CN104840419A - Sodium tetradecyl sulphate injection and preparation method thereof - Google Patents
Sodium tetradecyl sulphate injection and preparation method thereof Download PDFInfo
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- CN104840419A CN104840419A CN201510333589.1A CN201510333589A CN104840419A CN 104840419 A CN104840419 A CN 104840419A CN 201510333589 A CN201510333589 A CN 201510333589A CN 104840419 A CN104840419 A CN 104840419A
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- sodium tetradecyl
- tetradecyl sulfate
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Abstract
The invention discloses a sodium tetradecyl sulphate injection and a preparation method thereof. The raw material formula of the sodium tetradecyl sulphate injection disclosed by the invention comprises the following components: disodium hydrogen phosphate, sodium tetradecyl sulphate, phenyl methanol, water and a pH regulator, wherein the pH value of the sodium tetradecyl sulphate injection is 7.5-7.9. The preparation method of the sodium tetradecyl sulphate injection disclosed by the invention comprises the following steps: uniformly mixing the mixed solution of the aqueous solution of disodium hydrogen phosphate with a pH value of 8.4-8.8 and phenyl methanol with sodium tetradecyl sulphate, adding the pH regulator to adjust the pH value of the mixing system to 7.5-7.9, thus obtaining the sodium tetradecyl sulphate injection. The sodium tetradecyl sulphate injection disclosed by the invention is good in stability, high in active ingredient content and capable of meeting the requirements of pharmacopeia standards, and has a clinical application potential.
Description
Technical field
The present invention relates to a kind of sodium tetradecyl sulfate injection and preparation method thereof.
Background technology
Varicosis refers to due to factors such as blood stasis, vein tube wall weaknesses, thus the vein caused is tortuous and expansion.The position that varicosis the most often occurs is at lower limb.Varicose veins of the lower extremity is as the most important disease of Venous system, and incidence remains high always, and domestic sickness rate is up to 9.6%.According to the literature, the sickness rate of the states such as Italy, France, Spain and southern Wales reaches 30%, on average just has a people to suffer from varicose veins of the lower extremity in every 3 people.
Mainly detached by operation before the therapeutic modality of varicose veins of the lower extremity, and raising quality of life required along with people, operation detaches mode and is eliminated gradually, and Drug therapy becomes main flow.The method of Drug therapy varicose veins of the lower extremity mainly injection of sclerosing agent treatment in recent years, by directly being injected in lesion vessels by sclerosing agent, forming the center tube of fibrous tissue and closed tube chamber or vein, thus reaching the effect dispelling lesion vessels.
The advantage that sodium tetradecyl sulfate is high with its curative effect and side effect is little makes injection of sclerosing agent treat and achieves breakthrough progress.Sodium tetradecyl sulfate structural formula is as shown in the formula shown in I:
In recent years, sodium tetradecyl sulfate is widely used in clinical treatment varicose veins of the lower extremity abroad, and evident in efficacy.But the domestic system to sodium tetradecyl sulfate uses and develops under study for action always.It is not enough that instability due to raw material result in injection active component content, and the matured product of sodium tetradecyl sulfate injection is not developed always.Therefore, develop a kind of matured product that can be used in the sodium tetradecyl sulfate injection for the treatment of varicose veins of the lower extremity and become this area problem demanding prompt solution.
Summary of the invention
The technical problem to be solved in the present invention is to overcome in prior art the defect such as sodium tetradecyl sulfate injection poor stability, active component content deficiency for the treatment of varicose veins of the lower extremity, and provides a kind of sodium tetradecyl sulfate injection and preparation method thereof.The preparation method step of sodium tetradecyl sulfate injection of the present invention is simple, easy to operate, be beneficial to suitability for industrialized production.The potentiality that sodium tetradecyl sulfate injection good stability of the present invention, active component content be high, meet standards of pharmacopoeia requirement, have clinical practice.
The present invention solves the problems of the technologies described above by the following technical programs.
The invention provides a kind of sodium tetradecyl sulfate injection, its composition of raw materials comprises following component: sodium hydrogen phosphate, sodium tetradecyl sulfate, benzyl alcohol, water and pH adjusting agent; PH=7.5 ~ 7.9 of described sodium tetradecyl sulfate injection.
Described sodium tetradecyl sulfate injection, its composition of raw materials is made up of following component: sodium hydrogen phosphate, sodium tetradecyl sulfate, benzyl alcohol, water and pH adjusting agent; PH=7.5 ~ 7.9 of described sodium tetradecyl sulfate injection.
