CN105147620A - Erythromycin thiocyanate soluble powder and preparation method thereof - Google Patents
Erythromycin thiocyanate soluble powder and preparation method thereof Download PDFInfo
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- CN105147620A CN105147620A CN201510712463.5A CN201510712463A CN105147620A CN 105147620 A CN105147620 A CN 105147620A CN 201510712463 A CN201510712463 A CN 201510712463A CN 105147620 A CN105147620 A CN 105147620A
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- erythromycin thiocyanate
- soluble powder
- erythromycin
- thiocyanate soluble
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Abstract
The invention provides erythromycin thiocyanate soluble powder and relates to the field of veterinary medicine. The erythromycin thiocyanate soluble powder is prepared from, by mass, 1%-20% of erythromycin thiocyanate, 2%-40% of sodium citrate, 1%-20% of citric acid, 1%-5% of sodium dihydrogen phosphate, and the balance auxiliary materials. The invention further provides a method for preparing the erythromycin thiocyanate soluble powder. The prepared erythromycin thiocyanate soluble powder is good in solubility in water, the solubility of the erythromycin thiocyanate soluble powder in water reaches 5 g/L (counting as erythromycin), and the solubility of the erythromycin thiocyanate soluble powder in water is greatly increased. A water solution obtained after the erythromycin thiocyanate soluble powder is dissolved in water is very stable at the temperature of 25 DEG C and under the light shielding condition, and the degradation amount after 4 h is smaller than 5%.
Description
Technical field
The present invention relates to veterinary field, particularly veterinary drug, be specifically related to a kind of erythromycin thiocyanate soluble powder and preparation method thereof.
Background technology
Erythromycin thiocyanate, mainly through drinking water administration, treats the infectious disease that birds is caused by gram positive bacteria and mycoplasma.The poorly water-soluble of erythromycin thiocyanate, the requirement preparing soluble powder cannot be met, often need to add cosolvent, but the cosolvent of acidity can cause the decomposition of erythromycin thiocyanate and limit it and use, and other cosolvents (as PEG etc.), solubilizing agent (as sodium lauryl sulphate etc.) are not obvious to its hydrotropy, solubilization.Erythromycin thiocyanate soluble powder dissolubility in water that usual method is made can only reach about 0.15g/L (in erythromycin), and dissolution velocity is comparatively slow, needs the Keep agitation long period, cause inconvenience to animals administer during dissolving.
During modern large-scale cultivation factory drinking water administration; often need soluble powder to dissolve to be mixed with concentrated solution; then administration after working concentration is diluted to by automatic water-drinking line; ten times or even decades of times of the drug level working concentration often of the concentrated solution of its preparation, the sustainable 1-4 hour of administration time.The dissolubility of erythromycin thiocyanate in water is low; its dissolubility in water is close to working concentration; administration is diluted through automatic water-drinking line after cannot being mixed with concentrated solution; therefore, modern large-scale cultivation industry is had higher requirement to the dissolubility of erythromycin thiocyanate soluble powder and the stability in concentrated solution.
Summary of the invention
The present invention aims to provide a kind of erythromycin thiocyanate soluble powder that dissolubility is good in water, stability is high and preparation method thereof, adapts to the administration requirements of modern cultivation automatic water-drinking line.
The present invention is the technical scheme realizing the employing of its object:
A kind of erythromycin thiocyanate soluble powder, described erythromycin thiocyanate soluble powder comprises following component: described component is to account for the mass percent of the erythromycin thiocyanate soluble powder of preparation, the erythromycin thiocyanate of 1-20%, the sodium citrate of 2-40%, the citric acid of 1-20%, the sodium dihydrogen phosphate of 1-5%, surplus is adjuvant.
Described erythromycin thiocyanate soluble powder comprises following component: described component is to account for the mass percent of the erythromycin thiocyanate soluble powder of preparation, the erythromycin thiocyanate of 5-10%, the sodium citrate of 12-25%, the citric acid of 2-7%, the sodium dihydrogen phosphate of 1.5-3%, surplus is adjuvant.
Described adjuvant is soluble starch, the mixture of one or more added in beneficial powder, maltodextrin, beta-schardinger dextrin-, xylitol.
The weight ratio of sodium citrate and erythromycin thiocyanate is (2-10): 1.
