CN111388498A - Spectinolincomycin hydrochloride soluble powder capable of being mutually dissolved with oil seedlings after being dissolved in water and preparation method thereof - Google Patents
Spectinolincomycin hydrochloride soluble powder capable of being mutually dissolved with oil seedlings after being dissolved in water and preparation method thereof Download PDFInfo
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- CN111388498A CN111388498A CN202010207013.1A CN202010207013A CN111388498A CN 111388498 A CN111388498 A CN 111388498A CN 202010207013 A CN202010207013 A CN 202010207013A CN 111388498 A CN111388498 A CN 111388498A
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- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
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- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Abstract
The invention discloses a soluble powder of spectinolincomycin hydrochloride which can be dissolved in water and then can be mutually dissolved with oil seedlings, belonging to the technical field of veterinary drug preparations. The composition of the spectinolincomycin hydrochloride soluble powder which can be mutually dissolved with oil seedlings after being dissolved in water is as follows: 40 parts of spectinomycin hydrochloride, 20 parts of lincomycin hydrochloride, 2-4 parts of emulsifier, 1.5-2.5 parts of dispersant, 5-10 parts of buffering agent, 0.5-1.0 part of stabilizer and 22.5-31 parts of auxiliary material. The soluble powder can be uniformly mixed with the oil seedlings without any oil seedling diluent after being dissolved in water; solves the problems of poor dissolving effect, low uniformity, low bioavailability, higher use cost and the like of the prior art which needs to be dissolved in the oil seedling diluent. The invention is convenient for the cultivation clinical operation and application on the basis of ensuring the quality and the curative effect of the products, and reduces the use cost.
Description
Technical Field
The invention belongs to the technical field of veterinary drug preparations, and particularly relates to spectinolincomycin hydrochloride soluble powder capable of being mutually dissolved with oil seedlings after being dissolved in water and a preparation method thereof.
Background
Lincomycin (lincomycin) belongs to lincomamide antibiotics and has strong antibacterial action on most of anaerobic bacteria and gram-positive bacteria. Spectinomycin (spectinomycin) belongs to aminoglycoside antibiotics, and has a detailed inhibitory effect on gram-positive bacteria, gram-negative bacteria and mycoplasma. The compound compatibility of the lincomycin hydrochloride and the spectinomycin hydrochloride has a synergistic effect, a wider antibacterial spectrum, a quick effect and small toxic and side effects, and the therapeutic dosage has no adverse effect on breeding animals such as chickens and pigs, and has good prevention and treatment effects on chronic respiratory diseases of chickens caused by mycoplasma and diarrhea and enteritis caused by escherichia coli.
At present, the compound formulations of lincomycin hydrochloride and spectinomycin hydrochloride comprise a premix, soluble powder and aqueous injection. The stability of the injection is poor after the injection is placed for a long time, the titer and the pH value of the spectinomycin hydrochloride in the injection are rapidly reduced, the injection is not beneficial to transportation, long-term storage and use, the soluble powder can be used as the injection after being diluted, and can also be directly taken by drinking water, so that the injection is widely applied to a breeding link, generally, the injection is uniformly mixed with oil seedlings and then is injected intramuscularly at the same time in the young stage of breeding animals, the effects of preventing and treating diseases are achieved, and the secondary stress to the animals is avoided.
The spectinomycin hydrochloride soluble powder used in the market at present is generally prepared by mixing spectinomycin hydrochloride and lincomycin hydrochloride, and when the spectinomycin hydrochloride soluble powder is used together with oil seedlings, the spectinomycin hydrochloride soluble powder needs to be dissolved in oil seedling diluent firstly and then is uniformly mixed with the oil seedlings for use, so that the spectinomycin hydrochloride soluble powder has the advantages of poor dissolving effect, low uniformity, low bioavailability and higher use cost of the oil seedling diluent, and causes a lot of inconvenience for clinical culture application. Therefore, the key point for preparing the spectinolincomycin hydrochloride soluble powder is how to remove the dependence on the oil seedling diluent and uniformly mix the oil seedling after dissolving the oil seedling in water.
