CN114796108B - Tilmicosin solution and preparation method thereof - Google Patents
Tilmicosin solution and preparation method thereof Download PDFInfo
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- CN114796108B CN114796108B CN202210753943.6A CN202210753943A CN114796108B CN 114796108 B CN114796108 B CN 114796108B CN 202210753943 A CN202210753943 A CN 202210753943A CN 114796108 B CN114796108 B CN 114796108B
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- A—HUMAN NECESSITIES
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- 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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/61—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule the organic macromolecular compound being a polysaccharide or a derivative thereof
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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Abstract
The invention provides a tilmicosin solution and a preparation method thereof, and solves the technical problems that the quality guarantee storage and the subsequent use of a product are influenced by the inevitable layering of the existing tilmicosin solution during long-time storage. The tilmicosin solution is prepared from the following raw materials in parts by weight: 1-2 parts of hydroxypropyl methylcellulose, 0.1-0.2 part of raw material A, 8-12 parts of tilmicosin and a proper amount of purified water; wherein the viscosity of the hydroxypropyl methylcellulose is 3-2000 mPa.s; the raw material A is one of sodium alginate, alginic acid sulfate and sodium alginate polysaccharide diester; the invention also discloses a preparation method of the tilmicosin solution; can be widely applied to the technical field of pharmaceutical preparations.
Description
Technical Field
The application relates to the technical field of pharmaceutical preparations, in particular to a tilmicosin solution and a preparation method thereof.
Background
Since 2020, antibiotics are generally prohibited from being added into feed due to announcements issued by Ministry of agriculture, the use of antibiotics in large livestock farms is generally changed into drinking water administration. Tilmicosin is a semisynthetic macrolide antibiotic special for livestock, is generally prepared by tylosin semisynthesis, has a wide antibacterial spectrum, has an inhibiting effect on all gram-positive bacteria and part of gram-negative bacteria, mycoplasmas, spirochaetes and the like, is mainly used for treating infectious diseases of livestock such as cows, goats, sheep, cows, pigs, chickens and the like caused by sensitive bacteria, and particularly has a more obvious effect on treating respiratory tract infection of livestock. Because tilmicosin is extremely insoluble in water and has strong bitter taste, the palatability of the livestock is influenced, and the curative effect is influenced because the livestock does not like to take food in the drinking water administration process.
As is well known, the existing raw materials for preparing the tilmicosin solution use a mixing agent, a solubilizer, an emulsifier, a co-emulsifier, an oil phase substance and water, and the aim is to disperse the tilmicosin in the water to form an oil-in-water type micro-emulsion molecule so as to achieve the uniform and stable effect; meanwhile, a flavoring agent and a taste blocking agent are added to improve the palatability of the product. Although the prepared tilmicosin solution is an O/W type molecular microemulsion and has good water solubility, the tilmicosin solution is inevitably layered after being stored for a long time because water and oil cannot be mutually dissolved, and the quality guarantee storage and the subsequent use of the product are influenced. This problem is urgently solved.
Disclosure of Invention
The invention aims to solve the technical defects and provides a tilmicosin solution and a preparation method thereof, so that the quality-guaranteeing storage and the subsequent use of the tilmicosin solution are ensured.
Therefore, the invention provides a tilmicosin solution which is prepared from the following raw materials in parts by weight: 1-2 parts of hydroxypropyl methylcellulose, 0.1-0.2 part of raw material A, 8-12 parts of tilmicosin and a proper amount of purified water; wherein the viscosity of the hydroxypropyl methylcellulose is 3-2000 mPa.s; the raw material A is one of sodium alginate, alginic acid sulfate and sodium alginate polysaccharide diester.
Preferably, the tilmicosin solution is prepared from the following raw materials in parts by weight: 2 parts of hydroxypropyl methylcellulose, 0.2 part of sodium alginate, 10 parts of tilmicosin and a proper amount of purified water; wherein the viscosity of the hydroxypropyl methylcellulose is 3 mPa.s.
Preferably, the tilmicosin solution is prepared from the following raw materials in parts by weight: 2 parts of hydroxypropyl methylcellulose, 0.2 part of sodium alginate, 10 parts of tilmicosin and a proper amount of purified water; wherein the viscosity of the hydroxypropyl methylcellulose is 5 mPa.s.