Prepare a method for erythromycin thiocyanate soluble powder, comprise the following steps:
A, raw material prepare: to account for the mass percent of the erythromycin thiocyanate soluble powder of preparation, and prepare the erythromycin thiocyanate of 1-20%, the sodium citrate of 10-40%, the citric acid of 1-20%, the sodium dihydrogen phosphate of 1-5%, surplus is adjuvant, for subsequent use;
The preparation of B, erythromycin thiocyanate soluble powder: the erythromycin thiocyanate that steps A prepares is added to the water, stir, then sodium citrate, citric acid, sodium dihydrogen phosphate is added successively, stir, obtain mixed aqueous solution, regulate the pH value of mixed aqueous solution to 4.5-6.0 with alkaline solution, then in mixed aqueous solution, add adjuvant, stir, spray-driedly namely obtain erythromycin thiocyanate soluble powder.
In rate-determining steps B, the concentration of erythromycin thiocyanate soluble powder in water is 1-50%.
Described alkaline solution is the NaOH solution of 10mol/L.
Beneficial effect of the present invention: the dissolubility of erythromycin thiocyanate soluble powder of the present invention in water is good, its dissolubility in water reaches 5g/L (in erythromycin), and its dissolubility in water improves greatly.Aqueous solution after erythromycin thiocyanate soluble powder is water-soluble 25 DEG C, lucifuge condition is highly stable, 4h degradation amount is less than 5%.
The effect of sodium citrate is hydrotropy effect, improve the dissolubility of erythromycin thiocyanate, citric acid also plays hydrotropy effect, the pH value of solution can be reduced simultaneously, further raising dissolubility, sodium dihydrogen phosphate works the cushioning effect keeping pH value, can keep the acidity of pH and the stability of pH simultaneously, thus improve the dissolubility of product in the finished product course of dissolution of ejection.
The consumption of sodium citrate, citric acid, sodium dihydrogen phosphate controls object and is to make erythromycin thiocyanate reach dissolving, and make gained solution obtain suitable pH value, for the adjustment of the pH value in later stage is prepared, the many meetings of consumption make the pH of solution reduce, thus cause difficulty to adjustment pH, solution ph too low (pH<4) can cause erythromycin thiocyanate decomposition failure in solution, the too high meeting of pH value causes the dissolubility of soluble powder to reduce, and the concentration after causing the erythromycin thiocyanate soluble powder of preparation water-soluble is low.
It is adjuvant that the present invention selects to add beneficial powder and beta-schardinger dextrin-etc., especially beneficial powder is added, provide safeguard for the later stage sprays into powder-type, selected adjuvant is adapted at stable in properties in spray-drying process, applicablely spray into soluble powder, and for later stage soluble powder dissolve make aqueous solution time dissolubility and stability provide safeguard, be adapted to modern cultivation completely, administration after automatic water-drinking line is diluted to working concentration, the sustainable 1-4 hour of administration time, still ensures the stability in the high-dissolvability of the erythromycin thiocyanate powder in aqueous solution and concentrated solution.
Detailed description of the invention
The present invention aims to provide a kind of erythromycin thiocyanate soluble powder that dissolubility is good in water, stability is high and preparation method thereof, and below in conjunction with specific embodiment, the present invention is further illustrated.
The preparation of embodiment 1:5% (in erythromycin) erythromycin thiocyanate soluble powder
25g erythromycin thiocyanate (in erythromycin 20g) is joined in 2L water, stir, add 50g sodium citrate, 10g citric acid and 8g sodium dihydrogen phosphate successively, stirring and dissolving, pH to 5.1 is regulated by the NaOH solution of 10mol/L, add 307g water soluble starch, spraying dry must about 400g erythromycin thiocyanate soluble powder, content 5% (in erythromycin).
Embodiment 2
31g erythromycin thiocyanate (in erythromycin 25g) is joined in 2.5L water, stir, add 75g sodium citrate, 25g citric acid and 7.5g sodium dihydrogen phosphate successively, stirring and dissolving, pH to 4.8 is regulated by the NaOH solution of 10mol/L, add 361.5g and add beneficial powder, spraying dry must about 500g erythromycin thiocyanate soluble powder, content 5% (in erythromycin).