Preferably, in described composition of raw materials, the quality of described benzyl alcohol accounts for 2% ~ 8% of described sodium tetradecyl sulfate injection gross mass, is more preferably 3% ~ 6%, such as 4% and 5%.
Preferably, in described composition of raw materials, the quality of described sodium hydrogen phosphate accounts for 0.2% ~ 2% of described sodium tetradecyl sulfate injection gross mass; Be more preferably 0.4% ~ 0.9%, such as 0.5%.
Preferably, in described composition of raw materials, the quality of described sodium tetradecyl sulfate accounts for 0.5% ~ 5% of described sodium tetradecyl sulfate injection gross mass; Be more preferably 1% ~ 3%, such as 1.2%.
Preferably, in described composition of raw materials, the quality of described pH adjusting agent accounts for 0.01% ~ 0.08% of described sodium tetradecyl sulfate injection gross mass; Be more preferably 0.02% ~ 0.06%.
Preferably, in described composition of raw materials, described pH adjusting agent is sodium hydroxide and/or sodium dihydrogen phosphate.
Preferably, the water in described composition of raw materials is water for injection.
In the present invention, according to this area general knowledge, described sodium hydrogen phosphate can be the form of its hydrate, also can be disodium hydrogen phosphate,anhydrous.Described hydrate can be in the dihydrate of sodium hydrogen phosphate, heptahydrate and dodecahydrate one or more.
Present invention also offers a kind of preparation method of described sodium tetradecyl sulfate injection, it comprises the steps: the mixed liquor of aqueous solution by the described sodium hydrogen phosphate of pH=8.4 ~ 8.8 and described benzyl alcohol, mix homogeneously with described sodium tetradecyl sulfate, add pH to 7.5 ~ 7.9 that described pH adjusting agent makes mixed system.
Preferably, pH=8.5 ~ 8.7 of the aqueous solution of described sodium hydrogen phosphate and the mixed liquor of described benzyl alcohol, such as 8.6.
Preferably, the preparation method of described sodium tetradecyl sulfate injection, also comprises the steps: described benzyl alcohol to join in the aqueous solution of described sodium hydrogen phosphate, then adds described sodium tetradecyl sulfate, add pH to 7.5 ~ 7.9 that described pH adjusting agent makes mixed system again.
More preferably, the preparation method of described sodium tetradecyl sulfate injection, described benzyl alcohol is also comprised the steps: to join in the aqueous solution of described sodium hydrogen phosphate, then described sodium tetradecyl sulfate is added and dispersed with stirring, add pH to 7.5 ~ 7.9 that described pH adjusting agent makes mixed system again.
More preferably, the preparation method of described sodium tetradecyl sulfate injection, also to comprise the steps: described benzyl alcohol to join in the aqueous solution of described sodium hydrogen phosphate and stirring and dissolving, then described sodium tetradecyl sulfate is added and dispersed with stirring, add pH to 7.5 ~ 7.9 that described pH adjusting agent makes mixed system again.
Preferably, described " making pH to 7.5 ~ 7.9 of mixed system " is for making pH to 7.5 ~ 7.7 of mixed system.
Preferably, the preparation method of described sodium tetradecyl sulfate injection, what also comprise in the step of the step of standardize solution, the step of filtration and fill is one or more.
On the basis meeting this area general knowledge, above-mentioned each optimum condition, can combination in any, obtains the preferred embodiments of the invention.
Agents useful for same of the present invention and raw material are all commercially.
Positive progressive effect of the present invention is: sodium tetradecyl sulfate injection good stability of the present invention, active component content be high, the potentiality that meet standards of pharmacopoeia requirement, have clinical practice.
Accompanying drawing explanation
Fig. 1 is product temperatures involved factor setting-out 0 day result of the test electron microscope photo scanning of embodiment 3
Fig. 2 is product temperatures involved factor setting-out 0 day result of the test electron microscope photo scanning of embodiment 1
Fig. 3 is product temperatures involved factor setting-out 0 day result of the test electron microscope photo scanning of embodiment 5
Fig. 4 is product temperatures involved factor setting-out 10 days result of the test electron microscope photo scannings of embodiment 1
Fig. 5 is product temperatures involved factor setting-out 10 days result of the test electron microscope photo scannings of embodiment 5
Detailed description of the invention
Mode below by embodiment further illustrates the present invention, but does not therefore limit the present invention among described scope of embodiments.The experimental technique of unreceipted actual conditions in the following example, conventionally and condition, or selects according to catalogue.