The invention also provides a preparation method of the tilmicosin solution, which comprises the following steps:
s1, adding 1-2 parts of hydroxypropyl methylcellulose into a proper amount of purified water, and stirring at 55-65 ℃ until the hydroxypropyl methylcellulose is completely dissolved to obtain a solution A;
s2, taking 0.1-0.2 part of the raw material A, 8-12 parts of tilmicosin and a proper amount of purified water, and grinding a mixed solution until the mixed solution becomes uniform milky white liquid to prepare a solution B; the raw material A is one of sodium alginate, alginic acid sulfate and sodium alginate polysaccharide diester;
s3, carrying out mixed liquor grinding on the solution A prepared in the step S1 and the solution B prepared in the step S2, adding a proper amount of purified water in the liquid grinding process, and continuing to grind the mixed liquor until the solution is clear to obtain the tilmicosin solution.
Preferably, in step S1, the viscosity of hypromellose is 3 to 2000 mpa.s.
Preferably, in step S2, the raw material a is dissolved in an appropriate amount of purified water, and then tilmicosin is added to perform mixed solution milling.
Preferably, in step S2, the weight ratio of tilmicosin to purified water is 1: 1-1.75.
Preferably, in step S2, the temperature of the purified water is 20 to 40 ℃.
Preferably, in step S1, 1-2 g of hypromellose is taken; in step S2, taking 0.1-0.2 g of raw material A and 8-12 g of tilmicosin; in step S3, the solution B is added into the solution A to be mixed and milled, a proper amount of purified water is added in the liquid milling process until the mixed solution is 100ml, and the mixed solution milling is continued until the solution is clear.
The hydroxypropyl methylcellulose is used as a framework material and is combined with tilmicosin modified by sodium alginate to form a medicine-containing gel framework which is uniformly dispersed in water. The hydrophilic gel skeleton forms gel after contacting water, the release speed of the medicament tilmicosin is determined by the gradual corrosion speed of the gel layer, and the sodium alginate and the medicament are gathered together, so that the stability of the sodium alginate and the medicament in the skeleton material is improved.
The invention adopts a liquid mill to carry out liquid milling, and the liquid mill, namely a sand mill or a ball mill, is usually used for thinning materials and plays a role in crushing. The main effect of the process is to make the active medicinal ingredient tilmicosin enter the skeleton body by virtue of strong collision, friction and shearing action generated among materials during grinding, and uniformly disperse the tilmicosin in medium purified water.
The invention has the beneficial effects that: the invention provides a tilmicosin solution and a preparation method thereof, the process is simple, liquid milling equipment is adopted, hydroxypropyl methylcellulose is used as a hydrophilic framework material to prepare a framework drug, and sodium alginate is used for assisting the combination of the framework material and tilmicosin, so that the drug is uniformly dispersed in water to form a stable phase. The raw materials of the invention do not use oil phase, thus avoiding the layering condition when the product is added into drinking water in different proportions in the prior art; the preparation process of the invention does not adopt the mode of adding acid into soluble salt in the prior art to improve the solubility of the product, thereby avoiding the influence on the palatability caused by the stimulation of low pH value to the livestock, and the invention does not need to additionally add a flavoring agent. In addition, the requirement on water quality is not high, and the water can still keep stable in high-hardness water.
Detailed Description
In order to make the technical problems, technical solutions and advantageous effects to be solved by the present application clearer, the present application is further described in detail below with reference to the embodiments.
The following description is of the preferred embodiment of the present application and should not be taken as limiting the present application, but rather the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present application.
Example 1:
the invention provides a preparation method of a tilmicosin solution, which comprises the following steps:
s1, adding 2g of hydroxypropyl methylcellulose with the viscosity of 3 mPa.s into 10ml of purified water, and stirring at the temperature of 55-65 ℃ until the hydroxypropyl methylcellulose is completely dissolved to obtain a solution A;
s2, dissolving 0.2g of sodium alginate in 10ml of purified water at the temperature of 25 ℃, adding 10g of tilmicosin, and grinding the mixed solution until the mixed solution becomes uniform milky white liquid to obtain a solution B;
and S3, adding the solution B into the solution A, grinding the mixed solution, adding a proper amount of purified water in the liquid grinding process until the mixed solution is 100ml, and continuing grinding the mixed solution until the solution is clear to obtain the tilmicosin solution.