Embodiment 3
25g erythromycin thiocyanate (in erythromycin 20g) is joined in 1.0L water, stir, add 75g sodium citrate, 28g citric acid and 12g sodium dihydrogen phosphate successively, stirring and dissolving, pH to 5.0 is regulated by the NaOH solution of 10mol/L, add 260g and add beneficial powder, spraying dry must about 400g erythromycin thiocyanate soluble powder, content 5% (in erythromycin).
Embodiment 4
13g erythromycin thiocyanate (in erythromycin 10g) is joined in 1.0L water, stir, add 52g sodium citrate, 20g citric acid and 5.4g sodium dihydrogen phosphate successively, stirring and dissolving, pH to 5.5 is regulated by the NaOH solution of 10mol/L, add 109.6g maltodextrin, spraying dry must about 200g erythromycin thiocyanate soluble powder, content 5% (in erythromycin).
Embodiment 5
18g erythromycin thiocyanate (in erythromycin 15g) is joined in 1.0L water, stir, add 90g sodium citrate, 45g citric acid and 13.5g sodium dihydrogen phosphate successively, stirring and dissolving, pH to 6.0 is regulated by the NaOH solution of 10mol/L, add 133.5g water soluble starch, spraying dry must about 300g erythromycin thiocyanate soluble powder, content 5% (in erythromycin).
Embodiment 6: dissolubility test
1. the erythromycin thiocyanate soluble powder 100g of preparation in Example 1, adds in 1L water, stirs 1min, dissolves clarification, and room temperature lucifuge places 30min, generates without precipitation.
2. the erythromycin thiocyanate soluble powder 100g of preparation in Example 2, adds in 1L water, stirs 1min, dissolves clarification, and room temperature lucifuge places 30min, generates without precipitation.
3. the erythromycin thiocyanate soluble powder 100g of preparation in Example 3, adds in 1L water, stirs 1min, dissolves clarification, and room temperature lucifuge places 30min, generates without precipitation.
4. the erythromycin thiocyanate soluble powder 100g of preparation in Example 4, adds in 1L water, stirs 1min, dissolves clarification, and room temperature lucifuge places 30min, generates without precipitation.
5. the erythromycin thiocyanate soluble powder 100g of preparation in Example 5, adds in 1L water, stirs 1min, dissolves clarification, and room temperature lucifuge places 30min, generates without precipitation.
6. contrast: erythromycin thiocyanate soluble powder erythromycin thiocyanate and water soluble starch being mixed and made into 5% (in erythromycin), get 10g and add in 1L water, stir 1min, muddy, place 30min, bottom adularescent precipitates.
Obviously, show that erythromycin thiocyanate soluble powder prepared by this technique has good dissolubility.
Embodiment 7: solution stability testing
1.-5. each erythromycin thiocyanate aqueous solution in Example 6, sample after just dissolving rear (0h) and room temperature lucifuge placement 4h, its content is detected according to erythromycin thiocyanate soluble powder quality standard (" Chinese veterinary pharmacopoeia version in 2010 "), just to dissolve the content of rear (0h) for 100%, calculate the relative amount after placing 4h, the results are shown in following table:
The stability of erythromycin thiocyanate soluble powder aqueous solution
Obviously, the degradation rate of erythromycin thiocyanate soluble powder of the present invention after 4 hours is only less than 3.2%, shows erythromycin thiocyanate soluble powder good stability of the present invention.
Claims (7)
1. an erythromycin thiocyanate soluble powder, it is characterized in that, described erythromycin thiocyanate soluble powder comprises following component: described component is to account for the mass percent of the erythromycin thiocyanate soluble powder of preparation, the erythromycin thiocyanate of 1-20%, the sodium citrate of 2-40%, the citric acid of 1-20%, the sodium dihydrogen phosphate of 1-5%, surplus is adjuvant.
2. a kind of erythromycin thiocyanate soluble powder according to claim 1, it is characterized in that, described erythromycin thiocyanate soluble powder comprises following component: described component is to account for the mass percent of the erythromycin thiocyanate soluble powder of preparation, the erythromycin thiocyanate of 5-10%, the sodium citrate of 12-25%, the citric acid of 2-7%, the sodium dihydrogen phosphate of 1.5-3%, surplus is adjuvant.
3. a kind of erythromycin thiocyanate soluble powder according to claim 1, is characterized in that, described adjuvant is soluble starch, the mixture of one or more added in beneficial powder, maltodextrin, beta-schardinger dextrin-, xylitol.