Embodiment 1
Measure 700ml water for injection, add 5g disodium hydrogen phosphate,anhydrous, stirring and dissolving, measure 30ml benzyl alcohol and join stirring and dissolving in solution, survey mixed system pH=8.42, take again 12g sodium tetradecyl sulfate join in above-mentioned medicinal liquid stir make dispersion, regulate medicinal liquid pH to 7.57 with 5.2ml sodium dihydrogen phosphate (0.5mol/l).With water for injection, above-mentioned medicinal liquid is settled to 1000ml, repetition measurement pH value 7.64.Filter, fill and get final product.
Embodiment 2
Measure 700ml water for injection, add 9g disodium hydrogen phosphate,anhydrous, stirring and dissolving, measure 50ml benzyl alcohol and join stirring and dissolving in solution, survey mixed system pH=8.77, then take 30g sodium tetradecyl sulfate and join in above-mentioned medicinal liquid to stir and make dispersion, regulate medicinal liquid pH to 7.54 with 5.3ml sodium hydroxide solution (1.0mol/l), with water for injection, above-mentioned medicinal liquid is settled to 1000ml, repetition measurement pH value 7.58.Filter, fill and get final product.
Embodiment 3
Measure 700ml water for injection, add 5g disodium hydrogen phosphate,anhydrous, stirring and dissolving, measure 30ml propylene glycol and join stirring and dissolving in solution, survey mixed system pH=8.51, take again 12g sodium tetradecyl sulfate join in above-mentioned medicinal liquid stir make dispersion, regulate medicinal liquid pH to 7.55 with 5.6ml sodium dihydrogen phosphate (0.5mol/l).With water for injection, above-mentioned medicinal liquid is settled to 1000ml, repetition measurement pH value 7.61.Filter, fill and get final product.
Embodiment 4
Measure 700ml water for injection, add 5g disodium hydrogen phosphate,anhydrous, stirring and dissolving, take 12g sodium tetradecyl sulfate and join dispersed with stirring in solution, measuring 30ml benzyl alcohol again joins in above-mentioned solution, survey mixed system pH=8.43, regulate medicinal liquid pH to 7.56 with 5.9ml sodium dihydrogen phosphate (0.6mol/l).With water for injection, above-mentioned medicinal liquid is settled to 1000ml, repetition measurement pH value 7.62.Filter, fill and get final product.
Embodiment 5
Measure 700ml water for injection, add 30ml benzyl alcohol, stirring and dissolving, take 12g sodium tetradecyl sulfate dispersed with stirring in above-mentioned solution, add 5g disodium hydrogen phosphate,anhydrous again to join in above-mentioned medicinal liquid and stir, survey mixed system pH=8.51, regulate medicinal liquid pH to 7.55 with 3.5ml sodium dihydrogen phosphate (1.0mol/l).With water for injection, above-mentioned medicinal liquid is settled to 1000ml, repetition measurement pH value 7.58.Filter, fill and get final product.
Embodiment 6
Measure 700ml water for injection, add 12g sodium tetradecyl sulfate, dispersed with stirring, take 5g disodium hydrogen phosphate,anhydrous stirring and dissolving in above-mentioned solution, measure 20ml benzyl alcohol again to join in above-mentioned medicinal liquid and stir, survey mixed system pH=8.49, regulate medicinal liquid pH to 7.54 with 4.7ml sodium dihydrogen phosphate (0.8mol/l).With water for injection, above-mentioned medicinal liquid is settled to 1000ml, repetition measurement pH value 7.57.Filter, fill and get final product.
Embodiment 7
Measure 700ml water for injection, add 12g sodium tetradecyl sulfate, dispersed with stirring, measure 30ml benzyl alcohol stirring and dissolving in above-mentioned solution, take 5g disodium hydrogen phosphate,anhydrous again to join in above-mentioned medicinal liquid and stir, survey mixed system pH=8.44, regulate medicinal liquid pH to 7.55 with 5.7ml sodium dihydrogen phosphate (0.6mol/l).With water for injection, above-mentioned medicinal liquid is settled to 1000ml, repetition measurement pH value 7.61.Filter, fill and get final product.
Effect example 1
Particle size determination is carried out to the product prepared in above-described embodiment and comparative example, sample drop is added on copper mesh, dry, observe under transmission electron microscope (model: JEM-2010HT), draw scale determination sample particle diameter; And carry out pH and the inspection of sodium tetradecyl sulfate content according under BP2013 version sodium tetradecyl sulfate injection item, the results are shown in Table 1.