Example 2:
the invention provides a preparation method of tilmicosin solution, which comprises the following steps:
s1, adding 2g of hydroxypropyl methylcellulose with the viscosity of 3 mPa.s into 10ml of purified water, and stirring at the temperature of 55-65 ℃ until the hydroxypropyl methylcellulose is completely dissolved to obtain a solution A;
s2, dissolving 0.2g of alginic acid sulfate in 10ml of purified water at the temperature of 25 ℃, adding 10g of tilmicosin, and grinding the mixture until the mixture becomes uniform milky white liquid to obtain a solution B;
and S3, adding the solution B into the solution A, grinding the mixed solution, adding a proper amount of purified water in the liquid grinding process until the mixed solution is 100ml, and continuing grinding the mixed solution until the solution is clear to obtain the tilmicosin solution.
Example 3:
the invention provides a preparation method of tilmicosin solution, which comprises the following steps:
s1, adding 2g of hydroxypropyl methylcellulose with the viscosity of 3 mPa.s into 10ml of purified water, and stirring at the temperature of 55-65 ℃ until the hydroxypropyl methylcellulose is completely dissolved to obtain a solution A;
s2, dissolving 0.2g of brown algae polysaccharide diester sodium in 10ml of purified water with the temperature of 25 ℃, adding 10g of tilmicosin, and grinding the mixture until the mixture becomes uniform milky white liquid to obtain a solution B;
and S3, adding the solution B into the solution A, grinding the mixed solution, adding a proper amount of purified water in the liquid grinding process until the mixed solution is 100ml, and continuing grinding the mixed solution until the solution is clear to obtain the tilmicosin solution.
Example 4:
the invention provides a preparation method of tilmicosin solution, which comprises the following steps:
s1, adding 2g of hydroxypropyl methylcellulose with the viscosity of 5 mPa.s into 10ml of purified water, and stirring at the temperature of 55-65 ℃ until the hydroxypropyl methylcellulose is completely dissolved to obtain a solution A;
s2, dissolving 0.2g of sodium alginate in 10ml of purified water at the temperature of 25 ℃, adding 10g of tilmicosin, and grinding the mixed solution until the mixed solution becomes uniform milky white liquid to obtain a solution B;
and S3, adding the solution B into the solution A, grinding the mixed solution, adding a proper amount of purified water in the liquid grinding process until the mixed solution is 100ml, and continuing grinding the mixed solution until the solution is clear to obtain the tilmicosin solution.
Example 5:
the invention provides a preparation method of tilmicosin solution, which comprises the following steps:
s1, adding 2g of hydroxypropyl methylcellulose with the viscosity of 50 mPa.s into 10ml of purified water, and stirring at the temperature of 55-65 ℃ until the hydroxypropyl methylcellulose is completely dissolved to obtain a solution A;
s2, dissolving 0.2g of sodium alginate in 10ml of purified water at the temperature of 25 ℃, adding 10g of tilmicosin, and grinding the mixed solution until the mixed solution becomes uniform milky white liquid to obtain a solution B;
and S3, adding the solution B into the solution A to grind a mixed solution, adding a proper amount of purified water in the liquid grinding process until the mixed solution is 100ml, and continuing grinding the mixed solution until the solution is clear to obtain the tilmicosin solution.
Example 6:
the invention provides a preparation method of tilmicosin solution, which comprises the following steps:
s1, adding 2g of hydroxypropyl methylcellulose with the viscosity of 2000 mPa.s into 10ml of purified water, and stirring at the temperature of 55-65 ℃ until the hydroxypropyl methylcellulose is completely dissolved to obtain a solution A;
s2, dissolving 0.2g of sodium alginate in 10ml of purified water at the temperature of 25 ℃, adding 10g of tilmicosin, and grinding the mixed solution until the mixed solution becomes uniform milky white liquid to obtain a solution B;
and S3, adding the solution B into the solution A, grinding the mixed solution, adding a proper amount of purified water in the liquid grinding process until the mixed solution is 100ml, and continuing grinding the mixed solution until the solution is clear to obtain the tilmicosin solution.
