(CCCCCCCCCCCCCCC)[N+](C(C)(C)C)(C)C Chemical compound C(CCCCCCCCCCCCCCC)[N+](C(C)(C)C)(C)C HFERDKMSOGYJNM-UHFFFAOYSA-N 0.000 description 1
- 231100000111 LD50 Toxicity 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000002280 amphoteric surfactant Substances 0.000 description 1
- 239000012752 auxiliary agent Substances 0.000 description 1
- 238000005660 chlorination reaction Methods 0.000 description 1
- 230000009514 concussion Effects 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000004945 emulsification Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000006260 foam Substances 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 231100000647 material safety data sheet Toxicity 0.000 description 1
- 231100001224 moderate toxicity Toxicity 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
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- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention relates to a method for detecting residual disinfecting Cetyltrimethylammonium Chloride (CTAC) used in the production process of sodium hyaluronate. The method comprises the following steps: preparing a CTAC standard solution to structure a linear regression equation; preparing a sample solution, using an improved bismuth potassium iodide test solution for developing and measuring the absorbency value; and calculating the content of the CTAC with the linear regression equation. The structuring method of the linear regression equation is as follows: after using the improved bismuth potassium iodide test solution for developing of the prepared 2 Mug/ml, 4 Mug/ml, 8 Mug/ml, 10 Mug/ml and 20 Mug/ml standard solutions, measuring the absorbency under 290nm. By adopting the method to detect the content of the CTAC, the shortcoming that the content and the residue of the CTAC serving as a disinfectant or a reaction agent can not be monitored at present can be overcome, the detection time is greatly shortened, and the detection cost is lowered. The method provided by the invention is particularly suitable for detecting CTAC in labs.
Description
Technical field:
The present invention relates to a kind of detection method of hexadecyltrimethylammonium chloride, espespecially is the detection method of the residual hexadecyltrimethylammonium chloride of cleaning-sterilizing in the production run.
Background technology:
The Chinese another name of hexadecyltrimethylammonium chloride: cetane trimethyl ammonium chloride; CTAC; 1631, chlorination trimethyl cetyltrimethyl ammonium.
English name: Hexadecyl trimethylammonium chloride, structural formula is as follows:
English another name: CTAC; Cetyltrimethylammonium chloride
CAS number: 112-02-7
Molecular formula: C19H42ClN
Linear formula: CH3 (CH2) 15N (Cl) (CH3) 3
Molecular weight: 320.00
Purity: 〉=99%
MDL number: MFCD00011773
Beilstein number: 3657974
EC number: 203-928-6
Hexadecyltrimethylammonium chloride is white crystalline powder, is soluble in isopropyl alcohol, and water soluble produces a large amount of foams during concussion, can good compatibility be arranged with kation, nonionic, amphoteric surfactant; Chemical stability is good, heat-resisting, fast light, withstand voltage, strong alkali-acid resistance; Have the performances such as good infiltration, softening, emulsification, antistatic, biodegradability and sterilization.Be widely used in medical industry auxiliary agent, protein flocculation and water treatment flocculation, sanitizer, cleaning and disinfecting sterilization etc.
Hexadecyltrimethylammonium chloride MSDS data is shown as 4 grades of toxicity, moderate toxicity, and LD50 is 400mg/kg.So consider in view of the safety in utilization of product, be necessary that CTAC residual in the product is carried out the residual quantity limit to be detected.In present disclosed document, no matter be American Pharmacopeia or Japanese Pharmacopoeia, there is no at present the detection method for this content of material or residual volume.
Summary of the invention:
The detection method that the purpose of this invention is to provide the residual hexadecyltrimethylammonium chloride of sterilization in a kind of sodium hyaluronate production run, to solve the residual safety issue that is caused of hexadecyltrimethylammonium chloride, the method detects accurately, and inspection cost, checkability height, work for inspection are carried out conveniently.
For realizing purpose of the present invention, the technical solution adopted in the present invention is:
The detection method of the residual hexadecyltrimethylammonium chloride of sterilization is characterized in that in a kind of sodium hyaluronate production run, may further comprise the steps:
(1) preparation of typical curve: take by weighing the hexadecyltrimethylammonium chloride reference substance, add hydrochloric acid solution and the constant volume that is dissolved in water, be mixed with the hexadecyltrimethylammonium chloride storing solution; With the dilution of hexadecyltrimethylammonium chloride storing solution, be mixed with the hexadecyltrimethylammonium chloride titer of 2 μ g/ml, 4 μ g/ml, 8 μ g/ml, 10 μ g/ml, 20 μ g/ml; Pipette each hexadecyltrimethylammonium chloride titer of certain volume, place test tube, pipette the isopyknic described hydrochloric acid solution of titer in two blank tubes, in above-mentioned each pipe, add the improvement bismuth potassium iodide test solution, mix at the vortex oscillator immediately, room temperature is placed 5-15min, take blank tube as contrast, survey the absorbance under the 290nm, draw linear regression equation;
(2) sample solution preparation: take by weighing/pipette the hexadecyltrimethylammonium chloride sample, add the constant volume that is dissolved in water behind the described hydrochloric acid solution, add the improvement bismuth potassium iodide test solution, mix at the vortex oscillator immediately, room temperature is placed 5-15min, take blank tube as contrast, surveys the absorbance under the 290nm; Described hexadecyltrimethylammonium chloride sample is after using the hexadecyltrimethylammonium chloride sterilization, the Liquid Residue that may contain hexadecyltrimethylammonium chloride after cleaning up with purified water;
(3) by linear regression equation, calculate the content of hexadecyltrimethylammonium chloride.