Product cut size, content and pH check result in table 1 embodiment 1,2 and embodiment 3 ~ 5
| Sample | Particle diameter (nm) | Content (%) | pH |
| To greatest extent | 10～100 | 95.0～105.0 | 7.5～7.9 |
| Embodiment 1 | 64.3 | 101.2 | 7.64 |
| Embodiment 2 | 81.5 | 99.6 | 7.58 |
| Embodiment 3 | 601.2 | 68.4 | 7.61 |
| Embodiment 4 | 186.5 | 83.5 | 7.62 |
| Embodiment 5 | 73.5 | 99.4 | 7.58 |
| Embodiment 6 | 221.9 | 72.5 | 7.57 |
| Embodiment 7 | 230.5 | 76.7 | 7.61 |
Content in table 1 is the sodium tetradecyl sulfate content in injection.
Result shows: the product content of embodiment 1 and 2 and embodiment 5 meets States Pharmacopoeia specifications.And embodiment 3,2,4,5 content detection result is all lower than standards of pharmacopoeia.
Above-mentioned content is a normal phenomenon more than 100%, and pharmacopeia all allows more than 100% the requirement of various content of drug, and this product requires to be 95.0 ~ 105.0%.
Effect example 2
The product of Example 1 and 2 and embodiment 5 carries out temperatures involved factorial experiments.Experimental technique: sample is put 60 DEG C and place pick test after 0 day, 5 days and 10 days, detect according under BP2013 version sodium tetradecyl sulfate injection item, detect sodium tetradecyl sulfate content and pH value.
The temperatures involved factorial experiments result of the product of table 2 embodiment 1,2 and embodiment 5
Content in table 2 is the sodium tetradecyl sulfate content in injection.
Result shows: product equal conformance with standard of content 0 day time of embodiment 1, embodiment 2 and embodiment 5, and embodiment 5 is through the setting-out of 10 days temperatures involved factors, 2013 years version regulations that content is starkly lower than " British Pharmacopoeia ".The product of embodiment 1 and 2, places 10 days testing results still conformance with standard, illustrates that stability is higher under high temperature (60 DEG C) condition.Embodiment 1 and 2 has finally prepared steady quality, reliably sodium tetradecyl sulfate injection.
Effect example 3
The product of embodiment 1, embodiment 3 and 5 is carried out Electronic Speculum sign.Concrete grammar: sample drop is added on copper mesh, under oven dry is placed in transmission electron microscope (model: JEM-2010HT), resolution is amplified to 0.5 μm, observes the concrete form of sodium tetradecyl sulfate microemulsion product before and after influence factor prepared in each example.Concrete outcome is shown in accompanying drawing 1 ~ 5.As can be seen from Fig. 1 ~ 5:
Visible in Fig. 1, there is a large amount of gathering in 0 day in the product setting-out of embodiment 3, do not form microemulsion, particle diameter is much larger than 100nm;
Visible in Fig. 2, the microemulsion uniform particle diameter of the product setting-out formation in 0 day of embodiment 1, is uniformly dispersed;
Visible in Fig. 3, product setting-out 0 day particle diameter of embodiment 5 meets microemulsion standard, disperses also comparatively homogeneous;
Visible in Fig. 4, the product temperatures involved factor setting-out of embodiment 1 is after 10 days, and microemulsion system still remains stable, is uniformly dispersed, and particle diameter is 40-80nm;
Visible in Fig. 5, the product temperatures involved factor setting-out of embodiment 5 is after 10 days, and product is assembled gradually, and particle diameter becomes large, is greater than 100nm, and microemulsion system is destroyed.
The result of the transmission electron microscope result similar embodiment 1 of the product of embodiments of the invention 2.The result of the transmission electron microscope result similar embodiment 5 of the product of embodiments of the invention 4,6,7.
Claims (10)
1. a sodium tetradecyl sulfate injection, is characterized in that, its composition of raw materials comprises following component: sodium hydrogen phosphate, sodium tetradecyl sulfate, benzyl alcohol, water and pH adjusting agent; PH=7.5 ~ 7.9 of described sodium tetradecyl sulfate injection.
2. sodium tetradecyl sulfate injection as claimed in claim 1, is characterized in that: its composition of raw materials is made up of following component: sodium hydrogen phosphate, sodium tetradecyl sulfate, benzyl alcohol, water and pH adjusting agent; PH=7.5 ~ 7.9 of described sodium tetradecyl sulfate injection.