Example 7:
the invention provides a preparation method of a tilmicosin solution, which comprises the following steps:
s1, adding 1g of hydroxypropyl methylcellulose with the viscosity of 3 mPa.s into 10ml of purified water, and stirring at the temperature of 55-65 ℃ until the hydroxypropyl methylcellulose is completely dissolved to obtain a solution A;
s2, dissolving 0.1g of sodium alginate in 17.5ml of purified water at the temperature of 40 ℃, adding 10g of tilmicosin, and grinding the mixed solution until the mixed solution becomes uniform milky white liquid to obtain a solution B;
and S3, adding the solution B into the solution A, grinding the mixed solution, adding a proper amount of purified water in the liquid grinding process until the mixed solution is 100ml, and continuing grinding the mixed solution until the solution is clear to obtain the tilmicosin solution.
Example 8:
the invention provides a preparation method of tilmicosin solution, which comprises the following steps:
s1, adding 1.5g of hydroxypropyl methylcellulose with the viscosity of 3 mPa.s into 10ml of purified water, and stirring at the temperature of 55-65 ℃ until the hydroxypropyl methylcellulose is completely dissolved to obtain a solution A;
s2, dissolving 0.15g of sodium alginate in 10ml of purified water at the temperature of 20 ℃, adding 10g of tilmicosin, and grinding the mixed solution until the mixed solution becomes uniform milky white liquid to obtain a solution B;
and S3, adding the solution B into the solution A, grinding the mixed solution, adding a proper amount of purified water in the liquid grinding process until the mixed solution is 100ml, and continuing grinding the mixed solution until the solution is clear to obtain the tilmicosin solution.
It should be noted that:
in the above examples 1 to 8, the weight ratio of tilmicosin to purified water in step S2 is preferably controlled to 1:1 to 1.75. In actual production, the weight ratio may be not limited to this, and the prepared solution B may be a uniform milky white liquid.
In the above embodiments 1 to 8, hypromellose of the present invention is used as a framework material, and is combined with tilmicosin modified by sodium alginate to form a drug-containing gel framework uniformly dispersed in water. The hydrophilic gel skeleton forms gel after meeting water, the release speed of the medicament tilmicosin is determined by the gradual erosion speed of the gel layer, and the sodium alginate and the medicament are gathered together, so that the stability of the medicament in the skeleton material is improved. The functions of the alginic acid sulfate, the fucoidan sodium diester and the sodium alginate are the same, and the alginic acid sulfate, the fucoidan sodium diester and the sodium alginate are gathered together with tilmicosin, so that the stability of the tilmicosin in a framework material of hydroxypropyl methylcellulose is improved.
Test subjects:
tilmicosin solutions obtained in examples 1 to 8;
comparative examples 1 and 2 are commercially available tilmicosin solutions.
Homogeneity test 1:
equal amounts of tilmicosin solutions obtained in examples 1 to 8, comparative example 1 and comparative example 2 were taken, and homogeneity was observed at 40 ± 2 ℃ and a relative humidity of 75%, and the test results are shown in table 1:
table 1: results of homogeneity test 1 for tilmicosin solution of examples and comparative examples
Homogeneity test 2:
the tilmicosin solution obtained in example 1 to example 8, the comparative example 1 and the comparative example 2 are respectively taken in equal amount, mixed into standard hard water according to the ratio of 1:500, kept stand at room temperature, the stability of the tilmicosin aqueous solution is observed, the content is detected at 10d, 20d and 30d, and the test results are shown in the following table 2:
table 2: results of homogeneity test 2 for tilmicosin solution of examples and comparative examples
Homogeneity test 3:
the tilmicosin solution obtained in example 1 to example 8, the comparative example 1 and the comparative example 2 are respectively taken in equal amount, mixed into standard hard water according to the ratio of 1:1000, kept at room temperature, the stability of the tilmicosin aqueous solution is observed, the content is detected at 10d, 20d and 30d, and the test results are shown in Table 3:
table 3: table of results of homogeneity test 3 for tilmicosin solutions of examples and comparative examples
As can be seen from tables 1-3, compared with the existing tilmicosin solution containing an oil phase substance, the tilmicosin solution prepared by the method has good stability, so that the quality guarantee storage and the subsequent use of the tilmicosin solution are ensured.