4. a kind of erythromycin thiocyanate soluble powder according to claim 1, is characterized in that, the weight ratio of sodium citrate and erythromycin thiocyanate is (2-10): 1.
5. prepare a method for erythromycin thiocyanate soluble powder as claimed in claim 1, it is characterized in that, comprise the following steps:
A, raw material prepare: to account for the mass percent of the erythromycin thiocyanate soluble powder of preparation, and prepare the erythromycin thiocyanate of 1-20%, the sodium citrate of 2-40%, the citric acid of 1-20%, the sodium dihydrogen phosphate of 1-5%, surplus is adjuvant, for subsequent use;
The preparation of B, erythromycin thiocyanate soluble powder: the erythromycin thiocyanate that steps A prepares is added to the water, stir, then sodium citrate, citric acid, sodium dihydrogen phosphate is added successively, stir, obtain mixed aqueous solution, regulate the pH value of mixed aqueous solution to 4.5-6.0 with alkaline solution, then in mixed aqueous solution, add adjuvant, stir, spray-driedly namely obtain erythromycin thiocyanate soluble powder.
6. a kind of method preparing erythromycin thiocyanate soluble powder according to claim 5, is characterized in that: in rate-determining steps B, and the concentration of erythromycin thiocyanate soluble powder in water is 1-50%.
7. a kind of method preparing erythromycin thiocyanate soluble powder according to claim 5, is characterized in that: described alkaline solution is the NaOH solution of 10mol/L.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106176613A (en) * | 2016-08-30 | 2016-12-07 | 瑞普（天津）生物药业有限公司 | A kind of slow release erythromycin thiocyanate soluble powder for animals and preparation method thereof |
| CN106389454A (en) * | 2016-08-30 | 2017-02-15 | 瑞普（天津）生物药业有限公司 | Compound erythromycin thiocyanate soluble powder for livestock and preparation method therefor |
| CN108324689A (en) * | 2018-02-27 | 2018-07-27 | 江西农业大学 | A kind of erythromycin thiocyanate soluble powder and preparation method thereof |
| CN108853024A (en) * | 2018-07-27 | 2018-11-23 | 洛阳瑞华动物保健品有限公司 | A kind of colistin sulphate soluble powder and preparation method thereof |
| CN113197862A (en) * | 2021-04-16 | 2021-08-03 | 山东亚康药业股份有限公司 | High-content erythromycin thiocyanate soluble powder and preparation method thereof |
| CN117338729A (en) * | 2023-12-06 | 2024-01-05 | 山东国邦药业有限公司 | Erythromycin thiocyanate soluble particles and preparation method thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106176613A (en) * | 2016-08-30 | 2016-12-07 | 瑞普（天津）生物药业有限公司 | A kind of slow release erythromycin thiocyanate soluble powder for animals and preparation method thereof |
| CN106389454A (en) * | 2016-08-30 | 2017-02-15 | 瑞普（天津）生物药业有限公司 | Compound erythromycin thiocyanate soluble powder for livestock and preparation method therefor |
| CN108324689A (en) * | 2018-02-27 | 2018-07-27 | 江西农业大学 | A kind of erythromycin thiocyanate soluble powder and preparation method thereof |
| CN108853024A (en) * | 2018-07-27 | 2018-11-23 | 洛阳瑞华动物保健品有限公司 | A kind of colistin sulphate soluble powder and preparation method thereof |
| CN113197862A (en) * | 2021-04-16 | 2021-08-03 | 山东亚康药业股份有限公司 | High-content erythromycin thiocyanate soluble powder and preparation method thereof |
| CN117338729A (en) * | 2023-12-06 | 2024-01-05 | 山东国邦药业有限公司 | Erythromycin thiocyanate soluble particles and preparation method thereof |
| CN117338729B (en) * | 2023-12-06 | 2024-02-13 | 山东国邦药业有限公司 | Erythromycin thiocyanate soluble particles and preparation method thereof |
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Denomination of invention: A soluble erythromycin thiocyanate powder and its preparation method Effective date of registration: 20230221 Granted publication date: 20180417 Pledgee: Bank of Hebei Co.,Ltd. Baoding Gaoyang Sub branch Pledgor: BAODING JIZHONG PHARMACEUTICAL Co.,Ltd. Registration number: Y2023980033071 |