Disclosure of Invention
The invention aims to provide a spectinomycin hydrochloride soluble powder which can be dissolved in water and is mutually soluble with oil seedlings and a preparation method thereof, and solves the problems that in the prior art, the water-soluble powder needs to be dissolved in oil seedling diluent, the dissolving effect is poor, the uniformity is low, the bioavailability is low, the use cost is high, and the like. The invention ensures the quality and curative effect of the products, is convenient for the cultivation clinical operation and application, and simultaneously reduces the use cost.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
a soluble spectinomycin hydrochloride powder which can be dissolved in water and is mutually soluble with oil seedlings is composed of spectinomycin hydrochloride, lincomycin hydrochloride, an emulsifier, a dispersant, a buffering agent and a stabilizer, and the components are composed of the following components in percentage by weight:
40 parts of spectinomycin hydrochloride, 20 parts of lincomycin hydrochloride, 2-4 parts of emulsifier, 1.5-2.5 parts of dispersant, 5-10 parts of buffering agent, 0.5-1.0 part of stabilizer and 22.5-31 parts of auxiliary material.
On the basis of the above-mentioned scheme,
the emulsifier is at least one of sodium dodecyl sulfate and poloxamer 188;
the dispersant is PVP-K30
The buffer is at least one of citric acid and disodium ethylene diamine tetraacetate;
the stabilizing agent is urea;
the auxiliary material is anhydrous glucose.
Preferably, the buffer is citric acid and disodium ethylene diamine tetraacetate, and the content is 4-8 parts and 1-2 parts respectively.
The preparation method of the spectinolincomycin hydrochloride soluble powder which can be dissolved in water and mutually dissolved with oil seedlings comprises the following steps:
mixing emulsifier and anhydrous glucose, pulverizing, sieving, and weighing; weighing spectinomycin hydrochloride, lincomycin hydrochloride, a dispersing agent, a buffering agent and a stabilizing agent, and uniformly mixing the weighed spectinomycin hydrochloride, lincomycin hydrochloride, dispersing agent, buffering agent and stabilizing agent with the crushed and sieved emulsifying agent and anhydrous glucose through a three-dimensional mixer to obtain the spectinomycin hydrochloride.
The technical scheme of the invention has the advantages
The inventor obtains the prescription and the preparation method of the invention through a large number of long-term drug formulation tests, clinical application practices and creative analysis summaries, and successfully realizes the aim that the oil seedlings can be uniformly mixed with the oil seedlings after being dissolved in water without the dependence of oil seedling diluent.
The soluble powder of the spectinolincomycin hydrochloride can be uniformly mixed with the oil seedlings without any oil seedling diluent after being dissolved in water. Solubility tests and oil seedling mixing tests show that the solubility (solubility, dissolution time and stability) of the soluble powder in water and the mixing (uniformity and stability) of the soluble powder with oil seedlings after dissolution are superior to those of similar products in the market, the problems of low bioavailability of spectinolincomycin hydrochloride and high combined use cost with the oil seedlings are solved, and the irritation of intramuscular injection to organisms is reduced. Stability tests (accelerated tests) show that the invention effectively improves the stability of the spectinomycin hydrochloride soluble powder. Clinical application shows that the invention can be effectively applied to the actual operation of chicken farms, reduces stress and use cost and greatly promotes the high-quality development of the breeding industry.
Detailed Description
Terms used in the present invention have generally meanings as commonly understood by one of ordinary skill in the art, unless otherwise specified.
The present invention will be described in further detail with reference to the following data in conjunction with specific examples. The following examples are intended to illustrate the invention and are not intended to limit the scope of the invention in any way.
The test methods used in the following examples are all conventional methods unless otherwise specified; the materials, reagents and the like used are, unless otherwise specified, commercially available reagents and materials. The percentage concentrations stated in the examples are weight/weight (W/W) percentage concentrations unless otherwise stated.