In a preferred embodiment of the invention, the concentration of described hydrochloric acid solution is 0.6mol/L; Wherein in step (1) and the step (2), the amount that adds hydrochloric acid solution is 2ml.
In a preferred embodiment of the invention, in step (1) and the step (2), adding the amount that improves bismuth potassium iodide test solution is 0.5ml.
The preparation method of described improvement bismuth potassium iodide test solution gets basic bismuth nitrate 0.85g, add glacial acetic acid 10ml and water 40ml the dissolving after, add liquor kalii iodide (4 → 10) 20ml, shake up to get test solution, pipette again above-mentioned test solution 1ml, add 0.6mol/L hydrochloric acid solution 2ml, add water to 10ml, and get final product.
In a preferred embodiment of invention, in the step (2), the amount that takes by weighing/pipette the hexadecyltrimethylammonium chloride sample is 10mg.
The detection principle of the detection method of hexadecyltrimethylammonium chloride of the present invention reacts according to the amino that contains in the hexadecyltrimethylammonium chloride molecule and improvement bismuth potassium iodide test solution, produce the purple compound, this compound can produce absorption maximum at the 290nm place.
Utilize method of the present invention to detect hexadecyltrimethylammonium chloride content, can't monitor the shortcoming of its content and residual volume when remedying present hexadecyltrimethylammonium chloride as sanitizer or reaction reagent, greatly shortened detection time, reduce testing cost, be particularly suitable for the detection that the right hexadecyltrimethylammonium chloride content in laboratory carries out.
Embodiment
Can further be well understood to the present invention by specific embodiments of the invention given below, but they not limitation of the invention.
Embodiment
(1) take by weighing the hexadecyltrimethylammonium chloride reference substance, add 0.6mol/L hydrochloric acid solution 2ml, the constant volume that is dissolved in water is mixed with the hexadecyltrimethylammonium chloride storing solution of 200 μ g/ml; With the dilution of hexadecyltrimethylammonium chloride storing solution, be mixed with the titer of 1 μ g/ml, 2 μ g/ml, 4 μ g/ml, 8 μ g/ml, 10 μ g/ml; Pipette each titer of certain volume, place test tube, pipette the isopyknic 0.6mol/L hydrochloric acid solution of titer in two blank tubes, in above-mentioned each pipe, add improvement bismuth potassium iodide test solution 0.5ml, mix at the vortex oscillator immediately, room temperature is placed 5-15min, take blank tube as contrast, survey the absorbance under the 290nm, draw linear regression equation;
(2) sample solution preparation: take by weighing/pipette hexadecyltrimethylammonium chloride sample 5ml, add 0.6mol/L hydrochloric acid solution 2ml, be dissolved in water and be settled to 10ml, add improvement bismuth potassium iodide test solution 0.5ml, mix at the vortex oscillator immediately, room temperature is placed 5-15min, take blank tube as contrast, surveys the absorbance under the 290nm; The hexadecyltrimethylammonium chloride sample is after using the hexadecyltrimethylammonium chloride sterilization, the Liquid Residue that may contain hexadecyltrimethylammonium chloride after cleaning up with purified water.
(3) by linear regression equation, calculate the content of hexadecyltrimethylammonium chloride.
The improvement bismuth potassium iodide test solution is to get basic bismuth nitrate 0.85g, after adding glacial acetic acid 10ml and water 40ml and dissolving, adds liquor kalii iodide (4 → 10) 20ml, shakes up, and pipettes above-mentioned test solution 1ml again, adds 0.6mol/L hydrochloric acid solution 2ml, adds water to 10ml, and get final product.
Test findings:
After using the hexadecyltrimethylammonium chlorides sterilization according to the method for above-described embodiment to three times, the three place's Liquid Residue content detection that may contain hexadecyltrimethylammonium chloride after cleaning up with purified water the results are shown in Table 1:
Table 1
As known from Table 1, after method of the present invention is used the hexadecyltrimethylammonium chloride sterilization to three times, three place's Liquid Residues that may contain hexadecyltrimethylammonium chloride after cleaning up with purified water are tested, and have remedied the blank that does not have at present the method, have improved detection efficiency, accelerate sample dissolution, sample is easy to mixing, avoids the detection error brought because of incomplete mixing, reduces the use amount of reagent, reduce inspection cost, guaranteed the safety of medicine.