It should be noted that, in comparative example 2, the product is layered during the test, the effective component floats on the upper layer, and the situation is similar to the situation that water is mixed with oil, the oil phase carries the effective component, and the effective component floats on the water surface along with the oil phase after the product is layered after being placed, and then the upper layer content detected in tables 2 and 3 is higher than 100%.
The invention provides a tilmicosin solution and a preparation method thereof, the process is simple, liquid milling equipment is adopted, hydroxypropyl methylcellulose is used as a hydrophilic framework material to prepare a framework drug, and sodium alginate is used for assisting the combination of the framework material and tilmicosin, so that the drug is uniformly dispersed in water to form a stable phase. The raw materials of the invention do not use oil phase, thus avoiding the layering condition when the product is added into drinking water in different proportions in the prior art; the preparation process of the invention does not adopt the mode of adding acid into soluble salt in the prior art to improve the solubility of the product, thereby avoiding the influence on the palatability caused by the stimulation of low pH value to the livestock, and the invention does not need to additionally add a flavoring agent. In addition, the requirement on water quality is not high, and the water can still keep stable in high-hardness water.
The method used in the invention is a conventional method if no special provisions are made; the raw materials and the apparatus used were, unless otherwise specified, conventional commercially available products.
Claims (8)
1. The tilmicosin solution is characterized by being prepared from the following raw materials in parts by weight: 1-2 parts of hydroxypropyl methylcellulose, 0.1-0.2 part of raw material A, 8-12 parts of tilmicosin and a proper amount of purified water; wherein the viscosity of the hydroxypropyl methylcellulose is 3-2000 mPa & s; the raw material A is one of sodium alginate, alginic acid sulfate and sodium alginate polysaccharide diester.
2. The tilmicosin solution according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight: 2 parts of hydroxypropyl methylcellulose, 0.2 part of sodium alginate, 10 parts of tilmicosin and a proper amount of purified water; wherein the viscosity of the hypromellose is 3mPa · s.
3. The tilmicosin solution according to claim 1, which is prepared from the following raw materials in parts by weight: 2 parts of hydroxypropyl methylcellulose, 0.2 part of sodium alginate, 10 parts of tilmicosin and a proper amount of purified water; wherein the viscosity of the hydroxypropyl methylcellulose is 5mPa & s.
4. A preparation method of tilmicosin solution is characterized by comprising the following steps:
s1, adding 1-2 parts of hydroxypropyl methylcellulose into a proper amount of purified water, and stirring at 55-65 ℃ until the hydroxypropyl methylcellulose is completely dissolved to obtain a solution A, wherein the viscosity of the hydroxypropyl methylcellulose is 3-2000 mPa.s;
s2, taking 0.1-0.2 part of the raw material A, 8-12 parts of tilmicosin and a proper amount of purified water, and grinding a mixed solution until the mixed solution becomes uniform milky white liquid to prepare a solution B; the raw material A is one of sodium alginate, alginic acid sulfate and sodium alginate polysaccharide diester;
s3, carrying out mixed liquor grinding on the solution A prepared in the step S1 and the solution B prepared in the step S2, adding a proper amount of purified water in the liquid grinding process, and continuing to grind the mixed liquor until the solution is clear to obtain the tilmicosin solution.
5. The method of claim 4, wherein in step S2, the raw material A is dissolved in a proper amount of purified water, and then tilmicosin is added to the solution to perform the mixed solution milling.
6. The method according to claim 4, wherein in step S2, the weight ratio of tilmicosin to purified water is 1: 1-1.75.
7. The method of claim 4, wherein the purified water is at a temperature of 20 ℃ to 40 ℃ in step S2.
8. The method for preparing a tilmicosin solution according to claim 4, wherein in step S1, 1-2 g of hypromellose is taken; in step S2, taking 0.1-0.2 g of raw material A and 8-12 g of tilmicosin; in step S3, the solution B is added to the solution a to perform mixed solution milling, and a proper amount of purified water is added to the mixed solution a during the liquid milling process until the mixed solution is 100ml, and the mixed solution milling is continued until the solution is clear.
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