3. sodium tetradecyl sulfate injection as claimed in claim 1 or 2, is characterized in that:
In described composition of raw materials, the quality of described benzyl alcohol accounts for 2% ~ 8% of described sodium tetradecyl sulfate injection gross mass;
And/or in described composition of raw materials, the quality of described sodium hydrogen phosphate accounts for 0.2% ~ 2% of described sodium tetradecyl sulfate injection gross mass;
And/or in described composition of raw materials, the quality of described sodium tetradecyl sulfate accounts for 0.5% ~ 5% of described sodium tetradecyl sulfate injection gross mass;
And/or in described composition of raw materials, the quality of described pH adjusting agent accounts for 0.01% ~ 0.08% of described sodium tetradecyl sulfate injection gross mass;
And/or in described composition of raw materials, described pH adjusting agent is sodium hydroxide and/or sodium dihydrogen phosphate;
And/or the water in described composition of raw materials is water for injection.
4. sodium tetradecyl sulfate injection as claimed in claim 3, is characterized in that:
In described composition of raw materials, the quality of described benzyl alcohol accounts for 3% ~ 6% of described sodium tetradecyl sulfate injection gross mass;
And/or in described composition of raw materials, the quality of described sodium hydrogen phosphate accounts for 0.4% ~ 0.9% of described sodium tetradecyl sulfate injection gross mass;
And/or in described composition of raw materials, the quality of described sodium tetradecyl sulfate accounts for 1% ~ 3% of described sodium tetradecyl sulfate injection gross mass;
And/or in described composition of raw materials, the quality of described pH adjusting agent accounts for 0.02% ~ 0.06% of described sodium tetradecyl sulfate injection gross mass.
5. the preparation method of the sodium tetradecyl sulfate injection according to any one of Claims 1 to 4, it is characterized in that, it comprises the steps: the mixed liquor of aqueous solution by the described sodium hydrogen phosphate of pH=8.4 ~ 8.8 and described benzyl alcohol, mix homogeneously with described sodium tetradecyl sulfate, add pH to 7.5 ~ 7.9 that described pH adjusting agent makes mixed system.
6. preparation method as claimed in claim 5, it is characterized in that: the preparation method of described sodium tetradecyl sulfate injection, described benzyl alcohol is also comprised the steps: to join in the aqueous solution of described sodium hydrogen phosphate, then described sodium tetradecyl sulfate is added, add pH to 7.5 ~ 7.9 that described pH adjusting agent makes mixed system again.
7. preparation method as claimed in claim 6, it is characterized in that: described benzyl alcohol is joined in the aqueous solution of described sodium hydrogen phosphate, then add described sodium tetradecyl sulfate and dispersed with stirring, then add pH to 7.5 ~ 7.9 that described pH adjusting agent makes mixed system.
8. preparation method as claimed in claim 7, it is characterized in that: described benzyl alcohol to be joined in the aqueous solution of described sodium hydrogen phosphate and stirring and dissolving, then add described sodium tetradecyl sulfate and dispersed with stirring, then add pH to 7.5 ~ 7.9 that described pH adjusting agent makes mixed system.
9. preparation method as claimed in claim 5, is characterized in that: described " making pH to 7.5 ~ 7.9 of mixed system " is for making pH to 7.5 ~ 7.7 of mixed system.
10. preparation method as claimed in claim 5, is characterized in that: the preparation method of described sodium tetradecyl sulfate injection, and what also comprise in the step of the step of standardize solution, the step of filtration and fill is one or more.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109646427A (en) * | 2019-01-28 | 2019-04-19 | 上海上药第生化药业有限公司 | Application of the sodium tetradecyl sulfate in the drug of preparation treatment hepar damnification |
| CN111467333A (en) * | 2019-01-23 | 2020-07-31 | 上海上药第一生化药业有限公司 | Application of tetradecyl sodium sulfate in preparation of medicine for treating hemangioma |
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| US2011208A (en) * | 1933-09-02 | 1935-08-13 | Cadwell A Williams | Adjustable yoke end |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111467333A (en) * | 2019-01-23 | 2020-07-31 | 上海上药第一生化药业有限公司 | Application of tetradecyl sodium sulfate in preparation of medicine for treating hemangioma |
| CN109646427A (en) * | 2019-01-28 | 2019-04-19 | 上海上药第生化药业有限公司 | Application of the sodium tetradecyl sulfate in the drug of preparation treatment hepar damnification |
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