Claims (5)
1. the detection method of the residual hexadecyltrimethylammonium chloride of sterilization in the sodium hyaluronate production run is characterized in that, may further comprise the steps:
(1) preparation of typical curve: take by weighing the hexadecyltrimethylammonium chloride reference substance, add hydrochloric acid solution and the constant volume that is dissolved in water, be mixed with the hexadecyltrimethylammonium chloride storing solution; With the dilution of hexadecyltrimethylammonium chloride storing solution, be mixed with the hexadecyltrimethylammonium chloride titer of 1 μ g/ml, 2 μ g/ml, 4 μ g/ml, 8 μ g/ml, 10 μ g/ml; Pipette each hexadecyltrimethylammonium chloride titer of certain volume, place test tube, pipette the isopyknic described hydrochloric acid solution of titer in two blank tubes, in above-mentioned each pipe, add the improvement bismuth potassium iodide test solution, mix at the vortex oscillator immediately, room temperature is placed 5-15min, take blank tube as contrast, survey the absorbance under the 290nm, draw linear regression equation;
(2) sample solution preparation: take by weighing/pipette the hexadecyltrimethylammonium chloride sample, add the constant volume that is dissolved in water behind the described hydrochloric acid solution, add the improvement bismuth potassium iodide test solution, mix at the vortex oscillator immediately, room temperature is placed 5-15min, take blank tube as contrast, surveys the absorbance under the 290nm; Described hexadecyltrimethylammonium chloride sample is after using the hexadecyltrimethylammonium chloride sterilization, the Liquid Residue that may contain hexadecyltrimethylammonium chloride after cleaning up with purified water;
(3) by linear regression equation, calculate the content of hexadecyltrimethylammonium chloride.
2. the detection method of hexadecyltrimethylammonium chloride as claimed in claim 1 is characterized in that, the concentration of stating hydrochloric acid solution is 0.6mol/L; Wherein in step (1) and the step (2), the amount that adds hydrochloric acid solution is 2ml.
3. the detection method of the residual hexadecyltrimethylammonium chloride of sterilization in a kind of sodium hyaluronate production run as claimed in claim 1 is characterized in that in step (1) and the step (2), adding the amount that improves bismuth potassium iodide test solution is 0.5ml.
In a kind of sodium hyaluronate production run as claimed in claim 1 the sterilization residual hexadecyltrimethylammonium chloride detection method, it is characterized in that, the preparation method of described improvement bismuth potassium iodide test solution gets basic bismuth nitrate 0.85g, after adding glacial acetic acid 10ml and water 40ml dissolving, add liquor kalii iodide (4 → 10) 20ml, shake up to get test solution, pipette again above-mentioned test solution 1ml, add 0.6mol/L hydrochloric acid solution 2ml, add water to 10ml, and get final product.
5. the detection method of the residual hexadecyltrimethylammonium chloride of sterilization in a kind of sodium hyaluronate production run as claimed in claim 1 is characterized in that in the step (2), the amount that takes by weighing/pipette the hexadecyltrimethylammonium chloride sample is 10mg.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103389300A (en) * | 2013-08-13 | 2013-11-13 | 南京大学 | Method for detecting quaternary ammonium salt cationic surfactant |
| CN103616379A (en) * | 2013-12-04 | 2014-03-05 | 江苏天诺新材料科技股份有限公司 | Method for quickly and quantitatively measuring content of tetrapropylammonium bromide in zeolite synthesis waste liquid |
| CN104237219A (en) * | 2014-08-20 | 2014-12-24 | 浙江大学 | Semi-quantitative detection method of quaternary ammonium salt of water quality |
| CN106442841A (en) * | 2016-12-16 | 2017-02-22 | 上海景峰制药有限公司 | Separation and detection method of cationic surface active agent in medicine |
| CN112773734A (en) * | 2020-12-28 | 2021-05-11 | 杭州欧菲健康科技有限公司 | Hyaluronic acid skin-changing essence and preparation method thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103389300A (en) * | 2013-08-13 | 2013-11-13 | 南京大学 | Method for detecting quaternary ammonium salt cationic surfactant |
| CN103616379A (en) * | 2013-12-04 | 2014-03-05 | 江苏天诺新材料科技股份有限公司 | Method for quickly and quantitatively measuring content of tetrapropylammonium bromide in zeolite synthesis waste liquid |
| CN103616379B (en) * | 2013-12-04 | 2015-09-09 | 江苏天诺新材料科技股份有限公司 | The quantitative determination method of 4-propyl bromide content in zeolite synthesis waste liquid |
| CN104237219A (en) * | 2014-08-20 | 2014-12-24 | 浙江大学 | Semi-quantitative detection method of quaternary ammonium salt of water quality |
| CN104237219B (en) * | 2014-08-20 | 2016-08-24 | 浙江大学 | A kind of water quality quaternary ammonium salt semi-quantitative detection method |
| CN106442841A (en) * | 2016-12-16 | 2017-02-22 | 上海景峰制药有限公司 | Separation and detection method of cationic surface active agent in medicine |
| CN106442841B (en) * | 2016-12-16 | 2018-09-14 | 上海景峰制药有限公司 | The method for separating and detecting of cationic surfactant in a kind of drug |
| CN112773734A (en) * | 2020-12-28 | 2021-05-11 | 杭州欧菲健康科技有限公司 | Hyaluronic acid skin-changing essence and preparation method thereof |
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