Example 1
The preparation method comprises the following steps:
1) uniformly mixing sodium dodecyl sulfate, poloxamer 188 and anhydrous glucose according to a formula proportion, then crushing, sieving by a No. five sieve, and weighing for later use;
2) weighing spectinomycin hydrochloride, lincomycin hydrochloride, PVP-K30, citric acid, disodium ethylene diamine tetraacetate and urea, and uniformly mixing the components in the step 1) by a three-dimensional mixer.
Example 2
The preparation method comprises the following steps:
1) uniformly mixing sodium dodecyl sulfate and anhydrous glucose according to a formula proportion, crushing, sieving by a five-mesh sieve, and weighing for later use;
2) weighing spectinomycin hydrochloride, lincomycin hydrochloride, PVP-K30, citric acid, disodium ethylene diamine tetraacetate and urea, and uniformly mixing the components in the step 1) by a three-dimensional mixer.
Example 3
The preparation method comprises the following steps:
1) uniformly mixing poloxamer 188 and anhydrous glucose according to a formula proportion, then crushing, sieving by a No. five sieve, and weighing for later use;
2) weighing spectinomycin hydrochloride, lincomycin hydrochloride, PVP-K30, citric acid, disodium ethylene diamine tetraacetate and urea, and uniformly mixing the components in the step 1) by a three-dimensional mixer.
Example 4
The preparation method comprises the following steps:
1) uniformly mixing sodium dodecyl sulfate, poloxamer 188 and anhydrous glucose according to a formula proportion, then crushing, sieving by a No. five sieve, and weighing for later use;
2) weighing spectinomycin hydrochloride, lincomycin hydrochloride, PVP-K30, citric acid, disodium ethylene diamine tetraacetate and urea, and uniformly mixing the components in the step 1) by a three-dimensional mixer.
Example 5
The preparation method comprises the following steps:
1) uniformly mixing poloxamer 188 and anhydrous glucose according to a formula proportion, then crushing, sieving by a No. five sieve, and weighing for later use;
2) weighing spectinomycin hydrochloride, lincomycin hydrochloride, PVP-K30, citric acid, disodium ethylene diamine tetraacetate and urea, and uniformly mixing the components in the step 1) by a three-dimensional mixer.
Example 6
Solubility, dissolution time and stability were observed after dissolving the spectinomycin hydrochloride soluble powder prepared as in example 1 in water.
The test method comprises the steps of weighing 10g of sample respectively, adding the sample into a beaker filled with 10m L, 20m L, 30m L, 40m L and 50m L deionized water (at the normal temperature of 25 ℃), continuously stirring the sample for 10s by using a glass rod, standing the sample, and observing whether the sample is dissolved, the time required by the dissolution, the pH value and the stability of the solution after the dissolution.
And (3) test results: the results of observations made after dissolving the spectinolincomycin hydrochloride soluble powder prepared as in example 1 in water are shown in the following table:
TABLE 1
Example 7
The soluble powder of spectinolincomycin hydrochloride prepared as in example 1 was dissolved in water and mixed with oil seedlings to observe the mutual solubility effect.
Comparison products: 3 formula samples commonly used in the market at present: control 1, control 2 and control 3.
The test method comprises the steps of weighing 10g of samples respectively, adding the samples into a beaker filled with 30m L deionized water (normal temperature is 25 ℃), continuously stirring the samples for 10s by using a glass rod, standing the samples, observing whether the samples are dissolved or not, the time required by the dissolution and the pH value of the solution after the dissolution, mixing 30m L spectinolincomycin hydrochloride solution and 250m L oil seedlings respectively after the dissolution, and standing the samples to observe whether layering or precipitation occurs or not.
And (3) test results: the test results of the mixing of the soluble powder of spectinomycin hydrochloride prepared as in example 1 with oil seedlings after dissolving in water are shown in the following table:
TABLE 2
Example 8
And (3) drug stability test: the method comprises the steps of preparing spectinolincomycin hydrochloride soluble powder samples according to examples 1-5, weighing 20 g of each sample, putting the weighed sample into a brown glass bottle, pressing the bottle to seal the bottle, placing the bottle into a drug stability test box to perform an accelerated test, adjusting the temperature to 40 +/-2 ℃ and the humidity to 75 +/-5% relative humidity, regularly observing the samples for 6 months, and sampling, detecting and inspecting items at the end of 0, 1, 3 and 6 months during the test period. The test results are shown in the following table.
TABLE 3
Example 9
Clinical application, the method is characterized in that a certain Liaoning broiler farm is subjected to clinical tests, 20 g of spectinomycin hydrochloride soluble powder is dissolved by adding 60 ml of normal saline when the broiler grows to 7 days old, then 1000m L of Newcastle disease avian influenza dual vaccine is added and uniformly mixed, neck injection is carried out according to the injection amount of 0.3 ml/feather, the reaction on broiler stimulation during administration is obviously reduced, the death and culling rate caused by stress is reduced by 0.48%, the diarrhea rate in the next day is reduced by 8.02%, and meanwhile, the use cost of diluent is saved, and the method is specifically shown in the following table.
TABLE 4
Claims (4)
1. The spectinomycin hydrochloride soluble powder capable of being mutually dissolved with oil seedlings after being dissolved in water is characterized by comprising the following components in parts by weight:
40 parts of spectinomycin hydrochloride, 20 parts of lincomycin hydrochloride, 2-4 parts of emulsifier, 1.5-2.5 parts of dispersant, 5-10 parts of buffering agent, 0.5-1.0 part of stabilizer and 22.5-31 parts of auxiliary material.
2. The soluble powder of spectinolincomycin hydrochloride that is miscible with oil seedlings after dissolving in water according to claim 1,
the emulsifier is one or two of sodium dodecyl sulfate or poloxamer 188;
the dispersant is PVP-K30;
the buffer is citric acid and disodium ethylene diamine tetraacetate;
the stabilizing agent is urea;
the auxiliary material is anhydrous glucose.
3. The soluble powder of spectinolincomycin hydrochloride dissolved in water and miscible with oil seedlings as claimed in claim 2, wherein the citric acid and disodium edetate are used in an amount of 4-8 parts and 1-2 parts, respectively.
4. The method for preparing the spectinolincomycin hydrochloride soluble powder which is soluble in water and then miscible with oil seedlings as claimed in any one of claims 1 to 3, comprising the steps of:
mixing emulsifier and anhydrous glucose, pulverizing, sieving, and weighing; weighing spectinomycin hydrochloride, lincomycin hydrochloride, a dispersing agent, a buffering agent and a stabilizing agent, and uniformly mixing the weighed spectinomycin hydrochloride, lincomycin hydrochloride, dispersing agent, buffering agent and stabilizing agent with the crushed and sieved emulsifying agent and anhydrous glucose through a three-dimensional mixer to obtain the spectinomycin hydrochloride.
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Cited By (2)
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| CN112043720A (en) * | 2020-09-24 | 2020-12-08 | 厦门惠盈动物药业有限公司 | Spectinomycin lincomycin soluble powder capable of being completely dissolved in various solvents and preparation method thereof |
| CN114748495A (en) * | 2022-05-18 | 2022-07-15 | 广东温氏大华农生物科技有限公司 | Oil-water-soluble veterinary linke grand scale compound preparation and preparation method and application thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114748495A (en) * | 2022-05-18 | 2022-07-15 | 广东温氏大华农生物科技有限公司 | Oil-water-soluble veterinary linke grand scale compound preparation and preparation method and application thereof |
| CN114748495B (en) * | 2022-05-18 | 2023-02-03 | 广东温氏大华农生物科技有限公司 | Oil-water double-soluble veterinary linke grand compound preparation and preparation method and application thereof |
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Denomination of invention: A soluble powder of spectinomycin hydrochloride that is soluble in water and soluble in oil seedlings, and its preparation method Effective date of registration: 20230705 Granted publication date: 20210316 Pledgee: Weihai commercial bank Limited by Share Ltd. Ji'nan branch Pledgor: SHANDONG SOOCOM ANIMAL REMEDY CO.,LTD. Registration number: Y2023980047468 |
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